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The rate of recurrence of the rare but aggressive skin cancer Merkel cell carcinoma (MCC) is markedly higher than that for invasive melanoma, squamous cell carcinoma, or basal cell carcinoma, and more than half of all patients with stage IV disease will have a recurrence within 1 year of definitive therapy, results of a new study show.

A study of 618 patients with MCC who were enrolled in a Seattle-based data repository shows that among all patients the 5-year recurrence rate was 40%. The risk of recurrence within the first year was 11% for patients with pathologic stage I disease, 33% for those with stage IIA/IIB disease, 45% for those with stage IIIB disease, and 58% for patients with pathologic stage IV MCC.

Approximately 95% of all recurrences happened within 3 years of the initial diagnosis, report Aubriana McEvoy, MD, from the University of Washington in Seattle, and colleagues.

“This cohort study indicates that the highest yield (and likely most cost-effective) time period for detecting MCC recurrence is 1-3 years after diagnosis,” they write in a study published online in JAMA Dermatology.

The estimated annual incidence of MCC in the United States in 2018 was 2,000 according to the American Cancer Society. The annual incidence rate is rising rapidly, however, and is estimated to reach 3,284 by 2025, McEvoy and colleagues write.

Although MCC is known to have high recurrence rates and is associated with a higher mortality rate than malignant melanoma, recurrence rate data are not captured by either the Surveillance, Epidemiology, and End Results (SEER) database or by the National Cancer Database. As a result, estimates of recurrence rates with MCC have been all over the map, ranging from 27% to 77%, depending on the population studied.

But as senior author Paul Nghiem, MD, PhD, professor and chair of dermatology at the University of Washington, Seattle, told this news organization, recurrence rates over time in their study were remarkably consistent.

“The biggest surprise to me was that, when we broke our nearly 20-year cohort into three 5- or 6-year chunks, every one of the groups had a 40% recurrence rate, within 1%. So we feel really confident that’s the right number,” he said.

Dr. Nghiem and colleagues report that, in contrast to patients with MCC, approximately 19% of patients with melanoma will have a recurrence, as will an estimated 5%-9% of patients with squamous cell carcinoma and 1%-10% of patients with basal cell carcinoma.

The fact that recurrence rates of MCC have remained stable over time despite presumed improvements in definitive therapy is disappointing, Dr. Nghiem acknowledged. He noted that it’s still unclear whether immunotherapy will have the same dramatic effect on survival rates for patients with MCC as it has for patients with malignant melanoma.

The high recurrence rates following definitive therapy for patients with early-stage disease was a novel finding, commented Shawn Demehri, MD, PhD, director of the high-risk skin cancer clinic at Massachusetts General Hospital in Boston.

“When you’re looking at patients with stage I or stage II, and they have definitive surgery but still have recurrences at a higher rate than melanoma, it brings home the point that these are among the most aggressive tumors of the skin,” he said in an interview.

The high recurrence rates seen with MCC are attributable to a variety of factors.

“This is a rare cancer of mostly older individuals with a lot of comorbidities, and also a cancer that, even though it is a primary cancer, might be detected a little later than even a melanoma primary tumor, just because of the nature of the neuroendocrine tumor cells,” he said.

Dr. Demehri was not involved in the study.
 

Prospective cohort

The study cohort consisted of 618 patients with MCC. The median age of the patients was 69, and 227 (37%) were women. The patients were enrolled within 6 months of their diagnosis in the prospective data repository from 2003 through 2019. Of this group, 223 had a recurrence of MCC.

As noted, there was a high risk of recurrence within 1 year, ranging from 11% for patients with pathologic stage I tumors to 58% for those with stage IV disease, and 95% of all recurrences occurred within 3 years of definitive therapy.

To get a better picture of the natural history of MCC recurrence, the investigators studied a cohort of patients with pathologically confirmed MCC who were prospectively enrolled from January 2003 through April 2019 in a data repository maintained at the University of Washington.

In addition to disease stage, factors associated with increased recurrence risk in univariable analyses include immunosuppression (hazard ratio, 2.4; P < .001), male sex (HR, 1.9; P < .001), known primary lesion among patients with clinically detectable nodal disease (HR, 2.3; P = .001), and older age (HR, 1.1, P = .06 for each 10-year increase).

Of the 187 patients in the cohort who died during the study, 121 died from MCC. At 4 years after diagnosis, MCC-specific survival rates were 95% for patients with pathologic stage I, 84% with stage IIA/IIB, 80% with stage IIIA, 58% with stage IIIB, and 41% with stage IV.

Evidence supports close monitoring within the first 3 years for patients with stage I-II MCC. Local recurrence within or adjacent to the primary tumor scar was associated with a 5-year MCC-specific survival rate of 85%, compared with 88% of patients with stage I or II disease who did not have recurrences.

“Because more than 90% of MCC recurrences arise within 3 years, it is appropriate to adjust surveillance intensity accordingly. Stage- and time-specific recurrence data can assist in appropriately focusing surveillance resources on patients and time intervals in which recurrence risk is highest,” the authors wrote.

“If you’re a patient who has not had your cancer come back for 3, 4, or 5 years, you can really cut down on the intensity of your follow-up and scans,” Dr. Nghiem said.

“We do now have two excellent blood tests that are working very well, and we have really good ways to detect the cancer coming back early, and that’s important, because we have potentially curative therapies that tend to work better if you catch the cancer early,” he said.

The study was supported by the National Institutes of Health. Dr. Nghiem reported personal fees and institutional support outside the study from several companies and patents for Merkel cell therapies with the University of Washington and University of Denmark. Dr. Demehri has disclosed no relevant financial relationships.

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

The rate of recurrence of the rare but aggressive skin cancer Merkel cell carcinoma (MCC) is markedly higher than that for invasive melanoma, squamous cell carcinoma, or basal cell carcinoma, and more than half of all patients with stage IV disease will have a recurrence within 1 year of definitive therapy, results of a new study show.

A study of 618 patients with MCC who were enrolled in a Seattle-based data repository shows that among all patients the 5-year recurrence rate was 40%. The risk of recurrence within the first year was 11% for patients with pathologic stage I disease, 33% for those with stage IIA/IIB disease, 45% for those with stage IIIB disease, and 58% for patients with pathologic stage IV MCC.

Approximately 95% of all recurrences happened within 3 years of the initial diagnosis, report Aubriana McEvoy, MD, from the University of Washington in Seattle, and colleagues.

“This cohort study indicates that the highest yield (and likely most cost-effective) time period for detecting MCC recurrence is 1-3 years after diagnosis,” they write in a study published online in JAMA Dermatology.

The estimated annual incidence of MCC in the United States in 2018 was 2,000 according to the American Cancer Society. The annual incidence rate is rising rapidly, however, and is estimated to reach 3,284 by 2025, McEvoy and colleagues write.

Although MCC is known to have high recurrence rates and is associated with a higher mortality rate than malignant melanoma, recurrence rate data are not captured by either the Surveillance, Epidemiology, and End Results (SEER) database or by the National Cancer Database. As a result, estimates of recurrence rates with MCC have been all over the map, ranging from 27% to 77%, depending on the population studied.

But as senior author Paul Nghiem, MD, PhD, professor and chair of dermatology at the University of Washington, Seattle, told this news organization, recurrence rates over time in their study were remarkably consistent.

“The biggest surprise to me was that, when we broke our nearly 20-year cohort into three 5- or 6-year chunks, every one of the groups had a 40% recurrence rate, within 1%. So we feel really confident that’s the right number,” he said.

Dr. Nghiem and colleagues report that, in contrast to patients with MCC, approximately 19% of patients with melanoma will have a recurrence, as will an estimated 5%-9% of patients with squamous cell carcinoma and 1%-10% of patients with basal cell carcinoma.

The fact that recurrence rates of MCC have remained stable over time despite presumed improvements in definitive therapy is disappointing, Dr. Nghiem acknowledged. He noted that it’s still unclear whether immunotherapy will have the same dramatic effect on survival rates for patients with MCC as it has for patients with malignant melanoma.

The high recurrence rates following definitive therapy for patients with early-stage disease was a novel finding, commented Shawn Demehri, MD, PhD, director of the high-risk skin cancer clinic at Massachusetts General Hospital in Boston.

“When you’re looking at patients with stage I or stage II, and they have definitive surgery but still have recurrences at a higher rate than melanoma, it brings home the point that these are among the most aggressive tumors of the skin,” he said in an interview.

The high recurrence rates seen with MCC are attributable to a variety of factors.

“This is a rare cancer of mostly older individuals with a lot of comorbidities, and also a cancer that, even though it is a primary cancer, might be detected a little later than even a melanoma primary tumor, just because of the nature of the neuroendocrine tumor cells,” he said.

Dr. Demehri was not involved in the study.
 

Prospective cohort

The study cohort consisted of 618 patients with MCC. The median age of the patients was 69, and 227 (37%) were women. The patients were enrolled within 6 months of their diagnosis in the prospective data repository from 2003 through 2019. Of this group, 223 had a recurrence of MCC.

As noted, there was a high risk of recurrence within 1 year, ranging from 11% for patients with pathologic stage I tumors to 58% for those with stage IV disease, and 95% of all recurrences occurred within 3 years of definitive therapy.

To get a better picture of the natural history of MCC recurrence, the investigators studied a cohort of patients with pathologically confirmed MCC who were prospectively enrolled from January 2003 through April 2019 in a data repository maintained at the University of Washington.

In addition to disease stage, factors associated with increased recurrence risk in univariable analyses include immunosuppression (hazard ratio, 2.4; P < .001), male sex (HR, 1.9; P < .001), known primary lesion among patients with clinically detectable nodal disease (HR, 2.3; P = .001), and older age (HR, 1.1, P = .06 for each 10-year increase).

Of the 187 patients in the cohort who died during the study, 121 died from MCC. At 4 years after diagnosis, MCC-specific survival rates were 95% for patients with pathologic stage I, 84% with stage IIA/IIB, 80% with stage IIIA, 58% with stage IIIB, and 41% with stage IV.

Evidence supports close monitoring within the first 3 years for patients with stage I-II MCC. Local recurrence within or adjacent to the primary tumor scar was associated with a 5-year MCC-specific survival rate of 85%, compared with 88% of patients with stage I or II disease who did not have recurrences.

“Because more than 90% of MCC recurrences arise within 3 years, it is appropriate to adjust surveillance intensity accordingly. Stage- and time-specific recurrence data can assist in appropriately focusing surveillance resources on patients and time intervals in which recurrence risk is highest,” the authors wrote.

“If you’re a patient who has not had your cancer come back for 3, 4, or 5 years, you can really cut down on the intensity of your follow-up and scans,” Dr. Nghiem said.

“We do now have two excellent blood tests that are working very well, and we have really good ways to detect the cancer coming back early, and that’s important, because we have potentially curative therapies that tend to work better if you catch the cancer early,” he said.

The study was supported by the National Institutes of Health. Dr. Nghiem reported personal fees and institutional support outside the study from several companies and patents for Merkel cell therapies with the University of Washington and University of Denmark. Dr. Demehri has disclosed no relevant financial relationships.

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

The rate of recurrence of the rare but aggressive skin cancer Merkel cell carcinoma (MCC) is markedly higher than that for invasive melanoma, squamous cell carcinoma, or basal cell carcinoma, and more than half of all patients with stage IV disease will have a recurrence within 1 year of definitive therapy, results of a new study show.

A study of 618 patients with MCC who were enrolled in a Seattle-based data repository shows that among all patients the 5-year recurrence rate was 40%. The risk of recurrence within the first year was 11% for patients with pathologic stage I disease, 33% for those with stage IIA/IIB disease, 45% for those with stage IIIB disease, and 58% for patients with pathologic stage IV MCC.

Approximately 95% of all recurrences happened within 3 years of the initial diagnosis, report Aubriana McEvoy, MD, from the University of Washington in Seattle, and colleagues.

“This cohort study indicates that the highest yield (and likely most cost-effective) time period for detecting MCC recurrence is 1-3 years after diagnosis,” they write in a study published online in JAMA Dermatology.

The estimated annual incidence of MCC in the United States in 2018 was 2,000 according to the American Cancer Society. The annual incidence rate is rising rapidly, however, and is estimated to reach 3,284 by 2025, McEvoy and colleagues write.

Although MCC is known to have high recurrence rates and is associated with a higher mortality rate than malignant melanoma, recurrence rate data are not captured by either the Surveillance, Epidemiology, and End Results (SEER) database or by the National Cancer Database. As a result, estimates of recurrence rates with MCC have been all over the map, ranging from 27% to 77%, depending on the population studied.

But as senior author Paul Nghiem, MD, PhD, professor and chair of dermatology at the University of Washington, Seattle, told this news organization, recurrence rates over time in their study were remarkably consistent.

“The biggest surprise to me was that, when we broke our nearly 20-year cohort into three 5- or 6-year chunks, every one of the groups had a 40% recurrence rate, within 1%. So we feel really confident that’s the right number,” he said.

Dr. Nghiem and colleagues report that, in contrast to patients with MCC, approximately 19% of patients with melanoma will have a recurrence, as will an estimated 5%-9% of patients with squamous cell carcinoma and 1%-10% of patients with basal cell carcinoma.

The fact that recurrence rates of MCC have remained stable over time despite presumed improvements in definitive therapy is disappointing, Dr. Nghiem acknowledged. He noted that it’s still unclear whether immunotherapy will have the same dramatic effect on survival rates for patients with MCC as it has for patients with malignant melanoma.

The high recurrence rates following definitive therapy for patients with early-stage disease was a novel finding, commented Shawn Demehri, MD, PhD, director of the high-risk skin cancer clinic at Massachusetts General Hospital in Boston.

“When you’re looking at patients with stage I or stage II, and they have definitive surgery but still have recurrences at a higher rate than melanoma, it brings home the point that these are among the most aggressive tumors of the skin,” he said in an interview.

The high recurrence rates seen with MCC are attributable to a variety of factors.

“This is a rare cancer of mostly older individuals with a lot of comorbidities, and also a cancer that, even though it is a primary cancer, might be detected a little later than even a melanoma primary tumor, just because of the nature of the neuroendocrine tumor cells,” he said.

Dr. Demehri was not involved in the study.
 

Prospective cohort

The study cohort consisted of 618 patients with MCC. The median age of the patients was 69, and 227 (37%) were women. The patients were enrolled within 6 months of their diagnosis in the prospective data repository from 2003 through 2019. Of this group, 223 had a recurrence of MCC.

As noted, there was a high risk of recurrence within 1 year, ranging from 11% for patients with pathologic stage I tumors to 58% for those with stage IV disease, and 95% of all recurrences occurred within 3 years of definitive therapy.

To get a better picture of the natural history of MCC recurrence, the investigators studied a cohort of patients with pathologically confirmed MCC who were prospectively enrolled from January 2003 through April 2019 in a data repository maintained at the University of Washington.

In addition to disease stage, factors associated with increased recurrence risk in univariable analyses include immunosuppression (hazard ratio, 2.4; P < .001), male sex (HR, 1.9; P < .001), known primary lesion among patients with clinically detectable nodal disease (HR, 2.3; P = .001), and older age (HR, 1.1, P = .06 for each 10-year increase).

Of the 187 patients in the cohort who died during the study, 121 died from MCC. At 4 years after diagnosis, MCC-specific survival rates were 95% for patients with pathologic stage I, 84% with stage IIA/IIB, 80% with stage IIIA, 58% with stage IIIB, and 41% with stage IV.

Evidence supports close monitoring within the first 3 years for patients with stage I-II MCC. Local recurrence within or adjacent to the primary tumor scar was associated with a 5-year MCC-specific survival rate of 85%, compared with 88% of patients with stage I or II disease who did not have recurrences.

“Because more than 90% of MCC recurrences arise within 3 years, it is appropriate to adjust surveillance intensity accordingly. Stage- and time-specific recurrence data can assist in appropriately focusing surveillance resources on patients and time intervals in which recurrence risk is highest,” the authors wrote.

“If you’re a patient who has not had your cancer come back for 3, 4, or 5 years, you can really cut down on the intensity of your follow-up and scans,” Dr. Nghiem said.

“We do now have two excellent blood tests that are working very well, and we have really good ways to detect the cancer coming back early, and that’s important, because we have potentially curative therapies that tend to work better if you catch the cancer early,” he said.

The study was supported by the National Institutes of Health. Dr. Nghiem reported personal fees and institutional support outside the study from several companies and patents for Merkel cell therapies with the University of Washington and University of Denmark. Dr. Demehri has disclosed no relevant financial relationships.

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

PHOENIX – A liquid biopsy test may accurately predict recurrence of human papillomavirus (HPV)–driven oropharyngeal squamous cell carcinoma (OPSCC) earlier than standard clinical and imaging assessments, a new analysis indicates.

Of 80 patients who tested positive for circulating tumor tissue–modified viral (TTMV)-HPV DNA during surveillance, 74% (n = 59) had no other evidence of disease or had indeterminate disease status.

And of those patients, 93% (n = 55) “later had proven recurrent, metastatic disease on imaging and/or biopsy,” according to Glenn Hanna, MD, from the Dana-Farber Cancer Institute, Boston, who presented the results Feb. 24 at the 2022 Multidisciplinary Head and Neck Cancers Symposium.

“This is the first study to demonstrate broad clinical utility and validity of the biomarker in HPV-driven oropharyngeal cancer,” Dr. Hanna said in a press release.

Although patients with HPV-driven OPSCC generally have favorable outcomes, up to 25% will experience recurrence after treatment.

Post-treatment surveillance currently relies on physical examinations and imaging, but Dr. Hanna and colleagues wanted to determine whether a routine circulating cell-free TTMV-HPV DNA test could detect occult recurrence sooner.

Dr. Hanna and colleagues analyzed the records of 1,076 patients with HPV-driven OPSCC at 118 sites in the U.S. who had completed therapy more than 3 months previously and undergone an TTMV-HPV DNA test (NavDx, Naveris) between June 2020 and November 2021.

The results of the test, which used ultrasensitive digital droplet PCR to identify HPV subtypes 16, 18, 31, 33, and 35, were compared with subsequent clinical evidence of OPSCC via nasopharyngolaryngoscopy, radiologic evaluations, or tissue biopsy.

Approximately 7% of the patients tested positive (n = 80) for circulating TTMV-HPV DNA. Of those, 26.2% (n = 21) had known clinical recurrence, while 73.8% (n = 59) had no other evidence of disease or an intermediate disease status.

Among those with no clinical evidence of recurrence, 93.2% (n = 55) had their recurrence subsequently confirmed using imaging or biopsy. Of the 4 remaining patients, 2 had clinically suspicious lesions, and 2 had no other evidence of disease.

Overall, the data indicate that the biomarker test demonstrated a 95% positive predictive value (76 of 80 patients) for recurrence or persistence of HPV-driven OPSCC.

According to Dr. Hanna, a positive TTMV-HPV DNA test was the first indicator of recurrence for 72% of patients, and almost half of recurrences were detected more than 12 months after completing therapy.

“Incorporating a test for TTMV-HPV DNA into routine post-treatment follow-up can enable physicians to detect recurrent cancers earlier and allow us to start recommended interventions more quickly to improve outcomes,” Dr. Hanna said in the release.

The study was supported by Naveris, which developed the TTMV-HPV DNA test studied. Dr. Hanna declares relationships with Actuate Therapeutics, Altor BioScience, Bicara, BMS, GSK, Merck, Regeneron, Sanofi/Genzyme, and others.

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

PHOENIX – A liquid biopsy test may accurately predict recurrence of human papillomavirus (HPV)–driven oropharyngeal squamous cell carcinoma (OPSCC) earlier than standard clinical and imaging assessments, a new analysis indicates.

Of 80 patients who tested positive for circulating tumor tissue–modified viral (TTMV)-HPV DNA during surveillance, 74% (n = 59) had no other evidence of disease or had indeterminate disease status.

And of those patients, 93% (n = 55) “later had proven recurrent, metastatic disease on imaging and/or biopsy,” according to Glenn Hanna, MD, from the Dana-Farber Cancer Institute, Boston, who presented the results Feb. 24 at the 2022 Multidisciplinary Head and Neck Cancers Symposium.

“This is the first study to demonstrate broad clinical utility and validity of the biomarker in HPV-driven oropharyngeal cancer,” Dr. Hanna said in a press release.

Although patients with HPV-driven OPSCC generally have favorable outcomes, up to 25% will experience recurrence after treatment.

Post-treatment surveillance currently relies on physical examinations and imaging, but Dr. Hanna and colleagues wanted to determine whether a routine circulating cell-free TTMV-HPV DNA test could detect occult recurrence sooner.

Dr. Hanna and colleagues analyzed the records of 1,076 patients with HPV-driven OPSCC at 118 sites in the U.S. who had completed therapy more than 3 months previously and undergone an TTMV-HPV DNA test (NavDx, Naveris) between June 2020 and November 2021.

The results of the test, which used ultrasensitive digital droplet PCR to identify HPV subtypes 16, 18, 31, 33, and 35, were compared with subsequent clinical evidence of OPSCC via nasopharyngolaryngoscopy, radiologic evaluations, or tissue biopsy.

Approximately 7% of the patients tested positive (n = 80) for circulating TTMV-HPV DNA. Of those, 26.2% (n = 21) had known clinical recurrence, while 73.8% (n = 59) had no other evidence of disease or an intermediate disease status.

Among those with no clinical evidence of recurrence, 93.2% (n = 55) had their recurrence subsequently confirmed using imaging or biopsy. Of the 4 remaining patients, 2 had clinically suspicious lesions, and 2 had no other evidence of disease.

Overall, the data indicate that the biomarker test demonstrated a 95% positive predictive value (76 of 80 patients) for recurrence or persistence of HPV-driven OPSCC.

According to Dr. Hanna, a positive TTMV-HPV DNA test was the first indicator of recurrence for 72% of patients, and almost half of recurrences were detected more than 12 months after completing therapy.

“Incorporating a test for TTMV-HPV DNA into routine post-treatment follow-up can enable physicians to detect recurrent cancers earlier and allow us to start recommended interventions more quickly to improve outcomes,” Dr. Hanna said in the release.

The study was supported by Naveris, which developed the TTMV-HPV DNA test studied. Dr. Hanna declares relationships with Actuate Therapeutics, Altor BioScience, Bicara, BMS, GSK, Merck, Regeneron, Sanofi/Genzyme, and others.

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

PHOENIX – A liquid biopsy test may accurately predict recurrence of human papillomavirus (HPV)–driven oropharyngeal squamous cell carcinoma (OPSCC) earlier than standard clinical and imaging assessments, a new analysis indicates.

Of 80 patients who tested positive for circulating tumor tissue–modified viral (TTMV)-HPV DNA during surveillance, 74% (n = 59) had no other evidence of disease or had indeterminate disease status.

And of those patients, 93% (n = 55) “later had proven recurrent, metastatic disease on imaging and/or biopsy,” according to Glenn Hanna, MD, from the Dana-Farber Cancer Institute, Boston, who presented the results Feb. 24 at the 2022 Multidisciplinary Head and Neck Cancers Symposium.

“This is the first study to demonstrate broad clinical utility and validity of the biomarker in HPV-driven oropharyngeal cancer,” Dr. Hanna said in a press release.

Although patients with HPV-driven OPSCC generally have favorable outcomes, up to 25% will experience recurrence after treatment.

Post-treatment surveillance currently relies on physical examinations and imaging, but Dr. Hanna and colleagues wanted to determine whether a routine circulating cell-free TTMV-HPV DNA test could detect occult recurrence sooner.

Dr. Hanna and colleagues analyzed the records of 1,076 patients with HPV-driven OPSCC at 118 sites in the U.S. who had completed therapy more than 3 months previously and undergone an TTMV-HPV DNA test (NavDx, Naveris) between June 2020 and November 2021.

The results of the test, which used ultrasensitive digital droplet PCR to identify HPV subtypes 16, 18, 31, 33, and 35, were compared with subsequent clinical evidence of OPSCC via nasopharyngolaryngoscopy, radiologic evaluations, or tissue biopsy.

Approximately 7% of the patients tested positive (n = 80) for circulating TTMV-HPV DNA. Of those, 26.2% (n = 21) had known clinical recurrence, while 73.8% (n = 59) had no other evidence of disease or an intermediate disease status.

Among those with no clinical evidence of recurrence, 93.2% (n = 55) had their recurrence subsequently confirmed using imaging or biopsy. Of the 4 remaining patients, 2 had clinically suspicious lesions, and 2 had no other evidence of disease.

Overall, the data indicate that the biomarker test demonstrated a 95% positive predictive value (76 of 80 patients) for recurrence or persistence of HPV-driven OPSCC.

According to Dr. Hanna, a positive TTMV-HPV DNA test was the first indicator of recurrence for 72% of patients, and almost half of recurrences were detected more than 12 months after completing therapy.

“Incorporating a test for TTMV-HPV DNA into routine post-treatment follow-up can enable physicians to detect recurrent cancers earlier and allow us to start recommended interventions more quickly to improve outcomes,” Dr. Hanna said in the release.

The study was supported by Naveris, which developed the TTMV-HPV DNA test studied. Dr. Hanna declares relationships with Actuate Therapeutics, Altor BioScience, Bicara, BMS, GSK, Merck, Regeneron, Sanofi/Genzyme, and others.

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

Incidence rates for testicular cancer have been rising in the United States, as have related mortality rates, but there are wide variations by race/ethnicity and geographic location, a new analysis shows.

Testicular cancer is the most common type of malignancy in young men between the ages of 20 and 34 years, although overall, it is relatively uncommon and represents only 0.5% of all new cancer cases in the U.S.

The new analysis shows that age-adjusted testicular cancer–specific mortality rates in the United States increased from 1999-2019, particularly among Hispanic men. During the same period, mortality rates declined somewhat among Black men as compared to White men.

“Given that testicular cancer generally has a favorable prognosis, it is concerning that mortality rates for this disease are increasing,” said lead author Anushka Ghosh, BS, a clinical research coordinator at Massachusetts General Hospital, Boston. “It is crucial to understand these trends and make targeted efforts to address any geographic, racial, and ethnic gaps in testicular cancer care.”

She presented the findings at the Genitourinary Cancers Symposium (GUCS) 2022.

“Testicular cancer is a rare but very curable disease,” said Daniel Geynisman, MD, associate professor in the Department of Hematology/Oncology at Fox Chase Cancer Center, Philadelphia, who was approached for comment. “The increase in testicular cancer deaths for Hispanic men is concerning.”

“Whether this change relates to suboptimal access to appropriate care or change in biology as a result of socioeconomic or geographic changes in Hispanic men over the recent years is unknown but needs to be urgently explored and addressed,” he added.
 

Details of the new findings

For their analysis, Ms. Ghosh and colleagues assessed recent changes in testicular cancer mortality rates over time in the United States with respect to race, ethnicity, and geography. They used the Centers for Disease Control’s Wide-Ranging Online Data for Epidemiologic Research database to obtain the number of age-adjusted death rates for individuals across all U.S. counties over a 21-year period (1999-2019).

During this period, overall age-adjusted testicular cancer mortality rates rose slowly but not significantly, with an overall increase of 0.0002 per 100,000 population per year. This increase was significantly worse among Hispanic men, among whom the increase was 0.0019 per 100,000, compared with a 0.0003 per 100,000 decrease among non-Hispanic men (comparison P = .010).

But when stratified by race (Black vs. White), the authors saw that Black men had somewhat improved rates. Among Black men, the rate decreased by 0.0007 per 100,000, compared with an increase of 0.0006 per 100,000 among White men, a difference that reached statistical significance (P = .049).

“We also observed significant geographical differences in mortality rates,” said Ms. Ghosh.

They divided the U.S. into four regions: the Northeast, the Midwest, the South, and the West. There were no differences in the South and the Midwest, but mortality rates decreased in the Northeast by 0.00092 per 100,000 and rose in the West by 0.00086 per 100,000 (P for difference between slopes = .032).

The authors also looked at differences in urbanization categories or population density and found that large central metro regions (central counties in metro areas with population greater than 1 million) and small metro regions (counties with population 50,000-249,999) were significantly different. While testicular cancer mortality rates decreased slightly in large central metropolitan regions by 0.0004, rates increased slightly in small metropolitan regions (0.0022; P for difference = .048). No other significant differences based on urbanization were noted.

Also approached for comment, Matt D. Galsky, MD, director of genitourinary medical oncology at the Tisch Cancer Institute at Mount Sinai, noted that the finding that testicular cancer mortality rates increased from 1999-2019 was not statistically significant.

However, there were significant trends among subgroups. Testicular cancer mortality increased during this period among Hispanic men, he pointed out. “Importantly, while statistically significant, the differences are numerically small. That said, testicular cancer is a generally a highly curable malignancy, so any disparities related to mortality may be notable and worth further investigation.

“There are several potential underlying causes of such disparities, some of which could be probed with additional clinical details, and some of which might involve a more complex interplay of access and tumor biology,” he continued. “For example, testicular cancers are broadly separated into two subtypes: seminoma and nonseminoma. Whether the trends in these two subtypes in Hispanic men are different compared to non-Hispanic men could be one clue into the observed disparities.”

Ms. Ghosh, Dr. Geynisman, and Dr. Galsky have disclosed no relevant financial relationships.

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

Incidence rates for testicular cancer have been rising in the United States, as have related mortality rates, but there are wide variations by race/ethnicity and geographic location, a new analysis shows.

Testicular cancer is the most common type of malignancy in young men between the ages of 20 and 34 years, although overall, it is relatively uncommon and represents only 0.5% of all new cancer cases in the U.S.

The new analysis shows that age-adjusted testicular cancer–specific mortality rates in the United States increased from 1999-2019, particularly among Hispanic men. During the same period, mortality rates declined somewhat among Black men as compared to White men.

“Given that testicular cancer generally has a favorable prognosis, it is concerning that mortality rates for this disease are increasing,” said lead author Anushka Ghosh, BS, a clinical research coordinator at Massachusetts General Hospital, Boston. “It is crucial to understand these trends and make targeted efforts to address any geographic, racial, and ethnic gaps in testicular cancer care.”

She presented the findings at the Genitourinary Cancers Symposium (GUCS) 2022.

“Testicular cancer is a rare but very curable disease,” said Daniel Geynisman, MD, associate professor in the Department of Hematology/Oncology at Fox Chase Cancer Center, Philadelphia, who was approached for comment. “The increase in testicular cancer deaths for Hispanic men is concerning.”

“Whether this change relates to suboptimal access to appropriate care or change in biology as a result of socioeconomic or geographic changes in Hispanic men over the recent years is unknown but needs to be urgently explored and addressed,” he added.
 

Details of the new findings

For their analysis, Ms. Ghosh and colleagues assessed recent changes in testicular cancer mortality rates over time in the United States with respect to race, ethnicity, and geography. They used the Centers for Disease Control’s Wide-Ranging Online Data for Epidemiologic Research database to obtain the number of age-adjusted death rates for individuals across all U.S. counties over a 21-year period (1999-2019).

During this period, overall age-adjusted testicular cancer mortality rates rose slowly but not significantly, with an overall increase of 0.0002 per 100,000 population per year. This increase was significantly worse among Hispanic men, among whom the increase was 0.0019 per 100,000, compared with a 0.0003 per 100,000 decrease among non-Hispanic men (comparison P = .010).

But when stratified by race (Black vs. White), the authors saw that Black men had somewhat improved rates. Among Black men, the rate decreased by 0.0007 per 100,000, compared with an increase of 0.0006 per 100,000 among White men, a difference that reached statistical significance (P = .049).

“We also observed significant geographical differences in mortality rates,” said Ms. Ghosh.

They divided the U.S. into four regions: the Northeast, the Midwest, the South, and the West. There were no differences in the South and the Midwest, but mortality rates decreased in the Northeast by 0.00092 per 100,000 and rose in the West by 0.00086 per 100,000 (P for difference between slopes = .032).

The authors also looked at differences in urbanization categories or population density and found that large central metro regions (central counties in metro areas with population greater than 1 million) and small metro regions (counties with population 50,000-249,999) were significantly different. While testicular cancer mortality rates decreased slightly in large central metropolitan regions by 0.0004, rates increased slightly in small metropolitan regions (0.0022; P for difference = .048). No other significant differences based on urbanization were noted.

Also approached for comment, Matt D. Galsky, MD, director of genitourinary medical oncology at the Tisch Cancer Institute at Mount Sinai, noted that the finding that testicular cancer mortality rates increased from 1999-2019 was not statistically significant.

However, there were significant trends among subgroups. Testicular cancer mortality increased during this period among Hispanic men, he pointed out. “Importantly, while statistically significant, the differences are numerically small. That said, testicular cancer is a generally a highly curable malignancy, so any disparities related to mortality may be notable and worth further investigation.

“There are several potential underlying causes of such disparities, some of which could be probed with additional clinical details, and some of which might involve a more complex interplay of access and tumor biology,” he continued. “For example, testicular cancers are broadly separated into two subtypes: seminoma and nonseminoma. Whether the trends in these two subtypes in Hispanic men are different compared to non-Hispanic men could be one clue into the observed disparities.”

Ms. Ghosh, Dr. Geynisman, and Dr. Galsky have disclosed no relevant financial relationships.

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

Incidence rates for testicular cancer have been rising in the United States, as have related mortality rates, but there are wide variations by race/ethnicity and geographic location, a new analysis shows.

Testicular cancer is the most common type of malignancy in young men between the ages of 20 and 34 years, although overall, it is relatively uncommon and represents only 0.5% of all new cancer cases in the U.S.

The new analysis shows that age-adjusted testicular cancer–specific mortality rates in the United States increased from 1999-2019, particularly among Hispanic men. During the same period, mortality rates declined somewhat among Black men as compared to White men.

“Given that testicular cancer generally has a favorable prognosis, it is concerning that mortality rates for this disease are increasing,” said lead author Anushka Ghosh, BS, a clinical research coordinator at Massachusetts General Hospital, Boston. “It is crucial to understand these trends and make targeted efforts to address any geographic, racial, and ethnic gaps in testicular cancer care.”

She presented the findings at the Genitourinary Cancers Symposium (GUCS) 2022.

“Testicular cancer is a rare but very curable disease,” said Daniel Geynisman, MD, associate professor in the Department of Hematology/Oncology at Fox Chase Cancer Center, Philadelphia, who was approached for comment. “The increase in testicular cancer deaths for Hispanic men is concerning.”

“Whether this change relates to suboptimal access to appropriate care or change in biology as a result of socioeconomic or geographic changes in Hispanic men over the recent years is unknown but needs to be urgently explored and addressed,” he added.
 

Details of the new findings

For their analysis, Ms. Ghosh and colleagues assessed recent changes in testicular cancer mortality rates over time in the United States with respect to race, ethnicity, and geography. They used the Centers for Disease Control’s Wide-Ranging Online Data for Epidemiologic Research database to obtain the number of age-adjusted death rates for individuals across all U.S. counties over a 21-year period (1999-2019).

During this period, overall age-adjusted testicular cancer mortality rates rose slowly but not significantly, with an overall increase of 0.0002 per 100,000 population per year. This increase was significantly worse among Hispanic men, among whom the increase was 0.0019 per 100,000, compared with a 0.0003 per 100,000 decrease among non-Hispanic men (comparison P = .010).

But when stratified by race (Black vs. White), the authors saw that Black men had somewhat improved rates. Among Black men, the rate decreased by 0.0007 per 100,000, compared with an increase of 0.0006 per 100,000 among White men, a difference that reached statistical significance (P = .049).

“We also observed significant geographical differences in mortality rates,” said Ms. Ghosh.

They divided the U.S. into four regions: the Northeast, the Midwest, the South, and the West. There were no differences in the South and the Midwest, but mortality rates decreased in the Northeast by 0.00092 per 100,000 and rose in the West by 0.00086 per 100,000 (P for difference between slopes = .032).

The authors also looked at differences in urbanization categories or population density and found that large central metro regions (central counties in metro areas with population greater than 1 million) and small metro regions (counties with population 50,000-249,999) were significantly different. While testicular cancer mortality rates decreased slightly in large central metropolitan regions by 0.0004, rates increased slightly in small metropolitan regions (0.0022; P for difference = .048). No other significant differences based on urbanization were noted.

Also approached for comment, Matt D. Galsky, MD, director of genitourinary medical oncology at the Tisch Cancer Institute at Mount Sinai, noted that the finding that testicular cancer mortality rates increased from 1999-2019 was not statistically significant.

However, there were significant trends among subgroups. Testicular cancer mortality increased during this period among Hispanic men, he pointed out. “Importantly, while statistically significant, the differences are numerically small. That said, testicular cancer is a generally a highly curable malignancy, so any disparities related to mortality may be notable and worth further investigation.

“There are several potential underlying causes of such disparities, some of which could be probed with additional clinical details, and some of which might involve a more complex interplay of access and tumor biology,” he continued. “For example, testicular cancers are broadly separated into two subtypes: seminoma and nonseminoma. Whether the trends in these two subtypes in Hispanic men are different compared to non-Hispanic men could be one clue into the observed disparities.”

Ms. Ghosh, Dr. Geynisman, and Dr. Galsky have disclosed no relevant financial relationships.

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

The U.S. Preventive Services Task Force (USPSTF) criteria for lung cancer screening should be expanded to include more women, especially those with a history of breast cancer, according to a new study published in BJS Open.

The 2021 screening guidelines include adults aged between 50 and 80 years who have a 20–pack-year smoking history and currently smoke or have quit within the past 15 years, but the guidelines do not include nonsmokers or patients with a history of previous malignancies, such as breast cancer.

Led by Daniela Molena, MD, a thoracic surgeon and director of esophageal surgery at Memorial Sloan Kettering Cancer Center, New York, researchers conducted an analysis of 2,192 women with first-time lung cancer who underwent lung resections at Memorial Sloan Kettering between January 2000 and December 2017. The study’s objective was to determine stage at diagnosis, survival, and eligibility for lung cancer screening among patients with lung cancer who had a previous breast cancer diagnosis and those who did not have a history of breast cancer.

Only 331 (15.1%) patients were previously diagnosed with breast cancer, which was not statistically significant. “Overall, there were no statistically significant differences in genomic or oncogenic pathway alterations between the two groups, which suggests that lung cancer in patients who previously had breast cancer may not be affected at the genomic level by the previous breast cancer,” the authors wrote.

However, at 58.4%, more than half of patients in the study (1,281 patients) were prior smokers and only 33.3% met the USPSTF criteria for lung cancer screening, which the authors said was concerning.

“The most important finding of the study was that a high percentage of women with lung cancer, regardless of breast cancer history, did not meet the current USPSTF criteria for lung cancer screening. This is very important given the observation that nearly half of the women included in the study did not have a history of smoking. As such, the role of imaging for other causes, such as cancer surveillance, becomes especially important for early cancer diagnosis,” Dr. Molena and colleagues wrote. “To reduce late-stage cancer diagnoses, further assessment of guidelines for lung cancer screening for all women may be needed.”

Instead, for almost half of women in the study group with a history of breast cancer, the lung cancer was detected on a routine follow-up imaging scan.

USPSTF guidelines for lung cancer screening do not include previous malignancy as a high-risk feature requiring evaluation, which may explain why so few women in this study were screened for lung cancer, even though lung cancer is more common in breast cancer survivors than the general population. Approximately 10% of women who have had breast cancer will develop a second malignancy within 10 years and in most cases, it will be lung cancer. Plus, according to the National Cancer Institute, breast, lung, and colorectal cancers are the three most common cancers in women and account for approximately 50% of all new cancer diagnoses in women in 2020.

A 2018 analysis published in Frontiers in Oncology found that, of more than 6,000 women with secondary primary lung cancer after having had breast cancer, 42% had distant-stage disease at the time of diagnosis which, Dr. Molena and colleagues said, suggests an ongoing need to update screening recommendations.

“Given that lung cancer has a 5-year overall survival rate of less than 20% (highlighting the benefits of early-stage diagnosis), a better understanding of lung cancer in women with a history of breast cancer could have important implications for screening and surveillance,” the authors wrote.

Estrogen is known to play a role in the development of lung cancer by activating the epidermal growth factor receptor (EGFR). Previous research has shown an increased risk of lung cancer in patients with estrogen receptor–negative, progesterone receptor–negative, HER2-negative, or triple-negative breast cancer.

“Antiestrogen treatment has been demonstrated to decrease the incidence of lung cancer and has been associated with improved long-term survival in patients with lung cancer after breast cancer. Future studies should seek to identify high-risk populations on the basis of hormone receptor status and antiestrogen therapy use,” the authors wrote.

The authors noted a number of limitations to the study, including the single hospital as the sole source of data, plus, the analysis did not account for the length of time since patients quit smoking and a lung cancer diagnosis. Nor did it consider other risk factors, such as radiation, chemotherapy, or antiestrogen therapies.

The authors did not disclose any study-related conflicts of interests.

This article was updated 3/2/22.

The U.S. Preventive Services Task Force (USPSTF) criteria for lung cancer screening should be expanded to include more women, especially those with a history of breast cancer, according to a new study published in BJS Open.

The 2021 screening guidelines include adults aged between 50 and 80 years who have a 20–pack-year smoking history and currently smoke or have quit within the past 15 years, but the guidelines do not include nonsmokers or patients with a history of previous malignancies, such as breast cancer.

Led by Daniela Molena, MD, a thoracic surgeon and director of esophageal surgery at Memorial Sloan Kettering Cancer Center, New York, researchers conducted an analysis of 2,192 women with first-time lung cancer who underwent lung resections at Memorial Sloan Kettering between January 2000 and December 2017. The study’s objective was to determine stage at diagnosis, survival, and eligibility for lung cancer screening among patients with lung cancer who had a previous breast cancer diagnosis and those who did not have a history of breast cancer.

Only 331 (15.1%) patients were previously diagnosed with breast cancer, which was not statistically significant. “Overall, there were no statistically significant differences in genomic or oncogenic pathway alterations between the two groups, which suggests that lung cancer in patients who previously had breast cancer may not be affected at the genomic level by the previous breast cancer,” the authors wrote.

However, at 58.4%, more than half of patients in the study (1,281 patients) were prior smokers and only 33.3% met the USPSTF criteria for lung cancer screening, which the authors said was concerning.

“The most important finding of the study was that a high percentage of women with lung cancer, regardless of breast cancer history, did not meet the current USPSTF criteria for lung cancer screening. This is very important given the observation that nearly half of the women included in the study did not have a history of smoking. As such, the role of imaging for other causes, such as cancer surveillance, becomes especially important for early cancer diagnosis,” Dr. Molena and colleagues wrote. “To reduce late-stage cancer diagnoses, further assessment of guidelines for lung cancer screening for all women may be needed.”

Instead, for almost half of women in the study group with a history of breast cancer, the lung cancer was detected on a routine follow-up imaging scan.

USPSTF guidelines for lung cancer screening do not include previous malignancy as a high-risk feature requiring evaluation, which may explain why so few women in this study were screened for lung cancer, even though lung cancer is more common in breast cancer survivors than the general population. Approximately 10% of women who have had breast cancer will develop a second malignancy within 10 years and in most cases, it will be lung cancer. Plus, according to the National Cancer Institute, breast, lung, and colorectal cancers are the three most common cancers in women and account for approximately 50% of all new cancer diagnoses in women in 2020.

A 2018 analysis published in Frontiers in Oncology found that, of more than 6,000 women with secondary primary lung cancer after having had breast cancer, 42% had distant-stage disease at the time of diagnosis which, Dr. Molena and colleagues said, suggests an ongoing need to update screening recommendations.

“Given that lung cancer has a 5-year overall survival rate of less than 20% (highlighting the benefits of early-stage diagnosis), a better understanding of lung cancer in women with a history of breast cancer could have important implications for screening and surveillance,” the authors wrote.

Estrogen is known to play a role in the development of lung cancer by activating the epidermal growth factor receptor (EGFR). Previous research has shown an increased risk of lung cancer in patients with estrogen receptor–negative, progesterone receptor–negative, HER2-negative, or triple-negative breast cancer.

“Antiestrogen treatment has been demonstrated to decrease the incidence of lung cancer and has been associated with improved long-term survival in patients with lung cancer after breast cancer. Future studies should seek to identify high-risk populations on the basis of hormone receptor status and antiestrogen therapy use,” the authors wrote.

The authors noted a number of limitations to the study, including the single hospital as the sole source of data, plus, the analysis did not account for the length of time since patients quit smoking and a lung cancer diagnosis. Nor did it consider other risk factors, such as radiation, chemotherapy, or antiestrogen therapies.

The authors did not disclose any study-related conflicts of interests.

This article was updated 3/2/22.

The U.S. Preventive Services Task Force (USPSTF) criteria for lung cancer screening should be expanded to include more women, especially those with a history of breast cancer, according to a new study published in BJS Open.

The 2021 screening guidelines include adults aged between 50 and 80 years who have a 20–pack-year smoking history and currently smoke or have quit within the past 15 years, but the guidelines do not include nonsmokers or patients with a history of previous malignancies, such as breast cancer.

Led by Daniela Molena, MD, a thoracic surgeon and director of esophageal surgery at Memorial Sloan Kettering Cancer Center, New York, researchers conducted an analysis of 2,192 women with first-time lung cancer who underwent lung resections at Memorial Sloan Kettering between January 2000 and December 2017. The study’s objective was to determine stage at diagnosis, survival, and eligibility for lung cancer screening among patients with lung cancer who had a previous breast cancer diagnosis and those who did not have a history of breast cancer.

Only 331 (15.1%) patients were previously diagnosed with breast cancer, which was not statistically significant. “Overall, there were no statistically significant differences in genomic or oncogenic pathway alterations between the two groups, which suggests that lung cancer in patients who previously had breast cancer may not be affected at the genomic level by the previous breast cancer,” the authors wrote.

However, at 58.4%, more than half of patients in the study (1,281 patients) were prior smokers and only 33.3% met the USPSTF criteria for lung cancer screening, which the authors said was concerning.

“The most important finding of the study was that a high percentage of women with lung cancer, regardless of breast cancer history, did not meet the current USPSTF criteria for lung cancer screening. This is very important given the observation that nearly half of the women included in the study did not have a history of smoking. As such, the role of imaging for other causes, such as cancer surveillance, becomes especially important for early cancer diagnosis,” Dr. Molena and colleagues wrote. “To reduce late-stage cancer diagnoses, further assessment of guidelines for lung cancer screening for all women may be needed.”

Instead, for almost half of women in the study group with a history of breast cancer, the lung cancer was detected on a routine follow-up imaging scan.

USPSTF guidelines for lung cancer screening do not include previous malignancy as a high-risk feature requiring evaluation, which may explain why so few women in this study were screened for lung cancer, even though lung cancer is more common in breast cancer survivors than the general population. Approximately 10% of women who have had breast cancer will develop a second malignancy within 10 years and in most cases, it will be lung cancer. Plus, according to the National Cancer Institute, breast, lung, and colorectal cancers are the three most common cancers in women and account for approximately 50% of all new cancer diagnoses in women in 2020.

A 2018 analysis published in Frontiers in Oncology found that, of more than 6,000 women with secondary primary lung cancer after having had breast cancer, 42% had distant-stage disease at the time of diagnosis which, Dr. Molena and colleagues said, suggests an ongoing need to update screening recommendations.

“Given that lung cancer has a 5-year overall survival rate of less than 20% (highlighting the benefits of early-stage diagnosis), a better understanding of lung cancer in women with a history of breast cancer could have important implications for screening and surveillance,” the authors wrote.

Estrogen is known to play a role in the development of lung cancer by activating the epidermal growth factor receptor (EGFR). Previous research has shown an increased risk of lung cancer in patients with estrogen receptor–negative, progesterone receptor–negative, HER2-negative, or triple-negative breast cancer.

“Antiestrogen treatment has been demonstrated to decrease the incidence of lung cancer and has been associated with improved long-term survival in patients with lung cancer after breast cancer. Future studies should seek to identify high-risk populations on the basis of hormone receptor status and antiestrogen therapy use,” the authors wrote.

The authors noted a number of limitations to the study, including the single hospital as the sole source of data, plus, the analysis did not account for the length of time since patients quit smoking and a lung cancer diagnosis. Nor did it consider other risk factors, such as radiation, chemotherapy, or antiestrogen therapies.

The authors did not disclose any study-related conflicts of interests.

This article was updated 3/2/22.

U.S. prices for brand-name lung cancer drugs generally increased between 2015 and 2020 without evidence of price competition, a cross-sectional analysis revealed.

The findings underscore the need for price reform, according to the investigators, who analyzed prices for 17 brand-name medications used for treating metastatic non–small cell lung cancer (NSCLC).

Prices increased during the study period and correlated within each drug class, Aakash Desai, MBBS, and colleagues from the Mayo Clinic, Rochester, Minn., found.

“Because numerous new drugs have been approved for the treatment of NSCLC in recent years, we sought to specifically study the price competition among drugs used to treat this cancer subtype,” they explained, noting that for most drug classes price increases outpaced changes in the consumer price index for prescription medications and the inflation rate.

The findings were published Jan. 25, 2022, in JAMA Network Open.

Multiple brand-name medications across several drug classes, including four immune checkpoint inhibitors (pembrolizumab, nivolumab, atezolizumab, and durvalumab), five epidermal growth factor receptor inhibitors (gefitinib, afatinib, erlotinib, osimertinib, and dacomitinib), five anaplastic lymphoma kinase inhibitors (crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib), two BRAF inhibitors (dabrafenib, vemurafenib), and one MEK inhibitor (trametinib) were included in the analysis.

Median Pearson correlation coefficients approached 1.0 for all drug classes, indicating that prices increased despite within-class drug competition. Median values ranged from 0.898 for epidermal growth factor inhibitors to 0.999 for anaplastic lymphoma kinase inhibitors and BRAF and MEK inhibitors, the investigators found.

Median compounded annual growth rates (CAGRs) were 1.81% for immune checkpoint inhibitors, 2.56% for epidermal growth factor receptor inhibitors, 2.46% for anaplastic lymphoma kinase and ROS1 inhibitors, and 3.06% for BRAF and MEK inhibitors.

“With the exception of the immunotherapy class, the median cost CAGR outpaced the annual growth rate of the consumer price index for prescription drugs at 2.10% and, for all classes, the average yearly inflation rate of 1.75% during the same period,” they wrote.

Also of note, only one price decrease occurred among all therapeutic classes studied.

“This was observed for erlotinib between 2019 and 2020, and it corresponded with the introduction of a generic competitor to the market,” the authors said.

The findings are reminiscent of an earlier study that showed a 25% increase in the price of 24 patented injectable anticancer agents in the United States over a period of 8 years after launch.

“These increases in cost were not offset by supplemental U.S. Food and Drug Administration approvals, new competitors, or new off-label indications. Thus, price increases over time were not substantially reduced by market competition and increased at similar rates among drugs within the same class,” they wrote, adding that “although one might expect oncology drug prices to decrease over time after market entry, the list price of most anticancer agents increases paradoxically.”

The “lock-step price increases” observed without evidence of price competition in this analysis raise concerns about the affordability of promising oncology drugs, they said, concluding that “academic, industry, and government partnerships should be developed to address the high costs of prescription oncology drugs, which may soon be unaffordable for most patients if the trends discovered in the present study continue.”

Dr. Desai reported having no disclosures.

U.S. prices for brand-name lung cancer drugs generally increased between 2015 and 2020 without evidence of price competition, a cross-sectional analysis revealed.

The findings underscore the need for price reform, according to the investigators, who analyzed prices for 17 brand-name medications used for treating metastatic non–small cell lung cancer (NSCLC).

Prices increased during the study period and correlated within each drug class, Aakash Desai, MBBS, and colleagues from the Mayo Clinic, Rochester, Minn., found.

“Because numerous new drugs have been approved for the treatment of NSCLC in recent years, we sought to specifically study the price competition among drugs used to treat this cancer subtype,” they explained, noting that for most drug classes price increases outpaced changes in the consumer price index for prescription medications and the inflation rate.

The findings were published Jan. 25, 2022, in JAMA Network Open.

Multiple brand-name medications across several drug classes, including four immune checkpoint inhibitors (pembrolizumab, nivolumab, atezolizumab, and durvalumab), five epidermal growth factor receptor inhibitors (gefitinib, afatinib, erlotinib, osimertinib, and dacomitinib), five anaplastic lymphoma kinase inhibitors (crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib), two BRAF inhibitors (dabrafenib, vemurafenib), and one MEK inhibitor (trametinib) were included in the analysis.

Median Pearson correlation coefficients approached 1.0 for all drug classes, indicating that prices increased despite within-class drug competition. Median values ranged from 0.898 for epidermal growth factor inhibitors to 0.999 for anaplastic lymphoma kinase inhibitors and BRAF and MEK inhibitors, the investigators found.

Median compounded annual growth rates (CAGRs) were 1.81% for immune checkpoint inhibitors, 2.56% for epidermal growth factor receptor inhibitors, 2.46% for anaplastic lymphoma kinase and ROS1 inhibitors, and 3.06% for BRAF and MEK inhibitors.

“With the exception of the immunotherapy class, the median cost CAGR outpaced the annual growth rate of the consumer price index for prescription drugs at 2.10% and, for all classes, the average yearly inflation rate of 1.75% during the same period,” they wrote.

Also of note, only one price decrease occurred among all therapeutic classes studied.

“This was observed for erlotinib between 2019 and 2020, and it corresponded with the introduction of a generic competitor to the market,” the authors said.

The findings are reminiscent of an earlier study that showed a 25% increase in the price of 24 patented injectable anticancer agents in the United States over a period of 8 years after launch.

“These increases in cost were not offset by supplemental U.S. Food and Drug Administration approvals, new competitors, or new off-label indications. Thus, price increases over time were not substantially reduced by market competition and increased at similar rates among drugs within the same class,” they wrote, adding that “although one might expect oncology drug prices to decrease over time after market entry, the list price of most anticancer agents increases paradoxically.”

The “lock-step price increases” observed without evidence of price competition in this analysis raise concerns about the affordability of promising oncology drugs, they said, concluding that “academic, industry, and government partnerships should be developed to address the high costs of prescription oncology drugs, which may soon be unaffordable for most patients if the trends discovered in the present study continue.”

Dr. Desai reported having no disclosures.

U.S. prices for brand-name lung cancer drugs generally increased between 2015 and 2020 without evidence of price competition, a cross-sectional analysis revealed.

The findings underscore the need for price reform, according to the investigators, who analyzed prices for 17 brand-name medications used for treating metastatic non–small cell lung cancer (NSCLC).

Prices increased during the study period and correlated within each drug class, Aakash Desai, MBBS, and colleagues from the Mayo Clinic, Rochester, Minn., found.

“Because numerous new drugs have been approved for the treatment of NSCLC in recent years, we sought to specifically study the price competition among drugs used to treat this cancer subtype,” they explained, noting that for most drug classes price increases outpaced changes in the consumer price index for prescription medications and the inflation rate.

The findings were published Jan. 25, 2022, in JAMA Network Open.

Multiple brand-name medications across several drug classes, including four immune checkpoint inhibitors (pembrolizumab, nivolumab, atezolizumab, and durvalumab), five epidermal growth factor receptor inhibitors (gefitinib, afatinib, erlotinib, osimertinib, and dacomitinib), five anaplastic lymphoma kinase inhibitors (crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib), two BRAF inhibitors (dabrafenib, vemurafenib), and one MEK inhibitor (trametinib) were included in the analysis.

Median Pearson correlation coefficients approached 1.0 for all drug classes, indicating that prices increased despite within-class drug competition. Median values ranged from 0.898 for epidermal growth factor inhibitors to 0.999 for anaplastic lymphoma kinase inhibitors and BRAF and MEK inhibitors, the investigators found.

Median compounded annual growth rates (CAGRs) were 1.81% for immune checkpoint inhibitors, 2.56% for epidermal growth factor receptor inhibitors, 2.46% for anaplastic lymphoma kinase and ROS1 inhibitors, and 3.06% for BRAF and MEK inhibitors.

“With the exception of the immunotherapy class, the median cost CAGR outpaced the annual growth rate of the consumer price index for prescription drugs at 2.10% and, for all classes, the average yearly inflation rate of 1.75% during the same period,” they wrote.

Also of note, only one price decrease occurred among all therapeutic classes studied.

“This was observed for erlotinib between 2019 and 2020, and it corresponded with the introduction of a generic competitor to the market,” the authors said.

The findings are reminiscent of an earlier study that showed a 25% increase in the price of 24 patented injectable anticancer agents in the United States over a period of 8 years after launch.

“These increases in cost were not offset by supplemental U.S. Food and Drug Administration approvals, new competitors, or new off-label indications. Thus, price increases over time were not substantially reduced by market competition and increased at similar rates among drugs within the same class,” they wrote, adding that “although one might expect oncology drug prices to decrease over time after market entry, the list price of most anticancer agents increases paradoxically.”

The “lock-step price increases” observed without evidence of price competition in this analysis raise concerns about the affordability of promising oncology drugs, they said, concluding that “academic, industry, and government partnerships should be developed to address the high costs of prescription oncology drugs, which may soon be unaffordable for most patients if the trends discovered in the present study continue.”

Dr. Desai reported having no disclosures.

A new treatment option for patients with refractory/relapsed multiple myeloma who have already tried four or more therapies has been approved by the U.S. Food and Drug Administration.

The product, ciltacabtagene autoleucel (cilta-cel), will be marketed as Carvykti by Janssen and Legend Biotech. It is a chimeric antigen receptor (CAR) T-cell therapy directed against B-cell maturation antigen (BCMA), which is a new target for therapies for multiple myeloma.

There are already two other therapies on the market that target BCMA – another CAR T cell, idecabtagene vicleucel (Abecma), which was approved by the FDA in March 2021, and a drug conjugate, belantamab mafodotin (Blenrep), which was approved in August 2020.

The approval of cilta-cel was based on clinical data from the CARTITUDE-1 study, which were initially presented in December 2020 at the annual meeting of the American Society of Hematology, as reported at the time by this news organization.

The trial involved 97 patients with relapsed/refractory multiple myeloma who had already received a median of six previous treatments (range, three to 18), including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

“The treatment journey for the majority of patients living with multiple myeloma is a relentless cycle of remission and relapse, with fewer patients achieving a deep response as they progress through later lines of therapy,” commented Sundar Jagannath, MBBS, professor of medicine, hematology, and medical oncology at Mount Sinai, who was a principal investigator on the pivotal study.

“That is why I have been really excited about the results from the CARTITUDE-1 study, which has demonstrated that cilta-cel can provide deep and durable responses and long-term treatment-free intervals, even in this heavily pretreated multiple myeloma patient population,” he said.

“Today’s approval of Carvykti helps address a great unmet need for these patients,” he commented in a press release from the manufacturer.

Like other CAR T-cell therapies, ciltacabtagene autoleucel is a one-time treatment. It involves collecting blood from the patient, extracting T cells, genetically engineering them, then transfusing them back to the patient, who in the meantime has undergone conditioning.

The results from CARTITUDE-1 show that this one-time treatment resulted in deep and durable responses.

The overall response rate was 98%, and the majority of patients (78%) achieved a stringent complete response, in which physicians are unable to observe any signs or symptoms of disease via imaging or other tests after treatment.

At a median of 18 months’ follow-up, the median duration of response was 21.8 months.

“The responses in the CARTITUDE-1 study showed durability over time and resulted in the majority of heavily pretreated patients achieving deep responses after 18-month follow-up,” commented Mr. Jagannath.

“The approval of cilta-cel provides physicians an immunotherapy treatment option that offers patients an opportunity to be free from anti-myeloma therapies for a period of time,” he added.

As with other CAR T-cell therapies, there were serious side effects, and these products are available only through restricted programs under a risk evaluation and mitigation strategy.

The product information for Cartykti includes a boxed warning that mentions cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome, parkinsonism, Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged and/or recurrent cytopenias.

The most common adverse reactions (reported in greater than or equal to 20% of patients) are pyrexia, CRS, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections–pathogens unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.

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

A new treatment option for patients with refractory/relapsed multiple myeloma who have already tried four or more therapies has been approved by the U.S. Food and Drug Administration.

The product, ciltacabtagene autoleucel (cilta-cel), will be marketed as Carvykti by Janssen and Legend Biotech. It is a chimeric antigen receptor (CAR) T-cell therapy directed against B-cell maturation antigen (BCMA), which is a new target for therapies for multiple myeloma.

There are already two other therapies on the market that target BCMA – another CAR T cell, idecabtagene vicleucel (Abecma), which was approved by the FDA in March 2021, and a drug conjugate, belantamab mafodotin (Blenrep), which was approved in August 2020.

The approval of cilta-cel was based on clinical data from the CARTITUDE-1 study, which were initially presented in December 2020 at the annual meeting of the American Society of Hematology, as reported at the time by this news organization.

The trial involved 97 patients with relapsed/refractory multiple myeloma who had already received a median of six previous treatments (range, three to 18), including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

“The treatment journey for the majority of patients living with multiple myeloma is a relentless cycle of remission and relapse, with fewer patients achieving a deep response as they progress through later lines of therapy,” commented Sundar Jagannath, MBBS, professor of medicine, hematology, and medical oncology at Mount Sinai, who was a principal investigator on the pivotal study.

“That is why I have been really excited about the results from the CARTITUDE-1 study, which has demonstrated that cilta-cel can provide deep and durable responses and long-term treatment-free intervals, even in this heavily pretreated multiple myeloma patient population,” he said.

“Today’s approval of Carvykti helps address a great unmet need for these patients,” he commented in a press release from the manufacturer.

Like other CAR T-cell therapies, ciltacabtagene autoleucel is a one-time treatment. It involves collecting blood from the patient, extracting T cells, genetically engineering them, then transfusing them back to the patient, who in the meantime has undergone conditioning.

The results from CARTITUDE-1 show that this one-time treatment resulted in deep and durable responses.

The overall response rate was 98%, and the majority of patients (78%) achieved a stringent complete response, in which physicians are unable to observe any signs or symptoms of disease via imaging or other tests after treatment.

At a median of 18 months’ follow-up, the median duration of response was 21.8 months.

“The responses in the CARTITUDE-1 study showed durability over time and resulted in the majority of heavily pretreated patients achieving deep responses after 18-month follow-up,” commented Mr. Jagannath.

“The approval of cilta-cel provides physicians an immunotherapy treatment option that offers patients an opportunity to be free from anti-myeloma therapies for a period of time,” he added.

As with other CAR T-cell therapies, there were serious side effects, and these products are available only through restricted programs under a risk evaluation and mitigation strategy.

The product information for Cartykti includes a boxed warning that mentions cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome, parkinsonism, Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged and/or recurrent cytopenias.

The most common adverse reactions (reported in greater than or equal to 20% of patients) are pyrexia, CRS, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections–pathogens unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.

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

A new treatment option for patients with refractory/relapsed multiple myeloma who have already tried four or more therapies has been approved by the U.S. Food and Drug Administration.

The product, ciltacabtagene autoleucel (cilta-cel), will be marketed as Carvykti by Janssen and Legend Biotech. It is a chimeric antigen receptor (CAR) T-cell therapy directed against B-cell maturation antigen (BCMA), which is a new target for therapies for multiple myeloma.

There are already two other therapies on the market that target BCMA – another CAR T cell, idecabtagene vicleucel (Abecma), which was approved by the FDA in March 2021, and a drug conjugate, belantamab mafodotin (Blenrep), which was approved in August 2020.

The approval of cilta-cel was based on clinical data from the CARTITUDE-1 study, which were initially presented in December 2020 at the annual meeting of the American Society of Hematology, as reported at the time by this news organization.

The trial involved 97 patients with relapsed/refractory multiple myeloma who had already received a median of six previous treatments (range, three to 18), including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

“The treatment journey for the majority of patients living with multiple myeloma is a relentless cycle of remission and relapse, with fewer patients achieving a deep response as they progress through later lines of therapy,” commented Sundar Jagannath, MBBS, professor of medicine, hematology, and medical oncology at Mount Sinai, who was a principal investigator on the pivotal study.

“That is why I have been really excited about the results from the CARTITUDE-1 study, which has demonstrated that cilta-cel can provide deep and durable responses and long-term treatment-free intervals, even in this heavily pretreated multiple myeloma patient population,” he said.

“Today’s approval of Carvykti helps address a great unmet need for these patients,” he commented in a press release from the manufacturer.

Like other CAR T-cell therapies, ciltacabtagene autoleucel is a one-time treatment. It involves collecting blood from the patient, extracting T cells, genetically engineering them, then transfusing them back to the patient, who in the meantime has undergone conditioning.

The results from CARTITUDE-1 show that this one-time treatment resulted in deep and durable responses.

The overall response rate was 98%, and the majority of patients (78%) achieved a stringent complete response, in which physicians are unable to observe any signs or symptoms of disease via imaging or other tests after treatment.

At a median of 18 months’ follow-up, the median duration of response was 21.8 months.

“The responses in the CARTITUDE-1 study showed durability over time and resulted in the majority of heavily pretreated patients achieving deep responses after 18-month follow-up,” commented Mr. Jagannath.

“The approval of cilta-cel provides physicians an immunotherapy treatment option that offers patients an opportunity to be free from anti-myeloma therapies for a period of time,” he added.

As with other CAR T-cell therapies, there were serious side effects, and these products are available only through restricted programs under a risk evaluation and mitigation strategy.

The product information for Cartykti includes a boxed warning that mentions cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome, parkinsonism, Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged and/or recurrent cytopenias.

The most common adverse reactions (reported in greater than or equal to 20% of patients) are pyrexia, CRS, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections–pathogens unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.

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

A New York state radiation oncologist accused of gross negligence and incompetence back in 2018 has now lost his medical license.

The state Board for Professional Medical Conduct has revoked the medical license of Won Sam Yi, MD, following a lengthy review of the care he provided to seven cancer patients; six of them died.

“He is a danger to potential new patients should he be reinstated as a radiation oncologist,” board members wrote, according to a news report in the Buffalo News.

Dr. Yi’s lawyer said that he is appealing the decision.

Dr. Yi was the former CEO of the now-defunct private cancer practice CCS Oncology, located in western New York.

In 2018, the state health department brought numerous charges of professional misconduct against Dr. Yi, including charges that he had failed to “account for prior doses of radiotherapy” as well as exceeding “appropriate tissue tolerances” during the treatment.

Now, the state’s Board for Professional Medical Conduct has upheld nearly all of the departmental charges that had been levied against him, and also found that Dr. Yi failed to take responsibility or show contrition for his treatment decisions.

However, whistleblower claims from a former CSS Oncology employee were dismissed.
 

Troubled history

CCS Oncology was once one of the largest private cancer practices in Erie and Niagara counties, both in the Buffalo metropolitan area.

Dr. Yi purchased CCS Oncology in 2008 and was its sole shareholder, and in 2012 he also acquired CCS Medical. As of 2016, the practices provided care to about 30% of cancer patients in the region. CCS also began acquiring other practices as it expanded into noncancer specialties, including primary care.

However, CCS began to struggle financially in late 2016, when health insurance provider Independent Health announced it was removing CCS Oncology from its network, and several vendors and lenders subsequently sued CCS and Dr. Yi for nonpayment.

The announcement from Independent Health was “financially devastating to CCS,” and also was “the direct cause” of the practice defaulting on its Bank of America loan and of the practice’s inability to pay not only its vendors but state and federal tax agencies, the Buffalo News reported. As a result, several vendors and lenders had sued CCS and Dr. Yi for nonpayment.

The FBI raided numerous CCS locations in March 2018, seizing financial and other data as part of an investigation into possible Medicare billing fraud. The following month, CCS filed for Chapter 11 bankruptcy, citing it owed millions of dollars to Bank of America and other creditors. Shortly afterward, the practice closed.
 

Medical misconduct

The state’s charges of professional misconduct accused Dr. Yi of “gross negligence,” “gross incompetence,” and several other cases of misconduct in treating seven patients between 2009 and 2013 at various CCS locations. The patients ranged in age from 27 to 72. Six of the seven patients died.

In one case, Dr. Yi was accused of providing whole-brain radiation therapy to a 43-year-old woman for about 6 weeks in 2012, but the treatment was “contrary to medical indications” and did not take into account prior doses of such treatment. The patient died in December of that year, and the board concluded that Dr. Yi had improperly treated her with a high dose of radiation that was intended to cure her cancer even though she was at a stage where her disease was incurable.

The state board eventually concluded that for all but one of the patients in question, Dr. Yi was guilty of misconduct in his treatment decisions. They wrote that Dr. Yi had frequently administered radiation doses without taking into account how much radiation therapy the patients had received previously and without considering the risk of serious complications for them.

Dr. Yi plans to appeal the board’s decision in state court, according to his attorney, Anthony Scher.

“Dr Yi has treated over 10,000 patients in his career,” Mr. Scher told the Buffalo News. “These handful of cases don’t represent the thousands of success stories that he’s had.”

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

A New York state radiation oncologist accused of gross negligence and incompetence back in 2018 has now lost his medical license.

The state Board for Professional Medical Conduct has revoked the medical license of Won Sam Yi, MD, following a lengthy review of the care he provided to seven cancer patients; six of them died.

“He is a danger to potential new patients should he be reinstated as a radiation oncologist,” board members wrote, according to a news report in the Buffalo News.

Dr. Yi’s lawyer said that he is appealing the decision.

Dr. Yi was the former CEO of the now-defunct private cancer practice CCS Oncology, located in western New York.

In 2018, the state health department brought numerous charges of professional misconduct against Dr. Yi, including charges that he had failed to “account for prior doses of radiotherapy” as well as exceeding “appropriate tissue tolerances” during the treatment.

Now, the state’s Board for Professional Medical Conduct has upheld nearly all of the departmental charges that had been levied against him, and also found that Dr. Yi failed to take responsibility or show contrition for his treatment decisions.

However, whistleblower claims from a former CSS Oncology employee were dismissed.
 

Troubled history

CCS Oncology was once one of the largest private cancer practices in Erie and Niagara counties, both in the Buffalo metropolitan area.

Dr. Yi purchased CCS Oncology in 2008 and was its sole shareholder, and in 2012 he also acquired CCS Medical. As of 2016, the practices provided care to about 30% of cancer patients in the region. CCS also began acquiring other practices as it expanded into noncancer specialties, including primary care.

However, CCS began to struggle financially in late 2016, when health insurance provider Independent Health announced it was removing CCS Oncology from its network, and several vendors and lenders subsequently sued CCS and Dr. Yi for nonpayment.

The announcement from Independent Health was “financially devastating to CCS,” and also was “the direct cause” of the practice defaulting on its Bank of America loan and of the practice’s inability to pay not only its vendors but state and federal tax agencies, the Buffalo News reported. As a result, several vendors and lenders had sued CCS and Dr. Yi for nonpayment.

The FBI raided numerous CCS locations in March 2018, seizing financial and other data as part of an investigation into possible Medicare billing fraud. The following month, CCS filed for Chapter 11 bankruptcy, citing it owed millions of dollars to Bank of America and other creditors. Shortly afterward, the practice closed.
 

Medical misconduct

The state’s charges of professional misconduct accused Dr. Yi of “gross negligence,” “gross incompetence,” and several other cases of misconduct in treating seven patients between 2009 and 2013 at various CCS locations. The patients ranged in age from 27 to 72. Six of the seven patients died.

In one case, Dr. Yi was accused of providing whole-brain radiation therapy to a 43-year-old woman for about 6 weeks in 2012, but the treatment was “contrary to medical indications” and did not take into account prior doses of such treatment. The patient died in December of that year, and the board concluded that Dr. Yi had improperly treated her with a high dose of radiation that was intended to cure her cancer even though she was at a stage where her disease was incurable.

The state board eventually concluded that for all but one of the patients in question, Dr. Yi was guilty of misconduct in his treatment decisions. They wrote that Dr. Yi had frequently administered radiation doses without taking into account how much radiation therapy the patients had received previously and without considering the risk of serious complications for them.

Dr. Yi plans to appeal the board’s decision in state court, according to his attorney, Anthony Scher.

“Dr Yi has treated over 10,000 patients in his career,” Mr. Scher told the Buffalo News. “These handful of cases don’t represent the thousands of success stories that he’s had.”

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

A New York state radiation oncologist accused of gross negligence and incompetence back in 2018 has now lost his medical license.

The state Board for Professional Medical Conduct has revoked the medical license of Won Sam Yi, MD, following a lengthy review of the care he provided to seven cancer patients; six of them died.

“He is a danger to potential new patients should he be reinstated as a radiation oncologist,” board members wrote, according to a news report in the Buffalo News.

Dr. Yi’s lawyer said that he is appealing the decision.

Dr. Yi was the former CEO of the now-defunct private cancer practice CCS Oncology, located in western New York.

In 2018, the state health department brought numerous charges of professional misconduct against Dr. Yi, including charges that he had failed to “account for prior doses of radiotherapy” as well as exceeding “appropriate tissue tolerances” during the treatment.

Now, the state’s Board for Professional Medical Conduct has upheld nearly all of the departmental charges that had been levied against him, and also found that Dr. Yi failed to take responsibility or show contrition for his treatment decisions.

However, whistleblower claims from a former CSS Oncology employee were dismissed.
 

Troubled history

CCS Oncology was once one of the largest private cancer practices in Erie and Niagara counties, both in the Buffalo metropolitan area.

Dr. Yi purchased CCS Oncology in 2008 and was its sole shareholder, and in 2012 he also acquired CCS Medical. As of 2016, the practices provided care to about 30% of cancer patients in the region. CCS also began acquiring other practices as it expanded into noncancer specialties, including primary care.

However, CCS began to struggle financially in late 2016, when health insurance provider Independent Health announced it was removing CCS Oncology from its network, and several vendors and lenders subsequently sued CCS and Dr. Yi for nonpayment.

The announcement from Independent Health was “financially devastating to CCS,” and also was “the direct cause” of the practice defaulting on its Bank of America loan and of the practice’s inability to pay not only its vendors but state and federal tax agencies, the Buffalo News reported. As a result, several vendors and lenders had sued CCS and Dr. Yi for nonpayment.

The FBI raided numerous CCS locations in March 2018, seizing financial and other data as part of an investigation into possible Medicare billing fraud. The following month, CCS filed for Chapter 11 bankruptcy, citing it owed millions of dollars to Bank of America and other creditors. Shortly afterward, the practice closed.
 

Medical misconduct

The state’s charges of professional misconduct accused Dr. Yi of “gross negligence,” “gross incompetence,” and several other cases of misconduct in treating seven patients between 2009 and 2013 at various CCS locations. The patients ranged in age from 27 to 72. Six of the seven patients died.

In one case, Dr. Yi was accused of providing whole-brain radiation therapy to a 43-year-old woman for about 6 weeks in 2012, but the treatment was “contrary to medical indications” and did not take into account prior doses of such treatment. The patient died in December of that year, and the board concluded that Dr. Yi had improperly treated her with a high dose of radiation that was intended to cure her cancer even though she was at a stage where her disease was incurable.

The state board eventually concluded that for all but one of the patients in question, Dr. Yi was guilty of misconduct in his treatment decisions. They wrote that Dr. Yi had frequently administered radiation doses without taking into account how much radiation therapy the patients had received previously and without considering the risk of serious complications for them.

Dr. Yi plans to appeal the board’s decision in state court, according to his attorney, Anthony Scher.

“Dr Yi has treated over 10,000 patients in his career,” Mr. Scher told the Buffalo News. “These handful of cases don’t represent the thousands of success stories that he’s had.”

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

About 5% of people who are eligible to receive lung cancer screening do not live close to a facility and have limited or no access to screening,a recent analysis shows.

That percentage, although quite small, still translates to more than 750,000 individuals who are eligible to receive lung cancer screening but live at least 40 miles from a facility.

Overall, a larger proportion of eligible individuals in rural areas had no access to a facility, but a greater number of people in urban areas had no access, especially at shorter distances.

Understanding access issues is important given that “lung cancer screening with low-dose computed tomography scanning (LDCT) reduces mortality among high-risk adults, ... [but] annual screening rates remain low,” write study authors Liora Sahar, PhD, of the American Cancer Society in Atlanta, and colleagues.

The study was published online Feb. 15 in the journal Cancer.

It expands on a previous report, which found that “less than 6% of those 55 to 79 years of age do not have access to registry screening facilities”.

The new analysis incorporates the most recent guidelines from the U.S. Preventive Services Task Force, which lowered the screening age to 50 years and compares access across urban and rural areas.

Dr. Sahar and colleagues calculated the distances from population centers to screening facilities and estimated the number of individuals living within different distances of those facilities – 10, 20, 40, 50, and 100 miles. Geographical subdivisions, or census tracts, were also classified along a spectrum of rural to urban.

The authors found that, overall, about 14.8 million people aged 50-80 years are eligible for lung cancer screening, and 5.1% of that population – or 753,038 individuals – do not live within 40 miles of a facility and have no access to screening.

The proportion of people affected by access issues varies by geographic location. For eligible people living 40 miles or more from a facility, almost 25% (n = 287,803) in rural counties had no access, compared with 1.6% (n = 195,120) in metropolitan areas.

At greater distances to facilities (50 and 100 miles), these proportions diminish. In rural counties, for instance, 16% of eligible individuals (n = 186,401) living 50 or more miles away and 2.8% (n = 33,504) living 100 or more miles away had no access to a facility.

Not surprisingly, across all distances, “there is a significantly higher percentage of rural residents who do not have access to facilities in comparison with those in urban settings,” the authors write. “There are fewer facilities in rural areas, so residents need to travel longer distances to reach a facility.”

Notably, however, distance to a facility was not necessarily the greatest barrier to screening. The authors found a greater number of eligible individuals living in or close to urban areas were not getting screening when facilities were 10 miles away – more than 2.8 million in metropolitan areas versus just over 1 million in rural areas.

“The total number of individuals with no access in urban areas exceeds that of rural individuals, particularly at shorter distances ... [which] reveals an additional underserved population.”

Identifying geographic areas with greater access issues can help researchers address barriers to screening and improve uptake. 

“Areas and local pockets with persistently low or no access across short and long distances should be considered for tailored interventions, such as implementing mobile units, repurposing existing imaging or health facilities, and adding appropriate navigation, radiology, and screening program staff to better support the communities,” the authors conclude.

The study was supported in part by the National Lung Cancer Roundtable. Coauthor Debra S. Dyer, MD, serves on the clinical advisory board for computer software company Imidex and on the GO2 Foundation scientific advisory board; she also serves as a consultant for Lung Ambition Alliance. Coauthor Ella A. Kazerooni, MD, reports past participation on the Bristol Myers Squibb Foundation advisory board. The other authors have disclosed no relevant financial relationships.

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

About 5% of people who are eligible to receive lung cancer screening do not live close to a facility and have limited or no access to screening,a recent analysis shows.

That percentage, although quite small, still translates to more than 750,000 individuals who are eligible to receive lung cancer screening but live at least 40 miles from a facility.

Overall, a larger proportion of eligible individuals in rural areas had no access to a facility, but a greater number of people in urban areas had no access, especially at shorter distances.

Understanding access issues is important given that “lung cancer screening with low-dose computed tomography scanning (LDCT) reduces mortality among high-risk adults, ... [but] annual screening rates remain low,” write study authors Liora Sahar, PhD, of the American Cancer Society in Atlanta, and colleagues.

The study was published online Feb. 15 in the journal Cancer.

It expands on a previous report, which found that “less than 6% of those 55 to 79 years of age do not have access to registry screening facilities”.

The new analysis incorporates the most recent guidelines from the U.S. Preventive Services Task Force, which lowered the screening age to 50 years and compares access across urban and rural areas.

Dr. Sahar and colleagues calculated the distances from population centers to screening facilities and estimated the number of individuals living within different distances of those facilities – 10, 20, 40, 50, and 100 miles. Geographical subdivisions, or census tracts, were also classified along a spectrum of rural to urban.

The authors found that, overall, about 14.8 million people aged 50-80 years are eligible for lung cancer screening, and 5.1% of that population – or 753,038 individuals – do not live within 40 miles of a facility and have no access to screening.

The proportion of people affected by access issues varies by geographic location. For eligible people living 40 miles or more from a facility, almost 25% (n = 287,803) in rural counties had no access, compared with 1.6% (n = 195,120) in metropolitan areas.

At greater distances to facilities (50 and 100 miles), these proportions diminish. In rural counties, for instance, 16% of eligible individuals (n = 186,401) living 50 or more miles away and 2.8% (n = 33,504) living 100 or more miles away had no access to a facility.

Not surprisingly, across all distances, “there is a significantly higher percentage of rural residents who do not have access to facilities in comparison with those in urban settings,” the authors write. “There are fewer facilities in rural areas, so residents need to travel longer distances to reach a facility.”

Notably, however, distance to a facility was not necessarily the greatest barrier to screening. The authors found a greater number of eligible individuals living in or close to urban areas were not getting screening when facilities were 10 miles away – more than 2.8 million in metropolitan areas versus just over 1 million in rural areas.

“The total number of individuals with no access in urban areas exceeds that of rural individuals, particularly at shorter distances ... [which] reveals an additional underserved population.”

Identifying geographic areas with greater access issues can help researchers address barriers to screening and improve uptake. 

“Areas and local pockets with persistently low or no access across short and long distances should be considered for tailored interventions, such as implementing mobile units, repurposing existing imaging or health facilities, and adding appropriate navigation, radiology, and screening program staff to better support the communities,” the authors conclude.

The study was supported in part by the National Lung Cancer Roundtable. Coauthor Debra S. Dyer, MD, serves on the clinical advisory board for computer software company Imidex and on the GO2 Foundation scientific advisory board; she also serves as a consultant for Lung Ambition Alliance. Coauthor Ella A. Kazerooni, MD, reports past participation on the Bristol Myers Squibb Foundation advisory board. The other authors have disclosed no relevant financial relationships.

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

About 5% of people who are eligible to receive lung cancer screening do not live close to a facility and have limited or no access to screening,a recent analysis shows.

That percentage, although quite small, still translates to more than 750,000 individuals who are eligible to receive lung cancer screening but live at least 40 miles from a facility.

Overall, a larger proportion of eligible individuals in rural areas had no access to a facility, but a greater number of people in urban areas had no access, especially at shorter distances.

Understanding access issues is important given that “lung cancer screening with low-dose computed tomography scanning (LDCT) reduces mortality among high-risk adults, ... [but] annual screening rates remain low,” write study authors Liora Sahar, PhD, of the American Cancer Society in Atlanta, and colleagues.

The study was published online Feb. 15 in the journal Cancer.

It expands on a previous report, which found that “less than 6% of those 55 to 79 years of age do not have access to registry screening facilities”.

The new analysis incorporates the most recent guidelines from the U.S. Preventive Services Task Force, which lowered the screening age to 50 years and compares access across urban and rural areas.

Dr. Sahar and colleagues calculated the distances from population centers to screening facilities and estimated the number of individuals living within different distances of those facilities – 10, 20, 40, 50, and 100 miles. Geographical subdivisions, or census tracts, were also classified along a spectrum of rural to urban.

The authors found that, overall, about 14.8 million people aged 50-80 years are eligible for lung cancer screening, and 5.1% of that population – or 753,038 individuals – do not live within 40 miles of a facility and have no access to screening.

The proportion of people affected by access issues varies by geographic location. For eligible people living 40 miles or more from a facility, almost 25% (n = 287,803) in rural counties had no access, compared with 1.6% (n = 195,120) in metropolitan areas.

At greater distances to facilities (50 and 100 miles), these proportions diminish. In rural counties, for instance, 16% of eligible individuals (n = 186,401) living 50 or more miles away and 2.8% (n = 33,504) living 100 or more miles away had no access to a facility.

Not surprisingly, across all distances, “there is a significantly higher percentage of rural residents who do not have access to facilities in comparison with those in urban settings,” the authors write. “There are fewer facilities in rural areas, so residents need to travel longer distances to reach a facility.”

Notably, however, distance to a facility was not necessarily the greatest barrier to screening. The authors found a greater number of eligible individuals living in or close to urban areas were not getting screening when facilities were 10 miles away – more than 2.8 million in metropolitan areas versus just over 1 million in rural areas.

“The total number of individuals with no access in urban areas exceeds that of rural individuals, particularly at shorter distances ... [which] reveals an additional underserved population.”

Identifying geographic areas with greater access issues can help researchers address barriers to screening and improve uptake. 

“Areas and local pockets with persistently low or no access across short and long distances should be considered for tailored interventions, such as implementing mobile units, repurposing existing imaging or health facilities, and adding appropriate navigation, radiology, and screening program staff to better support the communities,” the authors conclude.

The study was supported in part by the National Lung Cancer Roundtable. Coauthor Debra S. Dyer, MD, serves on the clinical advisory board for computer software company Imidex and on the GO2 Foundation scientific advisory board; she also serves as a consultant for Lung Ambition Alliance. Coauthor Ella A. Kazerooni, MD, reports past participation on the Bristol Myers Squibb Foundation advisory board. The other authors have disclosed no relevant financial relationships.

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

This study was published on Medrxiv.org as a preprint and has not yet been peer reviewed.

Key takeaways

• in analyses of more than 100,000 women that used Mendelian randomization (MR) as a tool to reduce residual confounding.
• The MR analyses showed no significant association between ANM and breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.
• The clear lack of a causal effect of ANM on the outcomes of coronary heart disease and ischemic stroke in the MR analyses despite a strong inverse association seen in the observational data of this study (without MR) suggests residual confounding plays a substantial role in driving the observed outcomes.

Why this matters

• The authors said that, to their knowledge, this is the first study that has shown a causal association between older ANM and higher risk of postmenopausal lung cancer.
• This finding was directionally opposite to the significant protective effect of increased ANM documented in an observational analysis of roughly the same data as well as prior reports that did not use MR. This “notable inconsistency” suggests very substantial residual confounding without MR that could be driven by factors such as smoking, diet, and exercise.
• If these results are replicated in additional datasets, it would highlight a need for randomized, controlled trials of antiestrogen therapies in postmenopausal women for the prevention or treatment of lung cancer.

Study design

• The study included data from 106,853 postmenopausal women enrolled in the Women’s Health Initiative (WHI) and 95,464 women who were 37-73 years old included in the UK Biobank (UKB). Analyses for each outcome also included data from smaller numbers of women obtained from several additional datasets.
• The MR analysis used up to 55 single-nucleotide polymorphisms previously discovered through a genome-wide association study of about 70,000 women of European ancestry and independent of all datasets analyzed in the current study. The authors included all single-nucleotide polymorphisms with a consistent direction of effect on ANM.
• The MR analysis for lung cancer included 113,371 women from the two primary datasets and an additional 3012 women from six additional datasets.
• The MR analysis for bone fracture involved 113,239 women from the WHI and UKB only. The MR analysis for osteoporosis involved 137,080 women from the WHI, UKB, and one additional external dataset.

Key results

• Results from a meta-analysis of the MR results using data from the WHI, UKB, and the additional datasets showed ANM was causally associated with an increased risk of lung cancer by an odds ratio of 1.35 for each 5-year increase in ANM. In contrast, the adjusted observational analysis of data just from the WHI and UKB showed a significant 11% relative risk reduction in the incidence of lung cancer for each 5-year increase in ANM.
• The MR results also showed causally protective effects for fracture, with a 24% relative risk reduction, and for osteoporosis, with a 19% relative risk reduction for each 5-year increase in ANM.
• The MR analyses showed no significant association between AMN and outcome for breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.

Limitations

The main limitation of the MR study was the potential for inadequate power for assessing some outcomes despite the large overall size of the study cohort. Lack of adequate power may be responsible for some of the nonsignificant associations seen in the study, such as for breast and endometrial cancers, where substantial prior evidence has implicated increased risk through the effects of prolonged exposure to endogenous or exogenous estrogens.

The healthy cohort effect in the UKB is a known weakness of this dataset that may have limited the number of cases and generalizability of findings.

Osteoporosis and Alzheimer’s disease were self-reported.

The study only included participants of European ancestry because most subjects in most of the cohorts examined were White women and the applied MR instruments were found by genome-wide association studies run predominantly in White women. The authors said the causal effects of ANM need study in more diverse populations.
 

Disclosures

• The study received no commercial funding.
• None of the authors had disclosures.

This is a summary of a preprint research study, “Genetic evidence for causal relationships between age at natural menopause and the risk of aging-associated adverse health outcomes,” written by authors primarily based at Stanford University School of Medicine i

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

This study was published on Medrxiv.org as a preprint and has not yet been peer reviewed.

Key takeaways

• in analyses of more than 100,000 women that used Mendelian randomization (MR) as a tool to reduce residual confounding.
• The MR analyses showed no significant association between ANM and breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.
• The clear lack of a causal effect of ANM on the outcomes of coronary heart disease and ischemic stroke in the MR analyses despite a strong inverse association seen in the observational data of this study (without MR) suggests residual confounding plays a substantial role in driving the observed outcomes.

Why this matters

• The authors said that, to their knowledge, this is the first study that has shown a causal association between older ANM and higher risk of postmenopausal lung cancer.
• This finding was directionally opposite to the significant protective effect of increased ANM documented in an observational analysis of roughly the same data as well as prior reports that did not use MR. This “notable inconsistency” suggests very substantial residual confounding without MR that could be driven by factors such as smoking, diet, and exercise.
• If these results are replicated in additional datasets, it would highlight a need for randomized, controlled trials of antiestrogen therapies in postmenopausal women for the prevention or treatment of lung cancer.

Study design

• The study included data from 106,853 postmenopausal women enrolled in the Women’s Health Initiative (WHI) and 95,464 women who were 37-73 years old included in the UK Biobank (UKB). Analyses for each outcome also included data from smaller numbers of women obtained from several additional datasets.
• The MR analysis used up to 55 single-nucleotide polymorphisms previously discovered through a genome-wide association study of about 70,000 women of European ancestry and independent of all datasets analyzed in the current study. The authors included all single-nucleotide polymorphisms with a consistent direction of effect on ANM.
• The MR analysis for lung cancer included 113,371 women from the two primary datasets and an additional 3012 women from six additional datasets.
• The MR analysis for bone fracture involved 113,239 women from the WHI and UKB only. The MR analysis for osteoporosis involved 137,080 women from the WHI, UKB, and one additional external dataset.

Key results

• Results from a meta-analysis of the MR results using data from the WHI, UKB, and the additional datasets showed ANM was causally associated with an increased risk of lung cancer by an odds ratio of 1.35 for each 5-year increase in ANM. In contrast, the adjusted observational analysis of data just from the WHI and UKB showed a significant 11% relative risk reduction in the incidence of lung cancer for each 5-year increase in ANM.
• The MR results also showed causally protective effects for fracture, with a 24% relative risk reduction, and for osteoporosis, with a 19% relative risk reduction for each 5-year increase in ANM.
• The MR analyses showed no significant association between AMN and outcome for breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.

Limitations

The main limitation of the MR study was the potential for inadequate power for assessing some outcomes despite the large overall size of the study cohort. Lack of adequate power may be responsible for some of the nonsignificant associations seen in the study, such as for breast and endometrial cancers, where substantial prior evidence has implicated increased risk through the effects of prolonged exposure to endogenous or exogenous estrogens.

The healthy cohort effect in the UKB is a known weakness of this dataset that may have limited the number of cases and generalizability of findings.

Osteoporosis and Alzheimer’s disease were self-reported.

The study only included participants of European ancestry because most subjects in most of the cohorts examined were White women and the applied MR instruments were found by genome-wide association studies run predominantly in White women. The authors said the causal effects of ANM need study in more diverse populations.
 

Disclosures

• The study received no commercial funding.
• None of the authors had disclosures.

This is a summary of a preprint research study, “Genetic evidence for causal relationships between age at natural menopause and the risk of aging-associated adverse health outcomes,” written by authors primarily based at Stanford University School of Medicine i

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

This study was published on Medrxiv.org as a preprint and has not yet been peer reviewed.

Key takeaways

• in analyses of more than 100,000 women that used Mendelian randomization (MR) as a tool to reduce residual confounding.
• The MR analyses showed no significant association between ANM and breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.
• The clear lack of a causal effect of ANM on the outcomes of coronary heart disease and ischemic stroke in the MR analyses despite a strong inverse association seen in the observational data of this study (without MR) suggests residual confounding plays a substantial role in driving the observed outcomes.

Why this matters

• The authors said that, to their knowledge, this is the first study that has shown a causal association between older ANM and higher risk of postmenopausal lung cancer.
• This finding was directionally opposite to the significant protective effect of increased ANM documented in an observational analysis of roughly the same data as well as prior reports that did not use MR. This “notable inconsistency” suggests very substantial residual confounding without MR that could be driven by factors such as smoking, diet, and exercise.
• If these results are replicated in additional datasets, it would highlight a need for randomized, controlled trials of antiestrogen therapies in postmenopausal women for the prevention or treatment of lung cancer.

Study design

• The study included data from 106,853 postmenopausal women enrolled in the Women’s Health Initiative (WHI) and 95,464 women who were 37-73 years old included in the UK Biobank (UKB). Analyses for each outcome also included data from smaller numbers of women obtained from several additional datasets.
• The MR analysis used up to 55 single-nucleotide polymorphisms previously discovered through a genome-wide association study of about 70,000 women of European ancestry and independent of all datasets analyzed in the current study. The authors included all single-nucleotide polymorphisms with a consistent direction of effect on ANM.
• The MR analysis for lung cancer included 113,371 women from the two primary datasets and an additional 3012 women from six additional datasets.
• The MR analysis for bone fracture involved 113,239 women from the WHI and UKB only. The MR analysis for osteoporosis involved 137,080 women from the WHI, UKB, and one additional external dataset.

Key results

• Results from a meta-analysis of the MR results using data from the WHI, UKB, and the additional datasets showed ANM was causally associated with an increased risk of lung cancer by an odds ratio of 1.35 for each 5-year increase in ANM. In contrast, the adjusted observational analysis of data just from the WHI and UKB showed a significant 11% relative risk reduction in the incidence of lung cancer for each 5-year increase in ANM.
• The MR results also showed causally protective effects for fracture, with a 24% relative risk reduction, and for osteoporosis, with a 19% relative risk reduction for each 5-year increase in ANM.
• The MR analyses showed no significant association between AMN and outcome for breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.

Limitations

The main limitation of the MR study was the potential for inadequate power for assessing some outcomes despite the large overall size of the study cohort. Lack of adequate power may be responsible for some of the nonsignificant associations seen in the study, such as for breast and endometrial cancers, where substantial prior evidence has implicated increased risk through the effects of prolonged exposure to endogenous or exogenous estrogens.

The healthy cohort effect in the UKB is a known weakness of this dataset that may have limited the number of cases and generalizability of findings.

Osteoporosis and Alzheimer’s disease were self-reported.

The study only included participants of European ancestry because most subjects in most of the cohorts examined were White women and the applied MR instruments were found by genome-wide association studies run predominantly in White women. The authors said the causal effects of ANM need study in more diverse populations.
 

Disclosures

• The study received no commercial funding.
• None of the authors had disclosures.

This is a summary of a preprint research study, “Genetic evidence for causal relationships between age at natural menopause and the risk of aging-associated adverse health outcomes,” written by authors primarily based at Stanford University School of Medicine i

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

Investigators presenting at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium called for neoadjuvant chemotherapy to be a new standard of care for high-grade upper tract urothelial carcinoma.

They made the call after finding that 63% of patients (36/57) had a pathologic response to gemcitabine/cisplatin before extirpative surgery, with pathologic response defined as less than pT2NO disease on postoperative pathology. Nineteen percent (11/57) had complete responses, with no evidence of the main tumor (ypT0N0).

The approach has a “favorable pathologic response, is well tolerated ... and thus should be considered a new standard of care option,” said investigators led by Wesley Yip, MD, a urologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York.

There was no comparator arm, but the results are in line with previous reports, including a 2014 investigation that found a 5-year disease specific survival (DSS) of 90.1% and 5-year overall survival (OS) of 80.2% among 31 upper tract urothelial carcinoma patients who received neoadjuvant chemotherapy, versus a 5-year DSS and OS of 57.6% among 81 historical controls.

Presentation moderator Stephen Boorjian, MD, chair of urology at the Mayo Clinic in Rochester, Minn., called the findings “valuable” but noted there’s level 1 evidence for an alternative approach, chemotherapy or nivolumab after surgery for patients with particularly worrisome postop pathology. It makes it tough to know if patients should be treated beforehand or afterwards.

“What do we do?” he asked.

Dr. Yip said it’s an open question at this point but that trials are underway to address the issue. In the meantime, “it’s definitely a multidisciplinary discussion to know what’s best for each patient,” he said. One of the factors that argues for the neoadjuvant approach is that substantially fewer patients are eligible for chemotherapy after nephroureterectomy because of diminished renal function. “Patients who might not be eligible ... are the ones we’d be targeting for” neoadjuvant chemotherapy (NAC), he said.

In the study, gemcitabine 1000 mg/m² and cisplatin 35 mg/m² were administered on days 1 and 8 of four 21-day cycles, followed by radical nephroureterectomy or ureterectomy.

Fifty-three of the subjects had high-grade disease by endoscopic biopsy, and the remaining four were enrolled based on imaging and selective cytology. There was no nodal disease on CT within 30 days of neoadjuvant chemotherapy initiation.

Two-year progression-free survival (PFS) was 91% among pathologic responders but only 52% among nonresponders. Every responder was alive at 2 years versus 80% of nonresponders.

Across the entire cohort, 5-year PFS was 61% and 5-year OS 79%; 89.5% of patients were alive at a median follow-up of 3.5 years.

Almost all of the patients completed at least three NAC cycles, and all of them went to surgery, which had a 90-day grade 3 or higher complication rate of 7%.

Sixty-three percent were men, and 95% were White. The median age was 66 years.

The work was funded by the National Institutes of Health and Memorial Sloan Kettering. Dr. Yip had no disclosures. Dr. Boorjian advises ArTara Therapeutics, FerGene, and Ferring.

Investigators presenting at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium called for neoadjuvant chemotherapy to be a new standard of care for high-grade upper tract urothelial carcinoma.

They made the call after finding that 63% of patients (36/57) had a pathologic response to gemcitabine/cisplatin before extirpative surgery, with pathologic response defined as less than pT2NO disease on postoperative pathology. Nineteen percent (11/57) had complete responses, with no evidence of the main tumor (ypT0N0).

The approach has a “favorable pathologic response, is well tolerated ... and thus should be considered a new standard of care option,” said investigators led by Wesley Yip, MD, a urologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York.

There was no comparator arm, but the results are in line with previous reports, including a 2014 investigation that found a 5-year disease specific survival (DSS) of 90.1% and 5-year overall survival (OS) of 80.2% among 31 upper tract urothelial carcinoma patients who received neoadjuvant chemotherapy, versus a 5-year DSS and OS of 57.6% among 81 historical controls.

Presentation moderator Stephen Boorjian, MD, chair of urology at the Mayo Clinic in Rochester, Minn., called the findings “valuable” but noted there’s level 1 evidence for an alternative approach, chemotherapy or nivolumab after surgery for patients with particularly worrisome postop pathology. It makes it tough to know if patients should be treated beforehand or afterwards.

“What do we do?” he asked.

Dr. Yip said it’s an open question at this point but that trials are underway to address the issue. In the meantime, “it’s definitely a multidisciplinary discussion to know what’s best for each patient,” he said. One of the factors that argues for the neoadjuvant approach is that substantially fewer patients are eligible for chemotherapy after nephroureterectomy because of diminished renal function. “Patients who might not be eligible ... are the ones we’d be targeting for” neoadjuvant chemotherapy (NAC), he said.

In the study, gemcitabine 1000 mg/m² and cisplatin 35 mg/m² were administered on days 1 and 8 of four 21-day cycles, followed by radical nephroureterectomy or ureterectomy.

Fifty-three of the subjects had high-grade disease by endoscopic biopsy, and the remaining four were enrolled based on imaging and selective cytology. There was no nodal disease on CT within 30 days of neoadjuvant chemotherapy initiation.

Two-year progression-free survival (PFS) was 91% among pathologic responders but only 52% among nonresponders. Every responder was alive at 2 years versus 80% of nonresponders.

Across the entire cohort, 5-year PFS was 61% and 5-year OS 79%; 89.5% of patients were alive at a median follow-up of 3.5 years.

Almost all of the patients completed at least three NAC cycles, and all of them went to surgery, which had a 90-day grade 3 or higher complication rate of 7%.

Sixty-three percent were men, and 95% were White. The median age was 66 years.

The work was funded by the National Institutes of Health and Memorial Sloan Kettering. Dr. Yip had no disclosures. Dr. Boorjian advises ArTara Therapeutics, FerGene, and Ferring.

Investigators presenting at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium called for neoadjuvant chemotherapy to be a new standard of care for high-grade upper tract urothelial carcinoma.

They made the call after finding that 63% of patients (36/57) had a pathologic response to gemcitabine/cisplatin before extirpative surgery, with pathologic response defined as less than pT2NO disease on postoperative pathology. Nineteen percent (11/57) had complete responses, with no evidence of the main tumor (ypT0N0).

The approach has a “favorable pathologic response, is well tolerated ... and thus should be considered a new standard of care option,” said investigators led by Wesley Yip, MD, a urologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York.

There was no comparator arm, but the results are in line with previous reports, including a 2014 investigation that found a 5-year disease specific survival (DSS) of 90.1% and 5-year overall survival (OS) of 80.2% among 31 upper tract urothelial carcinoma patients who received neoadjuvant chemotherapy, versus a 5-year DSS and OS of 57.6% among 81 historical controls.

Presentation moderator Stephen Boorjian, MD, chair of urology at the Mayo Clinic in Rochester, Minn., called the findings “valuable” but noted there’s level 1 evidence for an alternative approach, chemotherapy or nivolumab after surgery for patients with particularly worrisome postop pathology. It makes it tough to know if patients should be treated beforehand or afterwards.

“What do we do?” he asked.

Dr. Yip said it’s an open question at this point but that trials are underway to address the issue. In the meantime, “it’s definitely a multidisciplinary discussion to know what’s best for each patient,” he said. One of the factors that argues for the neoadjuvant approach is that substantially fewer patients are eligible for chemotherapy after nephroureterectomy because of diminished renal function. “Patients who might not be eligible ... are the ones we’d be targeting for” neoadjuvant chemotherapy (NAC), he said.

In the study, gemcitabine 1000 mg/m² and cisplatin 35 mg/m² were administered on days 1 and 8 of four 21-day cycles, followed by radical nephroureterectomy or ureterectomy.

Fifty-three of the subjects had high-grade disease by endoscopic biopsy, and the remaining four were enrolled based on imaging and selective cytology. There was no nodal disease on CT within 30 days of neoadjuvant chemotherapy initiation.

Two-year progression-free survival (PFS) was 91% among pathologic responders but only 52% among nonresponders. Every responder was alive at 2 years versus 80% of nonresponders.

Across the entire cohort, 5-year PFS was 61% and 5-year OS 79%; 89.5% of patients were alive at a median follow-up of 3.5 years.

Almost all of the patients completed at least three NAC cycles, and all of them went to surgery, which had a 90-day grade 3 or higher complication rate of 7%.

Sixty-three percent were men, and 95% were White. The median age was 66 years.

The work was funded by the National Institutes of Health and Memorial Sloan Kettering. Dr. Yip had no disclosures. Dr. Boorjian advises ArTara Therapeutics, FerGene, and Ferring.