Hematologic Malignancies

Early-onset cancer—diagnosed in adults aged ≤ 50 years—is on the rise. Researchers have studied a variety of factors driving the trend, such as type of cancer. However, geographic locality might have as much, if not more, to do with it, according to a study by researchers at Fox Chase Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center research facility.

Using the US Cancer Statistics Public Use Research Database, the researchers collected data from adults aged 20 to 49 years with invasive cancer (excluding in situ cases) diagnosed from 2015 through 2020. They calculated the incidence for each state using the national rate as the reference. Then, they calculated a second set of rates, comparing each state to the US in terms of overall incidence and advanced-stage incidence for all early-onset cancers.

The resulting maps indicated that early-onset cancer cases are not evenly distributed. States with worse-than-national rates are frequently near each other geographically. For instance, the rate of early-onset female breast cancer was worse than the national rate in 17 states, 16 of which were located in the eastern half of the US (Hawaii was the 17th state). Similarly, most states with worse-than-national rates of digestive cancers were located in the eastern half of the US, with a concentration in the South. Rates of male genital cancers were worse than national rates in 18 states, primarily in the eastern half of the country (plus Montana, Nebraska, and Puerto Rico).

Three states in the Southeast, 7 in the Northeast, and Puerto Rico had the highest incidence of lymphohematopoietic cancers. Incidence rates of endocrine cancers were worse than national rates in 25 states, which the researchers found formed “a horizontal core of the country running from east to west,” plus Puerto Rico. Rates of urinary system cancers were worse than national rates in 17 contiguous states, from New Mexico to Pennsylvania.

Rates of female genital cancers were worse than national rates in 16 states, largely in the Midwest and South, plus California and Puerto Rico. Skin cancer, on the other hand, was a great leveler, with worse-than-national rates in 32 states, mostly in the northern portion of the country.

Kentucky and West Virginia had the highest overall and advanced-stage incidence rates of early-onset cancer for all cancer sites combined. They were followed by Arkansas, Connecticut, Florida, Georgia, Iowa, Louisiana, Maine, Missouri, New Jersey, New York, North Carolina, Ohio, and Pennsylvania.

According to the researchers, this study provides the first analysis of age-adjusted rates of early-onset cancer based on state-level population and case numbers. Geographic patterns in early-onset cancer, they suggest, indicate possible similarities that could relate to demographic, socioeconomic, behavioral, or environmental risks. “Focusing prevention efforts on the highest-incidence states for the most prevalent sites may reduce the rate of early-onset cancer nationally.”

Early-onset cancer—diagnosed in adults aged ≤ 50 years—is on the rise. Researchers have studied a variety of factors driving the trend, such as type of cancer. However, geographic locality might have as much, if not more, to do with it, according to a study by researchers at Fox Chase Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center research facility.

Using the US Cancer Statistics Public Use Research Database, the researchers collected data from adults aged 20 to 49 years with invasive cancer (excluding in situ cases) diagnosed from 2015 through 2020. They calculated the incidence for each state using the national rate as the reference. Then, they calculated a second set of rates, comparing each state to the US in terms of overall incidence and advanced-stage incidence for all early-onset cancers.

The resulting maps indicated that early-onset cancer cases are not evenly distributed. States with worse-than-national rates are frequently near each other geographically. For instance, the rate of early-onset female breast cancer was worse than the national rate in 17 states, 16 of which were located in the eastern half of the US (Hawaii was the 17th state). Similarly, most states with worse-than-national rates of digestive cancers were located in the eastern half of the US, with a concentration in the South. Rates of male genital cancers were worse than national rates in 18 states, primarily in the eastern half of the country (plus Montana, Nebraska, and Puerto Rico).

Three states in the Southeast, 7 in the Northeast, and Puerto Rico had the highest incidence of lymphohematopoietic cancers. Incidence rates of endocrine cancers were worse than national rates in 25 states, which the researchers found formed “a horizontal core of the country running from east to west,” plus Puerto Rico. Rates of urinary system cancers were worse than national rates in 17 contiguous states, from New Mexico to Pennsylvania.

Rates of female genital cancers were worse than national rates in 16 states, largely in the Midwest and South, plus California and Puerto Rico. Skin cancer, on the other hand, was a great leveler, with worse-than-national rates in 32 states, mostly in the northern portion of the country.

Kentucky and West Virginia had the highest overall and advanced-stage incidence rates of early-onset cancer for all cancer sites combined. They were followed by Arkansas, Connecticut, Florida, Georgia, Iowa, Louisiana, Maine, Missouri, New Jersey, New York, North Carolina, Ohio, and Pennsylvania.

According to the researchers, this study provides the first analysis of age-adjusted rates of early-onset cancer based on state-level population and case numbers. Geographic patterns in early-onset cancer, they suggest, indicate possible similarities that could relate to demographic, socioeconomic, behavioral, or environmental risks. “Focusing prevention efforts on the highest-incidence states for the most prevalent sites may reduce the rate of early-onset cancer nationally.”

Early-onset cancer—diagnosed in adults aged ≤ 50 years—is on the rise. Researchers have studied a variety of factors driving the trend, such as type of cancer. However, geographic locality might have as much, if not more, to do with it, according to a study by researchers at Fox Chase Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center research facility.

Using the US Cancer Statistics Public Use Research Database, the researchers collected data from adults aged 20 to 49 years with invasive cancer (excluding in situ cases) diagnosed from 2015 through 2020. They calculated the incidence for each state using the national rate as the reference. Then, they calculated a second set of rates, comparing each state to the US in terms of overall incidence and advanced-stage incidence for all early-onset cancers.

The resulting maps indicated that early-onset cancer cases are not evenly distributed. States with worse-than-national rates are frequently near each other geographically. For instance, the rate of early-onset female breast cancer was worse than the national rate in 17 states, 16 of which were located in the eastern half of the US (Hawaii was the 17th state). Similarly, most states with worse-than-national rates of digestive cancers were located in the eastern half of the US, with a concentration in the South. Rates of male genital cancers were worse than national rates in 18 states, primarily in the eastern half of the country (plus Montana, Nebraska, and Puerto Rico).

Three states in the Southeast, 7 in the Northeast, and Puerto Rico had the highest incidence of lymphohematopoietic cancers. Incidence rates of endocrine cancers were worse than national rates in 25 states, which the researchers found formed “a horizontal core of the country running from east to west,” plus Puerto Rico. Rates of urinary system cancers were worse than national rates in 17 contiguous states, from New Mexico to Pennsylvania.

Rates of female genital cancers were worse than national rates in 16 states, largely in the Midwest and South, plus California and Puerto Rico. Skin cancer, on the other hand, was a great leveler, with worse-than-national rates in 32 states, mostly in the northern portion of the country.

Kentucky and West Virginia had the highest overall and advanced-stage incidence rates of early-onset cancer for all cancer sites combined. They were followed by Arkansas, Connecticut, Florida, Georgia, Iowa, Louisiana, Maine, Missouri, New Jersey, New York, North Carolina, Ohio, and Pennsylvania.

According to the researchers, this study provides the first analysis of age-adjusted rates of early-onset cancer based on state-level population and case numbers. Geographic patterns in early-onset cancer, they suggest, indicate possible similarities that could relate to demographic, socioeconomic, behavioral, or environmental risks. “Focusing prevention efforts on the highest-incidence states for the most prevalent sites may reduce the rate of early-onset cancer nationally.”

Click to view the Digital Edition.

In this issue: 

Hepatocellular Carcinoma
Special care for veterans, changes in staging, and biomarkers for early diagnosis

Lung Cancer
Guideline updates and racial disparities in veterans

Multiple Myeloma
Improving survival in the VA

Colorectal Cancer
Barriers to follow-up colonoscopies after FIT testing 

B-Cell Lymphomas
Findings from the VA's National TeleOncology Program and recent therapy updates

Breast Cancer
A look at the VA's Risk Assessment Pipeline and incidence among veterans vs the general population

Genitourinary Cancers
Molecular testing in prostate cancer, improving survival for metastatic RCC, and links between bladder cancer and Agent Orange exposure

Click to view the Digital Edition.

In this issue: 

Hepatocellular Carcinoma
Special care for veterans, changes in staging, and biomarkers for early diagnosis

Lung Cancer
Guideline updates and racial disparities in veterans

Multiple Myeloma
Improving survival in the VA

Colorectal Cancer
Barriers to follow-up colonoscopies after FIT testing 

B-Cell Lymphomas
Findings from the VA's National TeleOncology Program and recent therapy updates

Breast Cancer
A look at the VA's Risk Assessment Pipeline and incidence among veterans vs the general population

Genitourinary Cancers
Molecular testing in prostate cancer, improving survival for metastatic RCC, and links between bladder cancer and Agent Orange exposure

Click to view the Digital Edition.

In this issue: 

Hepatocellular Carcinoma
Special care for veterans, changes in staging, and biomarkers for early diagnosis

Lung Cancer
Guideline updates and racial disparities in veterans

Multiple Myeloma
Improving survival in the VA

Colorectal Cancer
Barriers to follow-up colonoscopies after FIT testing 

B-Cell Lymphomas
Findings from the VA's National TeleOncology Program and recent therapy updates

Breast Cancer
A look at the VA's Risk Assessment Pipeline and incidence among veterans vs the general population

Genitourinary Cancers
Molecular testing in prostate cancer, improving survival for metastatic RCC, and links between bladder cancer and Agent Orange exposure

CHICAGO—While it’s extremely difficult to link cancer rates to military service, researchers are starting to get some initial inklings of possible connections, a US Department of Veterans Affairs (VA) oncologist told an audience at the 2023 annual meeting of the Association of VA Hematology/Oncology.

One study found surprising levels of abnormal proteins and cancer in the blood of service members, said Christin DeStefano, MD, of David Grant US Air Force Medical Center at Travis Air Force Base in California. Another may have uncovered a link between military trauma and lymphoma. And an analysis of pilots found they have higher rates of certain kinds of cancer— but lower levels of other cancer types.

“It is hard to tell if service-related exposures heighten the risk of cancer. Some aspects of military service might increase cancer risk,” DeStefano said. “But other aspects of military service might decrease cancer risk.”

The VA has been especially focused on the possible link between military service and cancer since the passage of the PACT Act in 2022. The legislation prioritizes claims for cancer, terminal illnesses, and homelessness, and it’s sparked more than 4.1 million free toxic-exposure screenings for veterans.

VA Under Secretary for Health Shereef Elnahal, MD, MBA, noted in the keynote address at the 2023 AVAHO annual meeting that “Every type of solid tumor is now considered a presumptive condition associated with burden of exposure to veterans deployed anywhere in Central Command, either in the Persian Gulf War or the post-9/11 conflicts.”

DeStefano noted that there are a variety of challenges to analyzing data regarding connections between military exposure and cancer. For one, “it’s hard to include people from the time they enter the military to postmilitary service. Some are getting their health care in the civilian health care systems.” In addition, “There are a lot of problems with ICD-9 and ICD-10 codes, which can be very erroneous. Maybe somebody came in with a mass, the doctor or the nurse practitioner was busy and they put down ‘suspected cancer,’ and now they have that ICD code in their chart where they never actually had cancer.” This is why more reliable cancer registries are so important, she said.

Another challenge is figuring out when exposures occurred and whether they actually occurred in the military at all. “There are multiple studies suggesting that a first driver event is often acquired 20 to 40 years before a cancer diagnosis, often in one’s 20s and 30s,” she said. “It's hard to quantify an exposure, since there can be exposures before military service and exposures after military service. The amount of exposure and duration of exposure might differ, and individuals might metabolize the exposures differently from each other.”

To make matters more complicated, research is pointing in surprising directions. DeStefano highlighted her not-yet-published study of monoclonal gammopathy (MG), a condition in which abnormal proteins are found in the blood, in 534 service members. MG can be a cancer precursor. Those exposed to burn pits in Iraq had similar risks of MG (6.7%) vs an unexposed, matched control group (5.4%; P = .22), Dr. DeStefano said. Over a mean follow-up of 14 years and 10 years, respectively, 7% of participants in each group developed cancer.

“You might think, ‘this is a negative study. There's no difference.’ However, it is very notable that the prevalence of monoclonal gammopathy was 6.1%. That is 3 times as high as we would expect in somebody in their 40s,” she said. “Also, 7% having a cancer diagnosis is not insignificant.” She added: “It is very possible that many of these service members already have full-blown multiple myeloma or something associated with monoclonal gammopathy that just has not been diagnosed yet.”

In another study, this one published in 2021, Dr. DeStefano and colleagues tracked 8834 injured Iraq/Afghanistan veterans and compared them with matched controls to see if there was a link between severe trauma and cancer. There wasn’t  except for lymphoma (22 vs 7 cases, respectively; odds ratio = 3.1; 95% CI, 1.34-7.37; P = .008). The connection remained after adjustment for confounders.

What’s going on? “It’s possible that blast injury might induce some alterations to the immune system that might set the stage for lymphoma genesis,” she said. “Or maybe that blast injury is a surrogate for a toxic exposure: Maybe carcinogens are released during a blast injury.”

Dr. DeStefano also highlighted a 2022 study that tracked 386,190 Air Force officers. The study found that combat pilots (9.1% of the total) had greater adjusted odds of testicular and prostate cancers and melanoma than the other officers. Why? “Military pilots have exposure to cosmic ionizing radiation as well as ultraviolet radiation,” she said.

But while “these are scary, sobering things,” she noted that combat pilots were less likely to develop several cancers than the general population, including kidney, testicular, colorectal, bladder and thyroid cancer, and they were less likely to die from colorectal cancer.

CHICAGO—While it’s extremely difficult to link cancer rates to military service, researchers are starting to get some initial inklings of possible connections, a US Department of Veterans Affairs (VA) oncologist told an audience at the 2023 annual meeting of the Association of VA Hematology/Oncology.

One study found surprising levels of abnormal proteins and cancer in the blood of service members, said Christin DeStefano, MD, of David Grant US Air Force Medical Center at Travis Air Force Base in California. Another may have uncovered a link between military trauma and lymphoma. And an analysis of pilots found they have higher rates of certain kinds of cancer— but lower levels of other cancer types.

“It is hard to tell if service-related exposures heighten the risk of cancer. Some aspects of military service might increase cancer risk,” DeStefano said. “But other aspects of military service might decrease cancer risk.”

The VA has been especially focused on the possible link between military service and cancer since the passage of the PACT Act in 2022. The legislation prioritizes claims for cancer, terminal illnesses, and homelessness, and it’s sparked more than 4.1 million free toxic-exposure screenings for veterans.

VA Under Secretary for Health Shereef Elnahal, MD, MBA, noted in the keynote address at the 2023 AVAHO annual meeting that “Every type of solid tumor is now considered a presumptive condition associated with burden of exposure to veterans deployed anywhere in Central Command, either in the Persian Gulf War or the post-9/11 conflicts.”

DeStefano noted that there are a variety of challenges to analyzing data regarding connections between military exposure and cancer. For one, “it’s hard to include people from the time they enter the military to postmilitary service. Some are getting their health care in the civilian health care systems.” In addition, “There are a lot of problems with ICD-9 and ICD-10 codes, which can be very erroneous. Maybe somebody came in with a mass, the doctor or the nurse practitioner was busy and they put down ‘suspected cancer,’ and now they have that ICD code in their chart where they never actually had cancer.” This is why more reliable cancer registries are so important, she said.

Another challenge is figuring out when exposures occurred and whether they actually occurred in the military at all. “There are multiple studies suggesting that a first driver event is often acquired 20 to 40 years before a cancer diagnosis, often in one’s 20s and 30s,” she said. “It's hard to quantify an exposure, since there can be exposures before military service and exposures after military service. The amount of exposure and duration of exposure might differ, and individuals might metabolize the exposures differently from each other.”

To make matters more complicated, research is pointing in surprising directions. DeStefano highlighted her not-yet-published study of monoclonal gammopathy (MG), a condition in which abnormal proteins are found in the blood, in 534 service members. MG can be a cancer precursor. Those exposed to burn pits in Iraq had similar risks of MG (6.7%) vs an unexposed, matched control group (5.4%; P = .22), Dr. DeStefano said. Over a mean follow-up of 14 years and 10 years, respectively, 7% of participants in each group developed cancer.

“You might think, ‘this is a negative study. There's no difference.’ However, it is very notable that the prevalence of monoclonal gammopathy was 6.1%. That is 3 times as high as we would expect in somebody in their 40s,” she said. “Also, 7% having a cancer diagnosis is not insignificant.” She added: “It is very possible that many of these service members already have full-blown multiple myeloma or something associated with monoclonal gammopathy that just has not been diagnosed yet.”

In another study, this one published in 2021, Dr. DeStefano and colleagues tracked 8834 injured Iraq/Afghanistan veterans and compared them with matched controls to see if there was a link between severe trauma and cancer. There wasn’t  except for lymphoma (22 vs 7 cases, respectively; odds ratio = 3.1; 95% CI, 1.34-7.37; P = .008). The connection remained after adjustment for confounders.

What’s going on? “It’s possible that blast injury might induce some alterations to the immune system that might set the stage for lymphoma genesis,” she said. “Or maybe that blast injury is a surrogate for a toxic exposure: Maybe carcinogens are released during a blast injury.”

Dr. DeStefano also highlighted a 2022 study that tracked 386,190 Air Force officers. The study found that combat pilots (9.1% of the total) had greater adjusted odds of testicular and prostate cancers and melanoma than the other officers. Why? “Military pilots have exposure to cosmic ionizing radiation as well as ultraviolet radiation,” she said.

But while “these are scary, sobering things,” she noted that combat pilots were less likely to develop several cancers than the general population, including kidney, testicular, colorectal, bladder and thyroid cancer, and they were less likely to die from colorectal cancer.

CHICAGO—While it’s extremely difficult to link cancer rates to military service, researchers are starting to get some initial inklings of possible connections, a US Department of Veterans Affairs (VA) oncologist told an audience at the 2023 annual meeting of the Association of VA Hematology/Oncology.

One study found surprising levels of abnormal proteins and cancer in the blood of service members, said Christin DeStefano, MD, of David Grant US Air Force Medical Center at Travis Air Force Base in California. Another may have uncovered a link between military trauma and lymphoma. And an analysis of pilots found they have higher rates of certain kinds of cancer— but lower levels of other cancer types.

“It is hard to tell if service-related exposures heighten the risk of cancer. Some aspects of military service might increase cancer risk,” DeStefano said. “But other aspects of military service might decrease cancer risk.”

The VA has been especially focused on the possible link between military service and cancer since the passage of the PACT Act in 2022. The legislation prioritizes claims for cancer, terminal illnesses, and homelessness, and it’s sparked more than 4.1 million free toxic-exposure screenings for veterans.

VA Under Secretary for Health Shereef Elnahal, MD, MBA, noted in the keynote address at the 2023 AVAHO annual meeting that “Every type of solid tumor is now considered a presumptive condition associated with burden of exposure to veterans deployed anywhere in Central Command, either in the Persian Gulf War or the post-9/11 conflicts.”

DeStefano noted that there are a variety of challenges to analyzing data regarding connections between military exposure and cancer. For one, “it’s hard to include people from the time they enter the military to postmilitary service. Some are getting their health care in the civilian health care systems.” In addition, “There are a lot of problems with ICD-9 and ICD-10 codes, which can be very erroneous. Maybe somebody came in with a mass, the doctor or the nurse practitioner was busy and they put down ‘suspected cancer,’ and now they have that ICD code in their chart where they never actually had cancer.” This is why more reliable cancer registries are so important, she said.

Another challenge is figuring out when exposures occurred and whether they actually occurred in the military at all. “There are multiple studies suggesting that a first driver event is often acquired 20 to 40 years before a cancer diagnosis, often in one’s 20s and 30s,” she said. “It's hard to quantify an exposure, since there can be exposures before military service and exposures after military service. The amount of exposure and duration of exposure might differ, and individuals might metabolize the exposures differently from each other.”

To make matters more complicated, research is pointing in surprising directions. DeStefano highlighted her not-yet-published study of monoclonal gammopathy (MG), a condition in which abnormal proteins are found in the blood, in 534 service members. MG can be a cancer precursor. Those exposed to burn pits in Iraq had similar risks of MG (6.7%) vs an unexposed, matched control group (5.4%; P = .22), Dr. DeStefano said. Over a mean follow-up of 14 years and 10 years, respectively, 7% of participants in each group developed cancer.

“You might think, ‘this is a negative study. There's no difference.’ However, it is very notable that the prevalence of monoclonal gammopathy was 6.1%. That is 3 times as high as we would expect in somebody in their 40s,” she said. “Also, 7% having a cancer diagnosis is not insignificant.” She added: “It is very possible that many of these service members already have full-blown multiple myeloma or something associated with monoclonal gammopathy that just has not been diagnosed yet.”

In another study, this one published in 2021, Dr. DeStefano and colleagues tracked 8834 injured Iraq/Afghanistan veterans and compared them with matched controls to see if there was a link between severe trauma and cancer. There wasn’t  except for lymphoma (22 vs 7 cases, respectively; odds ratio = 3.1; 95% CI, 1.34-7.37; P = .008). The connection remained after adjustment for confounders.

What’s going on? “It’s possible that blast injury might induce some alterations to the immune system that might set the stage for lymphoma genesis,” she said. “Or maybe that blast injury is a surrogate for a toxic exposure: Maybe carcinogens are released during a blast injury.”

Dr. DeStefano also highlighted a 2022 study that tracked 386,190 Air Force officers. The study found that combat pilots (9.1% of the total) had greater adjusted odds of testicular and prostate cancers and melanoma than the other officers. Why? “Military pilots have exposure to cosmic ionizing radiation as well as ultraviolet radiation,” she said.

But while “these are scary, sobering things,” she noted that combat pilots were less likely to develop several cancers than the general population, including kidney, testicular, colorectal, bladder and thyroid cancer, and they were less likely to die from colorectal cancer.

SAN DIEGO – Radiation has become a crucial component of treatment for diffuse large B cell lymphoma (DLBCL) over the past 25 years. But radiologists presenting at an annual conference cautioned colleagues to keep the limitations of radiology in mind and not to assume that it’s always a necessary adjunct to chemotherapy.

For example, radiation may not be needed for advanced-stage patients who’ve received at least four cycles of R-CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisolone plus rituximab), and whose PET scans show no sign of disease at interim or end-of treatment phases, said Joanna Yang, MD, MPH, of Washington University in St. Louis, in a presentation at the annual meeting of the American Society for Radiation Oncology.

These patients “may be able to omit radiotherapy without sacrificing good outcomes,” Dr. Yang said. In contrast, those whose PET scans show signs of disease at interim and end-of-treatment points may benefit from radiotherapy to selected sites, she said.

Dr. Yang highlighted a 2021 study in Blood that tracked 723 patients with advanced-stage DLBCL who were diagnosed from 2005 to 2017. All were treated with R-CHOP, and some of those who were PET-positive – that is, showing signs of malignant disease – were treated with radiotherapy.

Over a mean follow-up of 4.3 years, the study reported “time to progression and overall survival at 3 years were 83% vs. 56% and 87% vs. 64% in patients with PET-NEG and PET-POS scans, respectively.”

These findings aren’t surprising, Dr. Yang said. But “the PET-positive patients who got radiation actually had outcomes that came close to the outcomes that the PET-negative patients were able to achieve.” Their 3-year overall survival was 80% vs. 87% in the PET-negative, no-radiation group vs. 44% in the PET-positive, no-radiation group.

Dr. Yang cautioned, however, that withholding radiation in PET-negative patients isn’t right for everyone: “This doesn’t mean this should be the approach for every single patient.”

What about early-stage DLBCL? In patients without risk factors, Dr. Yang recommends PET scans after four treatments with R-CHOP. “Getting that end-of-treatment PET is going to be super-critical because that’s going to help guide you in terms of the patients who you may feel comfortable omitting radiation versus the patients who remain PET-positive at the end of chemotherapy. Many places will also add an interim PET as well.”

According to her, radiotherapy is appropriate in patients who are PET-positive, based on the findings of the FLYER and LYSA-GOELAMS 02-03 trials.

In early-stage patients who have risk factors such as advanced age or bulky or extra-nodal disease, Dr. Yang suggests examining interim PET scans after three treatments with R-CHOP. If they are negative, another R-CHOP treatment is appropriate – with or without radiotherapy.

“There’s a lot that goes into that decision. The first thing I think about in patients who have risk factors is: What salvage options are available for my patient? Can they tolerate these salvage option? If they’re older, they might not be eligible for auto [autologous hematopoietic cell transplantation]. If they’re frail, they might not be eligible for auto or CAR T cells. If they have bulk, it’s certainly an area of concern. It seems like radiation does help control disease in areas of bulk for patients with DLBCL.”

If these patients are PET-positive, go directly to radiotherapy, Dr. Yang advised. Trials that support this approach include S1001, LYSA-GOELAMS 02-03, and RICOVER-noRTH, she said.

What about double-hit and triple-hit lymphomas, which are especially aggressive due to genetic variations? Research suggests that “even if double hit/triple hit is not responding to chemo, it still responds to radiation,” Dr. Yang said.

In regard to advanced-stage disease, “if patients are receiving full-dose chemo for least six cycles, I use that end-of-treatment PET to help guide me. And then I make an individualized decision based on how bulky that disease is, where the location is, how morbid a relapse would be. If they’re older or receiving reduced-dose chemotherapy, then I’ll more seriously consider radiation just because there are limited options for these patients. And we know that DLCBL is most commonly a disease of the elderly.”

In an adjoining presentation at ASTRO, Andrea Ng, MD, MPH, of Harvard Medical School/Dana-Farber Brigham Cancer Center, Boston, discussed which patients with incomplete response or refractory/relapsed DLCBL can benefit from radiotherapy.

She highlighted patients with good partial response and end-of-treatment PET-positive with evidence of residual 18F-fluorodeoxyglucose activity via PET scan (Deauville 4/5) – a group that “we’re increasingly seeing.” In these patients, “radiation can be quite effective” at doses of 36-45 Gy. She highlighted a study from 2011 that linked consolidation radiotherapy to 5-year event-free survival in 65% of patients.

As for relapsed/refractory disease in patients who aren’t candidates for further systemic therapy – the “frail without good options” – Dr. Ng said data about salvage radiotherapy is limited. However, a 2015 study tracked 65 patients who were treated with a median dose of 40 Gy with “curative” intent. Local control was “not great” at 72% at 2 years, Dr. Ng said, while overall survival was 60% and progress-free survival was 46%.

Dr. Ng, who was one of this study’s authors, said several groups did better: Those with refractory vs. relapsed disease and those who were responsive to chemotherapy vs. those who were not.

She also highlighted a similar 2019 study of 32 patients with refractory/relapsed disease treated with salvage radiotherapy (median dose of 42.7 Gy) found that 61.8% reached progress-free survival at 5 years – a better outcome.

Dr. Yang has no disclosures. Dr. Ng discloses royalties from UpToDate and Elsevier.
 

SAN DIEGO – Radiation has become a crucial component of treatment for diffuse large B cell lymphoma (DLBCL) over the past 25 years. But radiologists presenting at an annual conference cautioned colleagues to keep the limitations of radiology in mind and not to assume that it’s always a necessary adjunct to chemotherapy.

For example, radiation may not be needed for advanced-stage patients who’ve received at least four cycles of R-CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisolone plus rituximab), and whose PET scans show no sign of disease at interim or end-of treatment phases, said Joanna Yang, MD, MPH, of Washington University in St. Louis, in a presentation at the annual meeting of the American Society for Radiation Oncology.

These patients “may be able to omit radiotherapy without sacrificing good outcomes,” Dr. Yang said. In contrast, those whose PET scans show signs of disease at interim and end-of-treatment points may benefit from radiotherapy to selected sites, she said.

Dr. Yang highlighted a 2021 study in Blood that tracked 723 patients with advanced-stage DLBCL who were diagnosed from 2005 to 2017. All were treated with R-CHOP, and some of those who were PET-positive – that is, showing signs of malignant disease – were treated with radiotherapy.

Over a mean follow-up of 4.3 years, the study reported “time to progression and overall survival at 3 years were 83% vs. 56% and 87% vs. 64% in patients with PET-NEG and PET-POS scans, respectively.”

These findings aren’t surprising, Dr. Yang said. But “the PET-positive patients who got radiation actually had outcomes that came close to the outcomes that the PET-negative patients were able to achieve.” Their 3-year overall survival was 80% vs. 87% in the PET-negative, no-radiation group vs. 44% in the PET-positive, no-radiation group.

Dr. Yang cautioned, however, that withholding radiation in PET-negative patients isn’t right for everyone: “This doesn’t mean this should be the approach for every single patient.”

What about early-stage DLBCL? In patients without risk factors, Dr. Yang recommends PET scans after four treatments with R-CHOP. “Getting that end-of-treatment PET is going to be super-critical because that’s going to help guide you in terms of the patients who you may feel comfortable omitting radiation versus the patients who remain PET-positive at the end of chemotherapy. Many places will also add an interim PET as well.”

According to her, radiotherapy is appropriate in patients who are PET-positive, based on the findings of the FLYER and LYSA-GOELAMS 02-03 trials.

In early-stage patients who have risk factors such as advanced age or bulky or extra-nodal disease, Dr. Yang suggests examining interim PET scans after three treatments with R-CHOP. If they are negative, another R-CHOP treatment is appropriate – with or without radiotherapy.

“There’s a lot that goes into that decision. The first thing I think about in patients who have risk factors is: What salvage options are available for my patient? Can they tolerate these salvage option? If they’re older, they might not be eligible for auto [autologous hematopoietic cell transplantation]. If they’re frail, they might not be eligible for auto or CAR T cells. If they have bulk, it’s certainly an area of concern. It seems like radiation does help control disease in areas of bulk for patients with DLBCL.”

If these patients are PET-positive, go directly to radiotherapy, Dr. Yang advised. Trials that support this approach include S1001, LYSA-GOELAMS 02-03, and RICOVER-noRTH, she said.

What about double-hit and triple-hit lymphomas, which are especially aggressive due to genetic variations? Research suggests that “even if double hit/triple hit is not responding to chemo, it still responds to radiation,” Dr. Yang said.

In regard to advanced-stage disease, “if patients are receiving full-dose chemo for least six cycles, I use that end-of-treatment PET to help guide me. And then I make an individualized decision based on how bulky that disease is, where the location is, how morbid a relapse would be. If they’re older or receiving reduced-dose chemotherapy, then I’ll more seriously consider radiation just because there are limited options for these patients. And we know that DLCBL is most commonly a disease of the elderly.”

In an adjoining presentation at ASTRO, Andrea Ng, MD, MPH, of Harvard Medical School/Dana-Farber Brigham Cancer Center, Boston, discussed which patients with incomplete response or refractory/relapsed DLCBL can benefit from radiotherapy.

She highlighted patients with good partial response and end-of-treatment PET-positive with evidence of residual 18F-fluorodeoxyglucose activity via PET scan (Deauville 4/5) – a group that “we’re increasingly seeing.” In these patients, “radiation can be quite effective” at doses of 36-45 Gy. She highlighted a study from 2011 that linked consolidation radiotherapy to 5-year event-free survival in 65% of patients.

As for relapsed/refractory disease in patients who aren’t candidates for further systemic therapy – the “frail without good options” – Dr. Ng said data about salvage radiotherapy is limited. However, a 2015 study tracked 65 patients who were treated with a median dose of 40 Gy with “curative” intent. Local control was “not great” at 72% at 2 years, Dr. Ng said, while overall survival was 60% and progress-free survival was 46%.

Dr. Ng, who was one of this study’s authors, said several groups did better: Those with refractory vs. relapsed disease and those who were responsive to chemotherapy vs. those who were not.

She also highlighted a similar 2019 study of 32 patients with refractory/relapsed disease treated with salvage radiotherapy (median dose of 42.7 Gy) found that 61.8% reached progress-free survival at 5 years – a better outcome.

Dr. Yang has no disclosures. Dr. Ng discloses royalties from UpToDate and Elsevier.
 

SAN DIEGO – Radiation has become a crucial component of treatment for diffuse large B cell lymphoma (DLBCL) over the past 25 years. But radiologists presenting at an annual conference cautioned colleagues to keep the limitations of radiology in mind and not to assume that it’s always a necessary adjunct to chemotherapy.

For example, radiation may not be needed for advanced-stage patients who’ve received at least four cycles of R-CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisolone plus rituximab), and whose PET scans show no sign of disease at interim or end-of treatment phases, said Joanna Yang, MD, MPH, of Washington University in St. Louis, in a presentation at the annual meeting of the American Society for Radiation Oncology.

These patients “may be able to omit radiotherapy without sacrificing good outcomes,” Dr. Yang said. In contrast, those whose PET scans show signs of disease at interim and end-of-treatment points may benefit from radiotherapy to selected sites, she said.

Dr. Yang highlighted a 2021 study in Blood that tracked 723 patients with advanced-stage DLBCL who were diagnosed from 2005 to 2017. All were treated with R-CHOP, and some of those who were PET-positive – that is, showing signs of malignant disease – were treated with radiotherapy.

Over a mean follow-up of 4.3 years, the study reported “time to progression and overall survival at 3 years were 83% vs. 56% and 87% vs. 64% in patients with PET-NEG and PET-POS scans, respectively.”

These findings aren’t surprising, Dr. Yang said. But “the PET-positive patients who got radiation actually had outcomes that came close to the outcomes that the PET-negative patients were able to achieve.” Their 3-year overall survival was 80% vs. 87% in the PET-negative, no-radiation group vs. 44% in the PET-positive, no-radiation group.

Dr. Yang cautioned, however, that withholding radiation in PET-negative patients isn’t right for everyone: “This doesn’t mean this should be the approach for every single patient.”

What about early-stage DLBCL? In patients without risk factors, Dr. Yang recommends PET scans after four treatments with R-CHOP. “Getting that end-of-treatment PET is going to be super-critical because that’s going to help guide you in terms of the patients who you may feel comfortable omitting radiation versus the patients who remain PET-positive at the end of chemotherapy. Many places will also add an interim PET as well.”

According to her, radiotherapy is appropriate in patients who are PET-positive, based on the findings of the FLYER and LYSA-GOELAMS 02-03 trials.

In early-stage patients who have risk factors such as advanced age or bulky or extra-nodal disease, Dr. Yang suggests examining interim PET scans after three treatments with R-CHOP. If they are negative, another R-CHOP treatment is appropriate – with or without radiotherapy.

“There’s a lot that goes into that decision. The first thing I think about in patients who have risk factors is: What salvage options are available for my patient? Can they tolerate these salvage option? If they’re older, they might not be eligible for auto [autologous hematopoietic cell transplantation]. If they’re frail, they might not be eligible for auto or CAR T cells. If they have bulk, it’s certainly an area of concern. It seems like radiation does help control disease in areas of bulk for patients with DLBCL.”

If these patients are PET-positive, go directly to radiotherapy, Dr. Yang advised. Trials that support this approach include S1001, LYSA-GOELAMS 02-03, and RICOVER-noRTH, she said.

What about double-hit and triple-hit lymphomas, which are especially aggressive due to genetic variations? Research suggests that “even if double hit/triple hit is not responding to chemo, it still responds to radiation,” Dr. Yang said.

In regard to advanced-stage disease, “if patients are receiving full-dose chemo for least six cycles, I use that end-of-treatment PET to help guide me. And then I make an individualized decision based on how bulky that disease is, where the location is, how morbid a relapse would be. If they’re older or receiving reduced-dose chemotherapy, then I’ll more seriously consider radiation just because there are limited options for these patients. And we know that DLCBL is most commonly a disease of the elderly.”

In an adjoining presentation at ASTRO, Andrea Ng, MD, MPH, of Harvard Medical School/Dana-Farber Brigham Cancer Center, Boston, discussed which patients with incomplete response or refractory/relapsed DLCBL can benefit from radiotherapy.

She highlighted patients with good partial response and end-of-treatment PET-positive with evidence of residual 18F-fluorodeoxyglucose activity via PET scan (Deauville 4/5) – a group that “we’re increasingly seeing.” In these patients, “radiation can be quite effective” at doses of 36-45 Gy. She highlighted a study from 2011 that linked consolidation radiotherapy to 5-year event-free survival in 65% of patients.

As for relapsed/refractory disease in patients who aren’t candidates for further systemic therapy – the “frail without good options” – Dr. Ng said data about salvage radiotherapy is limited. However, a 2015 study tracked 65 patients who were treated with a median dose of 40 Gy with “curative” intent. Local control was “not great” at 72% at 2 years, Dr. Ng said, while overall survival was 60% and progress-free survival was 46%.

Dr. Ng, who was one of this study’s authors, said several groups did better: Those with refractory vs. relapsed disease and those who were responsive to chemotherapy vs. those who were not.

She also highlighted a similar 2019 study of 32 patients with refractory/relapsed disease treated with salvage radiotherapy (median dose of 42.7 Gy) found that 61.8% reached progress-free survival at 5 years – a better outcome.

Dr. Yang has no disclosures. Dr. Ng discloses royalties from UpToDate and Elsevier.
 

INTRODUCTION

Lymphadenopathy in Chronic Lymphocytic Leukemia (CLL) is a very common feature. However, sudden increase in lymphadenopathy or other symptoms like weight loss should be evaluated for possible metastatic malignancy. We describe a CLL patient with diffuse mediastinal lymphadenopathy who was diagnosed with metastatic bladder cancer without a primary bladder tumor mass on imaging.

CASE DESCRIPTION

A 60-year-old man with a 60 pack-year smoking history, alcoholic cirrhosis, and a 5-year history of stage 1 CLL presented with 3 months of progressive shortness of breath; persistent cough; chills; hemoptysis; and a steady weight loss of 35 lbs. Notably, he had no bladder symptoms. Initial labs showed leukocytosis of 35.8k with a lymphocytic predominance. Screening low-dose chest CT was positive for diffuse mediastinal lymphadenopathy. Subsequent PET/CT revealed numerous hypermetabolic lymph nodes in the neck, mediastinum, left hilum, and right periaortic abdominal region. CT Chest, Abdomen, Pelvis revealed progressive lymphadenopathy as seen in prior imaging, stable pulmonary nodules up to 4 mm in size, and splenomegaly. No distant primary sites, including of the bladder, were identified. Mediastinal lymph node biopsy confirmed metastatic poorly differentiated carcinoma with immunohistochemical staining negative for p40, p63, CK20, TTF-1, Napsin A, CDX2, CA19- 9, Calretinin, and D2-40 and positive for CK7, GATA3, Ber-EP4, and Uroplakin, supporting bladder as primary origin. Urology deferred a cystoscopy given his lack of urinary symptoms and positive biopsy and was started on Carboplatin/Gemcitabine for his metastatic disease. He was ineligible for Cisplatin given his cirrhosis and hearing impairment.

DISCUSSION

In patients with CLL, new onset mediastinal lymphadenopathy is concerning for disease progression and possible transformation to a diffuse b-cell lymphoma. However, this symptom has a broad differential, including primary lung carcinomas, sarcomas, and metastatic disease. While our patient’s PET/CT and pan-CT failed to identify a distant primary site, maintaining a low clinical suspicion for metastatic disease and doing a thorough work-up was paramount. Only through immunohistochemical staining were we able to diagnosis this patient with urothelial carcinoma.

CONCLUSIONS

Biopsy with immunohistochemical staining and maintaining a low suspicion for worsening lymphadenopathy can identify unusually presenting urothelial carcinomas in CLL patients.

INTRODUCTION

Lymphadenopathy in Chronic Lymphocytic Leukemia (CLL) is a very common feature. However, sudden increase in lymphadenopathy or other symptoms like weight loss should be evaluated for possible metastatic malignancy. We describe a CLL patient with diffuse mediastinal lymphadenopathy who was diagnosed with metastatic bladder cancer without a primary bladder tumor mass on imaging.

CASE DESCRIPTION

A 60-year-old man with a 60 pack-year smoking history, alcoholic cirrhosis, and a 5-year history of stage 1 CLL presented with 3 months of progressive shortness of breath; persistent cough; chills; hemoptysis; and a steady weight loss of 35 lbs. Notably, he had no bladder symptoms. Initial labs showed leukocytosis of 35.8k with a lymphocytic predominance. Screening low-dose chest CT was positive for diffuse mediastinal lymphadenopathy. Subsequent PET/CT revealed numerous hypermetabolic lymph nodes in the neck, mediastinum, left hilum, and right periaortic abdominal region. CT Chest, Abdomen, Pelvis revealed progressive lymphadenopathy as seen in prior imaging, stable pulmonary nodules up to 4 mm in size, and splenomegaly. No distant primary sites, including of the bladder, were identified. Mediastinal lymph node biopsy confirmed metastatic poorly differentiated carcinoma with immunohistochemical staining negative for p40, p63, CK20, TTF-1, Napsin A, CDX2, CA19- 9, Calretinin, and D2-40 and positive for CK7, GATA3, Ber-EP4, and Uroplakin, supporting bladder as primary origin. Urology deferred a cystoscopy given his lack of urinary symptoms and positive biopsy and was started on Carboplatin/Gemcitabine for his metastatic disease. He was ineligible for Cisplatin given his cirrhosis and hearing impairment.

DISCUSSION

In patients with CLL, new onset mediastinal lymphadenopathy is concerning for disease progression and possible transformation to a diffuse b-cell lymphoma. However, this symptom has a broad differential, including primary lung carcinomas, sarcomas, and metastatic disease. While our patient’s PET/CT and pan-CT failed to identify a distant primary site, maintaining a low clinical suspicion for metastatic disease and doing a thorough work-up was paramount. Only through immunohistochemical staining were we able to diagnosis this patient with urothelial carcinoma.

CONCLUSIONS

Biopsy with immunohistochemical staining and maintaining a low suspicion for worsening lymphadenopathy can identify unusually presenting urothelial carcinomas in CLL patients.

INTRODUCTION

Lymphadenopathy in Chronic Lymphocytic Leukemia (CLL) is a very common feature. However, sudden increase in lymphadenopathy or other symptoms like weight loss should be evaluated for possible metastatic malignancy. We describe a CLL patient with diffuse mediastinal lymphadenopathy who was diagnosed with metastatic bladder cancer without a primary bladder tumor mass on imaging.

CASE DESCRIPTION

A 60-year-old man with a 60 pack-year smoking history, alcoholic cirrhosis, and a 5-year history of stage 1 CLL presented with 3 months of progressive shortness of breath; persistent cough; chills; hemoptysis; and a steady weight loss of 35 lbs. Notably, he had no bladder symptoms. Initial labs showed leukocytosis of 35.8k with a lymphocytic predominance. Screening low-dose chest CT was positive for diffuse mediastinal lymphadenopathy. Subsequent PET/CT revealed numerous hypermetabolic lymph nodes in the neck, mediastinum, left hilum, and right periaortic abdominal region. CT Chest, Abdomen, Pelvis revealed progressive lymphadenopathy as seen in prior imaging, stable pulmonary nodules up to 4 mm in size, and splenomegaly. No distant primary sites, including of the bladder, were identified. Mediastinal lymph node biopsy confirmed metastatic poorly differentiated carcinoma with immunohistochemical staining negative for p40, p63, CK20, TTF-1, Napsin A, CDX2, CA19- 9, Calretinin, and D2-40 and positive for CK7, GATA3, Ber-EP4, and Uroplakin, supporting bladder as primary origin. Urology deferred a cystoscopy given his lack of urinary symptoms and positive biopsy and was started on Carboplatin/Gemcitabine for his metastatic disease. He was ineligible for Cisplatin given his cirrhosis and hearing impairment.

DISCUSSION

In patients with CLL, new onset mediastinal lymphadenopathy is concerning for disease progression and possible transformation to a diffuse b-cell lymphoma. However, this symptom has a broad differential, including primary lung carcinomas, sarcomas, and metastatic disease. While our patient’s PET/CT and pan-CT failed to identify a distant primary site, maintaining a low clinical suspicion for metastatic disease and doing a thorough work-up was paramount. Only through immunohistochemical staining were we able to diagnosis this patient with urothelial carcinoma.

CONCLUSIONS

Biopsy with immunohistochemical staining and maintaining a low suspicion for worsening lymphadenopathy can identify unusually presenting urothelial carcinomas in CLL patients.

The U.S. Food and Drug Administration has approved motixafortide (Aphexda, BioLineRx) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma.

The success of autologous stem cell transplantation (ASCT) depends on adequate mobilization of stem cells during the treatment process. Collection of a sufficient number of stem cells to perform two transplantations is recommended. However, in up to 47% of patients, collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session remains a challenge, BioLineRx explained in a press release today, announcing the approval.

The goal of combining motixafortide with filgrastim is to mobilize stem cells more reliably than filgrastim can alone, with fewer days of apheresis sessions and fewer doses of filgrastim.

“We believe [motixafortide] will play a critical role in addressing unmet needs and introduce a new treatment paradigm for” patients with multiple myeloma, CEO Philip Serlin said in the release.

The drug approval was based on the GENESIS trial, which randomized 122 patients to either motixafortide plus filgrastim or placebo plus filgrastim.

BioLineRx said the trial included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with about 70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.

Motixafortide plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of 6 million or more CD34+ cells/kg within two apheresis sessions, versus 9.5% of patients receiving the placebo plus filgrastim regimen. Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the motixafortide arm and 21.4% in the placebo arm.

However, “the data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted,” the company said.

Serious adverse reactions occurred in 5.4% of patients in the motixafortide arm, including vomiting, injection-site reaction, hypersensitivity reaction, injection-site cellulitis, hypokalemia, and hypoxia. The most common adverse reactions, occurring in more than 20% of patients, were injection site reactions (pain, erythema, and pruritus), pruritus, flushing, and back pain.

Labeling for the subcutaneous injection is available online.

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

The U.S. Food and Drug Administration has approved motixafortide (Aphexda, BioLineRx) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma.

The success of autologous stem cell transplantation (ASCT) depends on adequate mobilization of stem cells during the treatment process. Collection of a sufficient number of stem cells to perform two transplantations is recommended. However, in up to 47% of patients, collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session remains a challenge, BioLineRx explained in a press release today, announcing the approval.

The goal of combining motixafortide with filgrastim is to mobilize stem cells more reliably than filgrastim can alone, with fewer days of apheresis sessions and fewer doses of filgrastim.

“We believe [motixafortide] will play a critical role in addressing unmet needs and introduce a new treatment paradigm for” patients with multiple myeloma, CEO Philip Serlin said in the release.

The drug approval was based on the GENESIS trial, which randomized 122 patients to either motixafortide plus filgrastim or placebo plus filgrastim.

BioLineRx said the trial included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with about 70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.

Motixafortide plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of 6 million or more CD34+ cells/kg within two apheresis sessions, versus 9.5% of patients receiving the placebo plus filgrastim regimen. Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the motixafortide arm and 21.4% in the placebo arm.

However, “the data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted,” the company said.

Serious adverse reactions occurred in 5.4% of patients in the motixafortide arm, including vomiting, injection-site reaction, hypersensitivity reaction, injection-site cellulitis, hypokalemia, and hypoxia. The most common adverse reactions, occurring in more than 20% of patients, were injection site reactions (pain, erythema, and pruritus), pruritus, flushing, and back pain.

Labeling for the subcutaneous injection is available online.

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

The U.S. Food and Drug Administration has approved motixafortide (Aphexda, BioLineRx) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma.

The success of autologous stem cell transplantation (ASCT) depends on adequate mobilization of stem cells during the treatment process. Collection of a sufficient number of stem cells to perform two transplantations is recommended. However, in up to 47% of patients, collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session remains a challenge, BioLineRx explained in a press release today, announcing the approval.

The goal of combining motixafortide with filgrastim is to mobilize stem cells more reliably than filgrastim can alone, with fewer days of apheresis sessions and fewer doses of filgrastim.

“We believe [motixafortide] will play a critical role in addressing unmet needs and introduce a new treatment paradigm for” patients with multiple myeloma, CEO Philip Serlin said in the release.

The drug approval was based on the GENESIS trial, which randomized 122 patients to either motixafortide plus filgrastim or placebo plus filgrastim.

BioLineRx said the trial included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with about 70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.

Motixafortide plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of 6 million or more CD34+ cells/kg within two apheresis sessions, versus 9.5% of patients receiving the placebo plus filgrastim regimen. Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the motixafortide arm and 21.4% in the placebo arm.

However, “the data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted,” the company said.

Serious adverse reactions occurred in 5.4% of patients in the motixafortide arm, including vomiting, injection-site reaction, hypersensitivity reaction, injection-site cellulitis, hypokalemia, and hypoxia. The most common adverse reactions, occurring in more than 20% of patients, were injection site reactions (pain, erythema, and pruritus), pruritus, flushing, and back pain.

Labeling for the subcutaneous injection is available online.

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