TBD Meeting (4183-20)

Routinely collected clinical data help identify men with high-risk prostate cancer most likely to benefit from a gallium-68 prostate-specific membrane antigen (PSMA) PET/CT scan, according to a study reported at the American Society for Radiation Oncology Annual Meeting 2020.

Courtesy of University of California Los Angeles

“PSMA PET/CT is a novel molecular and functional imaging modality specific for prostate cancer cells that has good sensitivity and outstanding specificity in detecting metastasis,” noted study investigator T. Martin Ma, MD, PhD, of the University of California, Los Angeles.

The proPSMA trial, published in The Lancet earlier this year, found PSMA PET/CT to be superior to conventional imaging for primary staging of high-risk prostate cancer.

“These findings carry significant clinical implications and can affect treatment decision-making,” Dr. Ma noted.

With the current study, Dr. Ma and colleagues set out to assess the impact of PSMA PET/CT in nodal and metastatic upstaging in patients with high-risk prostate cancer and explore predictors of upstaging.

The researchers conducted a post hoc analysis of a single-center, prospective study of 262 patients with high-risk prostate cancer (cN1 or cN0 on conventional imaging) undergoing primary staging. Patients who had received 3 or more months of androgen deprivation therapy before their scan were excluded.
 

Study results

PSMA PET/CT led to nodal upstaging – from N0 to N1 – in 19.7% of patients and metastasis upstaging – from M0 to M1a, b, or c – in 9.4%.

“It is worth pointing out that the percentage of upstaging at the PSMA scan in our study is very similar to that in the proPSMA study,” Dr. Ma noted, with that trial finding nodal upstaging in 18% of patients and metastasis upstaging in 8%.

In multivariate analysis, independent predictors of nodal upstaging with PSMA PET/CT were higher percentage of positive cores at biopsy (odds ratio per decile, 1.21; P = .001) and higher Gleason grade (OR, 1.61; P = .025).

Similarly, independent predictors of metastasis upstaging were higher percentage of positive cores at biopsy (OR per decile, 1.19; P = .013) and higher Gleason grade (OR, 2.13; P = .024).

Other factors – clinical T stage and N stage, initial prostate-specific antigen level, and presence of two or more high-risk features – did not independently predict these outcomes.

When various combinations were assessed, the incidence of nodal upstaging was highest for patients who had a Gleason grade of 4 or 5 plus at least 50% positive cores (27.5% vs. 13.1% among all others). Similarly, incidence of metastasis upstaging was highest for those who had a Gleason grade of 5 plus at least 50% positive cores (20.6% vs. 5.9% among all others).

“Patients with percent-positive cores of 50% or more and Gleason grade group 4 or 5 will benefit the most from a PSMA PET/CT scan,” Dr. Ma concluded. “Future studies should validate the importance of these factors and identify whether changing treatment leads to improved outcomes.”

“The beauty of percent-positive cores is that it is an objective and routinely available piece of clinical information from systematic biopsy,” he added. “It may aid in the selection of patients in resource-limited settings and consideration of treatment intensification. We may also consider incorporation of percent positive cores into clinical risk stratification schemes for clinical use.”
 

A game changer

“PSMA PET has been a real game changer in high-risk prostate cancer and has implications in the various stages of prostate cancer management from diagnosis and staging to theranostics,” said Renu Eapen, MBBS, of Peter MacCallum Cancer Centre in Melbourne, who was not involved in this study.

“PSMA PET/CT has challenged conventional imaging in staging before curative intent surgery or radiotherapy,” Dr. Eapen added.

Accuracy of PSMA PET/CT was 27% higher than that of conventional imaging in the proPSMA trial, she noted in an interview. This superior accuracy can ultimately have management impact, while the imaging has additional benefits of lower radiation dose and reproducibility with high reporter agreement, potentially making it a “one-stop-shop” scan.

“This prospective study by Ma et al. is a great adjunct to the proPSMA results, with the aims of further stratifying patients who are likely to be upstaged on PSMA PET/CT,” Dr. Eapen said. “As the availability of PSMA PET/CT increases and more centers adopt this technology, we need studies like these to risk-stratify patients and select those who would benefit.”

The study did not receive any specific funding. Dr. Ma and Dr. Eapen disclosed no conflicts of interest.

SOURCE: Ma TM et al. ASTRO 2020, Abstract 58.

Routinely collected clinical data help identify men with high-risk prostate cancer most likely to benefit from a gallium-68 prostate-specific membrane antigen (PSMA) PET/CT scan, according to a study reported at the American Society for Radiation Oncology Annual Meeting 2020.

Courtesy of University of California Los Angeles

“PSMA PET/CT is a novel molecular and functional imaging modality specific for prostate cancer cells that has good sensitivity and outstanding specificity in detecting metastasis,” noted study investigator T. Martin Ma, MD, PhD, of the University of California, Los Angeles.

The proPSMA trial, published in The Lancet earlier this year, found PSMA PET/CT to be superior to conventional imaging for primary staging of high-risk prostate cancer.

“These findings carry significant clinical implications and can affect treatment decision-making,” Dr. Ma noted.

With the current study, Dr. Ma and colleagues set out to assess the impact of PSMA PET/CT in nodal and metastatic upstaging in patients with high-risk prostate cancer and explore predictors of upstaging.

The researchers conducted a post hoc analysis of a single-center, prospective study of 262 patients with high-risk prostate cancer (cN1 or cN0 on conventional imaging) undergoing primary staging. Patients who had received 3 or more months of androgen deprivation therapy before their scan were excluded.
 

Study results

PSMA PET/CT led to nodal upstaging – from N0 to N1 – in 19.7% of patients and metastasis upstaging – from M0 to M1a, b, or c – in 9.4%.

“It is worth pointing out that the percentage of upstaging at the PSMA scan in our study is very similar to that in the proPSMA study,” Dr. Ma noted, with that trial finding nodal upstaging in 18% of patients and metastasis upstaging in 8%.

In multivariate analysis, independent predictors of nodal upstaging with PSMA PET/CT were higher percentage of positive cores at biopsy (odds ratio per decile, 1.21; P = .001) and higher Gleason grade (OR, 1.61; P = .025).

Similarly, independent predictors of metastasis upstaging were higher percentage of positive cores at biopsy (OR per decile, 1.19; P = .013) and higher Gleason grade (OR, 2.13; P = .024).

Other factors – clinical T stage and N stage, initial prostate-specific antigen level, and presence of two or more high-risk features – did not independently predict these outcomes.

When various combinations were assessed, the incidence of nodal upstaging was highest for patients who had a Gleason grade of 4 or 5 plus at least 50% positive cores (27.5% vs. 13.1% among all others). Similarly, incidence of metastasis upstaging was highest for those who had a Gleason grade of 5 plus at least 50% positive cores (20.6% vs. 5.9% among all others).

“Patients with percent-positive cores of 50% or more and Gleason grade group 4 or 5 will benefit the most from a PSMA PET/CT scan,” Dr. Ma concluded. “Future studies should validate the importance of these factors and identify whether changing treatment leads to improved outcomes.”

“The beauty of percent-positive cores is that it is an objective and routinely available piece of clinical information from systematic biopsy,” he added. “It may aid in the selection of patients in resource-limited settings and consideration of treatment intensification. We may also consider incorporation of percent positive cores into clinical risk stratification schemes for clinical use.”
 

A game changer

“PSMA PET has been a real game changer in high-risk prostate cancer and has implications in the various stages of prostate cancer management from diagnosis and staging to theranostics,” said Renu Eapen, MBBS, of Peter MacCallum Cancer Centre in Melbourne, who was not involved in this study.

“PSMA PET/CT has challenged conventional imaging in staging before curative intent surgery or radiotherapy,” Dr. Eapen added.

Accuracy of PSMA PET/CT was 27% higher than that of conventional imaging in the proPSMA trial, she noted in an interview. This superior accuracy can ultimately have management impact, while the imaging has additional benefits of lower radiation dose and reproducibility with high reporter agreement, potentially making it a “one-stop-shop” scan.

“This prospective study by Ma et al. is a great adjunct to the proPSMA results, with the aims of further stratifying patients who are likely to be upstaged on PSMA PET/CT,” Dr. Eapen said. “As the availability of PSMA PET/CT increases and more centers adopt this technology, we need studies like these to risk-stratify patients and select those who would benefit.”

The study did not receive any specific funding. Dr. Ma and Dr. Eapen disclosed no conflicts of interest.

SOURCE: Ma TM et al. ASTRO 2020, Abstract 58.

Routinely collected clinical data help identify men with high-risk prostate cancer most likely to benefit from a gallium-68 prostate-specific membrane antigen (PSMA) PET/CT scan, according to a study reported at the American Society for Radiation Oncology Annual Meeting 2020.

Courtesy of University of California Los Angeles

“PSMA PET/CT is a novel molecular and functional imaging modality specific for prostate cancer cells that has good sensitivity and outstanding specificity in detecting metastasis,” noted study investigator T. Martin Ma, MD, PhD, of the University of California, Los Angeles.

The proPSMA trial, published in The Lancet earlier this year, found PSMA PET/CT to be superior to conventional imaging for primary staging of high-risk prostate cancer.

“These findings carry significant clinical implications and can affect treatment decision-making,” Dr. Ma noted.

With the current study, Dr. Ma and colleagues set out to assess the impact of PSMA PET/CT in nodal and metastatic upstaging in patients with high-risk prostate cancer and explore predictors of upstaging.

The researchers conducted a post hoc analysis of a single-center, prospective study of 262 patients with high-risk prostate cancer (cN1 or cN0 on conventional imaging) undergoing primary staging. Patients who had received 3 or more months of androgen deprivation therapy before their scan were excluded.
 

Study results

PSMA PET/CT led to nodal upstaging – from N0 to N1 – in 19.7% of patients and metastasis upstaging – from M0 to M1a, b, or c – in 9.4%.

“It is worth pointing out that the percentage of upstaging at the PSMA scan in our study is very similar to that in the proPSMA study,” Dr. Ma noted, with that trial finding nodal upstaging in 18% of patients and metastasis upstaging in 8%.

In multivariate analysis, independent predictors of nodal upstaging with PSMA PET/CT were higher percentage of positive cores at biopsy (odds ratio per decile, 1.21; P = .001) and higher Gleason grade (OR, 1.61; P = .025).

Similarly, independent predictors of metastasis upstaging were higher percentage of positive cores at biopsy (OR per decile, 1.19; P = .013) and higher Gleason grade (OR, 2.13; P = .024).

Other factors – clinical T stage and N stage, initial prostate-specific antigen level, and presence of two or more high-risk features – did not independently predict these outcomes.

When various combinations were assessed, the incidence of nodal upstaging was highest for patients who had a Gleason grade of 4 or 5 plus at least 50% positive cores (27.5% vs. 13.1% among all others). Similarly, incidence of metastasis upstaging was highest for those who had a Gleason grade of 5 plus at least 50% positive cores (20.6% vs. 5.9% among all others).

“Patients with percent-positive cores of 50% or more and Gleason grade group 4 or 5 will benefit the most from a PSMA PET/CT scan,” Dr. Ma concluded. “Future studies should validate the importance of these factors and identify whether changing treatment leads to improved outcomes.”

“The beauty of percent-positive cores is that it is an objective and routinely available piece of clinical information from systematic biopsy,” he added. “It may aid in the selection of patients in resource-limited settings and consideration of treatment intensification. We may also consider incorporation of percent positive cores into clinical risk stratification schemes for clinical use.”
 

A game changer

“PSMA PET has been a real game changer in high-risk prostate cancer and has implications in the various stages of prostate cancer management from diagnosis and staging to theranostics,” said Renu Eapen, MBBS, of Peter MacCallum Cancer Centre in Melbourne, who was not involved in this study.

“PSMA PET/CT has challenged conventional imaging in staging before curative intent surgery or radiotherapy,” Dr. Eapen added.

Accuracy of PSMA PET/CT was 27% higher than that of conventional imaging in the proPSMA trial, she noted in an interview. This superior accuracy can ultimately have management impact, while the imaging has additional benefits of lower radiation dose and reproducibility with high reporter agreement, potentially making it a “one-stop-shop” scan.

“This prospective study by Ma et al. is a great adjunct to the proPSMA results, with the aims of further stratifying patients who are likely to be upstaged on PSMA PET/CT,” Dr. Eapen said. “As the availability of PSMA PET/CT increases and more centers adopt this technology, we need studies like these to risk-stratify patients and select those who would benefit.”

The study did not receive any specific funding. Dr. Ma and Dr. Eapen disclosed no conflicts of interest.

SOURCE: Ma TM et al. ASTRO 2020, Abstract 58.

Treating lung cancer with proton beam radiotherapy instead of conventional photon radiotherapy almost halves the dose to the heart, reducing the risk of cardiovascular events over the next several years, a cohort study suggests.

Photo courtesy of Dr. Tris Arscott

The findings were reported at the American Society for Radiation Oncology Annual Meeting 2020.

Patients with lung cancer often have underlying cardiac risk factors, noted lead investigator Timothy Kegelman, MD, PhD, of University of Pennsylvania in Philadelphia.

“The dose to the heart correlates with adverse cardiovascular events following radiation therapy. One strategy to minimize dose to the heart is proton beam radiation,” Dr. Kegelman said.

He and his colleagues retrospectively studied consecutive patients with locally advanced non–small cell lung cancer (NSCLC) treated with chemotherapy plus either proton beam radiotherapy or conventional photon radiotherapy.

The team used electronic health records to ascertain incidence of six cardiovascular events: MI, atrial fibrillation, coronary artery disease, heart failure, stroke, and transient ischemic attack. Patients who had previously experienced an event were not considered as part of the at-risk population for that specific event after radiotherapy.

Analyses were based on 98 patients who received proton beam radiotherapy and 104 patients who received conventional photon radiotherapy.

At baseline, the proton cohort was older, had a heavier smoking history, and had a higher prevalence of previous cardiovascular events (46.9% vs. 31.7%; P = .03).

The total median radiation dose was identical for the proton and photon groups (66.6 Gy), but the former group had significantly lower measures of cardiac radiation dose, including roughly half the mean dose to the heart (6.9 vs. 13.3 Gy).
 

Outcomes and next steps

At a median follow-up of 29 months, the proton beam radiotherapy group had a significantly lower incidence of transient ischemic attack, compared with the photon radiotherapy group (1.1% vs. 8.2%; P = .04).

The proton group also had numerically lower incidences of MI (2.3% vs. 9.0%; P = .06) and stroke (3.2% vs. 6.1%; P = .50).

The proton and photon groups were similar as far as the incidence of total cardiovascular events (53.1% vs. 47.1%; P = .48) and the 3-year overall survival rate (38.8% vs. 42.1%; P = .99).

“Our future studies aim to examine the potential relationships between grade of cardiac event and type of radiotherapy and dose to cardiac substructures,” Dr. Kegelman commented.

In addition, his institution is participating in RTOG 1308, a phase 3 trial comparing photon and proton beam radiotherapy in patients with inoperable lung cancer that will better assess cardiac-related morbidity and mortality. The trial is expected to be completed by the end of 2025.
 

Accumulating evidence

“This study adds to a growing body of evidence about the potential importance of heart dose in any radiation modality,” said Daniel Gomez, MD, MBA, of Memorial Sloan Kettering Cancer Center in New York, who was not involved in the study.

The RTOG 0617 trial and the Lung ART trial previously showed correlations between lower radiation dose to the heart and better survival in patients with lung cancer, Dr. Gomez noted.

“It’s been well established that protons can improve heart dose, and therefore it’s been inferred that they may improve outcomes, but the exact mechanisms remain unclear,” Dr. Gomez said.

Proton beam radiotherapy performed well in a single-arm, phase 2 trial among patients with unresectable NSCLC.

“The ongoing phase 3 trial is using a more modern proton technique and has a larger population, with a randomized study design. It will be much more informative,” Dr. Gomez predicted.

The current study did not receive specific funding. Dr. Kegelman disclosed no relevant conflicts of interest. Dr. Gomez disclosed honoraria from Varian.

SOURCE: Kegelman TP et al. ASTRO 2020, Abstract 1046.

Treating lung cancer with proton beam radiotherapy instead of conventional photon radiotherapy almost halves the dose to the heart, reducing the risk of cardiovascular events over the next several years, a cohort study suggests.

Photo courtesy of Dr. Tris Arscott

The findings were reported at the American Society for Radiation Oncology Annual Meeting 2020.

Patients with lung cancer often have underlying cardiac risk factors, noted lead investigator Timothy Kegelman, MD, PhD, of University of Pennsylvania in Philadelphia.

“The dose to the heart correlates with adverse cardiovascular events following radiation therapy. One strategy to minimize dose to the heart is proton beam radiation,” Dr. Kegelman said.

He and his colleagues retrospectively studied consecutive patients with locally advanced non–small cell lung cancer (NSCLC) treated with chemotherapy plus either proton beam radiotherapy or conventional photon radiotherapy.

The team used electronic health records to ascertain incidence of six cardiovascular events: MI, atrial fibrillation, coronary artery disease, heart failure, stroke, and transient ischemic attack. Patients who had previously experienced an event were not considered as part of the at-risk population for that specific event after radiotherapy.

Analyses were based on 98 patients who received proton beam radiotherapy and 104 patients who received conventional photon radiotherapy.

At baseline, the proton cohort was older, had a heavier smoking history, and had a higher prevalence of previous cardiovascular events (46.9% vs. 31.7%; P = .03).

The total median radiation dose was identical for the proton and photon groups (66.6 Gy), but the former group had significantly lower measures of cardiac radiation dose, including roughly half the mean dose to the heart (6.9 vs. 13.3 Gy).
 

Outcomes and next steps

At a median follow-up of 29 months, the proton beam radiotherapy group had a significantly lower incidence of transient ischemic attack, compared with the photon radiotherapy group (1.1% vs. 8.2%; P = .04).

The proton group also had numerically lower incidences of MI (2.3% vs. 9.0%; P = .06) and stroke (3.2% vs. 6.1%; P = .50).

The proton and photon groups were similar as far as the incidence of total cardiovascular events (53.1% vs. 47.1%; P = .48) and the 3-year overall survival rate (38.8% vs. 42.1%; P = .99).

“Our future studies aim to examine the potential relationships between grade of cardiac event and type of radiotherapy and dose to cardiac substructures,” Dr. Kegelman commented.

In addition, his institution is participating in RTOG 1308, a phase 3 trial comparing photon and proton beam radiotherapy in patients with inoperable lung cancer that will better assess cardiac-related morbidity and mortality. The trial is expected to be completed by the end of 2025.
 

Accumulating evidence

“This study adds to a growing body of evidence about the potential importance of heart dose in any radiation modality,” said Daniel Gomez, MD, MBA, of Memorial Sloan Kettering Cancer Center in New York, who was not involved in the study.

The RTOG 0617 trial and the Lung ART trial previously showed correlations between lower radiation dose to the heart and better survival in patients with lung cancer, Dr. Gomez noted.

“It’s been well established that protons can improve heart dose, and therefore it’s been inferred that they may improve outcomes, but the exact mechanisms remain unclear,” Dr. Gomez said.

Proton beam radiotherapy performed well in a single-arm, phase 2 trial among patients with unresectable NSCLC.

“The ongoing phase 3 trial is using a more modern proton technique and has a larger population, with a randomized study design. It will be much more informative,” Dr. Gomez predicted.

The current study did not receive specific funding. Dr. Kegelman disclosed no relevant conflicts of interest. Dr. Gomez disclosed honoraria from Varian.

SOURCE: Kegelman TP et al. ASTRO 2020, Abstract 1046.

Treating lung cancer with proton beam radiotherapy instead of conventional photon radiotherapy almost halves the dose to the heart, reducing the risk of cardiovascular events over the next several years, a cohort study suggests.

Photo courtesy of Dr. Tris Arscott

The findings were reported at the American Society for Radiation Oncology Annual Meeting 2020.

Patients with lung cancer often have underlying cardiac risk factors, noted lead investigator Timothy Kegelman, MD, PhD, of University of Pennsylvania in Philadelphia.

“The dose to the heart correlates with adverse cardiovascular events following radiation therapy. One strategy to minimize dose to the heart is proton beam radiation,” Dr. Kegelman said.

He and his colleagues retrospectively studied consecutive patients with locally advanced non–small cell lung cancer (NSCLC) treated with chemotherapy plus either proton beam radiotherapy or conventional photon radiotherapy.

The team used electronic health records to ascertain incidence of six cardiovascular events: MI, atrial fibrillation, coronary artery disease, heart failure, stroke, and transient ischemic attack. Patients who had previously experienced an event were not considered as part of the at-risk population for that specific event after radiotherapy.

Analyses were based on 98 patients who received proton beam radiotherapy and 104 patients who received conventional photon radiotherapy.

At baseline, the proton cohort was older, had a heavier smoking history, and had a higher prevalence of previous cardiovascular events (46.9% vs. 31.7%; P = .03).

The total median radiation dose was identical for the proton and photon groups (66.6 Gy), but the former group had significantly lower measures of cardiac radiation dose, including roughly half the mean dose to the heart (6.9 vs. 13.3 Gy).
 

Outcomes and next steps

At a median follow-up of 29 months, the proton beam radiotherapy group had a significantly lower incidence of transient ischemic attack, compared with the photon radiotherapy group (1.1% vs. 8.2%; P = .04).

The proton group also had numerically lower incidences of MI (2.3% vs. 9.0%; P = .06) and stroke (3.2% vs. 6.1%; P = .50).

The proton and photon groups were similar as far as the incidence of total cardiovascular events (53.1% vs. 47.1%; P = .48) and the 3-year overall survival rate (38.8% vs. 42.1%; P = .99).

“Our future studies aim to examine the potential relationships between grade of cardiac event and type of radiotherapy and dose to cardiac substructures,” Dr. Kegelman commented.

In addition, his institution is participating in RTOG 1308, a phase 3 trial comparing photon and proton beam radiotherapy in patients with inoperable lung cancer that will better assess cardiac-related morbidity and mortality. The trial is expected to be completed by the end of 2025.
 

Accumulating evidence

“This study adds to a growing body of evidence about the potential importance of heart dose in any radiation modality,” said Daniel Gomez, MD, MBA, of Memorial Sloan Kettering Cancer Center in New York, who was not involved in the study.

The RTOG 0617 trial and the Lung ART trial previously showed correlations between lower radiation dose to the heart and better survival in patients with lung cancer, Dr. Gomez noted.

“It’s been well established that protons can improve heart dose, and therefore it’s been inferred that they may improve outcomes, but the exact mechanisms remain unclear,” Dr. Gomez said.

Proton beam radiotherapy performed well in a single-arm, phase 2 trial among patients with unresectable NSCLC.

“The ongoing phase 3 trial is using a more modern proton technique and has a larger population, with a randomized study design. It will be much more informative,” Dr. Gomez predicted.

The current study did not receive specific funding. Dr. Kegelman disclosed no relevant conflicts of interest. Dr. Gomez disclosed honoraria from Varian.

SOURCE: Kegelman TP et al. ASTRO 2020, Abstract 1046.

The first study to suggest benefit from low-dose radiotherapy for severe COVID-19–induced pneumonia involved only 20 patients, but the results were so promising that two larger randomized trials are now underway.

“RESCUE-119 was a trial based on the hypothesis that low-dose radiation therapy may help eliminate the stormy cytokine release and unchecked edema in hospitalized COVID-19 patients,” said Mohammed Khan, MD, PhD, Winship Cancer Institute of Emory University, Atlanta.

“We found patients had a quicker improvement in their time to clinical recovery with low-dose radiation therapy, compared to controls, and this was significant even in this small cohort of patients,” he said.

Dr. Khan was speaking at a special press briefing held during the virtual American Society for Radiation Oncology Annual Meeting 2020.

A total of 20 patients were involved in the trial. Ten patients were treated with low-dose radiotherapy; 10 others, who served as control patients, were treated with the best supportive care and COVID-directed therapies. The control patients were matched for age and comorbidities. All these patients were hospitalized and were oxygen dependent, Dr. Khan noted. In addition, for all patients, serial x-rays demonstrated consolidation and damage in the lung.

The intervention consisted of whole-lung low-dose radiotherapy delivered at a dose of 1.5 Gy.

The first five patients were assessed at an interim endpoint of 7 days to confirm the safety of the procedure. Subsequently, a total of 10 patients were treated with radiotherapy and were followed to day 28.

The main study endpoints were time to clinical recovery, determined on the basis of the patient’s being taken off oxygen, and improvement, evidenced on either serial x-rays or by inflammatory biomarkers.

The median time to clinical recovery was almost three times faster for the patients who received low-dose radiotherapy, at a median of 3 days; for control patients, the median was 12 days (P = .048).

“We also saw a trend toward getting patients out of hospital sooner,” Dr. Khan added. The mean time to hospital discharge was 12 days for the patients who received low-dose radiotherapy, compared with 20 days for control patients (P = .19).

Only one patient required intubation after receiving low-dose radiotherapy, whereas 4 of 10 control patients required some sort of intubation (P = .12), he noted.

Investigators also saw improvements on serial x-rays in 9 of 10 patients treated with low-dose radiotherapy, compared with only 4 patients in the control group. There was also a significant improvement in delirium among the low-dose radiotherapy group compared with control patients (P < .01). Before receiving low-dose radiotherapy, C-reactive protein levels increased by 22% per day. After receiving the 1.5-Gy radiation treatment, there was a sharp reduction in C-reactive protein levels (P < .01) as well as in lactate dehydrogenase levels (P = .03).

Overall survival, however, did not differ between the two treatment groups; 90% of both groups were alive at day 28.

“By focally dampening cytokine hyperactivation, [low-dose radiotherapy] may improve COVID-19 outcomes through immunomodulation,” Dr. Khan explained.
 

VENTED and PRE-VENT trials

These results from the small RESCUE-119 trial led to the launch of two larger phase 2 trials, the VENTED and the PRE-VENT trials, noted Arnab Chakravarti, MD, professor and chair of radiation oncology, the Ohio State University Comprehensive Cancer Center, Columbus.

To be enrolled in the VENTED trial, patients must have received mechanical ventilation. They will receive at least one dose of ultra-low-dose bilateral whole-lung radiotherapy, with the option of receiving a second dose. The primary objective is 30-day mortality rate.

“The hypothesis is that low-dose thoracic radiation will decrease inflammation and improve outcomes for these intubated COVID-19 patients,” Dr. Chakravarti explained.

The PRE-VENT trial will explore low-dose thoracic radiotherapy for hospitalized patients with severe respiratory compromise who have not yet been intubated. Two doses of low-dose radiotherapy will be tested and compared. The primary study objective is to determine which of the two doses appears to be the most efficacious, Dr. Chakravarti noted.

“The ultimate question to which we remain agnostic is whether the potential benefits of low-dose radiation therapy outweigh the risks,” he said.

Low-dose radiotherapy is readily available in most countries, unlike the newly developed COVID-19 drugs, which are only available in the developed world, he noted. “This creates a bit more economic equity in terms of COVID-19 treatment.”

In addition, it may offer a therapeutic option that could be useful in the future, “as low-dose radiation therapy does not discriminate against various viruses that may cause another pandemic,” he commented. It could offer “a stopgap measure where we don’t have to shut down society completely, which, as we have all witnessed, can cause tremendous financial and social unrest.”
 

Reasonable question

Whether or not radiotherapy has value for the short-term management of severe pulmonary inflammation caused by COVID-19 is a reasonable question to evaluate in clinical trials, commented discussant Ramesh Rengan, MD, PhD, professor and chair, department of radiation oncology, University of Washington, Seattle.

He noted that inflammatory cells are highly sensitive to radiation, and low-dose radiotherapy has been used effectively in other inflammatory conditions, such as arthritis. Indeed, before the discovery of antibiotics, low-dose radiation was used with reasonable efficacy to treat pneumonia.

“The pneumonia associated with this viral infection is a bit unique in that what happens is the infection triggers an inflammatory cascade – the so-called cytokine storm – that essentially overwhelms the lungs, thereby leading, unfortunately, to mortality,” Dr. Rengan noted. “So a big focus of our energy is how to stop this inflammatory cascade from occurring.”

Corticosteroids are currently the only therapeutic intervention that has shown any mortality benefit in COVID-19, he pointed out.

The question now being asked is: “Can we suppress inflammation specifically within the lung?” Dr. Rengan continued. The main problem with radiotherapy is that it has different effects on various tissues, both immediately and over the long term.

“The immediate benefit that we will likely see from these studies is the immediate sterilization of inflammatory cells,” he said. However, injury to normal lung tissue from low-dose radiotherapy could lead to inflammation weeks or months later, and this could contribute to the disease burden and increase the risk of dying.

Dr. Rengan also noted that there are some very real practical concerns about offering radiotherapy to COVID-19 patients, including potential COVID-19 transmission to vulnerable cancer patients.

Nevertheless, Dr. Rengan said the results to date are very important and that ongoing trials will provide important new information about the long-term impact of this particular treatment in high-risk patients.

“This is a race to the bottom – we are trying to find the lowest possible dose of radiation therapy that we can deliver to sterilize these inflammatory cells without creating any harm to the surrounding tissue,” he said.

“It also brings radiation oncologists into the fight against this deadly disease,” he added.

Dr. Rengan has received honoraria from Novocur and has served as a consultant to AstraZeneca.

A version of this article originally appeared on Medscape.com.

The first study to suggest benefit from low-dose radiotherapy for severe COVID-19–induced pneumonia involved only 20 patients, but the results were so promising that two larger randomized trials are now underway.

“RESCUE-119 was a trial based on the hypothesis that low-dose radiation therapy may help eliminate the stormy cytokine release and unchecked edema in hospitalized COVID-19 patients,” said Mohammed Khan, MD, PhD, Winship Cancer Institute of Emory University, Atlanta.

“We found patients had a quicker improvement in their time to clinical recovery with low-dose radiation therapy, compared to controls, and this was significant even in this small cohort of patients,” he said.

Dr. Khan was speaking at a special press briefing held during the virtual American Society for Radiation Oncology Annual Meeting 2020.

A total of 20 patients were involved in the trial. Ten patients were treated with low-dose radiotherapy; 10 others, who served as control patients, were treated with the best supportive care and COVID-directed therapies. The control patients were matched for age and comorbidities. All these patients were hospitalized and were oxygen dependent, Dr. Khan noted. In addition, for all patients, serial x-rays demonstrated consolidation and damage in the lung.

The intervention consisted of whole-lung low-dose radiotherapy delivered at a dose of 1.5 Gy.

The first five patients were assessed at an interim endpoint of 7 days to confirm the safety of the procedure. Subsequently, a total of 10 patients were treated with radiotherapy and were followed to day 28.

The main study endpoints were time to clinical recovery, determined on the basis of the patient’s being taken off oxygen, and improvement, evidenced on either serial x-rays or by inflammatory biomarkers.

The median time to clinical recovery was almost three times faster for the patients who received low-dose radiotherapy, at a median of 3 days; for control patients, the median was 12 days (P = .048).

“We also saw a trend toward getting patients out of hospital sooner,” Dr. Khan added. The mean time to hospital discharge was 12 days for the patients who received low-dose radiotherapy, compared with 20 days for control patients (P = .19).

Only one patient required intubation after receiving low-dose radiotherapy, whereas 4 of 10 control patients required some sort of intubation (P = .12), he noted.

Investigators also saw improvements on serial x-rays in 9 of 10 patients treated with low-dose radiotherapy, compared with only 4 patients in the control group. There was also a significant improvement in delirium among the low-dose radiotherapy group compared with control patients (P < .01). Before receiving low-dose radiotherapy, C-reactive protein levels increased by 22% per day. After receiving the 1.5-Gy radiation treatment, there was a sharp reduction in C-reactive protein levels (P < .01) as well as in lactate dehydrogenase levels (P = .03).

Overall survival, however, did not differ between the two treatment groups; 90% of both groups were alive at day 28.

“By focally dampening cytokine hyperactivation, [low-dose radiotherapy] may improve COVID-19 outcomes through immunomodulation,” Dr. Khan explained.
 

VENTED and PRE-VENT trials

These results from the small RESCUE-119 trial led to the launch of two larger phase 2 trials, the VENTED and the PRE-VENT trials, noted Arnab Chakravarti, MD, professor and chair of radiation oncology, the Ohio State University Comprehensive Cancer Center, Columbus.

To be enrolled in the VENTED trial, patients must have received mechanical ventilation. They will receive at least one dose of ultra-low-dose bilateral whole-lung radiotherapy, with the option of receiving a second dose. The primary objective is 30-day mortality rate.

“The hypothesis is that low-dose thoracic radiation will decrease inflammation and improve outcomes for these intubated COVID-19 patients,” Dr. Chakravarti explained.

The PRE-VENT trial will explore low-dose thoracic radiotherapy for hospitalized patients with severe respiratory compromise who have not yet been intubated. Two doses of low-dose radiotherapy will be tested and compared. The primary study objective is to determine which of the two doses appears to be the most efficacious, Dr. Chakravarti noted.

“The ultimate question to which we remain agnostic is whether the potential benefits of low-dose radiation therapy outweigh the risks,” he said.

Low-dose radiotherapy is readily available in most countries, unlike the newly developed COVID-19 drugs, which are only available in the developed world, he noted. “This creates a bit more economic equity in terms of COVID-19 treatment.”

In addition, it may offer a therapeutic option that could be useful in the future, “as low-dose radiation therapy does not discriminate against various viruses that may cause another pandemic,” he commented. It could offer “a stopgap measure where we don’t have to shut down society completely, which, as we have all witnessed, can cause tremendous financial and social unrest.”
 

Reasonable question

Whether or not radiotherapy has value for the short-term management of severe pulmonary inflammation caused by COVID-19 is a reasonable question to evaluate in clinical trials, commented discussant Ramesh Rengan, MD, PhD, professor and chair, department of radiation oncology, University of Washington, Seattle.

He noted that inflammatory cells are highly sensitive to radiation, and low-dose radiotherapy has been used effectively in other inflammatory conditions, such as arthritis. Indeed, before the discovery of antibiotics, low-dose radiation was used with reasonable efficacy to treat pneumonia.

“The pneumonia associated with this viral infection is a bit unique in that what happens is the infection triggers an inflammatory cascade – the so-called cytokine storm – that essentially overwhelms the lungs, thereby leading, unfortunately, to mortality,” Dr. Rengan noted. “So a big focus of our energy is how to stop this inflammatory cascade from occurring.”

Corticosteroids are currently the only therapeutic intervention that has shown any mortality benefit in COVID-19, he pointed out.

The question now being asked is: “Can we suppress inflammation specifically within the lung?” Dr. Rengan continued. The main problem with radiotherapy is that it has different effects on various tissues, both immediately and over the long term.

“The immediate benefit that we will likely see from these studies is the immediate sterilization of inflammatory cells,” he said. However, injury to normal lung tissue from low-dose radiotherapy could lead to inflammation weeks or months later, and this could contribute to the disease burden and increase the risk of dying.

Dr. Rengan also noted that there are some very real practical concerns about offering radiotherapy to COVID-19 patients, including potential COVID-19 transmission to vulnerable cancer patients.

Nevertheless, Dr. Rengan said the results to date are very important and that ongoing trials will provide important new information about the long-term impact of this particular treatment in high-risk patients.

“This is a race to the bottom – we are trying to find the lowest possible dose of radiation therapy that we can deliver to sterilize these inflammatory cells without creating any harm to the surrounding tissue,” he said.

“It also brings radiation oncologists into the fight against this deadly disease,” he added.

Dr. Rengan has received honoraria from Novocur and has served as a consultant to AstraZeneca.

A version of this article originally appeared on Medscape.com.

The first study to suggest benefit from low-dose radiotherapy for severe COVID-19–induced pneumonia involved only 20 patients, but the results were so promising that two larger randomized trials are now underway.

“RESCUE-119 was a trial based on the hypothesis that low-dose radiation therapy may help eliminate the stormy cytokine release and unchecked edema in hospitalized COVID-19 patients,” said Mohammed Khan, MD, PhD, Winship Cancer Institute of Emory University, Atlanta.

“We found patients had a quicker improvement in their time to clinical recovery with low-dose radiation therapy, compared to controls, and this was significant even in this small cohort of patients,” he said.

Dr. Khan was speaking at a special press briefing held during the virtual American Society for Radiation Oncology Annual Meeting 2020.

A total of 20 patients were involved in the trial. Ten patients were treated with low-dose radiotherapy; 10 others, who served as control patients, were treated with the best supportive care and COVID-directed therapies. The control patients were matched for age and comorbidities. All these patients were hospitalized and were oxygen dependent, Dr. Khan noted. In addition, for all patients, serial x-rays demonstrated consolidation and damage in the lung.

The intervention consisted of whole-lung low-dose radiotherapy delivered at a dose of 1.5 Gy.

The first five patients were assessed at an interim endpoint of 7 days to confirm the safety of the procedure. Subsequently, a total of 10 patients were treated with radiotherapy and were followed to day 28.

The main study endpoints were time to clinical recovery, determined on the basis of the patient’s being taken off oxygen, and improvement, evidenced on either serial x-rays or by inflammatory biomarkers.

The median time to clinical recovery was almost three times faster for the patients who received low-dose radiotherapy, at a median of 3 days; for control patients, the median was 12 days (P = .048).

“We also saw a trend toward getting patients out of hospital sooner,” Dr. Khan added. The mean time to hospital discharge was 12 days for the patients who received low-dose radiotherapy, compared with 20 days for control patients (P = .19).

Only one patient required intubation after receiving low-dose radiotherapy, whereas 4 of 10 control patients required some sort of intubation (P = .12), he noted.

Investigators also saw improvements on serial x-rays in 9 of 10 patients treated with low-dose radiotherapy, compared with only 4 patients in the control group. There was also a significant improvement in delirium among the low-dose radiotherapy group compared with control patients (P < .01). Before receiving low-dose radiotherapy, C-reactive protein levels increased by 22% per day. After receiving the 1.5-Gy radiation treatment, there was a sharp reduction in C-reactive protein levels (P < .01) as well as in lactate dehydrogenase levels (P = .03).

Overall survival, however, did not differ between the two treatment groups; 90% of both groups were alive at day 28.

“By focally dampening cytokine hyperactivation, [low-dose radiotherapy] may improve COVID-19 outcomes through immunomodulation,” Dr. Khan explained.
 

VENTED and PRE-VENT trials

These results from the small RESCUE-119 trial led to the launch of two larger phase 2 trials, the VENTED and the PRE-VENT trials, noted Arnab Chakravarti, MD, professor and chair of radiation oncology, the Ohio State University Comprehensive Cancer Center, Columbus.

To be enrolled in the VENTED trial, patients must have received mechanical ventilation. They will receive at least one dose of ultra-low-dose bilateral whole-lung radiotherapy, with the option of receiving a second dose. The primary objective is 30-day mortality rate.

“The hypothesis is that low-dose thoracic radiation will decrease inflammation and improve outcomes for these intubated COVID-19 patients,” Dr. Chakravarti explained.

The PRE-VENT trial will explore low-dose thoracic radiotherapy for hospitalized patients with severe respiratory compromise who have not yet been intubated. Two doses of low-dose radiotherapy will be tested and compared. The primary study objective is to determine which of the two doses appears to be the most efficacious, Dr. Chakravarti noted.

“The ultimate question to which we remain agnostic is whether the potential benefits of low-dose radiation therapy outweigh the risks,” he said.

Low-dose radiotherapy is readily available in most countries, unlike the newly developed COVID-19 drugs, which are only available in the developed world, he noted. “This creates a bit more economic equity in terms of COVID-19 treatment.”

In addition, it may offer a therapeutic option that could be useful in the future, “as low-dose radiation therapy does not discriminate against various viruses that may cause another pandemic,” he commented. It could offer “a stopgap measure where we don’t have to shut down society completely, which, as we have all witnessed, can cause tremendous financial and social unrest.”
 

Reasonable question

Whether or not radiotherapy has value for the short-term management of severe pulmonary inflammation caused by COVID-19 is a reasonable question to evaluate in clinical trials, commented discussant Ramesh Rengan, MD, PhD, professor and chair, department of radiation oncology, University of Washington, Seattle.

He noted that inflammatory cells are highly sensitive to radiation, and low-dose radiotherapy has been used effectively in other inflammatory conditions, such as arthritis. Indeed, before the discovery of antibiotics, low-dose radiation was used with reasonable efficacy to treat pneumonia.

“The pneumonia associated with this viral infection is a bit unique in that what happens is the infection triggers an inflammatory cascade – the so-called cytokine storm – that essentially overwhelms the lungs, thereby leading, unfortunately, to mortality,” Dr. Rengan noted. “So a big focus of our energy is how to stop this inflammatory cascade from occurring.”

Corticosteroids are currently the only therapeutic intervention that has shown any mortality benefit in COVID-19, he pointed out.

The question now being asked is: “Can we suppress inflammation specifically within the lung?” Dr. Rengan continued. The main problem with radiotherapy is that it has different effects on various tissues, both immediately and over the long term.

“The immediate benefit that we will likely see from these studies is the immediate sterilization of inflammatory cells,” he said. However, injury to normal lung tissue from low-dose radiotherapy could lead to inflammation weeks or months later, and this could contribute to the disease burden and increase the risk of dying.

Dr. Rengan also noted that there are some very real practical concerns about offering radiotherapy to COVID-19 patients, including potential COVID-19 transmission to vulnerable cancer patients.

Nevertheless, Dr. Rengan said the results to date are very important and that ongoing trials will provide important new information about the long-term impact of this particular treatment in high-risk patients.

“This is a race to the bottom – we are trying to find the lowest possible dose of radiation therapy that we can deliver to sterilize these inflammatory cells without creating any harm to the surrounding tissue,” he said.

“It also brings radiation oncologists into the fight against this deadly disease,” he added.

Dr. Rengan has received honoraria from Novocur and has served as a consultant to AstraZeneca.

A version of this article originally appeared on Medscape.com.

A short course of radiation therapy followed by neoadjuvant chemotherapy resulted in a clinical complete response (CR) in almost half of 90 patients with locally advanced rectal cancer, allowing the majority of responders to skip surgical resection, a retrospective study indicates.

Specifically, at a median follow-up of 16.6 months for living patients, the initial clinical CR rate was 48% overall.

“While we do not have enough follow-up yet to know the late side-effect profile of this regimen, our preliminary results are promising,” Re-I Chin, MD, of Washington University School of Medicine, St. Louis, Missouri, told Medscape Medical News in an email.

The study was presented at the virtual 2020 meeting of the American Society of Radiation Oncology (ASTRO).

“Certainly, longer follow-up will be needed in this study, but none of the observed patients to date has experienced an unsalvageable failure,” said meeting discussant Amol Narang, MD, of Johns Hopkins University, Baltimore, Maryland.

He reminded conference attendees that, despite good evidence supporting equivalency in oncologic outcomes between short-course radiation and long-course chemoradiation, the former is “highly underutilized in the US” with a mere 1% usage rate between 2004 and 2014.

The current study’s short-course treatment approach was compared in this setting to long-course chemoradiation and adjuvant chemotherapy in the RAPIDO trial reported at the 2020 annual meeting of the American Society of Clinical Oncology (ASCO), Narang pointed out.

Short-course patients had a higher rate of pathological complete response (pCR) and a lower rate of treatment failure compared with patients who received long-course chemoradiation and adjuvant chemotherapy; both patient groups underwent total mesorectal excision — which is different from the current analysis. The RAPIDO investigators concluded that the approach featuring the short course “can be considered as a new standard of care.”

Narang said the data collectively “begs the question as to whether the superiority of long-course chemoradiation should really have to be demonstrated to justify its use.”

But Chin highlighted toxicity issues. “Historically, there have been concerns regarding toxicity with short-course radiation therapy since it requires larger doses of radiation given over a shorter period of time,” Chin explained. “But [the short course] is particularly convenient for patients since it saves them more than a month of daily trips to the radiation oncology department.”
 

Seven local failures

The single-center study involved patients with newly diagnosed, nonmetastatic rectal adenocarcinoma treated with short-course radiation therapy followed by chemotherapy in 2018 and 2019. Nearly all (96%) had locally advanced disease, with either a T3/T4 tumor or node-positive disease. Median tumor size was 4.6 cm.

“Many of the patients in the study had low lying tumors,” Chin reported, with a median distance from the anal verge of 7 cm.

Radiation therapy was delivered in 25 Gy given in five fractions over 5 consecutive days, with the option to boost the dose to 30 Gy or 35 Gy in five fractions if extra-mesorectal lymph nodes were involved. Conventional 3D or intensity-modulated radiation was used and all patients completed treatment.

The median interval between diagnosis of rectal cancer and initiation of radiation therapy was 1.4 months, while the median interval between completion of radiation to initiation of chemotherapy was 2.7 weeks.

The most common chemotherapy regimen was FOLFOX – consisting of leucovorin, fluorouracil (5-FU), and oxaliplatin – or modified FOLFOX. For patients who received six or more cycles of chemotherapy, the median time spent on treatment was 3.9 months.

For those who completed at least six cycles of chemotherapy, the overall clinical CR was 51%, and, for patients with locally advanced disease, the clinical CR rate was 49%. Five of the 43 patients who achieved an initial clinical CR still underwent surgical resection because of patient or physician preference. Among this small group of patients, 4 of the 5 achieved a pCR, and the remaining patient achieved a pathological partial response (pPR).

A total of 42 patients (47% of the group) achieved a partial response following the radiation plus chemotherapy paradigm, and one patient had progressive disease. All underwent surgical resection. One patient did not complete chemotherapy and did not get surgery and subsequently died.

This left 38 patients to be managed nonoperatively. In this nonoperative cohort, 79% of patients continued to have a clinical CR at the end of follow-up. Of the 7 patients with local failure, 6 were salvaged by surgery, one was salvaged by chemotherapy, and all 7 treatment failures had no evidence of disease at last follow-up.

Of the small group of 5 patients who achieved an initial clinical CR following short-course radiation therapy and neoadjuvant chemotherapy, there were no further events in this group, whereas, for patients who achieved only an initial partial response or who had progressive disease, 72% remained event-free.

Approximately half of those who achieved a clinical CR to the treatment regimen had no late gastrointestinal toxicities, and no grade 3 or 4 toxicities were observed. “Surgical resection of tumors — even without a permanent stoma — can result in significantly decreased bowel function, so our goal is to treat patients without surgery and maintain good bowel function,” Chin noted.

“For rectal cancer, both short-course radiation therapy and nonoperative management are emerging treatment paradigms that may be more cost-effective and convenient compared to long-course chemoradiation followed by surgery, [especially since] the COVID-19 pandemic...has spurred changes in clinical practices in radiation oncology,” she said.

Chin has disclosed no relevant financial relationships. Narang reports receiving research support from Boston Scientific.
 

This article first appeared on Medscape.com.

A short course of radiation therapy followed by neoadjuvant chemotherapy resulted in a clinical complete response (CR) in almost half of 90 patients with locally advanced rectal cancer, allowing the majority of responders to skip surgical resection, a retrospective study indicates.

Specifically, at a median follow-up of 16.6 months for living patients, the initial clinical CR rate was 48% overall.

“While we do not have enough follow-up yet to know the late side-effect profile of this regimen, our preliminary results are promising,” Re-I Chin, MD, of Washington University School of Medicine, St. Louis, Missouri, told Medscape Medical News in an email.

The study was presented at the virtual 2020 meeting of the American Society of Radiation Oncology (ASTRO).

“Certainly, longer follow-up will be needed in this study, but none of the observed patients to date has experienced an unsalvageable failure,” said meeting discussant Amol Narang, MD, of Johns Hopkins University, Baltimore, Maryland.

He reminded conference attendees that, despite good evidence supporting equivalency in oncologic outcomes between short-course radiation and long-course chemoradiation, the former is “highly underutilized in the US” with a mere 1% usage rate between 2004 and 2014.

The current study’s short-course treatment approach was compared in this setting to long-course chemoradiation and adjuvant chemotherapy in the RAPIDO trial reported at the 2020 annual meeting of the American Society of Clinical Oncology (ASCO), Narang pointed out.

Short-course patients had a higher rate of pathological complete response (pCR) and a lower rate of treatment failure compared with patients who received long-course chemoradiation and adjuvant chemotherapy; both patient groups underwent total mesorectal excision — which is different from the current analysis. The RAPIDO investigators concluded that the approach featuring the short course “can be considered as a new standard of care.”

Narang said the data collectively “begs the question as to whether the superiority of long-course chemoradiation should really have to be demonstrated to justify its use.”

But Chin highlighted toxicity issues. “Historically, there have been concerns regarding toxicity with short-course radiation therapy since it requires larger doses of radiation given over a shorter period of time,” Chin explained. “But [the short course] is particularly convenient for patients since it saves them more than a month of daily trips to the radiation oncology department.”
 

Seven local failures

The single-center study involved patients with newly diagnosed, nonmetastatic rectal adenocarcinoma treated with short-course radiation therapy followed by chemotherapy in 2018 and 2019. Nearly all (96%) had locally advanced disease, with either a T3/T4 tumor or node-positive disease. Median tumor size was 4.6 cm.

“Many of the patients in the study had low lying tumors,” Chin reported, with a median distance from the anal verge of 7 cm.

Radiation therapy was delivered in 25 Gy given in five fractions over 5 consecutive days, with the option to boost the dose to 30 Gy or 35 Gy in five fractions if extra-mesorectal lymph nodes were involved. Conventional 3D or intensity-modulated radiation was used and all patients completed treatment.

The median interval between diagnosis of rectal cancer and initiation of radiation therapy was 1.4 months, while the median interval between completion of radiation to initiation of chemotherapy was 2.7 weeks.

The most common chemotherapy regimen was FOLFOX – consisting of leucovorin, fluorouracil (5-FU), and oxaliplatin – or modified FOLFOX. For patients who received six or more cycles of chemotherapy, the median time spent on treatment was 3.9 months.

For those who completed at least six cycles of chemotherapy, the overall clinical CR was 51%, and, for patients with locally advanced disease, the clinical CR rate was 49%. Five of the 43 patients who achieved an initial clinical CR still underwent surgical resection because of patient or physician preference. Among this small group of patients, 4 of the 5 achieved a pCR, and the remaining patient achieved a pathological partial response (pPR).

A total of 42 patients (47% of the group) achieved a partial response following the radiation plus chemotherapy paradigm, and one patient had progressive disease. All underwent surgical resection. One patient did not complete chemotherapy and did not get surgery and subsequently died.

This left 38 patients to be managed nonoperatively. In this nonoperative cohort, 79% of patients continued to have a clinical CR at the end of follow-up. Of the 7 patients with local failure, 6 were salvaged by surgery, one was salvaged by chemotherapy, and all 7 treatment failures had no evidence of disease at last follow-up.

Of the small group of 5 patients who achieved an initial clinical CR following short-course radiation therapy and neoadjuvant chemotherapy, there were no further events in this group, whereas, for patients who achieved only an initial partial response or who had progressive disease, 72% remained event-free.

Approximately half of those who achieved a clinical CR to the treatment regimen had no late gastrointestinal toxicities, and no grade 3 or 4 toxicities were observed. “Surgical resection of tumors — even without a permanent stoma — can result in significantly decreased bowel function, so our goal is to treat patients without surgery and maintain good bowel function,” Chin noted.

“For rectal cancer, both short-course radiation therapy and nonoperative management are emerging treatment paradigms that may be more cost-effective and convenient compared to long-course chemoradiation followed by surgery, [especially since] the COVID-19 pandemic...has spurred changes in clinical practices in radiation oncology,” she said.

Chin has disclosed no relevant financial relationships. Narang reports receiving research support from Boston Scientific.
 

This article first appeared on Medscape.com.

A short course of radiation therapy followed by neoadjuvant chemotherapy resulted in a clinical complete response (CR) in almost half of 90 patients with locally advanced rectal cancer, allowing the majority of responders to skip surgical resection, a retrospective study indicates.

Specifically, at a median follow-up of 16.6 months for living patients, the initial clinical CR rate was 48% overall.

“While we do not have enough follow-up yet to know the late side-effect profile of this regimen, our preliminary results are promising,” Re-I Chin, MD, of Washington University School of Medicine, St. Louis, Missouri, told Medscape Medical News in an email.

The study was presented at the virtual 2020 meeting of the American Society of Radiation Oncology (ASTRO).

“Certainly, longer follow-up will be needed in this study, but none of the observed patients to date has experienced an unsalvageable failure,” said meeting discussant Amol Narang, MD, of Johns Hopkins University, Baltimore, Maryland.

He reminded conference attendees that, despite good evidence supporting equivalency in oncologic outcomes between short-course radiation and long-course chemoradiation, the former is “highly underutilized in the US” with a mere 1% usage rate between 2004 and 2014.

The current study’s short-course treatment approach was compared in this setting to long-course chemoradiation and adjuvant chemotherapy in the RAPIDO trial reported at the 2020 annual meeting of the American Society of Clinical Oncology (ASCO), Narang pointed out.

Short-course patients had a higher rate of pathological complete response (pCR) and a lower rate of treatment failure compared with patients who received long-course chemoradiation and adjuvant chemotherapy; both patient groups underwent total mesorectal excision — which is different from the current analysis. The RAPIDO investigators concluded that the approach featuring the short course “can be considered as a new standard of care.”

Narang said the data collectively “begs the question as to whether the superiority of long-course chemoradiation should really have to be demonstrated to justify its use.”

But Chin highlighted toxicity issues. “Historically, there have been concerns regarding toxicity with short-course radiation therapy since it requires larger doses of radiation given over a shorter period of time,” Chin explained. “But [the short course] is particularly convenient for patients since it saves them more than a month of daily trips to the radiation oncology department.”
 

Seven local failures

The single-center study involved patients with newly diagnosed, nonmetastatic rectal adenocarcinoma treated with short-course radiation therapy followed by chemotherapy in 2018 and 2019. Nearly all (96%) had locally advanced disease, with either a T3/T4 tumor or node-positive disease. Median tumor size was 4.6 cm.

“Many of the patients in the study had low lying tumors,” Chin reported, with a median distance from the anal verge of 7 cm.

Radiation therapy was delivered in 25 Gy given in five fractions over 5 consecutive days, with the option to boost the dose to 30 Gy or 35 Gy in five fractions if extra-mesorectal lymph nodes were involved. Conventional 3D or intensity-modulated radiation was used and all patients completed treatment.

The median interval between diagnosis of rectal cancer and initiation of radiation therapy was 1.4 months, while the median interval between completion of radiation to initiation of chemotherapy was 2.7 weeks.

The most common chemotherapy regimen was FOLFOX – consisting of leucovorin, fluorouracil (5-FU), and oxaliplatin – or modified FOLFOX. For patients who received six or more cycles of chemotherapy, the median time spent on treatment was 3.9 months.

For those who completed at least six cycles of chemotherapy, the overall clinical CR was 51%, and, for patients with locally advanced disease, the clinical CR rate was 49%. Five of the 43 patients who achieved an initial clinical CR still underwent surgical resection because of patient or physician preference. Among this small group of patients, 4 of the 5 achieved a pCR, and the remaining patient achieved a pathological partial response (pPR).

A total of 42 patients (47% of the group) achieved a partial response following the radiation plus chemotherapy paradigm, and one patient had progressive disease. All underwent surgical resection. One patient did not complete chemotherapy and did not get surgery and subsequently died.

This left 38 patients to be managed nonoperatively. In this nonoperative cohort, 79% of patients continued to have a clinical CR at the end of follow-up. Of the 7 patients with local failure, 6 were salvaged by surgery, one was salvaged by chemotherapy, and all 7 treatment failures had no evidence of disease at last follow-up.

Of the small group of 5 patients who achieved an initial clinical CR following short-course radiation therapy and neoadjuvant chemotherapy, there were no further events in this group, whereas, for patients who achieved only an initial partial response or who had progressive disease, 72% remained event-free.

Approximately half of those who achieved a clinical CR to the treatment regimen had no late gastrointestinal toxicities, and no grade 3 or 4 toxicities were observed. “Surgical resection of tumors — even without a permanent stoma — can result in significantly decreased bowel function, so our goal is to treat patients without surgery and maintain good bowel function,” Chin noted.

“For rectal cancer, both short-course radiation therapy and nonoperative management are emerging treatment paradigms that may be more cost-effective and convenient compared to long-course chemoradiation followed by surgery, [especially since] the COVID-19 pandemic...has spurred changes in clinical practices in radiation oncology,” she said.

Chin has disclosed no relevant financial relationships. Narang reports receiving research support from Boston Scientific.
 

This article first appeared on Medscape.com.

For women who receive radiotherapy after undergoing hysterectomy for high-risk cervical cancer, image-guided intensity-modulated radiotherapy (IG-IMRT) is superior to three-dimensional conformal radiotherapy (3D-CRT) at reducing late gastrointestinal (GI) toxicity and is similarly efficacious, according to new findings.

“IG-IMRT should represent the new standard of care for postoperative pelvic radiation therapy in women with gynecological cancers,” said study lead author Supriya Chopra, MD, of the Tata Memorial Center in Mumbai, India.

She noted that the study, known as PARCER, is the first in gynecologic cancer to show the impact of advanced technology in reducing long-term morbidity and thus improving the experience of survivors.

At 4 years, rates of late GI toxicity of grade 2 or higher in the IG-IMRT and 3D-CRT arms were 19.2% and 36.2%, respectively (P = .005). Rates of toxicity of grade 3 or higher were 2.0% and 8.7%, respectively (P < .01).

Chopra presented the results at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online.

Postoperative radiotherapy is indicated for women with cervical and endometrial cancers who have high-risk features, but long-term follow-up has shown an increase in GI symptom burden and toxicity in long-term survivors after adjuvant radiotherapy.

“The uptake of IMRT has been relatively slow in gynecological cancers,” said Chopra. She explained that previous data suggested a benefit with the use of IMRT, but long-term postoperative effects were unclear.

The new data amount to a “practice-change use” of IMRT for this indication, said Sue Yom, MD, PhD, of the University of California, San Francisco, who was not involved with the study. “I see this as having potentially important future impacts on clinical practice.”

Yom explained that, although there have been studies in the United States on the use of postoperative IMRT for pelvic cancer, “this is the first phase 3 study that has shown definite long-term advantages with the use of IMRT, and I would consider it confirmatory.”

In 2015, the preliminary results of PARCER were presented at the plenary session at ASTRO. The results showed that patients treated with IG-IMRT had fewer late GI toxicities at a median follow-up of 20 months. However, the difference between groups was not statistically significant in this earlier analysis.
 

Now at 49 months’ follow-up

The study was conducted in three clinical sites of Tata Memorial Center and included a total of 300 patients with cervical cancer. The patients had undergone type III hysterectomy and had intermediate- or high-risk features, or they had undergone type I/II hysterectomy necessitating adjuvant chemoradiotherapy. They were randomly assigned to IG-IMRT (n = 151) or 3D-CRT (n = 149). Most patients (117 in the IG-IMRT arm and 114 in the 3D-CRT arm) received concurrent chemotherapy.

The primary endpoint was late GI toxicity of grade 2 or higher. Follow-up included clinical and quality-of-life evaluations, which were conducted every 3 months for 2 years and then every 6 months for years 2 to 5.

Chopra and colleagues evaluated 11 different GI-related side effects. Differences emerged over time between the two groups. Among the group that received IG-IMRT, significantly fewer patients reported moderate to severe acute diarrhea (17% in the IG-IMRT arm vs 27% in the 3D-CRT arm), late abdominal bloating (14% vs 28%), bowel obstruction (1% vs 7%), and anorexia/appetite loss (1% vs 7%).

Overall, for patients treated with IG-IMRT, grade 2 toxicity–free survival rates were significantly higher (78% with IG-IMRT vs 57% with 3D-CRT; P = .0009), as were grade 3 toxicity–free survival rates (97.6% vs 81.6%; P = .001).

As noted above, rates of disease-free survival were similar for both groups (73% with image-guided IMRT vs 68% with 3D-CRT; P = .30).

Funding for the study was provided by the Department of Science and Technology and the Department of Atomic Energy, Clinical Trials Center, in India, and by Varian International and the Terry Fox Foundation. Chopra and Yom have disclosed no relevant financial relationships.


This article first appeared on Medscape.com.

For women who receive radiotherapy after undergoing hysterectomy for high-risk cervical cancer, image-guided intensity-modulated radiotherapy (IG-IMRT) is superior to three-dimensional conformal radiotherapy (3D-CRT) at reducing late gastrointestinal (GI) toxicity and is similarly efficacious, according to new findings.

“IG-IMRT should represent the new standard of care for postoperative pelvic radiation therapy in women with gynecological cancers,” said study lead author Supriya Chopra, MD, of the Tata Memorial Center in Mumbai, India.

She noted that the study, known as PARCER, is the first in gynecologic cancer to show the impact of advanced technology in reducing long-term morbidity and thus improving the experience of survivors.

At 4 years, rates of late GI toxicity of grade 2 or higher in the IG-IMRT and 3D-CRT arms were 19.2% and 36.2%, respectively (P = .005). Rates of toxicity of grade 3 or higher were 2.0% and 8.7%, respectively (P < .01).

Chopra presented the results at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online.

Postoperative radiotherapy is indicated for women with cervical and endometrial cancers who have high-risk features, but long-term follow-up has shown an increase in GI symptom burden and toxicity in long-term survivors after adjuvant radiotherapy.

“The uptake of IMRT has been relatively slow in gynecological cancers,” said Chopra. She explained that previous data suggested a benefit with the use of IMRT, but long-term postoperative effects were unclear.

The new data amount to a “practice-change use” of IMRT for this indication, said Sue Yom, MD, PhD, of the University of California, San Francisco, who was not involved with the study. “I see this as having potentially important future impacts on clinical practice.”

Yom explained that, although there have been studies in the United States on the use of postoperative IMRT for pelvic cancer, “this is the first phase 3 study that has shown definite long-term advantages with the use of IMRT, and I would consider it confirmatory.”

In 2015, the preliminary results of PARCER were presented at the plenary session at ASTRO. The results showed that patients treated with IG-IMRT had fewer late GI toxicities at a median follow-up of 20 months. However, the difference between groups was not statistically significant in this earlier analysis.
 

Now at 49 months’ follow-up

The study was conducted in three clinical sites of Tata Memorial Center and included a total of 300 patients with cervical cancer. The patients had undergone type III hysterectomy and had intermediate- or high-risk features, or they had undergone type I/II hysterectomy necessitating adjuvant chemoradiotherapy. They were randomly assigned to IG-IMRT (n = 151) or 3D-CRT (n = 149). Most patients (117 in the IG-IMRT arm and 114 in the 3D-CRT arm) received concurrent chemotherapy.

The primary endpoint was late GI toxicity of grade 2 or higher. Follow-up included clinical and quality-of-life evaluations, which were conducted every 3 months for 2 years and then every 6 months for years 2 to 5.

Chopra and colleagues evaluated 11 different GI-related side effects. Differences emerged over time between the two groups. Among the group that received IG-IMRT, significantly fewer patients reported moderate to severe acute diarrhea (17% in the IG-IMRT arm vs 27% in the 3D-CRT arm), late abdominal bloating (14% vs 28%), bowel obstruction (1% vs 7%), and anorexia/appetite loss (1% vs 7%).

Overall, for patients treated with IG-IMRT, grade 2 toxicity–free survival rates were significantly higher (78% with IG-IMRT vs 57% with 3D-CRT; P = .0009), as were grade 3 toxicity–free survival rates (97.6% vs 81.6%; P = .001).

As noted above, rates of disease-free survival were similar for both groups (73% with image-guided IMRT vs 68% with 3D-CRT; P = .30).

Funding for the study was provided by the Department of Science and Technology and the Department of Atomic Energy, Clinical Trials Center, in India, and by Varian International and the Terry Fox Foundation. Chopra and Yom have disclosed no relevant financial relationships.


This article first appeared on Medscape.com.

For women who receive radiotherapy after undergoing hysterectomy for high-risk cervical cancer, image-guided intensity-modulated radiotherapy (IG-IMRT) is superior to three-dimensional conformal radiotherapy (3D-CRT) at reducing late gastrointestinal (GI) toxicity and is similarly efficacious, according to new findings.

“IG-IMRT should represent the new standard of care for postoperative pelvic radiation therapy in women with gynecological cancers,” said study lead author Supriya Chopra, MD, of the Tata Memorial Center in Mumbai, India.

She noted that the study, known as PARCER, is the first in gynecologic cancer to show the impact of advanced technology in reducing long-term morbidity and thus improving the experience of survivors.

At 4 years, rates of late GI toxicity of grade 2 or higher in the IG-IMRT and 3D-CRT arms were 19.2% and 36.2%, respectively (P = .005). Rates of toxicity of grade 3 or higher were 2.0% and 8.7%, respectively (P < .01).

Chopra presented the results at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online.

Postoperative radiotherapy is indicated for women with cervical and endometrial cancers who have high-risk features, but long-term follow-up has shown an increase in GI symptom burden and toxicity in long-term survivors after adjuvant radiotherapy.

“The uptake of IMRT has been relatively slow in gynecological cancers,” said Chopra. She explained that previous data suggested a benefit with the use of IMRT, but long-term postoperative effects were unclear.

The new data amount to a “practice-change use” of IMRT for this indication, said Sue Yom, MD, PhD, of the University of California, San Francisco, who was not involved with the study. “I see this as having potentially important future impacts on clinical practice.”

Yom explained that, although there have been studies in the United States on the use of postoperative IMRT for pelvic cancer, “this is the first phase 3 study that has shown definite long-term advantages with the use of IMRT, and I would consider it confirmatory.”

In 2015, the preliminary results of PARCER were presented at the plenary session at ASTRO. The results showed that patients treated with IG-IMRT had fewer late GI toxicities at a median follow-up of 20 months. However, the difference between groups was not statistically significant in this earlier analysis.
 

Now at 49 months’ follow-up

The study was conducted in three clinical sites of Tata Memorial Center and included a total of 300 patients with cervical cancer. The patients had undergone type III hysterectomy and had intermediate- or high-risk features, or they had undergone type I/II hysterectomy necessitating adjuvant chemoradiotherapy. They were randomly assigned to IG-IMRT (n = 151) or 3D-CRT (n = 149). Most patients (117 in the IG-IMRT arm and 114 in the 3D-CRT arm) received concurrent chemotherapy.

The primary endpoint was late GI toxicity of grade 2 or higher. Follow-up included clinical and quality-of-life evaluations, which were conducted every 3 months for 2 years and then every 6 months for years 2 to 5.

Chopra and colleagues evaluated 11 different GI-related side effects. Differences emerged over time between the two groups. Among the group that received IG-IMRT, significantly fewer patients reported moderate to severe acute diarrhea (17% in the IG-IMRT arm vs 27% in the 3D-CRT arm), late abdominal bloating (14% vs 28%), bowel obstruction (1% vs 7%), and anorexia/appetite loss (1% vs 7%).

Overall, for patients treated with IG-IMRT, grade 2 toxicity–free survival rates were significantly higher (78% with IG-IMRT vs 57% with 3D-CRT; P = .0009), as were grade 3 toxicity–free survival rates (97.6% vs 81.6%; P = .001).

As noted above, rates of disease-free survival were similar for both groups (73% with image-guided IMRT vs 68% with 3D-CRT; P = .30).

Funding for the study was provided by the Department of Science and Technology and the Department of Atomic Energy, Clinical Trials Center, in India, and by Varian International and the Terry Fox Foundation. Chopra and Yom have disclosed no relevant financial relationships.


This article first appeared on Medscape.com.

Many female radiation oncologists find their career choice strongly influences when they start a family, and some deal with infertility and pregnancy-related discrimination, a U.S. cross-sectional survey suggests.

Courtesy MD Anderson Cancer Center

Results from the survey were reported at the American Society for Radiation Oncology Annual Meeting 2020.

“Female radiation oncologists often spend their childbearing years in training and establishing careers,” commented lead investigator Anna Lee, MD, of the University of Texas MD Anderson Cancer Center in Houston.

“Currently, physician fertility and family planning are rarely discussed or taught in medical school or postgraduate training,” Dr. Lee said.

Dr. Lee and colleagues conducted a national anonymous cross-sectional online survey of female oncologists of all types and all career levels (including trainees). The team circulated a 39-item questionnaire exploring attitudes toward and experiences related to family planning and assisted reproductive technology (ART) by email and social media channels.

A total of 351 radiation oncologists participated, representing one-fifth of the specialty’s entire female workforce nationally and making this study the largest to date on family planning among these physicians.

Most respondents were aged 31-40 years (60%) and married (79%), had children (68%), and were in training (26%) or academic practice (48%).
 

Survey results

Fully 74% of respondents reported that their career plans strongly influenced the timing of when to start a family, and 29% said family planning considerations influenced their decision regarding their choice of academia versus private practice, Dr. Lee reported.

Overall, 24% of respondents indicated that they had difficulty with infertility or required fertility counseling/treatment, 66% said they wished fertility preservation was discussed at some point during their training, and 22% said either that ART would have benefited them if it had been available or that they were planning to or had already used fertility preservation.

On the topic of maternity leave, some respondents reported that their institution either had no formal leave policy during training or provided less than 1 month of leave (23%) and that they felt pressure to take less time off than was policy (15%).

“Of note, 32 women in our survey were not offered non–radiation-exposing assignments during pregnancy, and an additional 57 had to specifically ask for them,” Dr. Lee remarked.

About one-third of respondents each reported that they did not feel supported during training for issues related to fertility and/or pregnancy (33%) and that they experienced discrimination for being pregnant (32%) and taking maternity leave (30%).

“Systemic changes are necessary early in medical education and training to ensure women are supported and able to advance equitably in the field. As less than a third of the current radiation oncology workforce are women, improvement upon these issues will be necessary to draw more women into the field,” Dr. Lee commented. “Education on ART risks, benefits, and success rates can help physicians and those in training in their family planning, while the lack of education and structured policy can exacerbate the emotional, physical, and financial impact of infertility.

“Until recently, there has been a dearth of policy at the programmatic, institutional, and national level allowing time and protection for pregnancy and maternity leave,” she added. “Thankfully, this summer, the American Board of Medical Specialties announced a progressive leave policy for residents and fellows.”

The new policy, which goes into effect July 2021, allows a minimum of 6 weeks away without exhausting time allowed for vacation or sick leave and without requiring an extension in training.
 

When career and biology collide

“The collision of professional and biological clocks for women in medicine is an important issue highlighted by this study,” Reshma Jagsi, MD, DPhil, of the University of Michigan in Ann Arbor, said in an interview.

“Prior work focused on women in medicine more generally. A deeper dive into the experiences of women in a specific field may be even more compelling to drive change on the part of professional societies and organizations,” Dr. Jagsi added.

The infertility rate observed in the study could have potentially been skewed by the preponderance of younger respondents (resulting in underestimation) or by greater participation of those interested in the subject (resulting in overestimation), she noted. However, it aligns well with the rate in a study Dr. Jagsi and colleagues conducted among female physicians generally using somewhat different methods. That study was published in the Journal of Women’s Health.

Concern about radiation exposure and its potential reproductive health effects should not deter women from choosing radiation oncology as a specialty, according to Dr. Jagsi.

“Radiation exposure is actually very low in radiation oncology, much lower than in specialties like interventional cardiology, where physicians are in the room where fluoroscopy is being used. It is actually an important misconception about this field that merits correction,” she stressed. “Rather, the fertility concerns are related to the expectations of training and demands of work during the prime childbearing years more generally that can lead women to delay pregnancy, which is an issue common to all medical specialties.”

“The investigators’ conclusions are very reasonable,” Dr. Jagsi said. “Although one might quibble whether the exact proportions reflect the experiences of all women in the field perfectly due to the possibility of selection bias, one cannot question whether a substantial number of women are experiencing these challenges and that they merit intervention.”

The study did not receive specific funding. Dr. Lee and Dr. Jagsi disclosed no relevant conflicts of interest.

SOURCE: Lee A et al. ASTRO 2020, Abstract LBA 6.

Many female radiation oncologists find their career choice strongly influences when they start a family, and some deal with infertility and pregnancy-related discrimination, a U.S. cross-sectional survey suggests.

Courtesy MD Anderson Cancer Center

Results from the survey were reported at the American Society for Radiation Oncology Annual Meeting 2020.

“Female radiation oncologists often spend their childbearing years in training and establishing careers,” commented lead investigator Anna Lee, MD, of the University of Texas MD Anderson Cancer Center in Houston.

“Currently, physician fertility and family planning are rarely discussed or taught in medical school or postgraduate training,” Dr. Lee said.

Dr. Lee and colleagues conducted a national anonymous cross-sectional online survey of female oncologists of all types and all career levels (including trainees). The team circulated a 39-item questionnaire exploring attitudes toward and experiences related to family planning and assisted reproductive technology (ART) by email and social media channels.

A total of 351 radiation oncologists participated, representing one-fifth of the specialty’s entire female workforce nationally and making this study the largest to date on family planning among these physicians.

Most respondents were aged 31-40 years (60%) and married (79%), had children (68%), and were in training (26%) or academic practice (48%).
 

Survey results

Fully 74% of respondents reported that their career plans strongly influenced the timing of when to start a family, and 29% said family planning considerations influenced their decision regarding their choice of academia versus private practice, Dr. Lee reported.

Overall, 24% of respondents indicated that they had difficulty with infertility or required fertility counseling/treatment, 66% said they wished fertility preservation was discussed at some point during their training, and 22% said either that ART would have benefited them if it had been available or that they were planning to or had already used fertility preservation.

On the topic of maternity leave, some respondents reported that their institution either had no formal leave policy during training or provided less than 1 month of leave (23%) and that they felt pressure to take less time off than was policy (15%).

“Of note, 32 women in our survey were not offered non–radiation-exposing assignments during pregnancy, and an additional 57 had to specifically ask for them,” Dr. Lee remarked.

About one-third of respondents each reported that they did not feel supported during training for issues related to fertility and/or pregnancy (33%) and that they experienced discrimination for being pregnant (32%) and taking maternity leave (30%).

“Systemic changes are necessary early in medical education and training to ensure women are supported and able to advance equitably in the field. As less than a third of the current radiation oncology workforce are women, improvement upon these issues will be necessary to draw more women into the field,” Dr. Lee commented. “Education on ART risks, benefits, and success rates can help physicians and those in training in their family planning, while the lack of education and structured policy can exacerbate the emotional, physical, and financial impact of infertility.

“Until recently, there has been a dearth of policy at the programmatic, institutional, and national level allowing time and protection for pregnancy and maternity leave,” she added. “Thankfully, this summer, the American Board of Medical Specialties announced a progressive leave policy for residents and fellows.”

The new policy, which goes into effect July 2021, allows a minimum of 6 weeks away without exhausting time allowed for vacation or sick leave and without requiring an extension in training.
 

When career and biology collide

“The collision of professional and biological clocks for women in medicine is an important issue highlighted by this study,” Reshma Jagsi, MD, DPhil, of the University of Michigan in Ann Arbor, said in an interview.

“Prior work focused on women in medicine more generally. A deeper dive into the experiences of women in a specific field may be even more compelling to drive change on the part of professional societies and organizations,” Dr. Jagsi added.

The infertility rate observed in the study could have potentially been skewed by the preponderance of younger respondents (resulting in underestimation) or by greater participation of those interested in the subject (resulting in overestimation), she noted. However, it aligns well with the rate in a study Dr. Jagsi and colleagues conducted among female physicians generally using somewhat different methods. That study was published in the Journal of Women’s Health.

Concern about radiation exposure and its potential reproductive health effects should not deter women from choosing radiation oncology as a specialty, according to Dr. Jagsi.

“Radiation exposure is actually very low in radiation oncology, much lower than in specialties like interventional cardiology, where physicians are in the room where fluoroscopy is being used. It is actually an important misconception about this field that merits correction,” she stressed. “Rather, the fertility concerns are related to the expectations of training and demands of work during the prime childbearing years more generally that can lead women to delay pregnancy, which is an issue common to all medical specialties.”

“The investigators’ conclusions are very reasonable,” Dr. Jagsi said. “Although one might quibble whether the exact proportions reflect the experiences of all women in the field perfectly due to the possibility of selection bias, one cannot question whether a substantial number of women are experiencing these challenges and that they merit intervention.”

The study did not receive specific funding. Dr. Lee and Dr. Jagsi disclosed no relevant conflicts of interest.

SOURCE: Lee A et al. ASTRO 2020, Abstract LBA 6.

Many female radiation oncologists find their career choice strongly influences when they start a family, and some deal with infertility and pregnancy-related discrimination, a U.S. cross-sectional survey suggests.

Courtesy MD Anderson Cancer Center

Results from the survey were reported at the American Society for Radiation Oncology Annual Meeting 2020.

“Female radiation oncologists often spend their childbearing years in training and establishing careers,” commented lead investigator Anna Lee, MD, of the University of Texas MD Anderson Cancer Center in Houston.

“Currently, physician fertility and family planning are rarely discussed or taught in medical school or postgraduate training,” Dr. Lee said.

Dr. Lee and colleagues conducted a national anonymous cross-sectional online survey of female oncologists of all types and all career levels (including trainees). The team circulated a 39-item questionnaire exploring attitudes toward and experiences related to family planning and assisted reproductive technology (ART) by email and social media channels.

A total of 351 radiation oncologists participated, representing one-fifth of the specialty’s entire female workforce nationally and making this study the largest to date on family planning among these physicians.

Most respondents were aged 31-40 years (60%) and married (79%), had children (68%), and were in training (26%) or academic practice (48%).
 

Survey results

Fully 74% of respondents reported that their career plans strongly influenced the timing of when to start a family, and 29% said family planning considerations influenced their decision regarding their choice of academia versus private practice, Dr. Lee reported.

Overall, 24% of respondents indicated that they had difficulty with infertility or required fertility counseling/treatment, 66% said they wished fertility preservation was discussed at some point during their training, and 22% said either that ART would have benefited them if it had been available or that they were planning to or had already used fertility preservation.

On the topic of maternity leave, some respondents reported that their institution either had no formal leave policy during training or provided less than 1 month of leave (23%) and that they felt pressure to take less time off than was policy (15%).

“Of note, 32 women in our survey were not offered non–radiation-exposing assignments during pregnancy, and an additional 57 had to specifically ask for them,” Dr. Lee remarked.

About one-third of respondents each reported that they did not feel supported during training for issues related to fertility and/or pregnancy (33%) and that they experienced discrimination for being pregnant (32%) and taking maternity leave (30%).

“Systemic changes are necessary early in medical education and training to ensure women are supported and able to advance equitably in the field. As less than a third of the current radiation oncology workforce are women, improvement upon these issues will be necessary to draw more women into the field,” Dr. Lee commented. “Education on ART risks, benefits, and success rates can help physicians and those in training in their family planning, while the lack of education and structured policy can exacerbate the emotional, physical, and financial impact of infertility.

“Until recently, there has been a dearth of policy at the programmatic, institutional, and national level allowing time and protection for pregnancy and maternity leave,” she added. “Thankfully, this summer, the American Board of Medical Specialties announced a progressive leave policy for residents and fellows.”

The new policy, which goes into effect July 2021, allows a minimum of 6 weeks away without exhausting time allowed for vacation or sick leave and without requiring an extension in training.
 

When career and biology collide

“The collision of professional and biological clocks for women in medicine is an important issue highlighted by this study,” Reshma Jagsi, MD, DPhil, of the University of Michigan in Ann Arbor, said in an interview.

“Prior work focused on women in medicine more generally. A deeper dive into the experiences of women in a specific field may be even more compelling to drive change on the part of professional societies and organizations,” Dr. Jagsi added.

The infertility rate observed in the study could have potentially been skewed by the preponderance of younger respondents (resulting in underestimation) or by greater participation of those interested in the subject (resulting in overestimation), she noted. However, it aligns well with the rate in a study Dr. Jagsi and colleagues conducted among female physicians generally using somewhat different methods. That study was published in the Journal of Women’s Health.

Concern about radiation exposure and its potential reproductive health effects should not deter women from choosing radiation oncology as a specialty, according to Dr. Jagsi.

“Radiation exposure is actually very low in radiation oncology, much lower than in specialties like interventional cardiology, where physicians are in the room where fluoroscopy is being used. It is actually an important misconception about this field that merits correction,” she stressed. “Rather, the fertility concerns are related to the expectations of training and demands of work during the prime childbearing years more generally that can lead women to delay pregnancy, which is an issue common to all medical specialties.”

“The investigators’ conclusions are very reasonable,” Dr. Jagsi said. “Although one might quibble whether the exact proportions reflect the experiences of all women in the field perfectly due to the possibility of selection bias, one cannot question whether a substantial number of women are experiencing these challenges and that they merit intervention.”

The study did not receive specific funding. Dr. Lee and Dr. Jagsi disclosed no relevant conflicts of interest.

SOURCE: Lee A et al. ASTRO 2020, Abstract LBA 6.

The molecular makeup of medulloblastoma may be used to identify patients who can be safely treated with less radiation therapy, according to a secondary analysis of the Children’s Oncology Group ACNS0331 trial.

Results from this analysis were reported at the American Society for Radiation Oncology Annual Meeting 2020.

“Today, molecular diagnostics play a critical role in the classification of tumors, particularly medulloblastoma,” noted lead investigator Jeff M. Michalski, MD, of Washington University St. Louis, Mo.

“It is now recognized that medulloblastoma can be subgrouped into four distinct entities with unique demographics and tumor behaviors,” he said.

Those four groups are the SHH subgroup, the WNT subgroup, group 3, and group 4.

Study rationale and details

The benefits of current multimodality therapy in controlling and curing medulloblastoma come at the cost of toxicity, especially for younger patients, in terms of neurocognitive deficits, secondary cancers, and growth and neuro-endocrine abnormalities.

With this in mind, Dr. Michalski and colleagues conducted a phase 3 trial to test two strategies for reducing radiation in average-risk medulloblastoma without compromising outcomes.

After craniospinal irradiation (CSI), all patients were randomized to a radiation boost to the whole posterior fossa (PFRT) or an involved field volume (IFRT). Patients aged 8-21 years received CSI at the standard dose (23.4 Gy). Patients aged 3-7 years were randomized to standard-dose CSI or low-dose CSI (18 Gy).

There were 464 patients in whom PFRT to IFRT could be compared and 226 patients in whom standard and low-dose CSI could be compared.

Only 362 patients had sufficient tumor tissue to allow for classification into molecular subgroups. Among these patients, 43.1% fell into the group 4 subgroup, 21.0% into the group 3 subgroup, 18.2% into the SHH subgroup, and 17.7% into the WNT subgroup.
 

Survival results

The trial’s primary outcomes were event-free and overall survival. Events were defined as progression, recurrence, death, or second malignancy.

For the whole cohort, boost volume did not significantly affect outcomes. IFRT and PFRT yielded similar 5-year event-free survival (82.5% vs. 80.5%; P = .44) and overall survival (84.6% vs. 85.2%; P = .44). However, CSI dose did affect outcomes, with the low dose inferior to the standard dose on both 5-year event-free survival (71.4% vs. 82.9%; P = .028) and overall survival (77.5% vs. 85.6%; P = .049).

In analyses stratified by molecular subgroup, event-free survival did not differ significantly by boost volume within subgroups, except for the SHH subgroup, within which PFRT yielded worse outcomes (P = .018). Similarly, event-free survival did not differ significantly by CSI dose within subgroups, except for group 4, within which the low dose yielded a worse outcome (P = .047).

When specific genomic alterations were also considered, patients in the SHH group had worse outcomes if they had chromosome 14q loss, chromosome 10q loss, or p53 mutation. Patients in group 3 had worse outcomes if they had MYC amplification, iso-chromosome 17q, or both of these abnormalities.

No significant correlations were seen for group 4 patients, and there were too few patients in the WNT subgroup to assess correlations.

“Survival rates following reduced radiation boost volumes were comparable to standard treatment volumes for the primary tumor site. Interestingly, the SHH subgroup had worse event-free survival with whole posterior fossa radiation therapy,” Dr. Michalski commented. “Reduced dose of craniospinal axis irradiation was associated with higher event rates and worse survival, and group 4 was the primary subgroup that drove these inferior outcomes.”

“Specific genomic abnormalities are associated with worse outcomes, and future trials should consider subgroup and these genomic abnormalities in their study design,” he recommended.
 

‘A new era’ of risk stratification

Current evidence “leads us to conclude that certain molecular subgroups and specific genetic abnormalities within the subgroups are primary drivers of outcome and can be associated with far worse outcomes than what the conventional risk definition might suggest,” said invited discussant Stephanie Terezakis, MD, of the University of Minnesota in Minneapolis.

“In fact, differences in outcomes are greater between molecular subgroups and genomic abnormalities in large trial cohorts than between clinical trials when we use conventional risk definitions,” Dr. Terezakis said.

The ACNS0331 trial’s subgroup findings demonstrate that one size of therapy may not fit all, she elaborated. For example, some patients with favorable tumor biology may still be able to receive deintensified therapy and maintain excellent outcomes, whereas other patients with unfavorable tumor biology could potentially be newly classified as high risk and eligible for intensified therapy.

“This is the subject of ongoing discussions today to try to inform this next generation of trials, to see how we risk-stratify patients,” Dr. Terezakis concluded. “This model of conducting a national clinical trial with biologic endpoints has allowed us to usher in a new era where tumor biology may potentially guide our treatment approaches and lead to more personalized cancer care.”

The trial was funded by the National Cancer Institute, The Brain Tumor Charity, and St. Jude Children’s Research Hospital. Dr. Michalski disclosed relationships with ViewRay, Boston Scientific, Merck, and Blue Earth Diagnostics. Dr. Terezakis disclosed scientific grants from the Radiation Oncology Institute and the Sarcoma Foundation of America.

SOURCE: Michalski JM et al. ASTRO 2020, Abstract 1.

The molecular makeup of medulloblastoma may be used to identify patients who can be safely treated with less radiation therapy, according to a secondary analysis of the Children’s Oncology Group ACNS0331 trial.

Results from this analysis were reported at the American Society for Radiation Oncology Annual Meeting 2020.

“Today, molecular diagnostics play a critical role in the classification of tumors, particularly medulloblastoma,” noted lead investigator Jeff M. Michalski, MD, of Washington University St. Louis, Mo.

“It is now recognized that medulloblastoma can be subgrouped into four distinct entities with unique demographics and tumor behaviors,” he said.

Those four groups are the SHH subgroup, the WNT subgroup, group 3, and group 4.

Study rationale and details

The benefits of current multimodality therapy in controlling and curing medulloblastoma come at the cost of toxicity, especially for younger patients, in terms of neurocognitive deficits, secondary cancers, and growth and neuro-endocrine abnormalities.

With this in mind, Dr. Michalski and colleagues conducted a phase 3 trial to test two strategies for reducing radiation in average-risk medulloblastoma without compromising outcomes.

After craniospinal irradiation (CSI), all patients were randomized to a radiation boost to the whole posterior fossa (PFRT) or an involved field volume (IFRT). Patients aged 8-21 years received CSI at the standard dose (23.4 Gy). Patients aged 3-7 years were randomized to standard-dose CSI or low-dose CSI (18 Gy).

There were 464 patients in whom PFRT to IFRT could be compared and 226 patients in whom standard and low-dose CSI could be compared.

Only 362 patients had sufficient tumor tissue to allow for classification into molecular subgroups. Among these patients, 43.1% fell into the group 4 subgroup, 21.0% into the group 3 subgroup, 18.2% into the SHH subgroup, and 17.7% into the WNT subgroup.
 

Survival results

The trial’s primary outcomes were event-free and overall survival. Events were defined as progression, recurrence, death, or second malignancy.

For the whole cohort, boost volume did not significantly affect outcomes. IFRT and PFRT yielded similar 5-year event-free survival (82.5% vs. 80.5%; P = .44) and overall survival (84.6% vs. 85.2%; P = .44). However, CSI dose did affect outcomes, with the low dose inferior to the standard dose on both 5-year event-free survival (71.4% vs. 82.9%; P = .028) and overall survival (77.5% vs. 85.6%; P = .049).

In analyses stratified by molecular subgroup, event-free survival did not differ significantly by boost volume within subgroups, except for the SHH subgroup, within which PFRT yielded worse outcomes (P = .018). Similarly, event-free survival did not differ significantly by CSI dose within subgroups, except for group 4, within which the low dose yielded a worse outcome (P = .047).

When specific genomic alterations were also considered, patients in the SHH group had worse outcomes if they had chromosome 14q loss, chromosome 10q loss, or p53 mutation. Patients in group 3 had worse outcomes if they had MYC amplification, iso-chromosome 17q, or both of these abnormalities.

No significant correlations were seen for group 4 patients, and there were too few patients in the WNT subgroup to assess correlations.

“Survival rates following reduced radiation boost volumes were comparable to standard treatment volumes for the primary tumor site. Interestingly, the SHH subgroup had worse event-free survival with whole posterior fossa radiation therapy,” Dr. Michalski commented. “Reduced dose of craniospinal axis irradiation was associated with higher event rates and worse survival, and group 4 was the primary subgroup that drove these inferior outcomes.”

“Specific genomic abnormalities are associated with worse outcomes, and future trials should consider subgroup and these genomic abnormalities in their study design,” he recommended.
 

‘A new era’ of risk stratification

Current evidence “leads us to conclude that certain molecular subgroups and specific genetic abnormalities within the subgroups are primary drivers of outcome and can be associated with far worse outcomes than what the conventional risk definition might suggest,” said invited discussant Stephanie Terezakis, MD, of the University of Minnesota in Minneapolis.

“In fact, differences in outcomes are greater between molecular subgroups and genomic abnormalities in large trial cohorts than between clinical trials when we use conventional risk definitions,” Dr. Terezakis said.

The ACNS0331 trial’s subgroup findings demonstrate that one size of therapy may not fit all, she elaborated. For example, some patients with favorable tumor biology may still be able to receive deintensified therapy and maintain excellent outcomes, whereas other patients with unfavorable tumor biology could potentially be newly classified as high risk and eligible for intensified therapy.

“This is the subject of ongoing discussions today to try to inform this next generation of trials, to see how we risk-stratify patients,” Dr. Terezakis concluded. “This model of conducting a national clinical trial with biologic endpoints has allowed us to usher in a new era where tumor biology may potentially guide our treatment approaches and lead to more personalized cancer care.”

The trial was funded by the National Cancer Institute, The Brain Tumor Charity, and St. Jude Children’s Research Hospital. Dr. Michalski disclosed relationships with ViewRay, Boston Scientific, Merck, and Blue Earth Diagnostics. Dr. Terezakis disclosed scientific grants from the Radiation Oncology Institute and the Sarcoma Foundation of America.

SOURCE: Michalski JM et al. ASTRO 2020, Abstract 1.

The molecular makeup of medulloblastoma may be used to identify patients who can be safely treated with less radiation therapy, according to a secondary analysis of the Children’s Oncology Group ACNS0331 trial.

Results from this analysis were reported at the American Society for Radiation Oncology Annual Meeting 2020.

“Today, molecular diagnostics play a critical role in the classification of tumors, particularly medulloblastoma,” noted lead investigator Jeff M. Michalski, MD, of Washington University St. Louis, Mo.

“It is now recognized that medulloblastoma can be subgrouped into four distinct entities with unique demographics and tumor behaviors,” he said.

Those four groups are the SHH subgroup, the WNT subgroup, group 3, and group 4.

Study rationale and details

The benefits of current multimodality therapy in controlling and curing medulloblastoma come at the cost of toxicity, especially for younger patients, in terms of neurocognitive deficits, secondary cancers, and growth and neuro-endocrine abnormalities.

With this in mind, Dr. Michalski and colleagues conducted a phase 3 trial to test two strategies for reducing radiation in average-risk medulloblastoma without compromising outcomes.

After craniospinal irradiation (CSI), all patients were randomized to a radiation boost to the whole posterior fossa (PFRT) or an involved field volume (IFRT). Patients aged 8-21 years received CSI at the standard dose (23.4 Gy). Patients aged 3-7 years were randomized to standard-dose CSI or low-dose CSI (18 Gy).

There were 464 patients in whom PFRT to IFRT could be compared and 226 patients in whom standard and low-dose CSI could be compared.

Only 362 patients had sufficient tumor tissue to allow for classification into molecular subgroups. Among these patients, 43.1% fell into the group 4 subgroup, 21.0% into the group 3 subgroup, 18.2% into the SHH subgroup, and 17.7% into the WNT subgroup.
 

Survival results

The trial’s primary outcomes were event-free and overall survival. Events were defined as progression, recurrence, death, or second malignancy.

For the whole cohort, boost volume did not significantly affect outcomes. IFRT and PFRT yielded similar 5-year event-free survival (82.5% vs. 80.5%; P = .44) and overall survival (84.6% vs. 85.2%; P = .44). However, CSI dose did affect outcomes, with the low dose inferior to the standard dose on both 5-year event-free survival (71.4% vs. 82.9%; P = .028) and overall survival (77.5% vs. 85.6%; P = .049).

In analyses stratified by molecular subgroup, event-free survival did not differ significantly by boost volume within subgroups, except for the SHH subgroup, within which PFRT yielded worse outcomes (P = .018). Similarly, event-free survival did not differ significantly by CSI dose within subgroups, except for group 4, within which the low dose yielded a worse outcome (P = .047).

When specific genomic alterations were also considered, patients in the SHH group had worse outcomes if they had chromosome 14q loss, chromosome 10q loss, or p53 mutation. Patients in group 3 had worse outcomes if they had MYC amplification, iso-chromosome 17q, or both of these abnormalities.

No significant correlations were seen for group 4 patients, and there were too few patients in the WNT subgroup to assess correlations.

“Survival rates following reduced radiation boost volumes were comparable to standard treatment volumes for the primary tumor site. Interestingly, the SHH subgroup had worse event-free survival with whole posterior fossa radiation therapy,” Dr. Michalski commented. “Reduced dose of craniospinal axis irradiation was associated with higher event rates and worse survival, and group 4 was the primary subgroup that drove these inferior outcomes.”

“Specific genomic abnormalities are associated with worse outcomes, and future trials should consider subgroup and these genomic abnormalities in their study design,” he recommended.
 

‘A new era’ of risk stratification

Current evidence “leads us to conclude that certain molecular subgroups and specific genetic abnormalities within the subgroups are primary drivers of outcome and can be associated with far worse outcomes than what the conventional risk definition might suggest,” said invited discussant Stephanie Terezakis, MD, of the University of Minnesota in Minneapolis.

“In fact, differences in outcomes are greater between molecular subgroups and genomic abnormalities in large trial cohorts than between clinical trials when we use conventional risk definitions,” Dr. Terezakis said.

The ACNS0331 trial’s subgroup findings demonstrate that one size of therapy may not fit all, she elaborated. For example, some patients with favorable tumor biology may still be able to receive deintensified therapy and maintain excellent outcomes, whereas other patients with unfavorable tumor biology could potentially be newly classified as high risk and eligible for intensified therapy.

“This is the subject of ongoing discussions today to try to inform this next generation of trials, to see how we risk-stratify patients,” Dr. Terezakis concluded. “This model of conducting a national clinical trial with biologic endpoints has allowed us to usher in a new era where tumor biology may potentially guide our treatment approaches and lead to more personalized cancer care.”

The trial was funded by the National Cancer Institute, The Brain Tumor Charity, and St. Jude Children’s Research Hospital. Dr. Michalski disclosed relationships with ViewRay, Boston Scientific, Merck, and Blue Earth Diagnostics. Dr. Terezakis disclosed scientific grants from the Radiation Oncology Institute and the Sarcoma Foundation of America.

SOURCE: Michalski JM et al. ASTRO 2020, Abstract 1.

Integrating PET imaging into postprostatectomy radiation therapy (RT) decisions and planning can improve prostate cancer outcomes, first results of the EMPIRE-1 trial suggest.

The findings were reported in a plenary session at the American Society for Radiation Oncology Annual Meeting 2020.

“Quite frankly, this is an area where we are shooting in the dark with conventional imaging, and that’s where we think molecular imaging has a potential role,” noted coprincipal investigator Ashesh B. Jani, MD, of the Winship Cancer Institute of Emory University, Atlanta.

“We hypothesized that radiotherapy outcomes can be improved upon by PET by excluding patients with extrapelvic disease and also by improving treatment field decisions and target definition,” Dr. Jani added.

Patients with prostate cancer were eligible for EMPIRE-1 if they had undergone prostatectomy and had a detectable prostate-specific antigen (PSA) level but negative findings on conventional imaging (a bone scan plus abdominopelvic CT and/or MRI).

A total of 165 patients were randomized to RT guided by the conventional imaging alone or combined with PET imaging using the radiotracer fluciclovine (18F). Treatment decisions in the latter group were strictly based on where uptake was seen.
 

Study results

The trial’s primary endpoint was treatment failure, defined as a PSA level exceeding 0.2 ng/mL from nadir followed by another rise, a continued PSA rise despite RT, progression on imaging or digital rectal exam, or initiation of systemic therapy.

“Most imaging studies tend to focus on diagnostic accuracy, pathologic correlation, and decision changes. It’s a very high bar for an imaging study to influence failure rates,” Dr. Jani pointed out.

Adding 18F-PET to conventional imaging altered the treatment decision for 35.4% of patients in that group (P < .001). It also significantly altered a range of volumetric and dosimetric parameters.

At a median follow-up of 2.48 years, the 3-year rate of failure-free survival was 63.0% with conventional imaging alone and 75.5% with the addition of 18F-PET (P = .003). The corresponding 4-year rate was 51.2% and 75.5%, respectively (P < .001).

In multivariate analysis, the conventional imaging group had double the risk of failure events relative to the PET group (hazard ratio, 2.04; P = .033).

Provider-reported data showed no significant difference between imaging groups in maximum acute or late genitourinary toxicity and gastrointestinal toxicity. An analysis of patient-reported toxicity data is pending.

“Randomized trials of imaging tests with a primary cancer control endpoint are important but uncommonly done,” Dr. Jani commented. “This is the first such trial of PET over conventional imaging in the postprostatectomy radiotherapy setting.”

“Inclusion of fluciclovine resulted in a significant improvement in failure rate at 3 years. This warrants further investigation,” he maintained.

To that end, the investigators have launched the EMPIRE-2 trial, which is comparing RT guided by 18F-PET with PET using another radiotracer that is not yet approved by the Food and Drug Administration, gallium-68 prostate-specific membrane antigen.
 

Findings in context

“There are several remarkable aspects of the EMPIRE-1 trial worth noting,” said invited discussant Neha Vapiwala, MD, of the University of Pennsylvania, Philadelphia.

She commended the trial’s randomization, given a bias that more imaging is better, and the diversity of its participants that better reflects the general population of prostate cancer patients.

“The study procedures appear to be well tolerated despite a net overall increase in the radiation volume treated in the patients who underwent PET, although we do still await patient-reported toxicity,” Dr. Vapiwala noted. “Finally, a high bar was set, with a clinically meaningful primary endpoint for an imaging study.

“This study ultimately demonstrated that, in the PET arm, better selection with PET was able to result in better patient outcomes,” she maintained.

At the same time, Dr. Vapiwala recommended caution when reducing or withholding definitive local therapy based on PET results, as occurred in 14 patients.

“We must always be able to see the forest from the trees, and when evaluating our patients with PET scans, what we see and what we don’t see is just one piece of the puzzle. Existing level 1 evidence and oncologic principles must still apply,” she said. “While PET can help paint a more complete picture, it should not define the picture itself.”

The study was supported by the National Institutes of Health. Dr. Jani disclosed advisory board service for Blue Earth Diagnostics. Dr. Vapiwala disclosed no relevant conflicts of interest.

SOURCE: Jani A et al. ASTRO 2020, Abstract LBA1.

Integrating PET imaging into postprostatectomy radiation therapy (RT) decisions and planning can improve prostate cancer outcomes, first results of the EMPIRE-1 trial suggest.

The findings were reported in a plenary session at the American Society for Radiation Oncology Annual Meeting 2020.

“Quite frankly, this is an area where we are shooting in the dark with conventional imaging, and that’s where we think molecular imaging has a potential role,” noted coprincipal investigator Ashesh B. Jani, MD, of the Winship Cancer Institute of Emory University, Atlanta.

“We hypothesized that radiotherapy outcomes can be improved upon by PET by excluding patients with extrapelvic disease and also by improving treatment field decisions and target definition,” Dr. Jani added.

Patients with prostate cancer were eligible for EMPIRE-1 if they had undergone prostatectomy and had a detectable prostate-specific antigen (PSA) level but negative findings on conventional imaging (a bone scan plus abdominopelvic CT and/or MRI).

A total of 165 patients were randomized to RT guided by the conventional imaging alone or combined with PET imaging using the radiotracer fluciclovine (18F). Treatment decisions in the latter group were strictly based on where uptake was seen.
 

Study results

The trial’s primary endpoint was treatment failure, defined as a PSA level exceeding 0.2 ng/mL from nadir followed by another rise, a continued PSA rise despite RT, progression on imaging or digital rectal exam, or initiation of systemic therapy.

“Most imaging studies tend to focus on diagnostic accuracy, pathologic correlation, and decision changes. It’s a very high bar for an imaging study to influence failure rates,” Dr. Jani pointed out.

Adding 18F-PET to conventional imaging altered the treatment decision for 35.4% of patients in that group (P < .001). It also significantly altered a range of volumetric and dosimetric parameters.

At a median follow-up of 2.48 years, the 3-year rate of failure-free survival was 63.0% with conventional imaging alone and 75.5% with the addition of 18F-PET (P = .003). The corresponding 4-year rate was 51.2% and 75.5%, respectively (P < .001).

In multivariate analysis, the conventional imaging group had double the risk of failure events relative to the PET group (hazard ratio, 2.04; P = .033).

Provider-reported data showed no significant difference between imaging groups in maximum acute or late genitourinary toxicity and gastrointestinal toxicity. An analysis of patient-reported toxicity data is pending.

“Randomized trials of imaging tests with a primary cancer control endpoint are important but uncommonly done,” Dr. Jani commented. “This is the first such trial of PET over conventional imaging in the postprostatectomy radiotherapy setting.”

“Inclusion of fluciclovine resulted in a significant improvement in failure rate at 3 years. This warrants further investigation,” he maintained.

To that end, the investigators have launched the EMPIRE-2 trial, which is comparing RT guided by 18F-PET with PET using another radiotracer that is not yet approved by the Food and Drug Administration, gallium-68 prostate-specific membrane antigen.
 

Findings in context

“There are several remarkable aspects of the EMPIRE-1 trial worth noting,” said invited discussant Neha Vapiwala, MD, of the University of Pennsylvania, Philadelphia.

She commended the trial’s randomization, given a bias that more imaging is better, and the diversity of its participants that better reflects the general population of prostate cancer patients.

“The study procedures appear to be well tolerated despite a net overall increase in the radiation volume treated in the patients who underwent PET, although we do still await patient-reported toxicity,” Dr. Vapiwala noted. “Finally, a high bar was set, with a clinically meaningful primary endpoint for an imaging study.

“This study ultimately demonstrated that, in the PET arm, better selection with PET was able to result in better patient outcomes,” she maintained.

At the same time, Dr. Vapiwala recommended caution when reducing or withholding definitive local therapy based on PET results, as occurred in 14 patients.

“We must always be able to see the forest from the trees, and when evaluating our patients with PET scans, what we see and what we don’t see is just one piece of the puzzle. Existing level 1 evidence and oncologic principles must still apply,” she said. “While PET can help paint a more complete picture, it should not define the picture itself.”

The study was supported by the National Institutes of Health. Dr. Jani disclosed advisory board service for Blue Earth Diagnostics. Dr. Vapiwala disclosed no relevant conflicts of interest.

SOURCE: Jani A et al. ASTRO 2020, Abstract LBA1.

Integrating PET imaging into postprostatectomy radiation therapy (RT) decisions and planning can improve prostate cancer outcomes, first results of the EMPIRE-1 trial suggest.

The findings were reported in a plenary session at the American Society for Radiation Oncology Annual Meeting 2020.

“Quite frankly, this is an area where we are shooting in the dark with conventional imaging, and that’s where we think molecular imaging has a potential role,” noted coprincipal investigator Ashesh B. Jani, MD, of the Winship Cancer Institute of Emory University, Atlanta.

“We hypothesized that radiotherapy outcomes can be improved upon by PET by excluding patients with extrapelvic disease and also by improving treatment field decisions and target definition,” Dr. Jani added.

Patients with prostate cancer were eligible for EMPIRE-1 if they had undergone prostatectomy and had a detectable prostate-specific antigen (PSA) level but negative findings on conventional imaging (a bone scan plus abdominopelvic CT and/or MRI).

A total of 165 patients were randomized to RT guided by the conventional imaging alone or combined with PET imaging using the radiotracer fluciclovine (18F). Treatment decisions in the latter group were strictly based on where uptake was seen.
 

Study results

The trial’s primary endpoint was treatment failure, defined as a PSA level exceeding 0.2 ng/mL from nadir followed by another rise, a continued PSA rise despite RT, progression on imaging or digital rectal exam, or initiation of systemic therapy.

“Most imaging studies tend to focus on diagnostic accuracy, pathologic correlation, and decision changes. It’s a very high bar for an imaging study to influence failure rates,” Dr. Jani pointed out.

Adding 18F-PET to conventional imaging altered the treatment decision for 35.4% of patients in that group (P < .001). It also significantly altered a range of volumetric and dosimetric parameters.

At a median follow-up of 2.48 years, the 3-year rate of failure-free survival was 63.0% with conventional imaging alone and 75.5% with the addition of 18F-PET (P = .003). The corresponding 4-year rate was 51.2% and 75.5%, respectively (P < .001).

In multivariate analysis, the conventional imaging group had double the risk of failure events relative to the PET group (hazard ratio, 2.04; P = .033).

Provider-reported data showed no significant difference between imaging groups in maximum acute or late genitourinary toxicity and gastrointestinal toxicity. An analysis of patient-reported toxicity data is pending.

“Randomized trials of imaging tests with a primary cancer control endpoint are important but uncommonly done,” Dr. Jani commented. “This is the first such trial of PET over conventional imaging in the postprostatectomy radiotherapy setting.”

“Inclusion of fluciclovine resulted in a significant improvement in failure rate at 3 years. This warrants further investigation,” he maintained.

To that end, the investigators have launched the EMPIRE-2 trial, which is comparing RT guided by 18F-PET with PET using another radiotracer that is not yet approved by the Food and Drug Administration, gallium-68 prostate-specific membrane antigen.
 

Findings in context

“There are several remarkable aspects of the EMPIRE-1 trial worth noting,” said invited discussant Neha Vapiwala, MD, of the University of Pennsylvania, Philadelphia.

She commended the trial’s randomization, given a bias that more imaging is better, and the diversity of its participants that better reflects the general population of prostate cancer patients.

“The study procedures appear to be well tolerated despite a net overall increase in the radiation volume treated in the patients who underwent PET, although we do still await patient-reported toxicity,” Dr. Vapiwala noted. “Finally, a high bar was set, with a clinically meaningful primary endpoint for an imaging study.

“This study ultimately demonstrated that, in the PET arm, better selection with PET was able to result in better patient outcomes,” she maintained.

At the same time, Dr. Vapiwala recommended caution when reducing or withholding definitive local therapy based on PET results, as occurred in 14 patients.

“We must always be able to see the forest from the trees, and when evaluating our patients with PET scans, what we see and what we don’t see is just one piece of the puzzle. Existing level 1 evidence and oncologic principles must still apply,” she said. “While PET can help paint a more complete picture, it should not define the picture itself.”

The study was supported by the National Institutes of Health. Dr. Jani disclosed advisory board service for Blue Earth Diagnostics. Dr. Vapiwala disclosed no relevant conflicts of interest.

SOURCE: Jani A et al. ASTRO 2020, Abstract LBA1.

Stereotactic radiosurgery (SRS) should replace whole-brain radiotherapy (WBRT) as the new standard of care for patients with four or more brain metastases, say researchers who report results from a randomized trial conducted in patients with four to 15 brain metastases

“SRS was associated with reduced risk of neurocognitive deterioration compared to WBRT, as demonstrated by a constellation of neurocognitive tests, individually or by composite scores,” said lead author Jing Li, MD, PhD, associate professor of radiation oncology and codirector of the Brain Metastasis Clinic at the University of Texas MD Anderson Cancer Center, Houston.

She was speaking at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online this year because of the COVID pandemic.

“The results from this phase 3 randomized trial strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival,” said Li.

SRS is already the standard of care for patients with one to three brain metastases. Two previous phase 3 randomized trials showed that SRS was better at preserving cognitive function without compromising overall survival in comparison to WBRT.

However, there has been some controversy over the use of SRS for patients with multiple brain metastases, commented study discussant Sue S. Yom, MD, PhD, a professor in the Departments of Radiation Oncology and Otolaryngology–Head and Neck Surgery, University of California, San Francisco.

This study has shown, “in a practice-changing manner, that giving SRS can improve the quality of life of patients with metastatic disease,” she said.

Up to 30% of cancer patients develop brain metastases. Historically, these have been associated with poor overall survival, in the range of 1 to 4 months.
 

Reduces cognitive decline

The new trial involved 72 patients with four to 15 untreated, nonmelanoma brain metastases (up to 20 lesions were allowed at the time of treatment); the median number of brain metastases was eight. Most (83%) of the trial participants were White, nearly half were aged 60 years or older, and 58% were women.

Patients were randomly assigned to receive either SRS (15–24 Gy per Radiation Therapy Oncology Group protocol 9005) or WBRT (30 Gy in 10 fractions). On the basis of previous research, 62% of patients in the WBRT arm were also given memantine, a dementia drug that can help preserve cognitive function.

All participants completed neurocognitive testing, including testing of learning, memory, attention span, executive function, verbal fluency, processing speed, and motor dexterity, at enrollment and longitudinally.

The primary endpoints were Hopkins Verbal Learning Test – Revised Total Recall (HVLT-R TR) score and local control at 4 months. Secondary endpoints included overall survival, distant brain failure, toxicity, and time to initiation of systemic therapy.

In the primary endpoint analysis, at 4 months, the HVLT-R TR standardized z-score increased by +0.21 (standard error [SE], 0.27) for patients who received SRS, but it declined by –0.74 (SE, 0.36) for WBRT-treated patients (P = .041). On the basis of Clinical Trial Battery Composite score, neurocognitive function of patients in the SRS arm improved on average +0.23 (SE, 0.14) but declined an average –0.73 (SE, 0.35) in the WBRT arm (P = .008).

Li pointed out that there was also a “clinically meaningful and statistically significant benefit” with SRS at 1 month (P = .033) and 6 months (P = .012).

A total of 69 patients (35 for SRS and 34 for WBRT) were evaluable for overall survival, which was similar between the groups (SRS median, 7.8 months; WBRT median, 8.9 months; P = .59). Treatment with SRS resulted in better local control rates (95% at 4 months with SRS and 86.7% with WBRT; P = .09), but the median time to distant brain failure was shorter (10.5 months for WBRT and 6.3 months for SRS; P = .37).

In her discussion of the study, Yom noted that overall survival time was similar in the two arms and that, numerically, it may have even been a little longer in the SRS group. “While it is true that they had more relapses in untreated portions of the brain, they lived as long or longer than those who received WBRT and had better cognitive function,” she noted

Yom also noted that of particular importance was the finding that SRS was associated with shorter interruptions of systemic therapy (time to systemic therapy: SRS, 1.7 weeks; WBRT, 4.1 weeks; P = .001). Patients with metastatic disease usually have cancer in locations other than the brain. They may be receiving some type of systemic therapy, which is interrupted with WBRT, Li commented.

Toxicities of grade 3 or higher were observed in four patients in the WBRT arm and two in the SRS arm. Radiographic evidence of radiation necrosis, a side effect associated with SRS, was observed in 17% patients in the SRS arm of the trial (4% of all treated lesions).

The trial was halted early owing to the publication of another phase 3 trial (NRG Oncology CC 001), which provided level 1 evidence for replacing standard WBRT with hippocampal-avoidance WBRT. Despite the early trial termination, Li concluded that these results “strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival.”

Li has received research funding from BMS and Medtronic and honorarium from Novocure and Monteris.

This article first appeared on Medscape.com.

Stereotactic radiosurgery (SRS) should replace whole-brain radiotherapy (WBRT) as the new standard of care for patients with four or more brain metastases, say researchers who report results from a randomized trial conducted in patients with four to 15 brain metastases

“SRS was associated with reduced risk of neurocognitive deterioration compared to WBRT, as demonstrated by a constellation of neurocognitive tests, individually or by composite scores,” said lead author Jing Li, MD, PhD, associate professor of radiation oncology and codirector of the Brain Metastasis Clinic at the University of Texas MD Anderson Cancer Center, Houston.

She was speaking at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online this year because of the COVID pandemic.

“The results from this phase 3 randomized trial strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival,” said Li.

SRS is already the standard of care for patients with one to three brain metastases. Two previous phase 3 randomized trials showed that SRS was better at preserving cognitive function without compromising overall survival in comparison to WBRT.

However, there has been some controversy over the use of SRS for patients with multiple brain metastases, commented study discussant Sue S. Yom, MD, PhD, a professor in the Departments of Radiation Oncology and Otolaryngology–Head and Neck Surgery, University of California, San Francisco.

This study has shown, “in a practice-changing manner, that giving SRS can improve the quality of life of patients with metastatic disease,” she said.

Up to 30% of cancer patients develop brain metastases. Historically, these have been associated with poor overall survival, in the range of 1 to 4 months.
 

Reduces cognitive decline

The new trial involved 72 patients with four to 15 untreated, nonmelanoma brain metastases (up to 20 lesions were allowed at the time of treatment); the median number of brain metastases was eight. Most (83%) of the trial participants were White, nearly half were aged 60 years or older, and 58% were women.

Patients were randomly assigned to receive either SRS (15–24 Gy per Radiation Therapy Oncology Group protocol 9005) or WBRT (30 Gy in 10 fractions). On the basis of previous research, 62% of patients in the WBRT arm were also given memantine, a dementia drug that can help preserve cognitive function.

All participants completed neurocognitive testing, including testing of learning, memory, attention span, executive function, verbal fluency, processing speed, and motor dexterity, at enrollment and longitudinally.

The primary endpoints were Hopkins Verbal Learning Test – Revised Total Recall (HVLT-R TR) score and local control at 4 months. Secondary endpoints included overall survival, distant brain failure, toxicity, and time to initiation of systemic therapy.

In the primary endpoint analysis, at 4 months, the HVLT-R TR standardized z-score increased by +0.21 (standard error [SE], 0.27) for patients who received SRS, but it declined by –0.74 (SE, 0.36) for WBRT-treated patients (P = .041). On the basis of Clinical Trial Battery Composite score, neurocognitive function of patients in the SRS arm improved on average +0.23 (SE, 0.14) but declined an average –0.73 (SE, 0.35) in the WBRT arm (P = .008).

Li pointed out that there was also a “clinically meaningful and statistically significant benefit” with SRS at 1 month (P = .033) and 6 months (P = .012).

A total of 69 patients (35 for SRS and 34 for WBRT) were evaluable for overall survival, which was similar between the groups (SRS median, 7.8 months; WBRT median, 8.9 months; P = .59). Treatment with SRS resulted in better local control rates (95% at 4 months with SRS and 86.7% with WBRT; P = .09), but the median time to distant brain failure was shorter (10.5 months for WBRT and 6.3 months for SRS; P = .37).

In her discussion of the study, Yom noted that overall survival time was similar in the two arms and that, numerically, it may have even been a little longer in the SRS group. “While it is true that they had more relapses in untreated portions of the brain, they lived as long or longer than those who received WBRT and had better cognitive function,” she noted

Yom also noted that of particular importance was the finding that SRS was associated with shorter interruptions of systemic therapy (time to systemic therapy: SRS, 1.7 weeks; WBRT, 4.1 weeks; P = .001). Patients with metastatic disease usually have cancer in locations other than the brain. They may be receiving some type of systemic therapy, which is interrupted with WBRT, Li commented.

Toxicities of grade 3 or higher were observed in four patients in the WBRT arm and two in the SRS arm. Radiographic evidence of radiation necrosis, a side effect associated with SRS, was observed in 17% patients in the SRS arm of the trial (4% of all treated lesions).

The trial was halted early owing to the publication of another phase 3 trial (NRG Oncology CC 001), which provided level 1 evidence for replacing standard WBRT with hippocampal-avoidance WBRT. Despite the early trial termination, Li concluded that these results “strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival.”

Li has received research funding from BMS and Medtronic and honorarium from Novocure and Monteris.

This article first appeared on Medscape.com.

Stereotactic radiosurgery (SRS) should replace whole-brain radiotherapy (WBRT) as the new standard of care for patients with four or more brain metastases, say researchers who report results from a randomized trial conducted in patients with four to 15 brain metastases

“SRS was associated with reduced risk of neurocognitive deterioration compared to WBRT, as demonstrated by a constellation of neurocognitive tests, individually or by composite scores,” said lead author Jing Li, MD, PhD, associate professor of radiation oncology and codirector of the Brain Metastasis Clinic at the University of Texas MD Anderson Cancer Center, Houston.

She was speaking at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online this year because of the COVID pandemic.

“The results from this phase 3 randomized trial strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival,” said Li.

SRS is already the standard of care for patients with one to three brain metastases. Two previous phase 3 randomized trials showed that SRS was better at preserving cognitive function without compromising overall survival in comparison to WBRT.

However, there has been some controversy over the use of SRS for patients with multiple brain metastases, commented study discussant Sue S. Yom, MD, PhD, a professor in the Departments of Radiation Oncology and Otolaryngology–Head and Neck Surgery, University of California, San Francisco.

This study has shown, “in a practice-changing manner, that giving SRS can improve the quality of life of patients with metastatic disease,” she said.

Up to 30% of cancer patients develop brain metastases. Historically, these have been associated with poor overall survival, in the range of 1 to 4 months.
 

Reduces cognitive decline

The new trial involved 72 patients with four to 15 untreated, nonmelanoma brain metastases (up to 20 lesions were allowed at the time of treatment); the median number of brain metastases was eight. Most (83%) of the trial participants were White, nearly half were aged 60 years or older, and 58% were women.

Patients were randomly assigned to receive either SRS (15–24 Gy per Radiation Therapy Oncology Group protocol 9005) or WBRT (30 Gy in 10 fractions). On the basis of previous research, 62% of patients in the WBRT arm were also given memantine, a dementia drug that can help preserve cognitive function.

All participants completed neurocognitive testing, including testing of learning, memory, attention span, executive function, verbal fluency, processing speed, and motor dexterity, at enrollment and longitudinally.

The primary endpoints were Hopkins Verbal Learning Test – Revised Total Recall (HVLT-R TR) score and local control at 4 months. Secondary endpoints included overall survival, distant brain failure, toxicity, and time to initiation of systemic therapy.

In the primary endpoint analysis, at 4 months, the HVLT-R TR standardized z-score increased by +0.21 (standard error [SE], 0.27) for patients who received SRS, but it declined by –0.74 (SE, 0.36) for WBRT-treated patients (P = .041). On the basis of Clinical Trial Battery Composite score, neurocognitive function of patients in the SRS arm improved on average +0.23 (SE, 0.14) but declined an average –0.73 (SE, 0.35) in the WBRT arm (P = .008).

Li pointed out that there was also a “clinically meaningful and statistically significant benefit” with SRS at 1 month (P = .033) and 6 months (P = .012).

A total of 69 patients (35 for SRS and 34 for WBRT) were evaluable for overall survival, which was similar between the groups (SRS median, 7.8 months; WBRT median, 8.9 months; P = .59). Treatment with SRS resulted in better local control rates (95% at 4 months with SRS and 86.7% with WBRT; P = .09), but the median time to distant brain failure was shorter (10.5 months for WBRT and 6.3 months for SRS; P = .37).

In her discussion of the study, Yom noted that overall survival time was similar in the two arms and that, numerically, it may have even been a little longer in the SRS group. “While it is true that they had more relapses in untreated portions of the brain, they lived as long or longer than those who received WBRT and had better cognitive function,” she noted

Yom also noted that of particular importance was the finding that SRS was associated with shorter interruptions of systemic therapy (time to systemic therapy: SRS, 1.7 weeks; WBRT, 4.1 weeks; P = .001). Patients with metastatic disease usually have cancer in locations other than the brain. They may be receiving some type of systemic therapy, which is interrupted with WBRT, Li commented.

Toxicities of grade 3 or higher were observed in four patients in the WBRT arm and two in the SRS arm. Radiographic evidence of radiation necrosis, a side effect associated with SRS, was observed in 17% patients in the SRS arm of the trial (4% of all treated lesions).

The trial was halted early owing to the publication of another phase 3 trial (NRG Oncology CC 001), which provided level 1 evidence for replacing standard WBRT with hippocampal-avoidance WBRT. Despite the early trial termination, Li concluded that these results “strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival.”

Li has received research funding from BMS and Medtronic and honorarium from Novocure and Monteris.

This article first appeared on Medscape.com.

Sexual dysfunction is a common treatment-related problem observed across numerous cancer diagnoses, and a new survey finds that 87% of cancer survivors have had such problems.

However, most of them also reported that their oncologist had not formally discussed the topic, and female patients were particularly unlikely to be asked about sexual dysfunction.

“The main takeaway from our study is that sexual side effects following treatment are very common,” said lead author James Taylor, MD, MPH, chief resident in radiation oncology at the Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia, Pennsylvania.

“Nearly 9 in 10 patients reported some change after cancer treatment that negatively affected their sexual health,” he said.

Taylor was speaking at the American Society for Radiation Oncology (ASTRO) Annual Meeting, held virtually this year because of the pandemic.

“Negative effects on sexual health after cancer treatment are unfortunately very common,” he said. “This is not just patients treated with radiation but this includes chemotherapy, hormonal therapy, surgery, and other treatment modalities.”

Potential issues include physical complications such as erectile dysfunction with prostate cancer treatment or vaginal dryness with gynecological cancer treatment. One recent study found that one-third of men who had undergone treatment for prostate cancer reported that a subsequent lack of sexual function has had the greatest impact on their quality of life. Another study reported that nearly all patients with breast cancer taking endocrine therapy experience a high degree of sexual dysfunction, including vulvovaginal dryness and severe dyspareunia.
 

Not discussed, not warned

Taylor and colleagues developed a questionnaire with input from radiation oncologists, medical oncologists, and surgeons, which consisted of more than 25 questions and was specifically targeted at cancer survivors.

A total of 405 adults completed the electronic survey about their experiences with sexual side effects after cancer treatment (391 responses were eligible for analysis). Most of the respondents were women (81%), and the most common cancer types were breast (67%), prostate (16%), and endometrial (6%). Treatments included chemotherapy (78%), radiation therapy (54%), and hormone therapy (47%).

“The questionnaires were distributed at Thomas Jefferson and throughout social media,” said Taylor. “The responses from social media are important because it shows a broad representation of patients who are treated in multiple clinics across the United States.”

Most of the survivors who responded (n = 337, 87%) stated cancer treatment had impacted sexual function or desire, with 53.8% reporting body image distortion, 73.4% with dyspareunia, and 42.3% unable to achieve orgasm.

Only about one-quarter (27.9%) said they had been formally asked about their sexual health by their clinician.

“Only about 40% said that they have been preemptively warned that their sexual health may be affected by treatment,” said Taylor.

Women were far less likely to be asked about their sexual health by their provider. The survey showed that male respondents were twice as likely to say they had been asked about sexual health and counseled about the potential toxicity (53% vs 22%; P < .001), and a substantially higher percentage of men reported receiving a formal assessment tool such as a survey (32% vs 5%; P = .001) compared with female respondents.

Taylor noted that the survey demonstrated several things. “One is that sexual toxicity is exceedingly common, and number two, it identified a gender disparity,” he said. “But number 3, and I think that this is an important aspect of our study, is that the majority of respondents felt that they would like a standard questionnaire to initiate and guide a discussion on sexual health with their provider.”

The reason that aspect is very important, he emphasized, is that “we know metrics and questionnaires already exist, so this gives us an actionable intervention that we can distribute and help mitigate some of these disparities.”
 

Importance of being holistic

The results of the survey “highlight the importance of being holistic in our approach to patient survivorship,” commented Karen Winkfield, MD, PhD, associate professor of radiation oncology at Wake Forest University, Winston-Salem, North Carolina, and executive director of the Meharry-Vanderbilt Alliance, Nashville, Tennessee.

“We need to ask patients about all parts of their well-being, including sexual health,” Winkfield said. “Body dysmorphism can impact anyone, but especially patients who have had surgery or radiation,” she said, while chemotherapy can impact energy and libido and have other toxicities that impact sexual health.

“I encourage all oncologists to ask patients about their sexual health, and a standardized form that can be used across all sites will make this much easier,” Winkfield commented. “We owe it to our patients to treat them holistically.”

The authors have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Sexual dysfunction is a common treatment-related problem observed across numerous cancer diagnoses, and a new survey finds that 87% of cancer survivors have had such problems.

However, most of them also reported that their oncologist had not formally discussed the topic, and female patients were particularly unlikely to be asked about sexual dysfunction.

“The main takeaway from our study is that sexual side effects following treatment are very common,” said lead author James Taylor, MD, MPH, chief resident in radiation oncology at the Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia, Pennsylvania.

“Nearly 9 in 10 patients reported some change after cancer treatment that negatively affected their sexual health,” he said.

Taylor was speaking at the American Society for Radiation Oncology (ASTRO) Annual Meeting, held virtually this year because of the pandemic.

“Negative effects on sexual health after cancer treatment are unfortunately very common,” he said. “This is not just patients treated with radiation but this includes chemotherapy, hormonal therapy, surgery, and other treatment modalities.”

Potential issues include physical complications such as erectile dysfunction with prostate cancer treatment or vaginal dryness with gynecological cancer treatment. One recent study found that one-third of men who had undergone treatment for prostate cancer reported that a subsequent lack of sexual function has had the greatest impact on their quality of life. Another study reported that nearly all patients with breast cancer taking endocrine therapy experience a high degree of sexual dysfunction, including vulvovaginal dryness and severe dyspareunia.
 

Not discussed, not warned

Taylor and colleagues developed a questionnaire with input from radiation oncologists, medical oncologists, and surgeons, which consisted of more than 25 questions and was specifically targeted at cancer survivors.

A total of 405 adults completed the electronic survey about their experiences with sexual side effects after cancer treatment (391 responses were eligible for analysis). Most of the respondents were women (81%), and the most common cancer types were breast (67%), prostate (16%), and endometrial (6%). Treatments included chemotherapy (78%), radiation therapy (54%), and hormone therapy (47%).

“The questionnaires were distributed at Thomas Jefferson and throughout social media,” said Taylor. “The responses from social media are important because it shows a broad representation of patients who are treated in multiple clinics across the United States.”

Most of the survivors who responded (n = 337, 87%) stated cancer treatment had impacted sexual function or desire, with 53.8% reporting body image distortion, 73.4% with dyspareunia, and 42.3% unable to achieve orgasm.

Only about one-quarter (27.9%) said they had been formally asked about their sexual health by their clinician.

“Only about 40% said that they have been preemptively warned that their sexual health may be affected by treatment,” said Taylor.

Women were far less likely to be asked about their sexual health by their provider. The survey showed that male respondents were twice as likely to say they had been asked about sexual health and counseled about the potential toxicity (53% vs 22%; P < .001), and a substantially higher percentage of men reported receiving a formal assessment tool such as a survey (32% vs 5%; P = .001) compared with female respondents.

Taylor noted that the survey demonstrated several things. “One is that sexual toxicity is exceedingly common, and number two, it identified a gender disparity,” he said. “But number 3, and I think that this is an important aspect of our study, is that the majority of respondents felt that they would like a standard questionnaire to initiate and guide a discussion on sexual health with their provider.”

The reason that aspect is very important, he emphasized, is that “we know metrics and questionnaires already exist, so this gives us an actionable intervention that we can distribute and help mitigate some of these disparities.”
 

Importance of being holistic

The results of the survey “highlight the importance of being holistic in our approach to patient survivorship,” commented Karen Winkfield, MD, PhD, associate professor of radiation oncology at Wake Forest University, Winston-Salem, North Carolina, and executive director of the Meharry-Vanderbilt Alliance, Nashville, Tennessee.

“We need to ask patients about all parts of their well-being, including sexual health,” Winkfield said. “Body dysmorphism can impact anyone, but especially patients who have had surgery or radiation,” she said, while chemotherapy can impact energy and libido and have other toxicities that impact sexual health.

“I encourage all oncologists to ask patients about their sexual health, and a standardized form that can be used across all sites will make this much easier,” Winkfield commented. “We owe it to our patients to treat them holistically.”

The authors have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Sexual dysfunction is a common treatment-related problem observed across numerous cancer diagnoses, and a new survey finds that 87% of cancer survivors have had such problems.

However, most of them also reported that their oncologist had not formally discussed the topic, and female patients were particularly unlikely to be asked about sexual dysfunction.

“The main takeaway from our study is that sexual side effects following treatment are very common,” said lead author James Taylor, MD, MPH, chief resident in radiation oncology at the Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia, Pennsylvania.

“Nearly 9 in 10 patients reported some change after cancer treatment that negatively affected their sexual health,” he said.

Taylor was speaking at the American Society for Radiation Oncology (ASTRO) Annual Meeting, held virtually this year because of the pandemic.

“Negative effects on sexual health after cancer treatment are unfortunately very common,” he said. “This is not just patients treated with radiation but this includes chemotherapy, hormonal therapy, surgery, and other treatment modalities.”

Potential issues include physical complications such as erectile dysfunction with prostate cancer treatment or vaginal dryness with gynecological cancer treatment. One recent study found that one-third of men who had undergone treatment for prostate cancer reported that a subsequent lack of sexual function has had the greatest impact on their quality of life. Another study reported that nearly all patients with breast cancer taking endocrine therapy experience a high degree of sexual dysfunction, including vulvovaginal dryness and severe dyspareunia.
 

Not discussed, not warned

Taylor and colleagues developed a questionnaire with input from radiation oncologists, medical oncologists, and surgeons, which consisted of more than 25 questions and was specifically targeted at cancer survivors.

A total of 405 adults completed the electronic survey about their experiences with sexual side effects after cancer treatment (391 responses were eligible for analysis). Most of the respondents were women (81%), and the most common cancer types were breast (67%), prostate (16%), and endometrial (6%). Treatments included chemotherapy (78%), radiation therapy (54%), and hormone therapy (47%).

“The questionnaires were distributed at Thomas Jefferson and throughout social media,” said Taylor. “The responses from social media are important because it shows a broad representation of patients who are treated in multiple clinics across the United States.”

Most of the survivors who responded (n = 337, 87%) stated cancer treatment had impacted sexual function or desire, with 53.8% reporting body image distortion, 73.4% with dyspareunia, and 42.3% unable to achieve orgasm.

Only about one-quarter (27.9%) said they had been formally asked about their sexual health by their clinician.

“Only about 40% said that they have been preemptively warned that their sexual health may be affected by treatment,” said Taylor.

Women were far less likely to be asked about their sexual health by their provider. The survey showed that male respondents were twice as likely to say they had been asked about sexual health and counseled about the potential toxicity (53% vs 22%; P < .001), and a substantially higher percentage of men reported receiving a formal assessment tool such as a survey (32% vs 5%; P = .001) compared with female respondents.

Taylor noted that the survey demonstrated several things. “One is that sexual toxicity is exceedingly common, and number two, it identified a gender disparity,” he said. “But number 3, and I think that this is an important aspect of our study, is that the majority of respondents felt that they would like a standard questionnaire to initiate and guide a discussion on sexual health with their provider.”

The reason that aspect is very important, he emphasized, is that “we know metrics and questionnaires already exist, so this gives us an actionable intervention that we can distribute and help mitigate some of these disparities.”
 

Importance of being holistic

The results of the survey “highlight the importance of being holistic in our approach to patient survivorship,” commented Karen Winkfield, MD, PhD, associate professor of radiation oncology at Wake Forest University, Winston-Salem, North Carolina, and executive director of the Meharry-Vanderbilt Alliance, Nashville, Tennessee.

“We need to ask patients about all parts of their well-being, including sexual health,” Winkfield said. “Body dysmorphism can impact anyone, but especially patients who have had surgery or radiation,” she said, while chemotherapy can impact energy and libido and have other toxicities that impact sexual health.

“I encourage all oncologists to ask patients about their sexual health, and a standardized form that can be used across all sites will make this much easier,” Winkfield commented. “We owe it to our patients to treat them holistically.”

The authors have reported no relevant financial relationships.

This article first appeared on Medscape.com.