TBD Meeting (5431-23)

While poly (ADP-ribose) polymerase (PARP) inhibitors clearly show benefit in certain kinds of breast cancer, questions persist about ideal drug targets and the value of combining them with other medications, oncologists explained at the European Society for Medical Oncology Breast Cancer annual congress.

For now, the drugs are only approved in high-risk germline BRCA mutation (gBRCAmut) early breast cancer, oncologist Kevin Punie, MD, of Saint Augustine Hospital in Wilrijk, Belgium, said during a session at the meeting. Combining the drugs with chemotherapy “has not yet demonstrated significant benefits, and this is irrespective whether platinum was part of the chemotherapy backbone.”

PARP is a kind of enzyme that repairs damaged DNA in cells, especially cancerous ones. PARP inhibitors block the enzyme, potentially leading more cancer cells to die, the Dana-Farber Cancer Institute states.

In a separate presentation during the same session, oncologist Andrew Tutt, MBChB, PhD, noted that a study he led – a phase 3, double-blinded, randomized 2021 trial – found that patients with BRCA1- or BRCA2-mutated breast cancer who took the PARP inhibitor olarapib (Lynparza) versus placebo had improved outcomes on several measures, including 3-year invasive disease-free survival (85.9% vs. 77.1%, P < .001). However, the study noted that “olaparib had limited effects on global patient-reported quality of life.”

Dr. Tutt, of the Institute of Cancer Research, London, and Kings College London, said 57% of patients who took olarapib suffered nausea versus 24% of those who took placebo, and fatigue and anemia were also more common in the olarapib group. Anemia can be severe and lead to transfusions in some cases.

As Dr. Punie explained, there are many reasons to consider combining PARP inhibitors with other treatments such as chemotherapy, immunotherapy, and radiotherapy. The combinations may have synergetic effects, and they could have potential in both the neoadjuvant and adjuvant settings.

The combination of the PARP inhibitor olaparib and endocrine therapy is now approved by the European Medicines Agency for the adjuvant treatment of certain patients with germline BRCA1/2 mutations who have HER2-negative, high-risk early breast cancer, Dr. Punie noted.

The 2021 study led by Dr. Tutt reported that treatment or safety differences were found in those who received both olaparib and endocrine therapy versus those who only received olarapib.

So far, Dr. Punie said, “we not yet have enough clinical evidence to say that there’s really synergy between PNP inhibitors and other anticancer therapies.” According to the National Institutes of Health, medical synergy “describes the interaction of two or more drugs when their combined effect is greater than the sum of the effects seen when each drug is given alone.”

In regard to chemotherapy, it makes sense that PARP inhibitors would be helpful in combination, Dr. Punie said. DNA damage to cancer cells accumulates during chemotherapy, he said, and they’re more depending on PARP for repair.

Study results so far have been mixed. A 2022 study, for example, found that adding the experimental PARP inhibitor veliparib to the chemotherapy regimen carboplatin-paclitaxel didn’t improve outcomes, he said. A similar study examining the addition of olaparib to carboplatin-paclitaxel is ongoing.

As for combining radiotherapy and PARP inhibitors, Dr. Punie said that preclinical findings are promising, and research is underway. There’s also ongoing research into combining PARP inhibitors with immunotherapy.

Off-label use of olaparib with immunotherapy or sequential treatment may be appropriate in the setting of adjuvant gBRCAmut triple-negative breast cancer with residual disease, he said.

During his presentation, Dr. Tutt called for researchers to investigate the use of PARP inhibitors in the de-escalation of treatment in lower-risk gBRCAmut disease.

“Clearly, some patients require chemotherapy, and we know patients respond very well to neoadjuvant chemotherapy if they have a BRCA mutation, but we don’t yet know who we can de-escalate in,” he said.

He also highlighted the need to reduce anemia in patients on PARP inhibitors, “particularly if we’re moving into lower-risk populations or possibly considering prevention trials.

“The study of PARP inhibitor resistance ... is now urgent, so that we can address it,” he said.

Dr. Punie disclosed financial relationships with AstraZeneca, Eli Lilly, Exact Sciences, Focus Patient, Medscape, MSD, Mundi Pharma, Need, Novartis, Pierre Fabre, Pfizer, F. Hoffmann–La Roche, Sanofi, Seagen, and PharmaMar. Dr. Tutt disclosed financial relationships with Artios, Gilead, MD Anderson, Merck KGaA, Pfizer, Vertex, AstraZeneca, EM Partners, Medscape Education, CRUK, Inbiomotion, Myriad Genetics, and Breast Cancer Now.

While poly (ADP-ribose) polymerase (PARP) inhibitors clearly show benefit in certain kinds of breast cancer, questions persist about ideal drug targets and the value of combining them with other medications, oncologists explained at the European Society for Medical Oncology Breast Cancer annual congress.

For now, the drugs are only approved in high-risk germline BRCA mutation (gBRCAmut) early breast cancer, oncologist Kevin Punie, MD, of Saint Augustine Hospital in Wilrijk, Belgium, said during a session at the meeting. Combining the drugs with chemotherapy “has not yet demonstrated significant benefits, and this is irrespective whether platinum was part of the chemotherapy backbone.”

PARP is a kind of enzyme that repairs damaged DNA in cells, especially cancerous ones. PARP inhibitors block the enzyme, potentially leading more cancer cells to die, the Dana-Farber Cancer Institute states.

In a separate presentation during the same session, oncologist Andrew Tutt, MBChB, PhD, noted that a study he led – a phase 3, double-blinded, randomized 2021 trial – found that patients with BRCA1- or BRCA2-mutated breast cancer who took the PARP inhibitor olarapib (Lynparza) versus placebo had improved outcomes on several measures, including 3-year invasive disease-free survival (85.9% vs. 77.1%, P < .001). However, the study noted that “olaparib had limited effects on global patient-reported quality of life.”

Dr. Tutt, of the Institute of Cancer Research, London, and Kings College London, said 57% of patients who took olarapib suffered nausea versus 24% of those who took placebo, and fatigue and anemia were also more common in the olarapib group. Anemia can be severe and lead to transfusions in some cases.

As Dr. Punie explained, there are many reasons to consider combining PARP inhibitors with other treatments such as chemotherapy, immunotherapy, and radiotherapy. The combinations may have synergetic effects, and they could have potential in both the neoadjuvant and adjuvant settings.

The combination of the PARP inhibitor olaparib and endocrine therapy is now approved by the European Medicines Agency for the adjuvant treatment of certain patients with germline BRCA1/2 mutations who have HER2-negative, high-risk early breast cancer, Dr. Punie noted.

The 2021 study led by Dr. Tutt reported that treatment or safety differences were found in those who received both olaparib and endocrine therapy versus those who only received olarapib.

So far, Dr. Punie said, “we not yet have enough clinical evidence to say that there’s really synergy between PNP inhibitors and other anticancer therapies.” According to the National Institutes of Health, medical synergy “describes the interaction of two or more drugs when their combined effect is greater than the sum of the effects seen when each drug is given alone.”

In regard to chemotherapy, it makes sense that PARP inhibitors would be helpful in combination, Dr. Punie said. DNA damage to cancer cells accumulates during chemotherapy, he said, and they’re more depending on PARP for repair.

Study results so far have been mixed. A 2022 study, for example, found that adding the experimental PARP inhibitor veliparib to the chemotherapy regimen carboplatin-paclitaxel didn’t improve outcomes, he said. A similar study examining the addition of olaparib to carboplatin-paclitaxel is ongoing.

As for combining radiotherapy and PARP inhibitors, Dr. Punie said that preclinical findings are promising, and research is underway. There’s also ongoing research into combining PARP inhibitors with immunotherapy.

Off-label use of olaparib with immunotherapy or sequential treatment may be appropriate in the setting of adjuvant gBRCAmut triple-negative breast cancer with residual disease, he said.

During his presentation, Dr. Tutt called for researchers to investigate the use of PARP inhibitors in the de-escalation of treatment in lower-risk gBRCAmut disease.

“Clearly, some patients require chemotherapy, and we know patients respond very well to neoadjuvant chemotherapy if they have a BRCA mutation, but we don’t yet know who we can de-escalate in,” he said.

He also highlighted the need to reduce anemia in patients on PARP inhibitors, “particularly if we’re moving into lower-risk populations or possibly considering prevention trials.

“The study of PARP inhibitor resistance ... is now urgent, so that we can address it,” he said.

Dr. Punie disclosed financial relationships with AstraZeneca, Eli Lilly, Exact Sciences, Focus Patient, Medscape, MSD, Mundi Pharma, Need, Novartis, Pierre Fabre, Pfizer, F. Hoffmann–La Roche, Sanofi, Seagen, and PharmaMar. Dr. Tutt disclosed financial relationships with Artios, Gilead, MD Anderson, Merck KGaA, Pfizer, Vertex, AstraZeneca, EM Partners, Medscape Education, CRUK, Inbiomotion, Myriad Genetics, and Breast Cancer Now.

While poly (ADP-ribose) polymerase (PARP) inhibitors clearly show benefit in certain kinds of breast cancer, questions persist about ideal drug targets and the value of combining them with other medications, oncologists explained at the European Society for Medical Oncology Breast Cancer annual congress.

For now, the drugs are only approved in high-risk germline BRCA mutation (gBRCAmut) early breast cancer, oncologist Kevin Punie, MD, of Saint Augustine Hospital in Wilrijk, Belgium, said during a session at the meeting. Combining the drugs with chemotherapy “has not yet demonstrated significant benefits, and this is irrespective whether platinum was part of the chemotherapy backbone.”

PARP is a kind of enzyme that repairs damaged DNA in cells, especially cancerous ones. PARP inhibitors block the enzyme, potentially leading more cancer cells to die, the Dana-Farber Cancer Institute states.

In a separate presentation during the same session, oncologist Andrew Tutt, MBChB, PhD, noted that a study he led – a phase 3, double-blinded, randomized 2021 trial – found that patients with BRCA1- or BRCA2-mutated breast cancer who took the PARP inhibitor olarapib (Lynparza) versus placebo had improved outcomes on several measures, including 3-year invasive disease-free survival (85.9% vs. 77.1%, P < .001). However, the study noted that “olaparib had limited effects on global patient-reported quality of life.”

Dr. Tutt, of the Institute of Cancer Research, London, and Kings College London, said 57% of patients who took olarapib suffered nausea versus 24% of those who took placebo, and fatigue and anemia were also more common in the olarapib group. Anemia can be severe and lead to transfusions in some cases.

As Dr. Punie explained, there are many reasons to consider combining PARP inhibitors with other treatments such as chemotherapy, immunotherapy, and radiotherapy. The combinations may have synergetic effects, and they could have potential in both the neoadjuvant and adjuvant settings.

The combination of the PARP inhibitor olaparib and endocrine therapy is now approved by the European Medicines Agency for the adjuvant treatment of certain patients with germline BRCA1/2 mutations who have HER2-negative, high-risk early breast cancer, Dr. Punie noted.

The 2021 study led by Dr. Tutt reported that treatment or safety differences were found in those who received both olaparib and endocrine therapy versus those who only received olarapib.

So far, Dr. Punie said, “we not yet have enough clinical evidence to say that there’s really synergy between PNP inhibitors and other anticancer therapies.” According to the National Institutes of Health, medical synergy “describes the interaction of two or more drugs when their combined effect is greater than the sum of the effects seen when each drug is given alone.”

In regard to chemotherapy, it makes sense that PARP inhibitors would be helpful in combination, Dr. Punie said. DNA damage to cancer cells accumulates during chemotherapy, he said, and they’re more depending on PARP for repair.

Study results so far have been mixed. A 2022 study, for example, found that adding the experimental PARP inhibitor veliparib to the chemotherapy regimen carboplatin-paclitaxel didn’t improve outcomes, he said. A similar study examining the addition of olaparib to carboplatin-paclitaxel is ongoing.

As for combining radiotherapy and PARP inhibitors, Dr. Punie said that preclinical findings are promising, and research is underway. There’s also ongoing research into combining PARP inhibitors with immunotherapy.

Off-label use of olaparib with immunotherapy or sequential treatment may be appropriate in the setting of adjuvant gBRCAmut triple-negative breast cancer with residual disease, he said.

During his presentation, Dr. Tutt called for researchers to investigate the use of PARP inhibitors in the de-escalation of treatment in lower-risk gBRCAmut disease.

“Clearly, some patients require chemotherapy, and we know patients respond very well to neoadjuvant chemotherapy if they have a BRCA mutation, but we don’t yet know who we can de-escalate in,” he said.

He also highlighted the need to reduce anemia in patients on PARP inhibitors, “particularly if we’re moving into lower-risk populations or possibly considering prevention trials.

“The study of PARP inhibitor resistance ... is now urgent, so that we can address it,” he said.

Dr. Punie disclosed financial relationships with AstraZeneca, Eli Lilly, Exact Sciences, Focus Patient, Medscape, MSD, Mundi Pharma, Need, Novartis, Pierre Fabre, Pfizer, F. Hoffmann–La Roche, Sanofi, Seagen, and PharmaMar. Dr. Tutt disclosed financial relationships with Artios, Gilead, MD Anderson, Merck KGaA, Pfizer, Vertex, AstraZeneca, EM Partners, Medscape Education, CRUK, Inbiomotion, Myriad Genetics, and Breast Cancer Now.

Radiotherapy followed by immunotherapy within 1-12 months – but not sooner or later – may boost progression-free survival in patients with metastatic non–small cell lung cancer, according to a new study. However, patients still fared poorly on average since overall survival remained low and didn’t change significantly.

While not conclusive, the new research – released at European Lung Cancer Congress 2023 – offers early insight into the best timing for the experimental combination treatment, study coauthor Yanyan Lou, MD, PhD, an oncologist at Mayo Clinic in Jacksonville, Fla., said in an interview.

The wide availability of radiation therapy could also allow the therapy to be administered even in regions with poor access to sophisticated medical care, she said. “Radiation is a very feasible approach that pretty much everybody in your community can get.”

Radiotherapy is typically not added to immunotherapy in patients with non–small cell lung cancer. But “there has been recent interest in the combination: Would tumor necrosis from radiation enhance the immunogenicity of the tumor and thus enhance the effect of immunotherapy?” oncologist Toby Campbell, MD, of University of Wisconsin–Madison, said in an interview.

Research has indeed suggested that the treatments may have a synergistic effect, he said, and it’s clear that “strategies to try and increase immunogenicity are an important area to investigate.”

But he cautioned that “we have a long way to go to understanding how immunogenicity works and how the gut microbiome, tumor, immunotherapy, and the immune system interact with one another.”

For the new study, researchers retrospectively analyzed cases of 225 patients with metastatic non–small cell lung cancer (male = 56%, median age = 68, 79% adenocarcinoma) who were treated with immunotherapy at Mayo Clinic–Jacksonville from 2011 to 2022. The study excluded those who received targeted therapy or prior concurrent chemoradiotherapy and durvalumab.

The most common metastases were bone and central nervous system types (41% and 25%, respectively). Fifty-six percent of patients received radiotherapy before or during immunotherapy. Another 27% never received radiotherapy, and 17% received it after immunotherapy was discontinued.

Common types of immunotherapy included pembrolizumab (78%), nivolumab (14%), and atezolizumab (12%).

Overall, the researchers found no statistically significant differences in various outcomes between patients who received radiotherapy before or during immunotherapy compared with those who didn’t get radiotherapy (progression-free survival: 5.9 vs. 5.5 months, P = .66; overall survival: 16.9 vs. 13.1 months, P = .84; immune-related adverse events: 26.2% vs. 34.4%, P = .24).

However, the researchers found that progression-free survival was significantly higher in one group: Those who received radiotherapy 1-12 months before immunotherapy vs. those who received it less than 1 month before (12.6 vs. 4.2 months, hazard ratio [HR], 0.46, 95% confidence interval [CI], 0.26-0.83, P = .005,) and those who never received radiotherapy (12.6 vs. 5.5 months, HR, 0.56, 95% CI, 0.36-0.89, P = .0197).

There wasn’t a statistically significant difference in overall survival.

The small number of subjects and the variation in treatment protocols may have prevented the study from revealing a survival benefit, Dr. Lou said.

As for adverse effects, she said a preliminary analysis didn’t turn up any.

It’s not clear why a 1- to 12-month gap between radiotherapy and immunotherapy may be most effective, she said. Moving forward, “we need validate this in a large cohort,” she noted.

In regard to cost, immunotherapy is notoriously expensive. Pembrolizumab, for example, has a list price of $10,897 per 200-mg dose given every 3 weeks, and patients may take the drug for a year or two.

Dr. Campbell, who didn’t take part in the new study, said it suggests that research into radiation-immunotherapy combination treatment may be worthwhile.

No funding was reported. The study authors and Dr. Campbell reported no disclosures.

Radiotherapy followed by immunotherapy within 1-12 months – but not sooner or later – may boost progression-free survival in patients with metastatic non–small cell lung cancer, according to a new study. However, patients still fared poorly on average since overall survival remained low and didn’t change significantly.

While not conclusive, the new research – released at European Lung Cancer Congress 2023 – offers early insight into the best timing for the experimental combination treatment, study coauthor Yanyan Lou, MD, PhD, an oncologist at Mayo Clinic in Jacksonville, Fla., said in an interview.

The wide availability of radiation therapy could also allow the therapy to be administered even in regions with poor access to sophisticated medical care, she said. “Radiation is a very feasible approach that pretty much everybody in your community can get.”

Radiotherapy is typically not added to immunotherapy in patients with non–small cell lung cancer. But “there has been recent interest in the combination: Would tumor necrosis from radiation enhance the immunogenicity of the tumor and thus enhance the effect of immunotherapy?” oncologist Toby Campbell, MD, of University of Wisconsin–Madison, said in an interview.

Research has indeed suggested that the treatments may have a synergistic effect, he said, and it’s clear that “strategies to try and increase immunogenicity are an important area to investigate.”

But he cautioned that “we have a long way to go to understanding how immunogenicity works and how the gut microbiome, tumor, immunotherapy, and the immune system interact with one another.”

For the new study, researchers retrospectively analyzed cases of 225 patients with metastatic non–small cell lung cancer (male = 56%, median age = 68, 79% adenocarcinoma) who were treated with immunotherapy at Mayo Clinic–Jacksonville from 2011 to 2022. The study excluded those who received targeted therapy or prior concurrent chemoradiotherapy and durvalumab.

The most common metastases were bone and central nervous system types (41% and 25%, respectively). Fifty-six percent of patients received radiotherapy before or during immunotherapy. Another 27% never received radiotherapy, and 17% received it after immunotherapy was discontinued.

Common types of immunotherapy included pembrolizumab (78%), nivolumab (14%), and atezolizumab (12%).

Overall, the researchers found no statistically significant differences in various outcomes between patients who received radiotherapy before or during immunotherapy compared with those who didn’t get radiotherapy (progression-free survival: 5.9 vs. 5.5 months, P = .66; overall survival: 16.9 vs. 13.1 months, P = .84; immune-related adverse events: 26.2% vs. 34.4%, P = .24).

However, the researchers found that progression-free survival was significantly higher in one group: Those who received radiotherapy 1-12 months before immunotherapy vs. those who received it less than 1 month before (12.6 vs. 4.2 months, hazard ratio [HR], 0.46, 95% confidence interval [CI], 0.26-0.83, P = .005,) and those who never received radiotherapy (12.6 vs. 5.5 months, HR, 0.56, 95% CI, 0.36-0.89, P = .0197).

There wasn’t a statistically significant difference in overall survival.

The small number of subjects and the variation in treatment protocols may have prevented the study from revealing a survival benefit, Dr. Lou said.

As for adverse effects, she said a preliminary analysis didn’t turn up any.

It’s not clear why a 1- to 12-month gap between radiotherapy and immunotherapy may be most effective, she said. Moving forward, “we need validate this in a large cohort,” she noted.

In regard to cost, immunotherapy is notoriously expensive. Pembrolizumab, for example, has a list price of $10,897 per 200-mg dose given every 3 weeks, and patients may take the drug for a year or two.

Dr. Campbell, who didn’t take part in the new study, said it suggests that research into radiation-immunotherapy combination treatment may be worthwhile.

No funding was reported. The study authors and Dr. Campbell reported no disclosures.

Radiotherapy followed by immunotherapy within 1-12 months – but not sooner or later – may boost progression-free survival in patients with metastatic non–small cell lung cancer, according to a new study. However, patients still fared poorly on average since overall survival remained low and didn’t change significantly.

While not conclusive, the new research – released at European Lung Cancer Congress 2023 – offers early insight into the best timing for the experimental combination treatment, study coauthor Yanyan Lou, MD, PhD, an oncologist at Mayo Clinic in Jacksonville, Fla., said in an interview.

The wide availability of radiation therapy could also allow the therapy to be administered even in regions with poor access to sophisticated medical care, she said. “Radiation is a very feasible approach that pretty much everybody in your community can get.”

Radiotherapy is typically not added to immunotherapy in patients with non–small cell lung cancer. But “there has been recent interest in the combination: Would tumor necrosis from radiation enhance the immunogenicity of the tumor and thus enhance the effect of immunotherapy?” oncologist Toby Campbell, MD, of University of Wisconsin–Madison, said in an interview.

Research has indeed suggested that the treatments may have a synergistic effect, he said, and it’s clear that “strategies to try and increase immunogenicity are an important area to investigate.”

But he cautioned that “we have a long way to go to understanding how immunogenicity works and how the gut microbiome, tumor, immunotherapy, and the immune system interact with one another.”

For the new study, researchers retrospectively analyzed cases of 225 patients with metastatic non–small cell lung cancer (male = 56%, median age = 68, 79% adenocarcinoma) who were treated with immunotherapy at Mayo Clinic–Jacksonville from 2011 to 2022. The study excluded those who received targeted therapy or prior concurrent chemoradiotherapy and durvalumab.

The most common metastases were bone and central nervous system types (41% and 25%, respectively). Fifty-six percent of patients received radiotherapy before or during immunotherapy. Another 27% never received radiotherapy, and 17% received it after immunotherapy was discontinued.

Common types of immunotherapy included pembrolizumab (78%), nivolumab (14%), and atezolizumab (12%).

Overall, the researchers found no statistically significant differences in various outcomes between patients who received radiotherapy before or during immunotherapy compared with those who didn’t get radiotherapy (progression-free survival: 5.9 vs. 5.5 months, P = .66; overall survival: 16.9 vs. 13.1 months, P = .84; immune-related adverse events: 26.2% vs. 34.4%, P = .24).

However, the researchers found that progression-free survival was significantly higher in one group: Those who received radiotherapy 1-12 months before immunotherapy vs. those who received it less than 1 month before (12.6 vs. 4.2 months, hazard ratio [HR], 0.46, 95% confidence interval [CI], 0.26-0.83, P = .005,) and those who never received radiotherapy (12.6 vs. 5.5 months, HR, 0.56, 95% CI, 0.36-0.89, P = .0197).

There wasn’t a statistically significant difference in overall survival.

The small number of subjects and the variation in treatment protocols may have prevented the study from revealing a survival benefit, Dr. Lou said.

As for adverse effects, she said a preliminary analysis didn’t turn up any.

It’s not clear why a 1- to 12-month gap between radiotherapy and immunotherapy may be most effective, she said. Moving forward, “we need validate this in a large cohort,” she noted.

In regard to cost, immunotherapy is notoriously expensive. Pembrolizumab, for example, has a list price of $10,897 per 200-mg dose given every 3 weeks, and patients may take the drug for a year or two.

Dr. Campbell, who didn’t take part in the new study, said it suggests that research into radiation-immunotherapy combination treatment may be worthwhile.

No funding was reported. The study authors and Dr. Campbell reported no disclosures.

A new report offers more insight into the connection between cumulative smoking levels and lung cancer.

People who have smoked an average of 1 pack a day for 20-39 years tripled their tumor risk versus less-heavy smokers and 30-fold versus those who never smoked. For those who smoked the equivalent of 1 pack for 40-60 years, or 2 packs for 20-30 years, the risk levels grew by fourfold and 40-fold, respectively. For those who’ve smoked even more, the likelihood of developing lung cancer is high, but the risk remains stable and doesn’t grow more over time, according to the analysis.

The report, released at the annual European Lung Cancer Congress 2023 meeting, and an earlier related study “underscore the importance of smoking abstinence and early smoking cessation,” said study lead author J. Anthony Nations, MD, MBA, in an interview.

The earlier study, published in JAMA Oncology, relied on a “pack-year” analysis to evaluate the risk of lung cancer in smokers. A pack-year refers to the cigarette use of a person who smoked a pack a day for 1 year. It’s the equivalent of smoking half a pack for 2 years or 2 packs for 6 months.

By this measure, a smoker with 20 pack-years of cigarette use smoked the equivalent of a pack a day for 20 years or 2 packs a day for 10 years. U.S. guidelines recommend annual low-dose CT lung cancer screening in adults who are aged 50-80, have more than 20 pack-years of tobacco exposure, and either currently smoke or quit within the last 15 years.

The JAMA Oncology report “showed that, compared with never-smokers, current heavy and nonheavy smokers had [a] 40 and 10 times higher risk of lung cancer, respectively,” said Dr. Nations, who is also a pulmonologist with Washington D.C. Veterans Affairs Medical Center. “A smoking history of greater than 20 pack-years was considered heavy, but current heavy smokers had a median pack-year smoking history of 50 pack-years. This observation prompted us to want to look more closely at pack-year smoking history.”

For the new analysis, researchers tracked 2,505 older adults (mean age, 73 ± 5.7 years; 69% women, 17% African American) in the Cardiovascular Health Study. Of those, 532 were current smokers (18% less than 20 pack-years, 30% 20-39 pack-years, 34% 40–59 pack-years, and 18% greater than 60 pack-years).

Lung cancer occurred in 0.5% of those who never smoked, 5% of those who smoked less than 20 pack-years, 14.6% of those who smoked 20-39 pack-years, 17.7% of those who smoked 40-59 pack-years, and 16.0% for those who smoked more than 60 pack-years. In an analysis adjusted for age, sex, race, and competing risk of death, researchers found that those who smoked less than 20 pack-years were 9.73 times more likely to develop lung cancer than those who never smoked (hazard ratio, 9.73). The HRs of lung cancer versus never-smokers for the other groups were 30.33 (20-39 pack-years), 42.97 (40-59 pack-years), and 46.02 (greater than 60 pack-years.).

“While it was not surprising that the risk of lung cancer in current heavy smokers would be proportionately greater in smokers with higher pack-year smoking history, we were surprised to see that the risk almost plateaued in the heaviest current smokers,” Dr. Nations said.

As for the clinical message from the findings, Dr. Nations said they reveal that quitting smoking makes a difference in lung cancer risk, even after many years of heavy smoking. “Smokers who quit after a 30–pack-year smoking history will not incur the higher risk of those with a 40– or 50–pack-year smoking history.”

The previous JAMA Oncology paper also showed that quitting pays dividends by reducing lung cancer risk. Subjects with at least 20 pack-years of smoking who quit less than 15 years ago nearly halved their excess risk of lung cancer, compared with similar current smokers who didn’t quit.

In an interview, cancer researcher Robert J. Volk, PhD, of the University of Texas MD Anderson Cancer Center, Houston, praised the new analysis but noted that it has limitations: “The sample is fairly small – 532 adults who currently smoke – and the subgroups based on pack-years are even smaller.”

No study funding is reported. The study authors and Dr. Volk reported no disclosures.

*This article was updated on 4/17/23.

A new report offers more insight into the connection between cumulative smoking levels and lung cancer.

People who have smoked an average of 1 pack a day for 20-39 years tripled their tumor risk versus less-heavy smokers and 30-fold versus those who never smoked. For those who smoked the equivalent of 1 pack for 40-60 years, or 2 packs for 20-30 years, the risk levels grew by fourfold and 40-fold, respectively. For those who’ve smoked even more, the likelihood of developing lung cancer is high, but the risk remains stable and doesn’t grow more over time, according to the analysis.

The report, released at the annual European Lung Cancer Congress 2023 meeting, and an earlier related study “underscore the importance of smoking abstinence and early smoking cessation,” said study lead author J. Anthony Nations, MD, MBA, in an interview.

The earlier study, published in JAMA Oncology, relied on a “pack-year” analysis to evaluate the risk of lung cancer in smokers. A pack-year refers to the cigarette use of a person who smoked a pack a day for 1 year. It’s the equivalent of smoking half a pack for 2 years or 2 packs for 6 months.

By this measure, a smoker with 20 pack-years of cigarette use smoked the equivalent of a pack a day for 20 years or 2 packs a day for 10 years. U.S. guidelines recommend annual low-dose CT lung cancer screening in adults who are aged 50-80, have more than 20 pack-years of tobacco exposure, and either currently smoke or quit within the last 15 years.

The JAMA Oncology report “showed that, compared with never-smokers, current heavy and nonheavy smokers had [a] 40 and 10 times higher risk of lung cancer, respectively,” said Dr. Nations, who is also a pulmonologist with Washington D.C. Veterans Affairs Medical Center. “A smoking history of greater than 20 pack-years was considered heavy, but current heavy smokers had a median pack-year smoking history of 50 pack-years. This observation prompted us to want to look more closely at pack-year smoking history.”

For the new analysis, researchers tracked 2,505 older adults (mean age, 73 ± 5.7 years; 69% women, 17% African American) in the Cardiovascular Health Study. Of those, 532 were current smokers (18% less than 20 pack-years, 30% 20-39 pack-years, 34% 40–59 pack-years, and 18% greater than 60 pack-years).

Lung cancer occurred in 0.5% of those who never smoked, 5% of those who smoked less than 20 pack-years, 14.6% of those who smoked 20-39 pack-years, 17.7% of those who smoked 40-59 pack-years, and 16.0% for those who smoked more than 60 pack-years. In an analysis adjusted for age, sex, race, and competing risk of death, researchers found that those who smoked less than 20 pack-years were 9.73 times more likely to develop lung cancer than those who never smoked (hazard ratio, 9.73). The HRs of lung cancer versus never-smokers for the other groups were 30.33 (20-39 pack-years), 42.97 (40-59 pack-years), and 46.02 (greater than 60 pack-years.).

“While it was not surprising that the risk of lung cancer in current heavy smokers would be proportionately greater in smokers with higher pack-year smoking history, we were surprised to see that the risk almost plateaued in the heaviest current smokers,” Dr. Nations said.

As for the clinical message from the findings, Dr. Nations said they reveal that quitting smoking makes a difference in lung cancer risk, even after many years of heavy smoking. “Smokers who quit after a 30–pack-year smoking history will not incur the higher risk of those with a 40– or 50–pack-year smoking history.”

The previous JAMA Oncology paper also showed that quitting pays dividends by reducing lung cancer risk. Subjects with at least 20 pack-years of smoking who quit less than 15 years ago nearly halved their excess risk of lung cancer, compared with similar current smokers who didn’t quit.

In an interview, cancer researcher Robert J. Volk, PhD, of the University of Texas MD Anderson Cancer Center, Houston, praised the new analysis but noted that it has limitations: “The sample is fairly small – 532 adults who currently smoke – and the subgroups based on pack-years are even smaller.”

No study funding is reported. The study authors and Dr. Volk reported no disclosures.

*This article was updated on 4/17/23.

A new report offers more insight into the connection between cumulative smoking levels and lung cancer.

People who have smoked an average of 1 pack a day for 20-39 years tripled their tumor risk versus less-heavy smokers and 30-fold versus those who never smoked. For those who smoked the equivalent of 1 pack for 40-60 years, or 2 packs for 20-30 years, the risk levels grew by fourfold and 40-fold, respectively. For those who’ve smoked even more, the likelihood of developing lung cancer is high, but the risk remains stable and doesn’t grow more over time, according to the analysis.

The report, released at the annual European Lung Cancer Congress 2023 meeting, and an earlier related study “underscore the importance of smoking abstinence and early smoking cessation,” said study lead author J. Anthony Nations, MD, MBA, in an interview.

The earlier study, published in JAMA Oncology, relied on a “pack-year” analysis to evaluate the risk of lung cancer in smokers. A pack-year refers to the cigarette use of a person who smoked a pack a day for 1 year. It’s the equivalent of smoking half a pack for 2 years or 2 packs for 6 months.

By this measure, a smoker with 20 pack-years of cigarette use smoked the equivalent of a pack a day for 20 years or 2 packs a day for 10 years. U.S. guidelines recommend annual low-dose CT lung cancer screening in adults who are aged 50-80, have more than 20 pack-years of tobacco exposure, and either currently smoke or quit within the last 15 years.

The JAMA Oncology report “showed that, compared with never-smokers, current heavy and nonheavy smokers had [a] 40 and 10 times higher risk of lung cancer, respectively,” said Dr. Nations, who is also a pulmonologist with Washington D.C. Veterans Affairs Medical Center. “A smoking history of greater than 20 pack-years was considered heavy, but current heavy smokers had a median pack-year smoking history of 50 pack-years. This observation prompted us to want to look more closely at pack-year smoking history.”

For the new analysis, researchers tracked 2,505 older adults (mean age, 73 ± 5.7 years; 69% women, 17% African American) in the Cardiovascular Health Study. Of those, 532 were current smokers (18% less than 20 pack-years, 30% 20-39 pack-years, 34% 40–59 pack-years, and 18% greater than 60 pack-years).

Lung cancer occurred in 0.5% of those who never smoked, 5% of those who smoked less than 20 pack-years, 14.6% of those who smoked 20-39 pack-years, 17.7% of those who smoked 40-59 pack-years, and 16.0% for those who smoked more than 60 pack-years. In an analysis adjusted for age, sex, race, and competing risk of death, researchers found that those who smoked less than 20 pack-years were 9.73 times more likely to develop lung cancer than those who never smoked (hazard ratio, 9.73). The HRs of lung cancer versus never-smokers for the other groups were 30.33 (20-39 pack-years), 42.97 (40-59 pack-years), and 46.02 (greater than 60 pack-years.).

“While it was not surprising that the risk of lung cancer in current heavy smokers would be proportionately greater in smokers with higher pack-year smoking history, we were surprised to see that the risk almost plateaued in the heaviest current smokers,” Dr. Nations said.

As for the clinical message from the findings, Dr. Nations said they reveal that quitting smoking makes a difference in lung cancer risk, even after many years of heavy smoking. “Smokers who quit after a 30–pack-year smoking history will not incur the higher risk of those with a 40– or 50–pack-year smoking history.”

The previous JAMA Oncology paper also showed that quitting pays dividends by reducing lung cancer risk. Subjects with at least 20 pack-years of smoking who quit less than 15 years ago nearly halved their excess risk of lung cancer, compared with similar current smokers who didn’t quit.

In an interview, cancer researcher Robert J. Volk, PhD, of the University of Texas MD Anderson Cancer Center, Houston, praised the new analysis but noted that it has limitations: “The sample is fairly small – 532 adults who currently smoke – and the subgroups based on pack-years are even smaller.”

No study funding is reported. The study authors and Dr. Volk reported no disclosures.

*This article was updated on 4/17/23.

A new analysis suggests that the initial target of therapy – lung or brain – doesn’t affect overall survival rates in patients with non–small cell lung cancer that has spread to the brain.

“The findings of our study highlight the importance of adopting a personalized, case-based approach when treating each patient” instead of always treating the brain or lung first, lead author Arvind Kumar, a medical student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.

The study was released at European Lung Cancer Congress 2023.

According to the author, current guidelines recommend treating the brain first in patients with non–small cell lung cancer and a tumor that has spread to the brain.

“Determining whether the brain or body gets treated first depends on where the symptoms are coming from, how severe the symptoms are, how bulky the disease is, and how long the treatment to each is expected to take,” radiation oncologist Henry S. Park, MD, MPH, chief of the thoracic radiotherapy program at Yale University, New Haven, Conn., said in an interview. “Often the brain is treated first since surgery is used for both diagnosis of metastatic disease as well as removal of the brain metastasis, especially if it is causing symptoms. The radiosurgery that follows tends to occur within a day or a few days.”

However, he said, “if the brain disease is small and not causing symptoms, and the lung disease is more problematic, then we will often treat the body first and fit in the brain treatment later.”

For the new study, researchers identified 1,044 patients in the National Cancer Database with non–small cell lung cancer and brain metastases who received systemic therapy plus surgery, brain stereotactic radiosurgery, or lung radiation. All were treated from 2010 to 2019; 79.0% received brain treatment first, and the other 21.0% received lung treatment first.

There was no statistically significant difference in overall survival between those whose brains were treated first and those whose lungs were treated first (hazard ratio, 1.24, 95% confidence interval [CI], 0.91-1.70, P = .17). A propensity score–matched analysis turned up no difference in 5-year survival (38.2% of those whose brains were treated first, 95% CI, 27.5-34.4, vs. 38.0% of those whose lungs were treated first, 95% CI, 29.9-44.7, P = .32.)

“These results were consistent regardless of which combination of treatment modalities the patient received – neurosurgery versus brain stereotactic radiosurgery, thoracic surgery versus thoracic radiation,” the author said.

He cautioned that “our study only included patients who were considered candidates for either surgery or radiation to both the brain and lung. The results of our study should therefore be cautiously interpreted for patients who may have contraindications to such treatment.”

Dr. Park, who didn’t take part in the study, said “the results are consistent with what I would generally expect.”

He added: “The take-home message for clinicians should be that there is no one correct answer in how to manage non–small cell lung cancer with synchronous limited metastatic disease in only the brain. If the brain disease is bulky and/or causes symptoms while the body disease isn’t – or if a biopsy or surgery is required to prove that the patient in fact has metastatic disease – then the brain disease should be treated first. On the other hand, if the body disease is bulky and/or causing symptoms while the brain disease isn’t – and there is no need for surgery but rather only a biopsy of the brain – then the body disease can be treated first.”

No funding was reported. The study authors and Dr. Park reported no financial conflicts or other disclosures.

A new analysis suggests that the initial target of therapy – lung or brain – doesn’t affect overall survival rates in patients with non–small cell lung cancer that has spread to the brain.

“The findings of our study highlight the importance of adopting a personalized, case-based approach when treating each patient” instead of always treating the brain or lung first, lead author Arvind Kumar, a medical student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.

The study was released at European Lung Cancer Congress 2023.

According to the author, current guidelines recommend treating the brain first in patients with non–small cell lung cancer and a tumor that has spread to the brain.

“Determining whether the brain or body gets treated first depends on where the symptoms are coming from, how severe the symptoms are, how bulky the disease is, and how long the treatment to each is expected to take,” radiation oncologist Henry S. Park, MD, MPH, chief of the thoracic radiotherapy program at Yale University, New Haven, Conn., said in an interview. “Often the brain is treated first since surgery is used for both diagnosis of metastatic disease as well as removal of the brain metastasis, especially if it is causing symptoms. The radiosurgery that follows tends to occur within a day or a few days.”

However, he said, “if the brain disease is small and not causing symptoms, and the lung disease is more problematic, then we will often treat the body first and fit in the brain treatment later.”

For the new study, researchers identified 1,044 patients in the National Cancer Database with non–small cell lung cancer and brain metastases who received systemic therapy plus surgery, brain stereotactic radiosurgery, or lung radiation. All were treated from 2010 to 2019; 79.0% received brain treatment first, and the other 21.0% received lung treatment first.

There was no statistically significant difference in overall survival between those whose brains were treated first and those whose lungs were treated first (hazard ratio, 1.24, 95% confidence interval [CI], 0.91-1.70, P = .17). A propensity score–matched analysis turned up no difference in 5-year survival (38.2% of those whose brains were treated first, 95% CI, 27.5-34.4, vs. 38.0% of those whose lungs were treated first, 95% CI, 29.9-44.7, P = .32.)

“These results were consistent regardless of which combination of treatment modalities the patient received – neurosurgery versus brain stereotactic radiosurgery, thoracic surgery versus thoracic radiation,” the author said.

He cautioned that “our study only included patients who were considered candidates for either surgery or radiation to both the brain and lung. The results of our study should therefore be cautiously interpreted for patients who may have contraindications to such treatment.”

Dr. Park, who didn’t take part in the study, said “the results are consistent with what I would generally expect.”

He added: “The take-home message for clinicians should be that there is no one correct answer in how to manage non–small cell lung cancer with synchronous limited metastatic disease in only the brain. If the brain disease is bulky and/or causes symptoms while the body disease isn’t – or if a biopsy or surgery is required to prove that the patient in fact has metastatic disease – then the brain disease should be treated first. On the other hand, if the body disease is bulky and/or causing symptoms while the brain disease isn’t – and there is no need for surgery but rather only a biopsy of the brain – then the body disease can be treated first.”

No funding was reported. The study authors and Dr. Park reported no financial conflicts or other disclosures.

A new analysis suggests that the initial target of therapy – lung or brain – doesn’t affect overall survival rates in patients with non–small cell lung cancer that has spread to the brain.

“The findings of our study highlight the importance of adopting a personalized, case-based approach when treating each patient” instead of always treating the brain or lung first, lead author Arvind Kumar, a medical student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.

The study was released at European Lung Cancer Congress 2023.

According to the author, current guidelines recommend treating the brain first in patients with non–small cell lung cancer and a tumor that has spread to the brain.

“Determining whether the brain or body gets treated first depends on where the symptoms are coming from, how severe the symptoms are, how bulky the disease is, and how long the treatment to each is expected to take,” radiation oncologist Henry S. Park, MD, MPH, chief of the thoracic radiotherapy program at Yale University, New Haven, Conn., said in an interview. “Often the brain is treated first since surgery is used for both diagnosis of metastatic disease as well as removal of the brain metastasis, especially if it is causing symptoms. The radiosurgery that follows tends to occur within a day or a few days.”

However, he said, “if the brain disease is small and not causing symptoms, and the lung disease is more problematic, then we will often treat the body first and fit in the brain treatment later.”

For the new study, researchers identified 1,044 patients in the National Cancer Database with non–small cell lung cancer and brain metastases who received systemic therapy plus surgery, brain stereotactic radiosurgery, or lung radiation. All were treated from 2010 to 2019; 79.0% received brain treatment first, and the other 21.0% received lung treatment first.

There was no statistically significant difference in overall survival between those whose brains were treated first and those whose lungs were treated first (hazard ratio, 1.24, 95% confidence interval [CI], 0.91-1.70, P = .17). A propensity score–matched analysis turned up no difference in 5-year survival (38.2% of those whose brains were treated first, 95% CI, 27.5-34.4, vs. 38.0% of those whose lungs were treated first, 95% CI, 29.9-44.7, P = .32.)

“These results were consistent regardless of which combination of treatment modalities the patient received – neurosurgery versus brain stereotactic radiosurgery, thoracic surgery versus thoracic radiation,” the author said.

He cautioned that “our study only included patients who were considered candidates for either surgery or radiation to both the brain and lung. The results of our study should therefore be cautiously interpreted for patients who may have contraindications to such treatment.”

Dr. Park, who didn’t take part in the study, said “the results are consistent with what I would generally expect.”

He added: “The take-home message for clinicians should be that there is no one correct answer in how to manage non–small cell lung cancer with synchronous limited metastatic disease in only the brain. If the brain disease is bulky and/or causes symptoms while the body disease isn’t – or if a biopsy or surgery is required to prove that the patient in fact has metastatic disease – then the brain disease should be treated first. On the other hand, if the body disease is bulky and/or causing symptoms while the brain disease isn’t – and there is no need for surgery but rather only a biopsy of the brain – then the body disease can be treated first.”

No funding was reported. The study authors and Dr. Park reported no financial conflicts or other disclosures.

At a single robotic-assisted pulmonary lobectomy center, patients with public insurance or combined public and private insurance fared worse than those with private insurance, according to a new retrospective analysis.

The study used public insurance status as a marker for low socioeconomic status (SES) and suggests that patients with combined insurance may constitute a separate population that deserves more attention.

Lower SES has been linked to later stage diagnoses and worse outcomes in NSCLC. Private insurance is a generally-accepted indicator of higher SES, while public insurance like Medicare or Medicaid, alone or in combination with private supplementary insurance, is an indicator of lower SES.

Although previous studies have found associations between patients having public health insurance and experiencing later-stage diagnoses and worse overall survival, there have been few studies of surgical outcomes, and almost no research has examined combination health insurance, according to Allison O. Dumitriu Carcoana, who presented the research during a poster session at the European Lung Cancer Congress 2023.

“This is an important insurance subgroup for us because the majority of our patients fall into this subgroup by being over 65 years old and thus qualifying for Medicare while also paying for a private supplement,” said Ms. Dumitriu Carcoana, who is a medical student at University of South Florida Health Morsani College of Medicine, Tampa.

A previous analysis by the group found an association between private insurance status and better discharge status, as well as higher 5-year overall survival. After accumulating an additional 278 patients, the researchers examined 10-year survival outcomes.

In the new analysis, 52% of 711 participants had combination insurance, while 28% had private insurance, and 20% had public insurance. The subgroups all had similar demographic and histological characteristics. The study was unique in that it found no between-group differences in higher stage at diagnosis, whereas previous studies have found a greater risk of higher stage diagnosis among individuals with public insurance. As expected, patients in the combined insurance group had a higher mean age (P less than .0001) and higher Charlson comorbidity index scores (P = .0014), which in turn was associated with lower 10-year survival. The group also had the highest percentage of former smokers, while the public insurance group had the highest percentage of current smokers (P = .0003).

At both 5 and 10 years, the private insurance group had better OS than the group with public (P less than .001) and the combination insurance group (P = .08). Public health insurance was associated with worse OS at 5 years (hazard ratio, 1.83; P less than .005) but not at 10 years (HR, 1.18; P = .51), while combination insurance was associated with worse OS at 10 years (HR, 1.72; P = .02).

“We think that patients with public health insurance having the worst 5-year overall survival, despite their lower ages and fewer comorbid conditions, compared with patients with combination insurance, highlights the impact of lower socioeconomic status on health outcomes. These patients had the same tumor characteristics, BMI, sex, and race as our patients in the other two insurance groups. The only other significant risk factor [the group had besides having a higher proportion of patients with lower socioeconomic status was that it had a higher proportion of current smokers]. But the multivariate analyses showed that insurance status was an independent predictor of survival, regardless of smoking status or other comorbidities,” said Ms. Dumitriu Carcoana.

“At 10 years post-operatively, the survival curves have shifted and the combination patients had the worst 10-year overall survival. We attribute this to their higher number of comorbid conditions and increased age. In practice, [this means that] the group of patients with public insurance type, but no supplement, should be identified clinically, and the clinical team can initiate a discussion,” Ms. Dumitriu Carcoana said.

“Do these patients feel that they can make follow-up appointments, keep up with medication costs, and make the right lifestyle decisions postoperatively on their current insurance plan? If not, can they afford a private supplement? In our cohort specifically, it may also be important to do more preoperative counseling on the importance of smoking cessation,” she added.

The study is interesting, but it has some important limitations, according to Raja Flores, MD, who was not involved with the study. The authors stated that there was no difference between the insurance groups with respect to mortality or cancer stage, which is the most important predictor of survival. However, the poster didn't include details of the authors' analysis, making it difficult to interpret, Dr. Flores said.

The fact that the study includes a single surgeon has some disadvantages in terms of broader applicability, but it also controls for surgical technique. “Different surgeons have different ways of doing things, so if you had the same surgeon doing it the same way every time, you can look at other variables like insurance (status) and stage,” said Dr. Flores.

The results may also provide an argument against using robotic surgery in patients who do not have insurance, especially since they have not been proven to be better than standard minimally invasive surgery with no robotic assistance. With uninsured patients, “you’re using taxpayer money for a more expensive procedure that isn’t proving to be any better,” Dr. Flores explained.

The study was performed at a single center and cannot prove causation due to its retrospective nature.

Ms. Dumitriu Carcoana and Dr. Flores have no relevant financial disclosures.

*This article was updated on 4/13/2023.

At a single robotic-assisted pulmonary lobectomy center, patients with public insurance or combined public and private insurance fared worse than those with private insurance, according to a new retrospective analysis.

The study used public insurance status as a marker for low socioeconomic status (SES) and suggests that patients with combined insurance may constitute a separate population that deserves more attention.

Lower SES has been linked to later stage diagnoses and worse outcomes in NSCLC. Private insurance is a generally-accepted indicator of higher SES, while public insurance like Medicare or Medicaid, alone or in combination with private supplementary insurance, is an indicator of lower SES.

Although previous studies have found associations between patients having public health insurance and experiencing later-stage diagnoses and worse overall survival, there have been few studies of surgical outcomes, and almost no research has examined combination health insurance, according to Allison O. Dumitriu Carcoana, who presented the research during a poster session at the European Lung Cancer Congress 2023.

“This is an important insurance subgroup for us because the majority of our patients fall into this subgroup by being over 65 years old and thus qualifying for Medicare while also paying for a private supplement,” said Ms. Dumitriu Carcoana, who is a medical student at University of South Florida Health Morsani College of Medicine, Tampa.

A previous analysis by the group found an association between private insurance status and better discharge status, as well as higher 5-year overall survival. After accumulating an additional 278 patients, the researchers examined 10-year survival outcomes.

In the new analysis, 52% of 711 participants had combination insurance, while 28% had private insurance, and 20% had public insurance. The subgroups all had similar demographic and histological characteristics. The study was unique in that it found no between-group differences in higher stage at diagnosis, whereas previous studies have found a greater risk of higher stage diagnosis among individuals with public insurance. As expected, patients in the combined insurance group had a higher mean age (P less than .0001) and higher Charlson comorbidity index scores (P = .0014), which in turn was associated with lower 10-year survival. The group also had the highest percentage of former smokers, while the public insurance group had the highest percentage of current smokers (P = .0003).

At both 5 and 10 years, the private insurance group had better OS than the group with public (P less than .001) and the combination insurance group (P = .08). Public health insurance was associated with worse OS at 5 years (hazard ratio, 1.83; P less than .005) but not at 10 years (HR, 1.18; P = .51), while combination insurance was associated with worse OS at 10 years (HR, 1.72; P = .02).

“We think that patients with public health insurance having the worst 5-year overall survival, despite their lower ages and fewer comorbid conditions, compared with patients with combination insurance, highlights the impact of lower socioeconomic status on health outcomes. These patients had the same tumor characteristics, BMI, sex, and race as our patients in the other two insurance groups. The only other significant risk factor [the group had besides having a higher proportion of patients with lower socioeconomic status was that it had a higher proportion of current smokers]. But the multivariate analyses showed that insurance status was an independent predictor of survival, regardless of smoking status or other comorbidities,” said Ms. Dumitriu Carcoana.

“At 10 years post-operatively, the survival curves have shifted and the combination patients had the worst 10-year overall survival. We attribute this to their higher number of comorbid conditions and increased age. In practice, [this means that] the group of patients with public insurance type, but no supplement, should be identified clinically, and the clinical team can initiate a discussion,” Ms. Dumitriu Carcoana said.

“Do these patients feel that they can make follow-up appointments, keep up with medication costs, and make the right lifestyle decisions postoperatively on their current insurance plan? If not, can they afford a private supplement? In our cohort specifically, it may also be important to do more preoperative counseling on the importance of smoking cessation,” she added.

The study is interesting, but it has some important limitations, according to Raja Flores, MD, who was not involved with the study. The authors stated that there was no difference between the insurance groups with respect to mortality or cancer stage, which is the most important predictor of survival. However, the poster didn't include details of the authors' analysis, making it difficult to interpret, Dr. Flores said.

The fact that the study includes a single surgeon has some disadvantages in terms of broader applicability, but it also controls for surgical technique. “Different surgeons have different ways of doing things, so if you had the same surgeon doing it the same way every time, you can look at other variables like insurance (status) and stage,” said Dr. Flores.

The results may also provide an argument against using robotic surgery in patients who do not have insurance, especially since they have not been proven to be better than standard minimally invasive surgery with no robotic assistance. With uninsured patients, “you’re using taxpayer money for a more expensive procedure that isn’t proving to be any better,” Dr. Flores explained.

The study was performed at a single center and cannot prove causation due to its retrospective nature.

Ms. Dumitriu Carcoana and Dr. Flores have no relevant financial disclosures.

*This article was updated on 4/13/2023.

At a single robotic-assisted pulmonary lobectomy center, patients with public insurance or combined public and private insurance fared worse than those with private insurance, according to a new retrospective analysis.

The study used public insurance status as a marker for low socioeconomic status (SES) and suggests that patients with combined insurance may constitute a separate population that deserves more attention.

Lower SES has been linked to later stage diagnoses and worse outcomes in NSCLC. Private insurance is a generally-accepted indicator of higher SES, while public insurance like Medicare or Medicaid, alone or in combination with private supplementary insurance, is an indicator of lower SES.

Although previous studies have found associations between patients having public health insurance and experiencing later-stage diagnoses and worse overall survival, there have been few studies of surgical outcomes, and almost no research has examined combination health insurance, according to Allison O. Dumitriu Carcoana, who presented the research during a poster session at the European Lung Cancer Congress 2023.

“This is an important insurance subgroup for us because the majority of our patients fall into this subgroup by being over 65 years old and thus qualifying for Medicare while also paying for a private supplement,” said Ms. Dumitriu Carcoana, who is a medical student at University of South Florida Health Morsani College of Medicine, Tampa.

A previous analysis by the group found an association between private insurance status and better discharge status, as well as higher 5-year overall survival. After accumulating an additional 278 patients, the researchers examined 10-year survival outcomes.

In the new analysis, 52% of 711 participants had combination insurance, while 28% had private insurance, and 20% had public insurance. The subgroups all had similar demographic and histological characteristics. The study was unique in that it found no between-group differences in higher stage at diagnosis, whereas previous studies have found a greater risk of higher stage diagnosis among individuals with public insurance. As expected, patients in the combined insurance group had a higher mean age (P less than .0001) and higher Charlson comorbidity index scores (P = .0014), which in turn was associated with lower 10-year survival. The group also had the highest percentage of former smokers, while the public insurance group had the highest percentage of current smokers (P = .0003).

At both 5 and 10 years, the private insurance group had better OS than the group with public (P less than .001) and the combination insurance group (P = .08). Public health insurance was associated with worse OS at 5 years (hazard ratio, 1.83; P less than .005) but not at 10 years (HR, 1.18; P = .51), while combination insurance was associated with worse OS at 10 years (HR, 1.72; P = .02).

“We think that patients with public health insurance having the worst 5-year overall survival, despite their lower ages and fewer comorbid conditions, compared with patients with combination insurance, highlights the impact of lower socioeconomic status on health outcomes. These patients had the same tumor characteristics, BMI, sex, and race as our patients in the other two insurance groups. The only other significant risk factor [the group had besides having a higher proportion of patients with lower socioeconomic status was that it had a higher proportion of current smokers]. But the multivariate analyses showed that insurance status was an independent predictor of survival, regardless of smoking status or other comorbidities,” said Ms. Dumitriu Carcoana.

“At 10 years post-operatively, the survival curves have shifted and the combination patients had the worst 10-year overall survival. We attribute this to their higher number of comorbid conditions and increased age. In practice, [this means that] the group of patients with public insurance type, but no supplement, should be identified clinically, and the clinical team can initiate a discussion,” Ms. Dumitriu Carcoana said.

“Do these patients feel that they can make follow-up appointments, keep up with medication costs, and make the right lifestyle decisions postoperatively on their current insurance plan? If not, can they afford a private supplement? In our cohort specifically, it may also be important to do more preoperative counseling on the importance of smoking cessation,” she added.

The study is interesting, but it has some important limitations, according to Raja Flores, MD, who was not involved with the study. The authors stated that there was no difference between the insurance groups with respect to mortality or cancer stage, which is the most important predictor of survival. However, the poster didn't include details of the authors' analysis, making it difficult to interpret, Dr. Flores said.

The fact that the study includes a single surgeon has some disadvantages in terms of broader applicability, but it also controls for surgical technique. “Different surgeons have different ways of doing things, so if you had the same surgeon doing it the same way every time, you can look at other variables like insurance (status) and stage,” said Dr. Flores.

The results may also provide an argument against using robotic surgery in patients who do not have insurance, especially since they have not been proven to be better than standard minimally invasive surgery with no robotic assistance. With uninsured patients, “you’re using taxpayer money for a more expensive procedure that isn’t proving to be any better,” Dr. Flores explained.

The study was performed at a single center and cannot prove causation due to its retrospective nature.

Ms. Dumitriu Carcoana and Dr. Flores have no relevant financial disclosures.

*This article was updated on 4/13/2023.

A comparison of Food and Drug Administration and European Medicines Agency approvals of immune checkpoint inhibitors in the field of thoracic cancer found significantly longer approval times at the European agency, as well as some examples of different perspectives on biomarkers.

The findings of this new study suggest that patients in Europe may face delayed access to new therapies, the authors wrote in a poster presentation at the European Lung Cancer Congress 2023.

They also noted that some FDA approvals occurred before pivotal trial data became available, which can leave doubt about efficacy.

“Effective cancer management relies on availability of therapies which improve patient outcomes, such as immunotherapy. The two largest regulators involved in approving immunotherapies are the FDA and the EMA and therefore we aimed to compare the approval timings between both to see if a difference in approval timings was present,” coauthor Aakash Desai, MD, said in an interview.

Previously, the researchers conducted a study of cancer approval patterns at the FDA and EMA between 2010 and 2019, and found U.S. patients gain access to new cancer therapeutics more quickly than do European patients. Of 89 new therapies approved in that time span, the FDA approval occurred first in 85 cases (95%), though just 72% were submitted to FDA first. The median increased time it took for EMA approval compared with the FDA was 241 days. Thirty-nine percent of U.S. approvals came before the publication of the pivotal clinical trial, versus 9% of EMA approvals.

The new study focuses on thoracic oncology, where lung cancer is the leading cause of death. “As such, prompt approval timings for immunotherapies are crucial for effective treatment. Furthermore, lung cancer immunotherapies target certain biomarkers, of which, PD1 and PD-L1 are key,” said Dr. Desai, a fellow at Mayo Clinic, Rochester, Minn.

Still, Dr. Desai sounded a note of caution. “Just because a therapy is approved more quickly does not necessarily mean it is efficacious, as the clinical trials involving these drugs may not have been completed or fully reported at the time of authorization. [Drug developers] need to have a more global and coordinated approach to evaluating evidence and approval of drugs so the care received by a particular patient is not a factor of where they live,” he said.

The researchers surveyed approvals of seven immune checkpoint inhibitors (ICIs) approved by both the FDA and the EMA for thoracic malignancies, including non–small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and mesothelioma. The FDA approved 22 indications for the novel ICIs in thoracic malignancies, compared with 16 indications at the EMA. The difference in median approval times was larger for SCLC (179 versus 308 days) and mesothelioma (39 versus 280 days) than for NSCLC (242 versus 272 days).

“There are two discrepancies in biomarker requirements between the FDA and EMA, whereby the FDA has a broader requirement, despite these being ranked fairly consistently in terms of evidence of benefit by [European Society for Medical Oncology Magnitude of Clinical Benefit Scale and National Comprehensive Cancer Network] frameworks,” said Dr. Desai. In the case of atezolizumab for adjuvant NSCLC, the FDA required PDL1 levels of 1% or higher, while the EMA required 50% or higher. For durvalumab in unresectable NSCLC, the FDA had no PDL1 requirement, while the EMA required 1% or higher.

Dr. Desai suggested a need for further investigation into the differences between the two agencies. Asked why the two agencies might have different views on the biomarkers, Dr. Desai responded: “That is the million-dollar question. My guess is [the] EMA weighs subgroup data more than [the] FDA.”

Dr. Desai has no relevant financial disclosures.

A comparison of Food and Drug Administration and European Medicines Agency approvals of immune checkpoint inhibitors in the field of thoracic cancer found significantly longer approval times at the European agency, as well as some examples of different perspectives on biomarkers.

The findings of this new study suggest that patients in Europe may face delayed access to new therapies, the authors wrote in a poster presentation at the European Lung Cancer Congress 2023.

They also noted that some FDA approvals occurred before pivotal trial data became available, which can leave doubt about efficacy.

“Effective cancer management relies on availability of therapies which improve patient outcomes, such as immunotherapy. The two largest regulators involved in approving immunotherapies are the FDA and the EMA and therefore we aimed to compare the approval timings between both to see if a difference in approval timings was present,” coauthor Aakash Desai, MD, said in an interview.

Previously, the researchers conducted a study of cancer approval patterns at the FDA and EMA between 2010 and 2019, and found U.S. patients gain access to new cancer therapeutics more quickly than do European patients. Of 89 new therapies approved in that time span, the FDA approval occurred first in 85 cases (95%), though just 72% were submitted to FDA first. The median increased time it took for EMA approval compared with the FDA was 241 days. Thirty-nine percent of U.S. approvals came before the publication of the pivotal clinical trial, versus 9% of EMA approvals.

The new study focuses on thoracic oncology, where lung cancer is the leading cause of death. “As such, prompt approval timings for immunotherapies are crucial for effective treatment. Furthermore, lung cancer immunotherapies target certain biomarkers, of which, PD1 and PD-L1 are key,” said Dr. Desai, a fellow at Mayo Clinic, Rochester, Minn.

Still, Dr. Desai sounded a note of caution. “Just because a therapy is approved more quickly does not necessarily mean it is efficacious, as the clinical trials involving these drugs may not have been completed or fully reported at the time of authorization. [Drug developers] need to have a more global and coordinated approach to evaluating evidence and approval of drugs so the care received by a particular patient is not a factor of where they live,” he said.

The researchers surveyed approvals of seven immune checkpoint inhibitors (ICIs) approved by both the FDA and the EMA for thoracic malignancies, including non–small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and mesothelioma. The FDA approved 22 indications for the novel ICIs in thoracic malignancies, compared with 16 indications at the EMA. The difference in median approval times was larger for SCLC (179 versus 308 days) and mesothelioma (39 versus 280 days) than for NSCLC (242 versus 272 days).

“There are two discrepancies in biomarker requirements between the FDA and EMA, whereby the FDA has a broader requirement, despite these being ranked fairly consistently in terms of evidence of benefit by [European Society for Medical Oncology Magnitude of Clinical Benefit Scale and National Comprehensive Cancer Network] frameworks,” said Dr. Desai. In the case of atezolizumab for adjuvant NSCLC, the FDA required PDL1 levels of 1% or higher, while the EMA required 50% or higher. For durvalumab in unresectable NSCLC, the FDA had no PDL1 requirement, while the EMA required 1% or higher.

Dr. Desai suggested a need for further investigation into the differences between the two agencies. Asked why the two agencies might have different views on the biomarkers, Dr. Desai responded: “That is the million-dollar question. My guess is [the] EMA weighs subgroup data more than [the] FDA.”

Dr. Desai has no relevant financial disclosures.

A comparison of Food and Drug Administration and European Medicines Agency approvals of immune checkpoint inhibitors in the field of thoracic cancer found significantly longer approval times at the European agency, as well as some examples of different perspectives on biomarkers.

The findings of this new study suggest that patients in Europe may face delayed access to new therapies, the authors wrote in a poster presentation at the European Lung Cancer Congress 2023.

They also noted that some FDA approvals occurred before pivotal trial data became available, which can leave doubt about efficacy.

“Effective cancer management relies on availability of therapies which improve patient outcomes, such as immunotherapy. The two largest regulators involved in approving immunotherapies are the FDA and the EMA and therefore we aimed to compare the approval timings between both to see if a difference in approval timings was present,” coauthor Aakash Desai, MD, said in an interview.

Previously, the researchers conducted a study of cancer approval patterns at the FDA and EMA between 2010 and 2019, and found U.S. patients gain access to new cancer therapeutics more quickly than do European patients. Of 89 new therapies approved in that time span, the FDA approval occurred first in 85 cases (95%), though just 72% were submitted to FDA first. The median increased time it took for EMA approval compared with the FDA was 241 days. Thirty-nine percent of U.S. approvals came before the publication of the pivotal clinical trial, versus 9% of EMA approvals.

The new study focuses on thoracic oncology, where lung cancer is the leading cause of death. “As such, prompt approval timings for immunotherapies are crucial for effective treatment. Furthermore, lung cancer immunotherapies target certain biomarkers, of which, PD1 and PD-L1 are key,” said Dr. Desai, a fellow at Mayo Clinic, Rochester, Minn.

Still, Dr. Desai sounded a note of caution. “Just because a therapy is approved more quickly does not necessarily mean it is efficacious, as the clinical trials involving these drugs may not have been completed or fully reported at the time of authorization. [Drug developers] need to have a more global and coordinated approach to evaluating evidence and approval of drugs so the care received by a particular patient is not a factor of where they live,” he said.

The researchers surveyed approvals of seven immune checkpoint inhibitors (ICIs) approved by both the FDA and the EMA for thoracic malignancies, including non–small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and mesothelioma. The FDA approved 22 indications for the novel ICIs in thoracic malignancies, compared with 16 indications at the EMA. The difference in median approval times was larger for SCLC (179 versus 308 days) and mesothelioma (39 versus 280 days) than for NSCLC (242 versus 272 days).

“There are two discrepancies in biomarker requirements between the FDA and EMA, whereby the FDA has a broader requirement, despite these being ranked fairly consistently in terms of evidence of benefit by [European Society for Medical Oncology Magnitude of Clinical Benefit Scale and National Comprehensive Cancer Network] frameworks,” said Dr. Desai. In the case of atezolizumab for adjuvant NSCLC, the FDA required PDL1 levels of 1% or higher, while the EMA required 50% or higher. For durvalumab in unresectable NSCLC, the FDA had no PDL1 requirement, while the EMA required 1% or higher.

Dr. Desai suggested a need for further investigation into the differences between the two agencies. Asked why the two agencies might have different views on the biomarkers, Dr. Desai responded: “That is the million-dollar question. My guess is [the] EMA weighs subgroup data more than [the] FDA.”

Dr. Desai has no relevant financial disclosures.

A large, systematic review of phase III randomized, controlled trials in metastatic non–small cell lung cancer found quality of life (QoL) improvements in progression-free survival (PFS), but not overall survival (OS), among patients treated with targeted therapy.

The authors, including Fabio Salomone of the University of Naples Federico II, department of clinical medicine and surgery, also observed trends toward an association between QoL improvement and PFS among patients treated with chemotherapy and immunotherapy.

The new research was presented during a poster session at European Lung Cancer Congress 2023.

“The findings of the study support the thesis that QoL and survival in patients with NSCLC are linked. Although this is documented in the literature, this study sums up the evidence of a large number of RCTs, and provides detail in the QoL/survival relationship by treatment type. The subgroup analysis by treatment type is a key strength of the study showing that the QoL/survival link is stronger and more reliable in target(ed) therapies,” George Kypriotakis, PhD, who was not involved with the study, said in an interview.

Combining efficacy and quality of life improvement is an important consideration in clinical practice. “It is important that clinicians provide therapies that are also palliative and improve QoL,” said Dr. Kypriotakis, assistant professor of behavioral sciences at University of Texas MD Anderson Cancer Center, Houston. He noted that the finding of a PFS benefit is a good indicator of overall benefit, which is important since OS outcomes require a larger number of patients and longer follow-up to determine.

“PFS can still be a valid surrogate for OS, especially when it is positively associated with QoL,” noted Dr. Kypriotakis.

The study included 81 trials. Sixteen of the studies investigated immunotherapy, 50 investigated targeted therapy, and 17 investigated chemotherapy regimens. Thirty-seven percent of the trials found an improvement in QoL in the treatment arm compared with the control arm, 59.3% found no difference between arms, and 3.7% found a worse QoL in the treatment arm. There was no statistically significant association between an improvement in OS and QoL among the trials (P = .368).
 

Improved QoL tied to improved PFS

The researchers found an association between improved QoL and improved PFS. Among 60 trials that showed improved PFS, 43.3% found a superior QoL in the treatment arm, 53.3% showed no difference, and 3.3% showed reduced QoL. Among 20 trials that found no improvement in PFS, 20% demonstrated an improved QoL, 75% found no change, and 5% showed worse QoL (P = .0473).

A subanalysis of 48 targeted therapy trials found a correlation between PFS and QoL improvement (P = .0196). Among 25 trials involving patients receiving epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors showing an improved PFS, 60% showed improved QoL, 36% showed no difference, and 4% showed worsening (P = .0077). Seven of these trials showed no PFS benefit and no change in QoL.
 

Industry sponsorship may affect QOL results

The researchers found potential evidence that industry sponsorship may lead to a spin on QoL outcomes. Among 51 trials that showed no QoL benefit associated with treatment, the description of the QoL outcome in 37 industry-sponsored was judged to be neutral and coherent with the study findings in 26 cases, but unjustifiably favorable in 11 cases. Among 14 with nonprofit support, descriptions of QoL results were found to be neutral in all cases (P = .0232).

“Obviously, industry may be motivated to overemphasize treatment benefits, especially in measures that also have a qualitative/subjective dimension such as QoL. Assuming that the authors used a reliable criterion to evaluate “inappropriateness,” industry may be more likely to emphasize QoL improvements as a surrogate for OS, especially when seeking drug approval,” Dr. Kypriotakis said.

The study is retrospective and cannot prove causation.

Dr. Salomone and Dr. Kypriotakis have no relevant financial disclosures.

A large, systematic review of phase III randomized, controlled trials in metastatic non–small cell lung cancer found quality of life (QoL) improvements in progression-free survival (PFS), but not overall survival (OS), among patients treated with targeted therapy.

The authors, including Fabio Salomone of the University of Naples Federico II, department of clinical medicine and surgery, also observed trends toward an association between QoL improvement and PFS among patients treated with chemotherapy and immunotherapy.

The new research was presented during a poster session at European Lung Cancer Congress 2023.

“The findings of the study support the thesis that QoL and survival in patients with NSCLC are linked. Although this is documented in the literature, this study sums up the evidence of a large number of RCTs, and provides detail in the QoL/survival relationship by treatment type. The subgroup analysis by treatment type is a key strength of the study showing that the QoL/survival link is stronger and more reliable in target(ed) therapies,” George Kypriotakis, PhD, who was not involved with the study, said in an interview.

Combining efficacy and quality of life improvement is an important consideration in clinical practice. “It is important that clinicians provide therapies that are also palliative and improve QoL,” said Dr. Kypriotakis, assistant professor of behavioral sciences at University of Texas MD Anderson Cancer Center, Houston. He noted that the finding of a PFS benefit is a good indicator of overall benefit, which is important since OS outcomes require a larger number of patients and longer follow-up to determine.

“PFS can still be a valid surrogate for OS, especially when it is positively associated with QoL,” noted Dr. Kypriotakis.

The study included 81 trials. Sixteen of the studies investigated immunotherapy, 50 investigated targeted therapy, and 17 investigated chemotherapy regimens. Thirty-seven percent of the trials found an improvement in QoL in the treatment arm compared with the control arm, 59.3% found no difference between arms, and 3.7% found a worse QoL in the treatment arm. There was no statistically significant association between an improvement in OS and QoL among the trials (P = .368).
 

Improved QoL tied to improved PFS

The researchers found an association between improved QoL and improved PFS. Among 60 trials that showed improved PFS, 43.3% found a superior QoL in the treatment arm, 53.3% showed no difference, and 3.3% showed reduced QoL. Among 20 trials that found no improvement in PFS, 20% demonstrated an improved QoL, 75% found no change, and 5% showed worse QoL (P = .0473).

A subanalysis of 48 targeted therapy trials found a correlation between PFS and QoL improvement (P = .0196). Among 25 trials involving patients receiving epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors showing an improved PFS, 60% showed improved QoL, 36% showed no difference, and 4% showed worsening (P = .0077). Seven of these trials showed no PFS benefit and no change in QoL.
 

Industry sponsorship may affect QOL results

The researchers found potential evidence that industry sponsorship may lead to a spin on QoL outcomes. Among 51 trials that showed no QoL benefit associated with treatment, the description of the QoL outcome in 37 industry-sponsored was judged to be neutral and coherent with the study findings in 26 cases, but unjustifiably favorable in 11 cases. Among 14 with nonprofit support, descriptions of QoL results were found to be neutral in all cases (P = .0232).

“Obviously, industry may be motivated to overemphasize treatment benefits, especially in measures that also have a qualitative/subjective dimension such as QoL. Assuming that the authors used a reliable criterion to evaluate “inappropriateness,” industry may be more likely to emphasize QoL improvements as a surrogate for OS, especially when seeking drug approval,” Dr. Kypriotakis said.

The study is retrospective and cannot prove causation.

Dr. Salomone and Dr. Kypriotakis have no relevant financial disclosures.

A large, systematic review of phase III randomized, controlled trials in metastatic non–small cell lung cancer found quality of life (QoL) improvements in progression-free survival (PFS), but not overall survival (OS), among patients treated with targeted therapy.

The authors, including Fabio Salomone of the University of Naples Federico II, department of clinical medicine and surgery, also observed trends toward an association between QoL improvement and PFS among patients treated with chemotherapy and immunotherapy.

The new research was presented during a poster session at European Lung Cancer Congress 2023.

“The findings of the study support the thesis that QoL and survival in patients with NSCLC are linked. Although this is documented in the literature, this study sums up the evidence of a large number of RCTs, and provides detail in the QoL/survival relationship by treatment type. The subgroup analysis by treatment type is a key strength of the study showing that the QoL/survival link is stronger and more reliable in target(ed) therapies,” George Kypriotakis, PhD, who was not involved with the study, said in an interview.

Combining efficacy and quality of life improvement is an important consideration in clinical practice. “It is important that clinicians provide therapies that are also palliative and improve QoL,” said Dr. Kypriotakis, assistant professor of behavioral sciences at University of Texas MD Anderson Cancer Center, Houston. He noted that the finding of a PFS benefit is a good indicator of overall benefit, which is important since OS outcomes require a larger number of patients and longer follow-up to determine.

“PFS can still be a valid surrogate for OS, especially when it is positively associated with QoL,” noted Dr. Kypriotakis.

The study included 81 trials. Sixteen of the studies investigated immunotherapy, 50 investigated targeted therapy, and 17 investigated chemotherapy regimens. Thirty-seven percent of the trials found an improvement in QoL in the treatment arm compared with the control arm, 59.3% found no difference between arms, and 3.7% found a worse QoL in the treatment arm. There was no statistically significant association between an improvement in OS and QoL among the trials (P = .368).
 

Improved QoL tied to improved PFS

The researchers found an association between improved QoL and improved PFS. Among 60 trials that showed improved PFS, 43.3% found a superior QoL in the treatment arm, 53.3% showed no difference, and 3.3% showed reduced QoL. Among 20 trials that found no improvement in PFS, 20% demonstrated an improved QoL, 75% found no change, and 5% showed worse QoL (P = .0473).

A subanalysis of 48 targeted therapy trials found a correlation between PFS and QoL improvement (P = .0196). Among 25 trials involving patients receiving epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors showing an improved PFS, 60% showed improved QoL, 36% showed no difference, and 4% showed worsening (P = .0077). Seven of these trials showed no PFS benefit and no change in QoL.
 

Industry sponsorship may affect QOL results

The researchers found potential evidence that industry sponsorship may lead to a spin on QoL outcomes. Among 51 trials that showed no QoL benefit associated with treatment, the description of the QoL outcome in 37 industry-sponsored was judged to be neutral and coherent with the study findings in 26 cases, but unjustifiably favorable in 11 cases. Among 14 with nonprofit support, descriptions of QoL results were found to be neutral in all cases (P = .0232).

“Obviously, industry may be motivated to overemphasize treatment benefits, especially in measures that also have a qualitative/subjective dimension such as QoL. Assuming that the authors used a reliable criterion to evaluate “inappropriateness,” industry may be more likely to emphasize QoL improvements as a surrogate for OS, especially when seeking drug approval,” Dr. Kypriotakis said.

The study is retrospective and cannot prove causation.

Dr. Salomone and Dr. Kypriotakis have no relevant financial disclosures.