Genitourinary Cancer

The results of a large, matched cohort study from three major institutions have led investigators to call for broader use of trimodal therapy for muscle-invasive bladder cancer.

Radical cystectomy (RC), or the surgical removal of the whole bladder, prostate glands and seminal vesicles in men, or the bladder, uterus and fallopian tubes in women, is the traditional gold standard. But with trimodal therapy (TMT), patients can keep their bladders and avoid a long surgery. The procedure, which is called transurethral tumor resection, requires removing cancerous tumors from the bladder followed by chemoradiation.

After matching hundreds of patients requiring RC or TMT, “the oncologic outcomes seem to be equivalent. ...We do believe that TMT should be offered as an effective alternative for these patients,” said lead investigator Alexandre Zlotta, MD, PhD, director of uro-oncology at Mount Sinai Hospital, Toronto, after he presented the findings at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium

“The findings that patients with clinical T2 disease have similar outcomes with either approach is encouraging,” said Matthew Zibelman, MD,, an assistant hematology/oncology professor at Fox Chase Cancer Center, Philadelphia, when asked for comment.

Trimodal therapy is already an alternative to cystectomy in guidelines for patients with clinical T2-T3 disease who have no, or minor, unilateral hydronephrosis, and unifocal tumors of 7 cm or less, among other criteria.

However, oncologists shy away from it preferring to reserve trimodal therapy mostly for patients who are not candidates for surgery, Dr. Zlotta explained.

The problem is a lack of head-to-head randomized data comparing the two approaches. Attempts at trials in the past closed early because of lack of accrual, and it seems unlikely there’ll be another attempt in the future.
 

A ‘very valuable’ option

Dr. Zlotta and associates wanted to address the evidence gap with the next best thing, a large, matched cohort study. In lieu of a level 1 data, he said their work provides “the best possible evidence” comparing the two approaches and supports TMT as a “very valuable” option so long as centers can provide the necessary follow-up, including salvage cystectomy if needed.

Dr. Zibelman said the retrospective study “cannot completely account for unmeasured variables that may have predisposed patients to get trimodal therapy over surgery, which may have influenced the final data.”

Sill, “trimodal therapy likely provides oncologic outcomes similar to surgery in carefully selected patients ... and should be discussed ... as a bladder-preserving option,” he said.

The study matched 1 to 3, 282 patients undergoing trimodal therapy with 421 patients undergoing radical cystectomy. The patients were treated during 2005-2017 at Massachusetts General Hospital, Boston; the University of California, Los Angeles; or the Princess Margaret Cancer Centre, Toronto.

Patients had cT2-T3/4a disease without positive nodes or metastases. The entire cohort would have been eligible for either TMT or RC under current guidelines.

Propensity score matching produced well-balanced study arms, with a median age of about 71 years; cT2 disease in about 90%; hydronephrosis in about 11%, and adjuvant or neoadjuvant chemotherapy in about 60% of both arms.

At 5 years, both cancer-specific survival (78% with RC and 85% with TMT; P = .02) and overall survival favored TMT (66% RC vs. 78% TMT; P < .001), although Dr. Zlotta said the stark OS difference could have resulted from chance.

Trends also favored TMT in the primary outcome – 5-year metastasis free survival (73% RC vs. 78% TMT; P = .07) – as well as in distant failure-free survival (78% RC vs. 82% TMT; P = .14). The 5-year pelvic node failure-free survival was 96% in the RC group versus 94% with TMT (P = .33).

There were slight differences in surgical protocols between the study centers, and while adjuvant therapy was used at Massachusetts General, neoadjuvant chemotherapy was used in Toronto.

The differences might have introduced confounders, but “I have to say we were pretty reassured to see that we observed exactly the same results” regardless of where subjects were treated. It was “incredibly surprising, but comforting,” Dr. Zlotta said.

Another potential confounder – poor surgical technique – also wasn’t an issue. A median of 40 lymph nodes were removed during cystectomy, which “speaks to the quality of the surgical series,” he said.

The tumor recurrence rate was 20.5% in the TMT arm; 13% of patients had subsequent salvage cystectomies. Perioperative mortality was 2.1% in the RC arm.

There was no outside funding for the work. Dr. Zlotta had ties to numerous companies and honoraria/research funding from or being a consultant to AstraZeneca, Merck, Verity Pharmaceuticals, and others. Dr. Zibelman didn’t have any disclosures.

This article was updated on 3/10/22.

The results of a large, matched cohort study from three major institutions have led investigators to call for broader use of trimodal therapy for muscle-invasive bladder cancer.

Radical cystectomy (RC), or the surgical removal of the whole bladder, prostate glands and seminal vesicles in men, or the bladder, uterus and fallopian tubes in women, is the traditional gold standard. But with trimodal therapy (TMT), patients can keep their bladders and avoid a long surgery. The procedure, which is called transurethral tumor resection, requires removing cancerous tumors from the bladder followed by chemoradiation.

After matching hundreds of patients requiring RC or TMT, “the oncologic outcomes seem to be equivalent. ...We do believe that TMT should be offered as an effective alternative for these patients,” said lead investigator Alexandre Zlotta, MD, PhD, director of uro-oncology at Mount Sinai Hospital, Toronto, after he presented the findings at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium

“The findings that patients with clinical T2 disease have similar outcomes with either approach is encouraging,” said Matthew Zibelman, MD,, an assistant hematology/oncology professor at Fox Chase Cancer Center, Philadelphia, when asked for comment.

Trimodal therapy is already an alternative to cystectomy in guidelines for patients with clinical T2-T3 disease who have no, or minor, unilateral hydronephrosis, and unifocal tumors of 7 cm or less, among other criteria.

However, oncologists shy away from it preferring to reserve trimodal therapy mostly for patients who are not candidates for surgery, Dr. Zlotta explained.

The problem is a lack of head-to-head randomized data comparing the two approaches. Attempts at trials in the past closed early because of lack of accrual, and it seems unlikely there’ll be another attempt in the future.
 

A ‘very valuable’ option

Dr. Zlotta and associates wanted to address the evidence gap with the next best thing, a large, matched cohort study. In lieu of a level 1 data, he said their work provides “the best possible evidence” comparing the two approaches and supports TMT as a “very valuable” option so long as centers can provide the necessary follow-up, including salvage cystectomy if needed.

Dr. Zibelman said the retrospective study “cannot completely account for unmeasured variables that may have predisposed patients to get trimodal therapy over surgery, which may have influenced the final data.”

Sill, “trimodal therapy likely provides oncologic outcomes similar to surgery in carefully selected patients ... and should be discussed ... as a bladder-preserving option,” he said.

The study matched 1 to 3, 282 patients undergoing trimodal therapy with 421 patients undergoing radical cystectomy. The patients were treated during 2005-2017 at Massachusetts General Hospital, Boston; the University of California, Los Angeles; or the Princess Margaret Cancer Centre, Toronto.

Patients had cT2-T3/4a disease without positive nodes or metastases. The entire cohort would have been eligible for either TMT or RC under current guidelines.

Propensity score matching produced well-balanced study arms, with a median age of about 71 years; cT2 disease in about 90%; hydronephrosis in about 11%, and adjuvant or neoadjuvant chemotherapy in about 60% of both arms.

At 5 years, both cancer-specific survival (78% with RC and 85% with TMT; P = .02) and overall survival favored TMT (66% RC vs. 78% TMT; P < .001), although Dr. Zlotta said the stark OS difference could have resulted from chance.

Trends also favored TMT in the primary outcome – 5-year metastasis free survival (73% RC vs. 78% TMT; P = .07) – as well as in distant failure-free survival (78% RC vs. 82% TMT; P = .14). The 5-year pelvic node failure-free survival was 96% in the RC group versus 94% with TMT (P = .33).

There were slight differences in surgical protocols between the study centers, and while adjuvant therapy was used at Massachusetts General, neoadjuvant chemotherapy was used in Toronto.

The differences might have introduced confounders, but “I have to say we were pretty reassured to see that we observed exactly the same results” regardless of where subjects were treated. It was “incredibly surprising, but comforting,” Dr. Zlotta said.

Another potential confounder – poor surgical technique – also wasn’t an issue. A median of 40 lymph nodes were removed during cystectomy, which “speaks to the quality of the surgical series,” he said.

The tumor recurrence rate was 20.5% in the TMT arm; 13% of patients had subsequent salvage cystectomies. Perioperative mortality was 2.1% in the RC arm.

There was no outside funding for the work. Dr. Zlotta had ties to numerous companies and honoraria/research funding from or being a consultant to AstraZeneca, Merck, Verity Pharmaceuticals, and others. Dr. Zibelman didn’t have any disclosures.

This article was updated on 3/10/22.

The results of a large, matched cohort study from three major institutions have led investigators to call for broader use of trimodal therapy for muscle-invasive bladder cancer.

Radical cystectomy (RC), or the surgical removal of the whole bladder, prostate glands and seminal vesicles in men, or the bladder, uterus and fallopian tubes in women, is the traditional gold standard. But with trimodal therapy (TMT), patients can keep their bladders and avoid a long surgery. The procedure, which is called transurethral tumor resection, requires removing cancerous tumors from the bladder followed by chemoradiation.

After matching hundreds of patients requiring RC or TMT, “the oncologic outcomes seem to be equivalent. ...We do believe that TMT should be offered as an effective alternative for these patients,” said lead investigator Alexandre Zlotta, MD, PhD, director of uro-oncology at Mount Sinai Hospital, Toronto, after he presented the findings at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium

“The findings that patients with clinical T2 disease have similar outcomes with either approach is encouraging,” said Matthew Zibelman, MD,, an assistant hematology/oncology professor at Fox Chase Cancer Center, Philadelphia, when asked for comment.

Trimodal therapy is already an alternative to cystectomy in guidelines for patients with clinical T2-T3 disease who have no, or minor, unilateral hydronephrosis, and unifocal tumors of 7 cm or less, among other criteria.

However, oncologists shy away from it preferring to reserve trimodal therapy mostly for patients who are not candidates for surgery, Dr. Zlotta explained.

The problem is a lack of head-to-head randomized data comparing the two approaches. Attempts at trials in the past closed early because of lack of accrual, and it seems unlikely there’ll be another attempt in the future.
 

A ‘very valuable’ option

Dr. Zlotta and associates wanted to address the evidence gap with the next best thing, a large, matched cohort study. In lieu of a level 1 data, he said their work provides “the best possible evidence” comparing the two approaches and supports TMT as a “very valuable” option so long as centers can provide the necessary follow-up, including salvage cystectomy if needed.

Dr. Zibelman said the retrospective study “cannot completely account for unmeasured variables that may have predisposed patients to get trimodal therapy over surgery, which may have influenced the final data.”

Sill, “trimodal therapy likely provides oncologic outcomes similar to surgery in carefully selected patients ... and should be discussed ... as a bladder-preserving option,” he said.

The study matched 1 to 3, 282 patients undergoing trimodal therapy with 421 patients undergoing radical cystectomy. The patients were treated during 2005-2017 at Massachusetts General Hospital, Boston; the University of California, Los Angeles; or the Princess Margaret Cancer Centre, Toronto.

Patients had cT2-T3/4a disease without positive nodes or metastases. The entire cohort would have been eligible for either TMT or RC under current guidelines.

Propensity score matching produced well-balanced study arms, with a median age of about 71 years; cT2 disease in about 90%; hydronephrosis in about 11%, and adjuvant or neoadjuvant chemotherapy in about 60% of both arms.

At 5 years, both cancer-specific survival (78% with RC and 85% with TMT; P = .02) and overall survival favored TMT (66% RC vs. 78% TMT; P < .001), although Dr. Zlotta said the stark OS difference could have resulted from chance.

Trends also favored TMT in the primary outcome – 5-year metastasis free survival (73% RC vs. 78% TMT; P = .07) – as well as in distant failure-free survival (78% RC vs. 82% TMT; P = .14). The 5-year pelvic node failure-free survival was 96% in the RC group versus 94% with TMT (P = .33).

There were slight differences in surgical protocols between the study centers, and while adjuvant therapy was used at Massachusetts General, neoadjuvant chemotherapy was used in Toronto.

The differences might have introduced confounders, but “I have to say we were pretty reassured to see that we observed exactly the same results” regardless of where subjects were treated. It was “incredibly surprising, but comforting,” Dr. Zlotta said.

Another potential confounder – poor surgical technique – also wasn’t an issue. A median of 40 lymph nodes were removed during cystectomy, which “speaks to the quality of the surgical series,” he said.

The tumor recurrence rate was 20.5% in the TMT arm; 13% of patients had subsequent salvage cystectomies. Perioperative mortality was 2.1% in the RC arm.

There was no outside funding for the work. Dr. Zlotta had ties to numerous companies and honoraria/research funding from or being a consultant to AstraZeneca, Merck, Verity Pharmaceuticals, and others. Dr. Zibelman didn’t have any disclosures.

This article was updated on 3/10/22.

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.

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.

There was a remarkable reduction in bowel and urinary side effects when MRI was used instead of CT to guide stereotactic body radiotherapy (SBRT) for localized prostate cancer, shows a study from the University of California, Los Angeles.

Among the first 100 men in the phase 3 MIRAGE trial (Magnetic Resonance Imaging–Guided Versus Computed Tomography–Guided Stereotactic Body Radiotherapy for Prostate Cancer), MRI guidance more than halved the incidence of grade 2 or higher physician-reported genitourinary toxicity within 90 days of the procedure, which fell from 47.1% with CT to 22.4% with MRI.

While 13.7% of men had gastrointestinal complications with CT guidance, there wasn’t a single case in the MRI arm. The findings were presented Feb. 17 at the American Society of Clinical Oncology Genitourinary Cancers Symposium.

The investigators thought they’d need 300 men to detect a safety difference, but the results are so strong that they’ve scaled back enrollment to 154. In the meantime, MRI-guided SBRT is now offered routinely to men with localized prostate cancer at UCLA.

“Our final results are expected later this year, but we are extremely optimistic by what we’re seeing, and hope this technology will soon begin to offer men undergoing radiotherapy for prostate cancer better outcomes,” said lead investigator Amar Upadhyaya Kishan, MD, a genitourinary oncology radiologist, in a UCLA press release.

The better outcomes are caused by the enhanced imaging capabilities of MRI, including real time tracking and automatic beam shutoff when the prostate moves too far outside of the treatment boundary, Dr. Kishan explained on Twitter.

Because of the extra precision, “we felt we could safely reduce the planning margins to only 2 mm” with MRI, down from 4 mm with CT. It translated to smaller treatment volumes and less collateral tissue damage, he said.

Across the first 100 subjects, 49 men were randomized to MRI-guided SBRT and 51 to SBRT with CT guidance. Their prostates and proximal seminal vesicles were dosed with 40 Gy of radiation in five fractions. Rectal spacing and nodal irradiation were at physician discretion.

Patients in the MRI arm also reported significantly fewer urinary symptoms, including urgency, incontinence, burning sensations, and bowel dysfunction, such as pain, diarrhea, and obstruction, among others, at 1 month with MRI guidance. The differences diminished at 3 months with adverse event management in the CT arm.

Lymph nodes were irradiated in 29% of men in the CT group versus 20% in the MRI arm, and 37% of the CT group versus 27% with MRI had rectal spacing.

Baseline gland size was a median of 39 mL in both groups. Baseline International Prostate Symptom Scores were a median of 8 points in the MRI group but 5 points in the CT arm.

The work was funded by UCLA, among others. Dr. Kishan has ownership interests in ViewRay, the company that makes the MRI-guiding technology used in the trial, and reported honoraria and research funding from the company.

There was a remarkable reduction in bowel and urinary side effects when MRI was used instead of CT to guide stereotactic body radiotherapy (SBRT) for localized prostate cancer, shows a study from the University of California, Los Angeles.

Among the first 100 men in the phase 3 MIRAGE trial (Magnetic Resonance Imaging–Guided Versus Computed Tomography–Guided Stereotactic Body Radiotherapy for Prostate Cancer), MRI guidance more than halved the incidence of grade 2 or higher physician-reported genitourinary toxicity within 90 days of the procedure, which fell from 47.1% with CT to 22.4% with MRI.

While 13.7% of men had gastrointestinal complications with CT guidance, there wasn’t a single case in the MRI arm. The findings were presented Feb. 17 at the American Society of Clinical Oncology Genitourinary Cancers Symposium.

The investigators thought they’d need 300 men to detect a safety difference, but the results are so strong that they’ve scaled back enrollment to 154. In the meantime, MRI-guided SBRT is now offered routinely to men with localized prostate cancer at UCLA.

“Our final results are expected later this year, but we are extremely optimistic by what we’re seeing, and hope this technology will soon begin to offer men undergoing radiotherapy for prostate cancer better outcomes,” said lead investigator Amar Upadhyaya Kishan, MD, a genitourinary oncology radiologist, in a UCLA press release.

The better outcomes are caused by the enhanced imaging capabilities of MRI, including real time tracking and automatic beam shutoff when the prostate moves too far outside of the treatment boundary, Dr. Kishan explained on Twitter.

Because of the extra precision, “we felt we could safely reduce the planning margins to only 2 mm” with MRI, down from 4 mm with CT. It translated to smaller treatment volumes and less collateral tissue damage, he said.

Across the first 100 subjects, 49 men were randomized to MRI-guided SBRT and 51 to SBRT with CT guidance. Their prostates and proximal seminal vesicles were dosed with 40 Gy of radiation in five fractions. Rectal spacing and nodal irradiation were at physician discretion.

Patients in the MRI arm also reported significantly fewer urinary symptoms, including urgency, incontinence, burning sensations, and bowel dysfunction, such as pain, diarrhea, and obstruction, among others, at 1 month with MRI guidance. The differences diminished at 3 months with adverse event management in the CT arm.

Lymph nodes were irradiated in 29% of men in the CT group versus 20% in the MRI arm, and 37% of the CT group versus 27% with MRI had rectal spacing.

Baseline gland size was a median of 39 mL in both groups. Baseline International Prostate Symptom Scores were a median of 8 points in the MRI group but 5 points in the CT arm.

The work was funded by UCLA, among others. Dr. Kishan has ownership interests in ViewRay, the company that makes the MRI-guiding technology used in the trial, and reported honoraria and research funding from the company.

There was a remarkable reduction in bowel and urinary side effects when MRI was used instead of CT to guide stereotactic body radiotherapy (SBRT) for localized prostate cancer, shows a study from the University of California, Los Angeles.

Among the first 100 men in the phase 3 MIRAGE trial (Magnetic Resonance Imaging–Guided Versus Computed Tomography–Guided Stereotactic Body Radiotherapy for Prostate Cancer), MRI guidance more than halved the incidence of grade 2 or higher physician-reported genitourinary toxicity within 90 days of the procedure, which fell from 47.1% with CT to 22.4% with MRI.

While 13.7% of men had gastrointestinal complications with CT guidance, there wasn’t a single case in the MRI arm. The findings were presented Feb. 17 at the American Society of Clinical Oncology Genitourinary Cancers Symposium.

The investigators thought they’d need 300 men to detect a safety difference, but the results are so strong that they’ve scaled back enrollment to 154. In the meantime, MRI-guided SBRT is now offered routinely to men with localized prostate cancer at UCLA.

“Our final results are expected later this year, but we are extremely optimistic by what we’re seeing, and hope this technology will soon begin to offer men undergoing radiotherapy for prostate cancer better outcomes,” said lead investigator Amar Upadhyaya Kishan, MD, a genitourinary oncology radiologist, in a UCLA press release.

The better outcomes are caused by the enhanced imaging capabilities of MRI, including real time tracking and automatic beam shutoff when the prostate moves too far outside of the treatment boundary, Dr. Kishan explained on Twitter.

Because of the extra precision, “we felt we could safely reduce the planning margins to only 2 mm” with MRI, down from 4 mm with CT. It translated to smaller treatment volumes and less collateral tissue damage, he said.

Across the first 100 subjects, 49 men were randomized to MRI-guided SBRT and 51 to SBRT with CT guidance. Their prostates and proximal seminal vesicles were dosed with 40 Gy of radiation in five fractions. Rectal spacing and nodal irradiation were at physician discretion.

Patients in the MRI arm also reported significantly fewer urinary symptoms, including urgency, incontinence, burning sensations, and bowel dysfunction, such as pain, diarrhea, and obstruction, among others, at 1 month with MRI guidance. The differences diminished at 3 months with adverse event management in the CT arm.

Lymph nodes were irradiated in 29% of men in the CT group versus 20% in the MRI arm, and 37% of the CT group versus 27% with MRI had rectal spacing.

Baseline gland size was a median of 39 mL in both groups. Baseline International Prostate Symptom Scores were a median of 8 points in the MRI group but 5 points in the CT arm.

The work was funded by UCLA, among others. Dr. Kishan has ownership interests in ViewRay, the company that makes the MRI-guiding technology used in the trial, and reported honoraria and research funding from the company.

Twitter was all abuzz over an exchange that occurred Feb. 17 during the question-and-answer discussion that followed oral abstract presentations at the ASCO Genitourinary Cancers Symposium, held in San Francisco and also online. One of the panelists was accused of being less than professional in handling questions from the floor.

It began with a tweet from Sumanta Pal, MD, of the City of Hope, when he called out the behavior, although he did not identify the perpetrator.

“Yesterday we saw some reprehensible behavior emanating from the @ASCO #GU22 podium, with a well known investigator insulting (in a manner deeply imbued w microaggressions) an esteemed colleague at the mic. It’s a teachable moment & the lesson is simple: be kind to ur colleagues.”

It was not immediately clear what had occurred, and several people asked him to identify the people involved. One physician responded, “If it was bad enough to infer and share on Twitter, name the name.”

But even without details, the post provoked a reaction.

Erika Hamilton, MD, wrote, “I am not aware of this incident, but I always wonder ... if someone would do that from the podium, what would they/have they done and said when they didn’t think everyone was watching?”

Another tweet questioned why there were no codes of conduct in place, so that situations like this one wouldn’t happen.

“[It is] about time professional societies had codes of conduct in place for invited speakers, moderators of sessions etc,” wrote Deborah Verran, MD. “Then if it is breached the individual concerned is not invited back. This kind of incident also needs to be mentioned as part of the conference feedback process.”

As the number of clinicians chiming in increased, it soon became apparent that others were aware of the incident, and one posted a video clip, putting the mystery to rest.
 

Moderator quips, ‘Behave ... children’

The exchange occurred immediately following the oral abstract presentations on prostate cancer on Feb. 17. Two of these abstracts featured new data from large clinical trials investigating the use of PARP inhibitors in metastatic prostate cancer, which had slightly different results, leading to some debate. The PROpel trial with olaparib showed a benefit in all patients, irrespective of gene mutation status, but the MAGNITUDE trial with niraparib showed a benefit only in patients with gene alterations, and especially in those with BRCA1/2 mutations.

The invited discussant, Celestia Higano, MD, from the University of British Columbia, Vancouver, compared and contrasted the two trials and the differing results.

During the question-and-answer session that followed, Neeraj Agarwal, MD, from the Huntsman Cancer Institute, University of Utah, directed a question to Fred Saad, MD, who had presented the results of the PROpel trial.*

“As a practicing oncologist, I am very intrigued by the different results of the MAGNITUDE and PROpel trials. I am trying to figure out what do I do in my practice,” Dr. Agarwal began.

He continued on, explaining that he didn’t think that olaparib and niraparib were that different from one another for the two studies to have such differing results, when both of the drugs were given in combination with abiraterone.

The inclusion criteria for PROpel stipulated that patients undergo testing by ctDNA to determine if they were biomarker positive or not, but he pointed out that it is possible for testing to miss patients who might otherwise be positive for homologous recombination repair (HRR) gene alterations. He posed the question, could some of the patients deemed biomarker negative in fact have been positive but whose status was not detected by ctDNA testing?

At that point, Dr. Higano interrupted him before he had completed his question and asked, “Can I make a comment? Were you listening to my discussion?”

She then continued, pointing out that “you can’t talk about comparing olaparib and niraparib – these two trials had two very different populations.”

She emphasized that this was about the combinations in the populations being studied and not about olaparib and niraparib. “I clearly wasn’t very clear,” she said.

Dr. Agarwal then repeated that he wanted to know what to do with his patients and asked again about the accuracy of ctDNA testing.

“That’s a good question,” Dr. Higano said, “But the other comments you made weren’t.”

At that point, the moderator chimed in. “Let’s all calm down ... children.”

After a brief applause following the moderator’s comment, Dr. Saad then addressed the question.

When the video clip of this exchange was posted, a flood of tweets poured in, supporting Dr. Pal’s initial summation of the situation.

Alison Birtle, MD, tweeted, “I’m even more appalled having seen this exchange. Unacceptable. You don’t humiliate either the speaker or the delegate and the questions were entirely valid in my opinion. Basically what do I do tomorrow with these data so why ask were you listening. That’s just rude.”

Jason Kovac, MD, tweeted: “It’s absolutely not a proper way to behave. Whether it’s behind the scenes or to your face. You can hear the arrogance from everyone including the moderator with his children comment. This is the true face of medicine.”

Jarey Wang, MD, PhD, however, liked the moderator’s input. “Love it. ‘Let’s all calm down children.’ Good for the moderator.”

Several of the physicians who commented thought that the issue should have been addressed at the time it happened. Don S. Dizon, MD, wrote, “Calling out microagressions as they occur is so important. And very difficult. Agree, the teachable moment must be met with bravery. But it should happen in real time too.”

After 2 days of bantering on Twitter, with the thread growing increasingly longer and with the vast majority of posts supporting Dr. Pal’s initial assessment, Dr. Higano finally entered the discussion and defended her comments: “What you do not know is that the questioner and I are good colleagues,” she tweeted. “I have been involved in two of his academic promotions. My main concern was his comment re: how the two trials could have ‘so different results with the same combination.’ I sought to rectify wrong message.”

There were no direct replies to Dr. Higano’s tweet.

Perhaps the line to draw under this affair is the tweet from Simon Kim, MD, MPH, who wrote: “We can do better!”

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

Correction, 2/24/22: Dr. Fred Saad's name was misstated in an earlier version of this article.

Twitter was all abuzz over an exchange that occurred Feb. 17 during the question-and-answer discussion that followed oral abstract presentations at the ASCO Genitourinary Cancers Symposium, held in San Francisco and also online. One of the panelists was accused of being less than professional in handling questions from the floor.

It began with a tweet from Sumanta Pal, MD, of the City of Hope, when he called out the behavior, although he did not identify the perpetrator.

“Yesterday we saw some reprehensible behavior emanating from the @ASCO #GU22 podium, with a well known investigator insulting (in a manner deeply imbued w microaggressions) an esteemed colleague at the mic. It’s a teachable moment & the lesson is simple: be kind to ur colleagues.”

It was not immediately clear what had occurred, and several people asked him to identify the people involved. One physician responded, “If it was bad enough to infer and share on Twitter, name the name.”

But even without details, the post provoked a reaction.

Erika Hamilton, MD, wrote, “I am not aware of this incident, but I always wonder ... if someone would do that from the podium, what would they/have they done and said when they didn’t think everyone was watching?”

Another tweet questioned why there were no codes of conduct in place, so that situations like this one wouldn’t happen.

“[It is] about time professional societies had codes of conduct in place for invited speakers, moderators of sessions etc,” wrote Deborah Verran, MD. “Then if it is breached the individual concerned is not invited back. This kind of incident also needs to be mentioned as part of the conference feedback process.”

As the number of clinicians chiming in increased, it soon became apparent that others were aware of the incident, and one posted a video clip, putting the mystery to rest.
 

Moderator quips, ‘Behave ... children’

The exchange occurred immediately following the oral abstract presentations on prostate cancer on Feb. 17. Two of these abstracts featured new data from large clinical trials investigating the use of PARP inhibitors in metastatic prostate cancer, which had slightly different results, leading to some debate. The PROpel trial with olaparib showed a benefit in all patients, irrespective of gene mutation status, but the MAGNITUDE trial with niraparib showed a benefit only in patients with gene alterations, and especially in those with BRCA1/2 mutations.

The invited discussant, Celestia Higano, MD, from the University of British Columbia, Vancouver, compared and contrasted the two trials and the differing results.

During the question-and-answer session that followed, Neeraj Agarwal, MD, from the Huntsman Cancer Institute, University of Utah, directed a question to Fred Saad, MD, who had presented the results of the PROpel trial.*

“As a practicing oncologist, I am very intrigued by the different results of the MAGNITUDE and PROpel trials. I am trying to figure out what do I do in my practice,” Dr. Agarwal began.

He continued on, explaining that he didn’t think that olaparib and niraparib were that different from one another for the two studies to have such differing results, when both of the drugs were given in combination with abiraterone.

The inclusion criteria for PROpel stipulated that patients undergo testing by ctDNA to determine if they were biomarker positive or not, but he pointed out that it is possible for testing to miss patients who might otherwise be positive for homologous recombination repair (HRR) gene alterations. He posed the question, could some of the patients deemed biomarker negative in fact have been positive but whose status was not detected by ctDNA testing?

At that point, Dr. Higano interrupted him before he had completed his question and asked, “Can I make a comment? Were you listening to my discussion?”

She then continued, pointing out that “you can’t talk about comparing olaparib and niraparib – these two trials had two very different populations.”

She emphasized that this was about the combinations in the populations being studied and not about olaparib and niraparib. “I clearly wasn’t very clear,” she said.

Dr. Agarwal then repeated that he wanted to know what to do with his patients and asked again about the accuracy of ctDNA testing.

“That’s a good question,” Dr. Higano said, “But the other comments you made weren’t.”

At that point, the moderator chimed in. “Let’s all calm down ... children.”

After a brief applause following the moderator’s comment, Dr. Saad then addressed the question.

When the video clip of this exchange was posted, a flood of tweets poured in, supporting Dr. Pal’s initial summation of the situation.

Alison Birtle, MD, tweeted, “I’m even more appalled having seen this exchange. Unacceptable. You don’t humiliate either the speaker or the delegate and the questions were entirely valid in my opinion. Basically what do I do tomorrow with these data so why ask were you listening. That’s just rude.”

Jason Kovac, MD, tweeted: “It’s absolutely not a proper way to behave. Whether it’s behind the scenes or to your face. You can hear the arrogance from everyone including the moderator with his children comment. This is the true face of medicine.”

Jarey Wang, MD, PhD, however, liked the moderator’s input. “Love it. ‘Let’s all calm down children.’ Good for the moderator.”

Several of the physicians who commented thought that the issue should have been addressed at the time it happened. Don S. Dizon, MD, wrote, “Calling out microagressions as they occur is so important. And very difficult. Agree, the teachable moment must be met with bravery. But it should happen in real time too.”

After 2 days of bantering on Twitter, with the thread growing increasingly longer and with the vast majority of posts supporting Dr. Pal’s initial assessment, Dr. Higano finally entered the discussion and defended her comments: “What you do not know is that the questioner and I are good colleagues,” she tweeted. “I have been involved in two of his academic promotions. My main concern was his comment re: how the two trials could have ‘so different results with the same combination.’ I sought to rectify wrong message.”

There were no direct replies to Dr. Higano’s tweet.

Perhaps the line to draw under this affair is the tweet from Simon Kim, MD, MPH, who wrote: “We can do better!”

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

Correction, 2/24/22: Dr. Fred Saad's name was misstated in an earlier version of this article.

Twitter was all abuzz over an exchange that occurred Feb. 17 during the question-and-answer discussion that followed oral abstract presentations at the ASCO Genitourinary Cancers Symposium, held in San Francisco and also online. One of the panelists was accused of being less than professional in handling questions from the floor.

It began with a tweet from Sumanta Pal, MD, of the City of Hope, when he called out the behavior, although he did not identify the perpetrator.

“Yesterday we saw some reprehensible behavior emanating from the @ASCO #GU22 podium, with a well known investigator insulting (in a manner deeply imbued w microaggressions) an esteemed colleague at the mic. It’s a teachable moment & the lesson is simple: be kind to ur colleagues.”

It was not immediately clear what had occurred, and several people asked him to identify the people involved. One physician responded, “If it was bad enough to infer and share on Twitter, name the name.”

But even without details, the post provoked a reaction.

Erika Hamilton, MD, wrote, “I am not aware of this incident, but I always wonder ... if someone would do that from the podium, what would they/have they done and said when they didn’t think everyone was watching?”

Another tweet questioned why there were no codes of conduct in place, so that situations like this one wouldn’t happen.

“[It is] about time professional societies had codes of conduct in place for invited speakers, moderators of sessions etc,” wrote Deborah Verran, MD. “Then if it is breached the individual concerned is not invited back. This kind of incident also needs to be mentioned as part of the conference feedback process.”

As the number of clinicians chiming in increased, it soon became apparent that others were aware of the incident, and one posted a video clip, putting the mystery to rest.
 

Moderator quips, ‘Behave ... children’

The exchange occurred immediately following the oral abstract presentations on prostate cancer on Feb. 17. Two of these abstracts featured new data from large clinical trials investigating the use of PARP inhibitors in metastatic prostate cancer, which had slightly different results, leading to some debate. The PROpel trial with olaparib showed a benefit in all patients, irrespective of gene mutation status, but the MAGNITUDE trial with niraparib showed a benefit only in patients with gene alterations, and especially in those with BRCA1/2 mutations.

The invited discussant, Celestia Higano, MD, from the University of British Columbia, Vancouver, compared and contrasted the two trials and the differing results.

During the question-and-answer session that followed, Neeraj Agarwal, MD, from the Huntsman Cancer Institute, University of Utah, directed a question to Fred Saad, MD, who had presented the results of the PROpel trial.*

“As a practicing oncologist, I am very intrigued by the different results of the MAGNITUDE and PROpel trials. I am trying to figure out what do I do in my practice,” Dr. Agarwal began.

He continued on, explaining that he didn’t think that olaparib and niraparib were that different from one another for the two studies to have such differing results, when both of the drugs were given in combination with abiraterone.

The inclusion criteria for PROpel stipulated that patients undergo testing by ctDNA to determine if they were biomarker positive or not, but he pointed out that it is possible for testing to miss patients who might otherwise be positive for homologous recombination repair (HRR) gene alterations. He posed the question, could some of the patients deemed biomarker negative in fact have been positive but whose status was not detected by ctDNA testing?

At that point, Dr. Higano interrupted him before he had completed his question and asked, “Can I make a comment? Were you listening to my discussion?”

She then continued, pointing out that “you can’t talk about comparing olaparib and niraparib – these two trials had two very different populations.”

She emphasized that this was about the combinations in the populations being studied and not about olaparib and niraparib. “I clearly wasn’t very clear,” she said.

Dr. Agarwal then repeated that he wanted to know what to do with his patients and asked again about the accuracy of ctDNA testing.

“That’s a good question,” Dr. Higano said, “But the other comments you made weren’t.”

At that point, the moderator chimed in. “Let’s all calm down ... children.”

After a brief applause following the moderator’s comment, Dr. Saad then addressed the question.

When the video clip of this exchange was posted, a flood of tweets poured in, supporting Dr. Pal’s initial summation of the situation.

Alison Birtle, MD, tweeted, “I’m even more appalled having seen this exchange. Unacceptable. You don’t humiliate either the speaker or the delegate and the questions were entirely valid in my opinion. Basically what do I do tomorrow with these data so why ask were you listening. That’s just rude.”

Jason Kovac, MD, tweeted: “It’s absolutely not a proper way to behave. Whether it’s behind the scenes or to your face. You can hear the arrogance from everyone including the moderator with his children comment. This is the true face of medicine.”

Jarey Wang, MD, PhD, however, liked the moderator’s input. “Love it. ‘Let’s all calm down children.’ Good for the moderator.”

Several of the physicians who commented thought that the issue should have been addressed at the time it happened. Don S. Dizon, MD, wrote, “Calling out microagressions as they occur is so important. And very difficult. Agree, the teachable moment must be met with bravery. But it should happen in real time too.”

After 2 days of bantering on Twitter, with the thread growing increasingly longer and with the vast majority of posts supporting Dr. Pal’s initial assessment, Dr. Higano finally entered the discussion and defended her comments: “What you do not know is that the questioner and I are good colleagues,” she tweeted. “I have been involved in two of his academic promotions. My main concern was his comment re: how the two trials could have ‘so different results with the same combination.’ I sought to rectify wrong message.”

There were no direct replies to Dr. Higano’s tweet.

Perhaps the line to draw under this affair is the tweet from Simon Kim, MD, MPH, who wrote: “We can do better!”

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

Correction, 2/24/22: Dr. Fred Saad's name was misstated in an earlier version of this article.

The names of health care professionals and patients cited within the dialogue text have been changed to protect their privacy.

Early in my career, before I had any notion that years later I would be doing palliative care consults in a cancer center, I heard a senior physician refer to palliative care as “the most misunderstood” medical specialty. I wasn’t sure what she meant at that time, but over the years I have come to realize that she was right – most people, including many within health care, don’t have a good appreciation of what palliative care is or how it can help patients and health care teams.

A recent national survey about cancer-related health information found that of more than 1,000 surveyed Americans, less than 30% professed any knowledge of palliative care. Of those who had some knowledge of palliative care, around 30% believed palliative care was synonymous with hospice.¹ Another 15% believed that a patient would have to give up cancer-directed treatments to receive palliative care.¹

It’s not giving up

This persistent belief that palliative care is equivalent to hospice, or is tantamount to “giving up,” is one of the most commonly held myths I encounter in everyday practice.

I knock on the exam door and walk in.
A small, trim woman in her late 50s is sitting in a chair, arms folded across her chest, face drawn in.

“Hi,” I start. “I’m Sarah, the palliative care nurse practitioner who works in this clinic. I work closely with Dr. Smith.”
Dr. Smith is the patient’s oncologist.

“I really didn’t want to meet you,” she says in a quiet voice, her eyes large with concern.

I don’t take it personally. Few patients really want to be in the position of needing to meet the palliative care team.

“I looked up palliative care on Google and saw the word hospice.”

“Yeah,” I say. “I hear that a lot. Well, I can reassure you that this isn’t hospice.
In this clinic, our focus is on your cancer symptoms, your treatment side effects, and your quality of life.”

She looks visibly relieved. “Quality of life,” she echoes. “I need more of that.”
“OK,” I say. “So, tell me what you’re struggling with the most right now.”

That’s how many palliative care visits start. I actually prefer if patients haven’t heard of palliative care because it allows me to frame it for them, rather than having to start by addressing a myth or a prior negative experience. Even when patients haven’t had a negative experience with palliative care per se, typically, if they’ve interacted with palliative care in the past, it’s usually because someone they loved died in a hospital setting and it is the memory of that terrible loss that becomes synonymous with their recollection of palliative care.

Many patients I meet have never seen another outpatient palliative care practitioner – and this makes sense – we are still too few and far between. Most established palliative care teams are hospital based and many patients seen in the community do not have easy access to palliative care teams where they receive oncologic care.² As an embedded practitioner, I see patients in the same exam rooms and infusion centers where they receive their cancer therapies, so I’m effectively woven into the fabric of their oncology experience. Just being there in the cancer center allows me to be in the right place at the right time for the right patients and their care teams.
 

More than pain management

Another myth I tend to dispel a lot is that palliative care is just a euphemism for “pain management.” I have seen this less lately, but still occasionally in the chart I’ll see documented in a note, “patient is seeing palliative/pain management,” when a patient is seeing me or one of my colleagues. Unfortunately, when providers have limited or outdated views of what palliative care is or the value it brings to patient-centered cancer care, referrals to palliative care tend to be delayed.³

“I really think Ms. Lopez could benefit from seeing palliative care,” an oncology nurse practitioner says to an oncologist.
I’m standing nearby, about to see another patient in one of the exam rooms in our clinic.
“But I don’t think she’s ready. And besides, she doesn’t have any pain,” he says.
He turns to me quizzically. “What do you think?”

“Tell me about the patient,” I ask, taking a few steps in their direction.

“Well, she’s a 64-year-old woman with metastatic cancer.
She has a really poor appetite and is losing some weight.
Seems a bit down, kind of pessimistic about things.
Her scan showed some new growth, so guess I’m not surprised by that.”

“I might be able to help her with the appetite and the mood changes. 
I can at least talk with her and see where she’s at,” I offer.

“Alright,” he says. “We’ll put the palliative referral in.”
He hesitates. “But are you sure you want to see her? 
She doesn’t have any pain.” He sounds skeptical.

“Yeah, I mean, it sounds like she has symptoms that are bothering her, so I’d be happy to see her. She sounds completely appropriate for palliative care.”

I hear this assumption a lot – that palliative care is somehow equivalent to pain management and that unless a patient’s pain is severe, it’s not worth referring the patient to palliative care. Don’t get me wrong – we do a lot of pain management, but at its heart, palliative care is an interdisciplinary specialty focused on improving or maintaining quality of life for people with serious illness. Because the goal is so broad, care can take many shapes.⁴

In addition to pain, palliative care clinicians commonly treat nausea, shortness of breath, constipation or diarrhea, poor appetite, fatigue, anxiety, depression, and insomnia.
 

Palliative care is more than medical or nursing care

A related misconception about palliative care held by many lay people and health care workers alike is that palliative care is primarily medical or nursing care focused mostly on alleviating physical symptoms such as pain or nausea. This couldn’t be further from the truth.

We’ve been talking for a while.
Ms. Lopez tells me about her struggles to maintain her weight while undergoing chemotherapy. She has low-grade nausea that is impacting her ability and desire to eat more and didn’t think that her weight loss was severe enough to warrant taking medication.
We talk about how she may be able to use antinausea medication sparingly to alleviate nausea while also limiting side effects from the medications—which was a big concern for her.

I ask her what else is bothering her.

She tells me that she has always been a strong Catholic and even when life has gotten tough, her faith was never shaken – until now.
She is struggling to understand why she ended up with metastatic cancer at such a relatively young age—why would God do this to her?
She had plans for retirement that have since evaporated in the face of a foreshortened life.
Why did this happen to her of all people? She was completely healthy until her diagnosis.
Her face is wet with tears.

We talk a little about how a diagnosis like this can change so much of a person’s life and identity. I try to validate her experience. She’s clearly suffering from a sense that her life is not what she expected, and she is struggling to integrate how her future looks at this point.

I ask her what conversations with her priest have been like.

At this point you may be wondering where this conversation is going. Why are we talking about Ms. Lopez’s religion? Palliative care is best delivered through high functioning interdisciplinary teams that can include other supportive people in a patient’s life. We work in concert to try to bring comfort to a patient and their family.⁴ That support network can include nurses, physicians, social workers, and chaplains. In this case, Ms. Lopez had not yet reached out to her priest. She hasn’t had the time or energy to contact her priest given her symptoms.
 

“Can I contact your priest for you?
Maybe he can visit or call and chat with you?”
She nods and wipes tears away.
“That would be really nice,” she says. “I’d love it if he could pray with me.”

A few hours after the visit, I call Ms. Lopez’s priest.
I ask him to reach out to her and about her request for prayer.
He says he’s been thinking about her and that her presence has been missed at weekly Mass. He thanks me for the call and says he’ll call her tomorrow.

I say my own small prayer for Ms. Lopez and head home, the day’s work completed.

Sarah D'Ambruoso was born and raised in Maine. She completed her undergraduate and graduate nursing education at New York University and UCLA, respectively, and currently works as a palliative care nurse practitioner in an oncology clinic in Los Angeles. 

References

1. Cheng BT et al. Patterns of palliative care beliefs among adults in the U.S.: Analysis of a National Cancer Database. J Pain Symptom Manage. 2019 Aug 10. doi: 10.1016/j.jpainsymman.2019.07.030.

2. Finlay E et al. Filling the gap: Creating an outpatient palliative care program in your institution. Am Soc Clin Oncol Educ Book. 2018 May 23. doi: 10.1200/EDBK_200775.

3. Von Roenn JH et al. Barriers and approaches to the successful integration of palliative care and oncology practice. J Natl Compr Canc Netw. 2013 Mar. doi: 10.6004/jnccn.2013.0209.

4. Ferrell BR et al. Integration of palliative care into standard oncology care: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2016 Oct 31. doi: 10.1200/JCO.2016.70.1474.

The names of health care professionals and patients cited within the dialogue text have been changed to protect their privacy.

Early in my career, before I had any notion that years later I would be doing palliative care consults in a cancer center, I heard a senior physician refer to palliative care as “the most misunderstood” medical specialty. I wasn’t sure what she meant at that time, but over the years I have come to realize that she was right – most people, including many within health care, don’t have a good appreciation of what palliative care is or how it can help patients and health care teams.

A recent national survey about cancer-related health information found that of more than 1,000 surveyed Americans, less than 30% professed any knowledge of palliative care. Of those who had some knowledge of palliative care, around 30% believed palliative care was synonymous with hospice.¹ Another 15% believed that a patient would have to give up cancer-directed treatments to receive palliative care.¹

It’s not giving up

This persistent belief that palliative care is equivalent to hospice, or is tantamount to “giving up,” is one of the most commonly held myths I encounter in everyday practice.

I knock on the exam door and walk in.
A small, trim woman in her late 50s is sitting in a chair, arms folded across her chest, face drawn in.

“Hi,” I start. “I’m Sarah, the palliative care nurse practitioner who works in this clinic. I work closely with Dr. Smith.”
Dr. Smith is the patient’s oncologist.

“I really didn’t want to meet you,” she says in a quiet voice, her eyes large with concern.

I don’t take it personally. Few patients really want to be in the position of needing to meet the palliative care team.

“I looked up palliative care on Google and saw the word hospice.”

“Yeah,” I say. “I hear that a lot. Well, I can reassure you that this isn’t hospice.
In this clinic, our focus is on your cancer symptoms, your treatment side effects, and your quality of life.”

She looks visibly relieved. “Quality of life,” she echoes. “I need more of that.”
“OK,” I say. “So, tell me what you’re struggling with the most right now.”

That’s how many palliative care visits start. I actually prefer if patients haven’t heard of palliative care because it allows me to frame it for them, rather than having to start by addressing a myth or a prior negative experience. Even when patients haven’t had a negative experience with palliative care per se, typically, if they’ve interacted with palliative care in the past, it’s usually because someone they loved died in a hospital setting and it is the memory of that terrible loss that becomes synonymous with their recollection of palliative care.

Many patients I meet have never seen another outpatient palliative care practitioner – and this makes sense – we are still too few and far between. Most established palliative care teams are hospital based and many patients seen in the community do not have easy access to palliative care teams where they receive oncologic care.² As an embedded practitioner, I see patients in the same exam rooms and infusion centers where they receive their cancer therapies, so I’m effectively woven into the fabric of their oncology experience. Just being there in the cancer center allows me to be in the right place at the right time for the right patients and their care teams.
 

More than pain management

Another myth I tend to dispel a lot is that palliative care is just a euphemism for “pain management.” I have seen this less lately, but still occasionally in the chart I’ll see documented in a note, “patient is seeing palliative/pain management,” when a patient is seeing me or one of my colleagues. Unfortunately, when providers have limited or outdated views of what palliative care is or the value it brings to patient-centered cancer care, referrals to palliative care tend to be delayed.³

“I really think Ms. Lopez could benefit from seeing palliative care,” an oncology nurse practitioner says to an oncologist.
I’m standing nearby, about to see another patient in one of the exam rooms in our clinic.
“But I don’t think she’s ready. And besides, she doesn’t have any pain,” he says.
He turns to me quizzically. “What do you think?”

“Tell me about the patient,” I ask, taking a few steps in their direction.

“Well, she’s a 64-year-old woman with metastatic cancer.
She has a really poor appetite and is losing some weight.
Seems a bit down, kind of pessimistic about things.
Her scan showed some new growth, so guess I’m not surprised by that.”

“I might be able to help her with the appetite and the mood changes. 
I can at least talk with her and see where she’s at,” I offer.

“Alright,” he says. “We’ll put the palliative referral in.”
He hesitates. “But are you sure you want to see her? 
She doesn’t have any pain.” He sounds skeptical.

“Yeah, I mean, it sounds like she has symptoms that are bothering her, so I’d be happy to see her. She sounds completely appropriate for palliative care.”

I hear this assumption a lot – that palliative care is somehow equivalent to pain management and that unless a patient’s pain is severe, it’s not worth referring the patient to palliative care. Don’t get me wrong – we do a lot of pain management, but at its heart, palliative care is an interdisciplinary specialty focused on improving or maintaining quality of life for people with serious illness. Because the goal is so broad, care can take many shapes.⁴

In addition to pain, palliative care clinicians commonly treat nausea, shortness of breath, constipation or diarrhea, poor appetite, fatigue, anxiety, depression, and insomnia.
 

Palliative care is more than medical or nursing care

A related misconception about palliative care held by many lay people and health care workers alike is that palliative care is primarily medical or nursing care focused mostly on alleviating physical symptoms such as pain or nausea. This couldn’t be further from the truth.

We’ve been talking for a while.
Ms. Lopez tells me about her struggles to maintain her weight while undergoing chemotherapy. She has low-grade nausea that is impacting her ability and desire to eat more and didn’t think that her weight loss was severe enough to warrant taking medication.
We talk about how she may be able to use antinausea medication sparingly to alleviate nausea while also limiting side effects from the medications—which was a big concern for her.

I ask her what else is bothering her.

She tells me that she has always been a strong Catholic and even when life has gotten tough, her faith was never shaken – until now.
She is struggling to understand why she ended up with metastatic cancer at such a relatively young age—why would God do this to her?
She had plans for retirement that have since evaporated in the face of a foreshortened life.
Why did this happen to her of all people? She was completely healthy until her diagnosis.
Her face is wet with tears.

We talk a little about how a diagnosis like this can change so much of a person’s life and identity. I try to validate her experience. She’s clearly suffering from a sense that her life is not what she expected, and she is struggling to integrate how her future looks at this point.

I ask her what conversations with her priest have been like.

At this point you may be wondering where this conversation is going. Why are we talking about Ms. Lopez’s religion? Palliative care is best delivered through high functioning interdisciplinary teams that can include other supportive people in a patient’s life. We work in concert to try to bring comfort to a patient and their family.⁴ That support network can include nurses, physicians, social workers, and chaplains. In this case, Ms. Lopez had not yet reached out to her priest. She hasn’t had the time or energy to contact her priest given her symptoms.
 

“Can I contact your priest for you?
Maybe he can visit or call and chat with you?”
She nods and wipes tears away.
“That would be really nice,” she says. “I’d love it if he could pray with me.”

A few hours after the visit, I call Ms. Lopez’s priest.
I ask him to reach out to her and about her request for prayer.
He says he’s been thinking about her and that her presence has been missed at weekly Mass. He thanks me for the call and says he’ll call her tomorrow.

I say my own small prayer for Ms. Lopez and head home, the day’s work completed.

Sarah D'Ambruoso was born and raised in Maine. She completed her undergraduate and graduate nursing education at New York University and UCLA, respectively, and currently works as a palliative care nurse practitioner in an oncology clinic in Los Angeles. 

References

1. Cheng BT et al. Patterns of palliative care beliefs among adults in the U.S.: Analysis of a National Cancer Database. J Pain Symptom Manage. 2019 Aug 10. doi: 10.1016/j.jpainsymman.2019.07.030.

2. Finlay E et al. Filling the gap: Creating an outpatient palliative care program in your institution. Am Soc Clin Oncol Educ Book. 2018 May 23. doi: 10.1200/EDBK_200775.

3. Von Roenn JH et al. Barriers and approaches to the successful integration of palliative care and oncology practice. J Natl Compr Canc Netw. 2013 Mar. doi: 10.6004/jnccn.2013.0209.

4. Ferrell BR et al. Integration of palliative care into standard oncology care: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2016 Oct 31. doi: 10.1200/JCO.2016.70.1474.

The names of health care professionals and patients cited within the dialogue text have been changed to protect their privacy.

Early in my career, before I had any notion that years later I would be doing palliative care consults in a cancer center, I heard a senior physician refer to palliative care as “the most misunderstood” medical specialty. I wasn’t sure what she meant at that time, but over the years I have come to realize that she was right – most people, including many within health care, don’t have a good appreciation of what palliative care is or how it can help patients and health care teams.

A recent national survey about cancer-related health information found that of more than 1,000 surveyed Americans, less than 30% professed any knowledge of palliative care. Of those who had some knowledge of palliative care, around 30% believed palliative care was synonymous with hospice.¹ Another 15% believed that a patient would have to give up cancer-directed treatments to receive palliative care.¹

It’s not giving up

This persistent belief that palliative care is equivalent to hospice, or is tantamount to “giving up,” is one of the most commonly held myths I encounter in everyday practice.

I knock on the exam door and walk in.
A small, trim woman in her late 50s is sitting in a chair, arms folded across her chest, face drawn in.

“Hi,” I start. “I’m Sarah, the palliative care nurse practitioner who works in this clinic. I work closely with Dr. Smith.”
Dr. Smith is the patient’s oncologist.

“I really didn’t want to meet you,” she says in a quiet voice, her eyes large with concern.

I don’t take it personally. Few patients really want to be in the position of needing to meet the palliative care team.

“I looked up palliative care on Google and saw the word hospice.”

“Yeah,” I say. “I hear that a lot. Well, I can reassure you that this isn’t hospice.
In this clinic, our focus is on your cancer symptoms, your treatment side effects, and your quality of life.”

She looks visibly relieved. “Quality of life,” she echoes. “I need more of that.”
“OK,” I say. “So, tell me what you’re struggling with the most right now.”

That’s how many palliative care visits start. I actually prefer if patients haven’t heard of palliative care because it allows me to frame it for them, rather than having to start by addressing a myth or a prior negative experience. Even when patients haven’t had a negative experience with palliative care per se, typically, if they’ve interacted with palliative care in the past, it’s usually because someone they loved died in a hospital setting and it is the memory of that terrible loss that becomes synonymous with their recollection of palliative care.

Many patients I meet have never seen another outpatient palliative care practitioner – and this makes sense – we are still too few and far between. Most established palliative care teams are hospital based and many patients seen in the community do not have easy access to palliative care teams where they receive oncologic care.² As an embedded practitioner, I see patients in the same exam rooms and infusion centers where they receive their cancer therapies, so I’m effectively woven into the fabric of their oncology experience. Just being there in the cancer center allows me to be in the right place at the right time for the right patients and their care teams.
 

More than pain management

Another myth I tend to dispel a lot is that palliative care is just a euphemism for “pain management.” I have seen this less lately, but still occasionally in the chart I’ll see documented in a note, “patient is seeing palliative/pain management,” when a patient is seeing me or one of my colleagues. Unfortunately, when providers have limited or outdated views of what palliative care is or the value it brings to patient-centered cancer care, referrals to palliative care tend to be delayed.³

“I really think Ms. Lopez could benefit from seeing palliative care,” an oncology nurse practitioner says to an oncologist.
I’m standing nearby, about to see another patient in one of the exam rooms in our clinic.
“But I don’t think she’s ready. And besides, she doesn’t have any pain,” he says.
He turns to me quizzically. “What do you think?”

“Tell me about the patient,” I ask, taking a few steps in their direction.

“Well, she’s a 64-year-old woman with metastatic cancer.
She has a really poor appetite and is losing some weight.
Seems a bit down, kind of pessimistic about things.
Her scan showed some new growth, so guess I’m not surprised by that.”

“I might be able to help her with the appetite and the mood changes. 
I can at least talk with her and see where she’s at,” I offer.

“Alright,” he says. “We’ll put the palliative referral in.”
He hesitates. “But are you sure you want to see her? 
She doesn’t have any pain.” He sounds skeptical.

“Yeah, I mean, it sounds like she has symptoms that are bothering her, so I’d be happy to see her. She sounds completely appropriate for palliative care.”

I hear this assumption a lot – that palliative care is somehow equivalent to pain management and that unless a patient’s pain is severe, it’s not worth referring the patient to palliative care. Don’t get me wrong – we do a lot of pain management, but at its heart, palliative care is an interdisciplinary specialty focused on improving or maintaining quality of life for people with serious illness. Because the goal is so broad, care can take many shapes.⁴

In addition to pain, palliative care clinicians commonly treat nausea, shortness of breath, constipation or diarrhea, poor appetite, fatigue, anxiety, depression, and insomnia.
 

Palliative care is more than medical or nursing care

A related misconception about palliative care held by many lay people and health care workers alike is that palliative care is primarily medical or nursing care focused mostly on alleviating physical symptoms such as pain or nausea. This couldn’t be further from the truth.

We’ve been talking for a while.
Ms. Lopez tells me about her struggles to maintain her weight while undergoing chemotherapy. She has low-grade nausea that is impacting her ability and desire to eat more and didn’t think that her weight loss was severe enough to warrant taking medication.
We talk about how she may be able to use antinausea medication sparingly to alleviate nausea while also limiting side effects from the medications—which was a big concern for her.

I ask her what else is bothering her.

She tells me that she has always been a strong Catholic and even when life has gotten tough, her faith was never shaken – until now.
She is struggling to understand why she ended up with metastatic cancer at such a relatively young age—why would God do this to her?
She had plans for retirement that have since evaporated in the face of a foreshortened life.
Why did this happen to her of all people? She was completely healthy until her diagnosis.
Her face is wet with tears.

We talk a little about how a diagnosis like this can change so much of a person’s life and identity. I try to validate her experience. She’s clearly suffering from a sense that her life is not what she expected, and she is struggling to integrate how her future looks at this point.

I ask her what conversations with her priest have been like.

At this point you may be wondering where this conversation is going. Why are we talking about Ms. Lopez’s religion? Palliative care is best delivered through high functioning interdisciplinary teams that can include other supportive people in a patient’s life. We work in concert to try to bring comfort to a patient and their family.⁴ That support network can include nurses, physicians, social workers, and chaplains. In this case, Ms. Lopez had not yet reached out to her priest. She hasn’t had the time or energy to contact her priest given her symptoms.
 

“Can I contact your priest for you?
Maybe he can visit or call and chat with you?”
She nods and wipes tears away.
“That would be really nice,” she says. “I’d love it if he could pray with me.”

A few hours after the visit, I call Ms. Lopez’s priest.
I ask him to reach out to her and about her request for prayer.
He says he’s been thinking about her and that her presence has been missed at weekly Mass. He thanks me for the call and says he’ll call her tomorrow.

I say my own small prayer for Ms. Lopez and head home, the day’s work completed.

Sarah D'Ambruoso was born and raised in Maine. She completed her undergraduate and graduate nursing education at New York University and UCLA, respectively, and currently works as a palliative care nurse practitioner in an oncology clinic in Los Angeles. 

References

1. Cheng BT et al. Patterns of palliative care beliefs among adults in the U.S.: Analysis of a National Cancer Database. J Pain Symptom Manage. 2019 Aug 10. doi: 10.1016/j.jpainsymman.2019.07.030.

2. Finlay E et al. Filling the gap: Creating an outpatient palliative care program in your institution. Am Soc Clin Oncol Educ Book. 2018 May 23. doi: 10.1200/EDBK_200775.

3. Von Roenn JH et al. Barriers and approaches to the successful integration of palliative care and oncology practice. J Natl Compr Canc Netw. 2013 Mar. doi: 10.6004/jnccn.2013.0209.

4. Ferrell BR et al. Integration of palliative care into standard oncology care: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2016 Oct 31. doi: 10.1200/JCO.2016.70.1474.

Artificial intelligence (AI) performs as well as expert uropathologists – and in some cases better than general pathologists – in diagnosing and grading prostate cancer, suggests a new study.

AI has shown promise in the diagnosis and grading of prostate cancer. However studies so far have been siloed, “with limited proof for generalization across diverse multinational cohorts, representing one of the central barriers to implementation of AI algorithms in clinical practice,” the investigators wrote in Nature Medicine.

Wouter Bulten, from the Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands, and coauthors reported the outcomes of the international PANDA histopathology competition, in which 1,290 deep learning algorithm developers were challenged to come up with reproducible algorithms that could match the findings of human experts. Deep learning is a form of machine learning in which artificial neural networks “learn” from large datasets and apply that learning in a similar way to the human brain. At least one AI product for detecting prostate cancer – the Paige Prostate system – has already been approved for clinical use in the United States. The Food and Drug Administration authorized marketing it in September 2021, as an adjunct to – but not replacement for – pathologist review.

The developers of the new algorithms participating in the competition were given a set of 10,616 digitized prostate biopsies to learn from, then were tested against a panel of either one to six – depending on the country – experienced uropathologists on a set of 393 digitized slides. A selection of 15 teams were then invited to take part in a validation phase with an additional 1,616 slides.

Within the first 10 days of the competition, one algorithm already achieved greater than 0.90 agreement with the uropathologists; by day 33, the median performance of all the teams in the competition was greater than 0.85 agreement with the human experts.
 

Algorithms correctly detected tumors in 99.7% of cases

The algorithms selected for validation showed even higher levels of agreement – 0.931 on average (95% confidence interval, 0.918-0.944). These algorithms correctly detected tumors in 99.7% of cases (95% CI, 98.1%-99.7%), and correctly identified 92.9% of negative results (95% CI, 91.9%-96.7%).

When it came to classifying the prostate cancers based on Gleason grade, the algorithms showed significantly more agreement with uropathologists than did an international panel of 13 or 20 general pathologists.

“This higher sensitivity shows promise for reducing pathologist workload by automated identification and exclusion of most benign biopsies from review,” the authors wrote.

The study found that the AI algorithms missed 1%-1.9% of cancers, but the general pathologists missed 1.8%-7.3%. The algorithms demonstrated a sensitivity of 96.4%-98.2% and specificity of 75%-100% for tumors, whereas the pathologists showed a sensitivity of 91.9-96.5% and specificity of 92.3%-95%.
 

Benign cases were misclassified

The main error that the algorithms made was misclassifying benign cases as ISUP GG 1 cancer. The authors commented that this was likely caused by a shift in the distribution of cases between the training data given to the algorithms and the data set they were validated on.

They also noted that, in one validation set, the algorithms overgraded a “substantial proportion” of ISUP GG 3 cases as GG 4, whereas general pathologists tended to undergrade cases, particularly in the higher-grade cancers.

“These differences suggest that general pathologists supported by AI could reach higher agreements with uropathologists, potentially alleviating some of the rater variability associated with Gleason grading,” they wrote.

The authors also pointed out that the algorithms were validated on individual biopsies from each patient, whereas in the clinical context, a pathologist would likely have multiple biopsies from a single patient.

“Future studies can focus on patient-level evaluation of tissue samples, taking multiple cores and sections into account for the final diagnosis,” they wrote.

The study was supported by the Dutch Cancer Society, Netherlands Organization for Scientific Research, Google, Verily Life Sciences, Swedish Research Council, Swedish Cancer Society, Swedish eScience Research Center, EIT Health, Karolinska Institutet, Åke Wiberg Foundation, Prostatacancerförbundet, Academy of Finland, Cancer Foundation Finland, and ERAPerMed. The authors declared a range of grants and funding outside the study, including from Philips Digital Pathology Solutions. Several authors declared patents related to prostate cancer diagnoses, and 10 were employees of Google.

Artificial intelligence (AI) performs as well as expert uropathologists – and in some cases better than general pathologists – in diagnosing and grading prostate cancer, suggests a new study.

AI has shown promise in the diagnosis and grading of prostate cancer. However studies so far have been siloed, “with limited proof for generalization across diverse multinational cohorts, representing one of the central barriers to implementation of AI algorithms in clinical practice,” the investigators wrote in Nature Medicine.

Wouter Bulten, from the Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands, and coauthors reported the outcomes of the international PANDA histopathology competition, in which 1,290 deep learning algorithm developers were challenged to come up with reproducible algorithms that could match the findings of human experts. Deep learning is a form of machine learning in which artificial neural networks “learn” from large datasets and apply that learning in a similar way to the human brain. At least one AI product for detecting prostate cancer – the Paige Prostate system – has already been approved for clinical use in the United States. The Food and Drug Administration authorized marketing it in September 2021, as an adjunct to – but not replacement for – pathologist review.

The developers of the new algorithms participating in the competition were given a set of 10,616 digitized prostate biopsies to learn from, then were tested against a panel of either one to six – depending on the country – experienced uropathologists on a set of 393 digitized slides. A selection of 15 teams were then invited to take part in a validation phase with an additional 1,616 slides.

Within the first 10 days of the competition, one algorithm already achieved greater than 0.90 agreement with the uropathologists; by day 33, the median performance of all the teams in the competition was greater than 0.85 agreement with the human experts.
 

Algorithms correctly detected tumors in 99.7% of cases

The algorithms selected for validation showed even higher levels of agreement – 0.931 on average (95% confidence interval, 0.918-0.944). These algorithms correctly detected tumors in 99.7% of cases (95% CI, 98.1%-99.7%), and correctly identified 92.9% of negative results (95% CI, 91.9%-96.7%).

When it came to classifying the prostate cancers based on Gleason grade, the algorithms showed significantly more agreement with uropathologists than did an international panel of 13 or 20 general pathologists.

“This higher sensitivity shows promise for reducing pathologist workload by automated identification and exclusion of most benign biopsies from review,” the authors wrote.

The study found that the AI algorithms missed 1%-1.9% of cancers, but the general pathologists missed 1.8%-7.3%. The algorithms demonstrated a sensitivity of 96.4%-98.2% and specificity of 75%-100% for tumors, whereas the pathologists showed a sensitivity of 91.9-96.5% and specificity of 92.3%-95%.
 

Benign cases were misclassified

The main error that the algorithms made was misclassifying benign cases as ISUP GG 1 cancer. The authors commented that this was likely caused by a shift in the distribution of cases between the training data given to the algorithms and the data set they were validated on.

They also noted that, in one validation set, the algorithms overgraded a “substantial proportion” of ISUP GG 3 cases as GG 4, whereas general pathologists tended to undergrade cases, particularly in the higher-grade cancers.

“These differences suggest that general pathologists supported by AI could reach higher agreements with uropathologists, potentially alleviating some of the rater variability associated with Gleason grading,” they wrote.

The authors also pointed out that the algorithms were validated on individual biopsies from each patient, whereas in the clinical context, a pathologist would likely have multiple biopsies from a single patient.

“Future studies can focus on patient-level evaluation of tissue samples, taking multiple cores and sections into account for the final diagnosis,” they wrote.

The study was supported by the Dutch Cancer Society, Netherlands Organization for Scientific Research, Google, Verily Life Sciences, Swedish Research Council, Swedish Cancer Society, Swedish eScience Research Center, EIT Health, Karolinska Institutet, Åke Wiberg Foundation, Prostatacancerförbundet, Academy of Finland, Cancer Foundation Finland, and ERAPerMed. The authors declared a range of grants and funding outside the study, including from Philips Digital Pathology Solutions. Several authors declared patents related to prostate cancer diagnoses, and 10 were employees of Google.

Artificial intelligence (AI) performs as well as expert uropathologists – and in some cases better than general pathologists – in diagnosing and grading prostate cancer, suggests a new study.

AI has shown promise in the diagnosis and grading of prostate cancer. However studies so far have been siloed, “with limited proof for generalization across diverse multinational cohorts, representing one of the central barriers to implementation of AI algorithms in clinical practice,” the investigators wrote in Nature Medicine.

Wouter Bulten, from the Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands, and coauthors reported the outcomes of the international PANDA histopathology competition, in which 1,290 deep learning algorithm developers were challenged to come up with reproducible algorithms that could match the findings of human experts. Deep learning is a form of machine learning in which artificial neural networks “learn” from large datasets and apply that learning in a similar way to the human brain. At least one AI product for detecting prostate cancer – the Paige Prostate system – has already been approved for clinical use in the United States. The Food and Drug Administration authorized marketing it in September 2021, as an adjunct to – but not replacement for – pathologist review.

The developers of the new algorithms participating in the competition were given a set of 10,616 digitized prostate biopsies to learn from, then were tested against a panel of either one to six – depending on the country – experienced uropathologists on a set of 393 digitized slides. A selection of 15 teams were then invited to take part in a validation phase with an additional 1,616 slides.

Within the first 10 days of the competition, one algorithm already achieved greater than 0.90 agreement with the uropathologists; by day 33, the median performance of all the teams in the competition was greater than 0.85 agreement with the human experts.
 

Algorithms correctly detected tumors in 99.7% of cases

The algorithms selected for validation showed even higher levels of agreement – 0.931 on average (95% confidence interval, 0.918-0.944). These algorithms correctly detected tumors in 99.7% of cases (95% CI, 98.1%-99.7%), and correctly identified 92.9% of negative results (95% CI, 91.9%-96.7%).

When it came to classifying the prostate cancers based on Gleason grade, the algorithms showed significantly more agreement with uropathologists than did an international panel of 13 or 20 general pathologists.

“This higher sensitivity shows promise for reducing pathologist workload by automated identification and exclusion of most benign biopsies from review,” the authors wrote.

The study found that the AI algorithms missed 1%-1.9% of cancers, but the general pathologists missed 1.8%-7.3%. The algorithms demonstrated a sensitivity of 96.4%-98.2% and specificity of 75%-100% for tumors, whereas the pathologists showed a sensitivity of 91.9-96.5% and specificity of 92.3%-95%.
 

Benign cases were misclassified

The main error that the algorithms made was misclassifying benign cases as ISUP GG 1 cancer. The authors commented that this was likely caused by a shift in the distribution of cases between the training data given to the algorithms and the data set they were validated on.

They also noted that, in one validation set, the algorithms overgraded a “substantial proportion” of ISUP GG 3 cases as GG 4, whereas general pathologists tended to undergrade cases, particularly in the higher-grade cancers.

“These differences suggest that general pathologists supported by AI could reach higher agreements with uropathologists, potentially alleviating some of the rater variability associated with Gleason grading,” they wrote.

The authors also pointed out that the algorithms were validated on individual biopsies from each patient, whereas in the clinical context, a pathologist would likely have multiple biopsies from a single patient.

“Future studies can focus on patient-level evaluation of tissue samples, taking multiple cores and sections into account for the final diagnosis,” they wrote.

The study was supported by the Dutch Cancer Society, Netherlands Organization for Scientific Research, Google, Verily Life Sciences, Swedish Research Council, Swedish Cancer Society, Swedish eScience Research Center, EIT Health, Karolinska Institutet, Åke Wiberg Foundation, Prostatacancerförbundet, Academy of Finland, Cancer Foundation Finland, and ERAPerMed. The authors declared a range of grants and funding outside the study, including from Philips Digital Pathology Solutions. Several authors declared patents related to prostate cancer diagnoses, and 10 were employees of Google.

Cancer specialists have expressed disappointment at a decision by the National Institute for Health and Care Excellence not to recommend a targeted drug that can delay progression of a type of prostate cancer.

In draft guidance, NICE rejected olaparib (Lynparza, AstraZeneca) as a treatment option for hormone-relapsed metastatic prostate cancer with BRCA1/2 mutations.

The list price of the poly (ADP-ribose) polymerase inhibitor, at 37,491 pounds for an average cost of treatment, meant it was not cost effective to recommend for routine NHS use, the medicines regulator said.

The Institute of Cancer Research said the decision by NICE put patients in England and Wales at a disadvantage to those in Scotland where the regulator had approved olaparib for men with the same condition under a patient access scheme.

Kristian Helin, ICR chief executive, said: “I urge NICE and the manufacturer to come back to the table and try to find agreement on a way to make olaparib available at an agreeable price.”
 

Encouraging clinical evidence

Results from the PROfound trial, published in 2020 in the New England Journal of Medicine, suggested that progression-free survival for patients with prostate cancers who had faulty BRCA2, BRCA1, or ATM genes was significantly longer in the olaparib group than in a control group who received either enzalutamide or abiraterone.

Median survival in the Olaparib cohort was 7.4 months, compared with 3.6 months in the control group.

Retreatment with abiraterone or enzalutamide is not considered effective for men with this type of prostate cancer, and is not standard care in the NHS, NICE said.

Current treatment for metastatic hormone-relapsed prostate cancer is chemotherapy with docetaxel, cabazitaxel, or radium-223 dichloride.

NICE acknowledged that while an indirect comparison suggested that in men previously treated with docetaxel, olaparib increased survival, compared with cabazitaxel, there were no evidence directly comparing them.
 

Consultation period

Gillian Leng, CBE, NICE chief executive, said: “We know how important it is for people with this type of prostate cancer to have more treatment options that can help them live longer and enable them to maintain or improve their quality of life, as well as delay chemotherapy and its associated side effects.

“We’re therefore disappointed not to be able to recommend olaparib for use in this way. However, the company’s own economic model demonstrated that the drug does not offer enough benefit to justify the price it is asking.

“We’ll continue working with the company to try and address the issues highlighted by the committee.”

Johann De Bono, professor of experimental cancer medicine at the ICR, who leads the PROfound trial, said: “Olaparib is a precision drug that can extend life for men with some mutations in their tumors while sparing them the side effects of chemotherapy.

“I was delighted when olaparib was approved for NHS patients in Scotland earlier this year – and it’s disappointing that this decision means their counterparts in England and Wales will miss out on such a valuable new treatment option. It’s an example of the barriers that exist to making innovative drugs available at prices that the NHS can afford and is going to result in postcode prescribing across the U.K.”

The list price of olaparib is 2,317.50 pounds for a pack of 56 tablets covering 14 days of treatment. A confidential discount has been agreed by the manufacturer to make olaparib available to the NHS.

It is estimated that around 100 men would be eligible for treatment with olaparib if it was to be approved by NICE.

Consultation on the draft guidance closes on Jan. 31.

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

Cancer specialists have expressed disappointment at a decision by the National Institute for Health and Care Excellence not to recommend a targeted drug that can delay progression of a type of prostate cancer.

In draft guidance, NICE rejected olaparib (Lynparza, AstraZeneca) as a treatment option for hormone-relapsed metastatic prostate cancer with BRCA1/2 mutations.

The list price of the poly (ADP-ribose) polymerase inhibitor, at 37,491 pounds for an average cost of treatment, meant it was not cost effective to recommend for routine NHS use, the medicines regulator said.

The Institute of Cancer Research said the decision by NICE put patients in England and Wales at a disadvantage to those in Scotland where the regulator had approved olaparib for men with the same condition under a patient access scheme.

Kristian Helin, ICR chief executive, said: “I urge NICE and the manufacturer to come back to the table and try to find agreement on a way to make olaparib available at an agreeable price.”
 

Encouraging clinical evidence

Results from the PROfound trial, published in 2020 in the New England Journal of Medicine, suggested that progression-free survival for patients with prostate cancers who had faulty BRCA2, BRCA1, or ATM genes was significantly longer in the olaparib group than in a control group who received either enzalutamide or abiraterone.

Median survival in the Olaparib cohort was 7.4 months, compared with 3.6 months in the control group.

Retreatment with abiraterone or enzalutamide is not considered effective for men with this type of prostate cancer, and is not standard care in the NHS, NICE said.

Current treatment for metastatic hormone-relapsed prostate cancer is chemotherapy with docetaxel, cabazitaxel, or radium-223 dichloride.

NICE acknowledged that while an indirect comparison suggested that in men previously treated with docetaxel, olaparib increased survival, compared with cabazitaxel, there were no evidence directly comparing them.
 

Consultation period

Gillian Leng, CBE, NICE chief executive, said: “We know how important it is for people with this type of prostate cancer to have more treatment options that can help them live longer and enable them to maintain or improve their quality of life, as well as delay chemotherapy and its associated side effects.

“We’re therefore disappointed not to be able to recommend olaparib for use in this way. However, the company’s own economic model demonstrated that the drug does not offer enough benefit to justify the price it is asking.

“We’ll continue working with the company to try and address the issues highlighted by the committee.”

Johann De Bono, professor of experimental cancer medicine at the ICR, who leads the PROfound trial, said: “Olaparib is a precision drug that can extend life for men with some mutations in their tumors while sparing them the side effects of chemotherapy.

“I was delighted when olaparib was approved for NHS patients in Scotland earlier this year – and it’s disappointing that this decision means their counterparts in England and Wales will miss out on such a valuable new treatment option. It’s an example of the barriers that exist to making innovative drugs available at prices that the NHS can afford and is going to result in postcode prescribing across the U.K.”

The list price of olaparib is 2,317.50 pounds for a pack of 56 tablets covering 14 days of treatment. A confidential discount has been agreed by the manufacturer to make olaparib available to the NHS.

It is estimated that around 100 men would be eligible for treatment with olaparib if it was to be approved by NICE.

Consultation on the draft guidance closes on Jan. 31.

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

Cancer specialists have expressed disappointment at a decision by the National Institute for Health and Care Excellence not to recommend a targeted drug that can delay progression of a type of prostate cancer.

In draft guidance, NICE rejected olaparib (Lynparza, AstraZeneca) as a treatment option for hormone-relapsed metastatic prostate cancer with BRCA1/2 mutations.

The list price of the poly (ADP-ribose) polymerase inhibitor, at 37,491 pounds for an average cost of treatment, meant it was not cost effective to recommend for routine NHS use, the medicines regulator said.

The Institute of Cancer Research said the decision by NICE put patients in England and Wales at a disadvantage to those in Scotland where the regulator had approved olaparib for men with the same condition under a patient access scheme.

Kristian Helin, ICR chief executive, said: “I urge NICE and the manufacturer to come back to the table and try to find agreement on a way to make olaparib available at an agreeable price.”
 

Encouraging clinical evidence

Results from the PROfound trial, published in 2020 in the New England Journal of Medicine, suggested that progression-free survival for patients with prostate cancers who had faulty BRCA2, BRCA1, or ATM genes was significantly longer in the olaparib group than in a control group who received either enzalutamide or abiraterone.

Median survival in the Olaparib cohort was 7.4 months, compared with 3.6 months in the control group.

Retreatment with abiraterone or enzalutamide is not considered effective for men with this type of prostate cancer, and is not standard care in the NHS, NICE said.

Current treatment for metastatic hormone-relapsed prostate cancer is chemotherapy with docetaxel, cabazitaxel, or radium-223 dichloride.

NICE acknowledged that while an indirect comparison suggested that in men previously treated with docetaxel, olaparib increased survival, compared with cabazitaxel, there were no evidence directly comparing them.
 

Consultation period

Gillian Leng, CBE, NICE chief executive, said: “We know how important it is for people with this type of prostate cancer to have more treatment options that can help them live longer and enable them to maintain or improve their quality of life, as well as delay chemotherapy and its associated side effects.

“We’re therefore disappointed not to be able to recommend olaparib for use in this way. However, the company’s own economic model demonstrated that the drug does not offer enough benefit to justify the price it is asking.

“We’ll continue working with the company to try and address the issues highlighted by the committee.”

Johann De Bono, professor of experimental cancer medicine at the ICR, who leads the PROfound trial, said: “Olaparib is a precision drug that can extend life for men with some mutations in their tumors while sparing them the side effects of chemotherapy.

“I was delighted when olaparib was approved for NHS patients in Scotland earlier this year – and it’s disappointing that this decision means their counterparts in England and Wales will miss out on such a valuable new treatment option. It’s an example of the barriers that exist to making innovative drugs available at prices that the NHS can afford and is going to result in postcode prescribing across the U.K.”

The list price of olaparib is 2,317.50 pounds for a pack of 56 tablets covering 14 days of treatment. A confidential discount has been agreed by the manufacturer to make olaparib available to the NHS.

It is estimated that around 100 men would be eligible for treatment with olaparib if it was to be approved by NICE.

Consultation on the draft guidance closes on Jan. 31.

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

Black patients often have worse outcomes than White patients for a range of diseases and conditions, including prostate cancer. But now, a new study revealed a surprising twist: Black men who received radiation therapy for localized prostate cancer fared better.

Overall, Black men have a 50% higher risk of being diagnosed with prostate cancer, and an 80% greater risk of death than White men. Those numbers have complicated roots: There are differences in access to medical care, clinical trial enrollment, access to screening, and frequency of definitive treatment.

The new study, published online Dec. 29, 2021, in JAMA Network Open, was a meta-analysis of 8,814 men (18.5% Black, 81.5% White) who participated in 7 randomized, clinical trials that compared definitive radiotherapy with or without short- or long-term androgen deprivation therapy. The researchers found that Black men had more features of high-risk disease, but they were less likely than White men to experience biochemical recurrence (subdistribution hazard ratio, 0.79; P < .001), distant metastasis (sHR, 0.69; P = .002), or prostate cancer-specific mortality (sHR, 0.68; P = .01).

“These results provide high-level evidence challenging the common belief that Black men who are diagnosed with prostate cancer will necessarily have a worse prognosis than White men,” said study coauthor Amar Kishan, MD, in a press release. Dr. Kishan is associate professor and vice chair of clinical and translational research at the University of California, Los Angeles, and a researcher at the UCLA Jonsson Comprehensive Cancer Center.

“This is especially important because an unfounded belief can inadvertently contribute to ‘cancer injustice,’ leading to the use of more aggressive treatments than might be necessary – potentially reducing quality of life and diverting attention away from other important factors that can influence outcome, including access to more comprehensive health care,” Dr. Kishan said.

Better health care coverage may indeed be the driving force behind the benefit, according to an accompanying editorial authored by Bogdana Schmidt, MD, MPH and Neeraj Agarwal, MD, of the Huntsman Cancer Institute at the University of Utah, Salt Lake City. The results suggest that, when Black men with prostate cancer get the high quality of care seen in clinical trials and receive definitive therapy, they achieve good results.

It also suggests a path toward improving outcomes. “Through a multidisciplinary effort of enriching cohort studies with Black men, enrolling Black men into clinical trials and continuing the search for tumor-specific genomic factors, treatment-specific response factors, and pharmacologic response differences, as a community we can unequivocally improve prostate cancer care for Black men,” the editorial authors wrote.

Enrollment in clinical trials has also been linked to improved outcomes in studies of docetaxel and prednisone, enzalutamide and androgen deprivation therapy, and abiraterone acetate and prednisone. Other studies have shown that Black men in clinical trials or who get treated in high-volume centers are less likely to experience the adverse outcomes seen more widely among Black men.

The new finding that Black men have better outcomes with radiotherapy may also have a biological basis, as a retrospective study of patients undergoing prostatectomy for prostate cancer found that Black men had lower levels of mismatch repair genes and DNA repair activity.

The study isn’t the first to implicate access to care in outcome differential between Black and White men with prostate cancer. A 2019 study compared outcomes between White and Black men within registries that have standardized access, which is expected to minimize racial disparities. The researchers found no differences in prostate cancer–specific mortality within these databases. However, the differences in outcomes surfaced between Black and White men when they examined data from a large federal registry that reflects social and economic barriers to health care.

The authors of both the study and the editorial have extensive financial relationships with pharmaceutical companies.

Black patients often have worse outcomes than White patients for a range of diseases and conditions, including prostate cancer. But now, a new study revealed a surprising twist: Black men who received radiation therapy for localized prostate cancer fared better.

Overall, Black men have a 50% higher risk of being diagnosed with prostate cancer, and an 80% greater risk of death than White men. Those numbers have complicated roots: There are differences in access to medical care, clinical trial enrollment, access to screening, and frequency of definitive treatment.

The new study, published online Dec. 29, 2021, in JAMA Network Open, was a meta-analysis of 8,814 men (18.5% Black, 81.5% White) who participated in 7 randomized, clinical trials that compared definitive radiotherapy with or without short- or long-term androgen deprivation therapy. The researchers found that Black men had more features of high-risk disease, but they were less likely than White men to experience biochemical recurrence (subdistribution hazard ratio, 0.79; P < .001), distant metastasis (sHR, 0.69; P = .002), or prostate cancer-specific mortality (sHR, 0.68; P = .01).

“These results provide high-level evidence challenging the common belief that Black men who are diagnosed with prostate cancer will necessarily have a worse prognosis than White men,” said study coauthor Amar Kishan, MD, in a press release. Dr. Kishan is associate professor and vice chair of clinical and translational research at the University of California, Los Angeles, and a researcher at the UCLA Jonsson Comprehensive Cancer Center.

“This is especially important because an unfounded belief can inadvertently contribute to ‘cancer injustice,’ leading to the use of more aggressive treatments than might be necessary – potentially reducing quality of life and diverting attention away from other important factors that can influence outcome, including access to more comprehensive health care,” Dr. Kishan said.

Better health care coverage may indeed be the driving force behind the benefit, according to an accompanying editorial authored by Bogdana Schmidt, MD, MPH and Neeraj Agarwal, MD, of the Huntsman Cancer Institute at the University of Utah, Salt Lake City. The results suggest that, when Black men with prostate cancer get the high quality of care seen in clinical trials and receive definitive therapy, they achieve good results.

It also suggests a path toward improving outcomes. “Through a multidisciplinary effort of enriching cohort studies with Black men, enrolling Black men into clinical trials and continuing the search for tumor-specific genomic factors, treatment-specific response factors, and pharmacologic response differences, as a community we can unequivocally improve prostate cancer care for Black men,” the editorial authors wrote.

Enrollment in clinical trials has also been linked to improved outcomes in studies of docetaxel and prednisone, enzalutamide and androgen deprivation therapy, and abiraterone acetate and prednisone. Other studies have shown that Black men in clinical trials or who get treated in high-volume centers are less likely to experience the adverse outcomes seen more widely among Black men.

The new finding that Black men have better outcomes with radiotherapy may also have a biological basis, as a retrospective study of patients undergoing prostatectomy for prostate cancer found that Black men had lower levels of mismatch repair genes and DNA repair activity.

The study isn’t the first to implicate access to care in outcome differential between Black and White men with prostate cancer. A 2019 study compared outcomes between White and Black men within registries that have standardized access, which is expected to minimize racial disparities. The researchers found no differences in prostate cancer–specific mortality within these databases. However, the differences in outcomes surfaced between Black and White men when they examined data from a large federal registry that reflects social and economic barriers to health care.

The authors of both the study and the editorial have extensive financial relationships with pharmaceutical companies.

Black patients often have worse outcomes than White patients for a range of diseases and conditions, including prostate cancer. But now, a new study revealed a surprising twist: Black men who received radiation therapy for localized prostate cancer fared better.

Overall, Black men have a 50% higher risk of being diagnosed with prostate cancer, and an 80% greater risk of death than White men. Those numbers have complicated roots: There are differences in access to medical care, clinical trial enrollment, access to screening, and frequency of definitive treatment.

The new study, published online Dec. 29, 2021, in JAMA Network Open, was a meta-analysis of 8,814 men (18.5% Black, 81.5% White) who participated in 7 randomized, clinical trials that compared definitive radiotherapy with or without short- or long-term androgen deprivation therapy. The researchers found that Black men had more features of high-risk disease, but they were less likely than White men to experience biochemical recurrence (subdistribution hazard ratio, 0.79; P < .001), distant metastasis (sHR, 0.69; P = .002), or prostate cancer-specific mortality (sHR, 0.68; P = .01).

“These results provide high-level evidence challenging the common belief that Black men who are diagnosed with prostate cancer will necessarily have a worse prognosis than White men,” said study coauthor Amar Kishan, MD, in a press release. Dr. Kishan is associate professor and vice chair of clinical and translational research at the University of California, Los Angeles, and a researcher at the UCLA Jonsson Comprehensive Cancer Center.

“This is especially important because an unfounded belief can inadvertently contribute to ‘cancer injustice,’ leading to the use of more aggressive treatments than might be necessary – potentially reducing quality of life and diverting attention away from other important factors that can influence outcome, including access to more comprehensive health care,” Dr. Kishan said.

Better health care coverage may indeed be the driving force behind the benefit, according to an accompanying editorial authored by Bogdana Schmidt, MD, MPH and Neeraj Agarwal, MD, of the Huntsman Cancer Institute at the University of Utah, Salt Lake City. The results suggest that, when Black men with prostate cancer get the high quality of care seen in clinical trials and receive definitive therapy, they achieve good results.

It also suggests a path toward improving outcomes. “Through a multidisciplinary effort of enriching cohort studies with Black men, enrolling Black men into clinical trials and continuing the search for tumor-specific genomic factors, treatment-specific response factors, and pharmacologic response differences, as a community we can unequivocally improve prostate cancer care for Black men,” the editorial authors wrote.

Enrollment in clinical trials has also been linked to improved outcomes in studies of docetaxel and prednisone, enzalutamide and androgen deprivation therapy, and abiraterone acetate and prednisone. Other studies have shown that Black men in clinical trials or who get treated in high-volume centers are less likely to experience the adverse outcomes seen more widely among Black men.

The new finding that Black men have better outcomes with radiotherapy may also have a biological basis, as a retrospective study of patients undergoing prostatectomy for prostate cancer found that Black men had lower levels of mismatch repair genes and DNA repair activity.

The study isn’t the first to implicate access to care in outcome differential between Black and White men with prostate cancer. A 2019 study compared outcomes between White and Black men within registries that have standardized access, which is expected to minimize racial disparities. The researchers found no differences in prostate cancer–specific mortality within these databases. However, the differences in outcomes surfaced between Black and White men when they examined data from a large federal registry that reflects social and economic barriers to health care.

The authors of both the study and the editorial have extensive financial relationships with pharmaceutical companies.

SAN ANTONIO – In a large prospective, international cohort, food additive nitrates and nitrites, artificial sweeteners (especially aspartame and acesulfame-K), and dietary trans fatty acids were found to be associated with increased cancer risks.

The findings were reported in three poster presentations (P1-09-01, P1-09-02 and P3-12-35) at the 2021 San Antonio Breast Cancer Symposium from the ongoing French NutriNet-Santé web-based study of 171,000 people that was launched in France in 2009 to investigate nutrition and health relationships. The authors of the analyses note that while evidence of deleterious health effects has been established for the dietary focus of their studies, and cancer risks have been suspected, strong evidence of a cancer association has been lacking.

Nitrates and nitrites are used in processed meats to increase shelf life and to avoid bacterial growth, said Eloi Chazelas, PhD, Nutritional Epidemiology Research Team (EREN) at Sorbonne Paris Nord University. Dr. Chazelas looked at consumption of nitrites and nitrates through repeated 24 hour dietary records, linked to a comprehensive food composition database. The study’s main outcome measure was adjusted associations between nitrite and nitrate exposures and the risk of cancer (overall and by main cancer sites).

During follow-up, 966 breast and 400 prostate cancers were diagnosed among 3,311 first incident cancer cases. Breast cancer risk was elevated (HR = 1.24 [1.03-1.48], P = 0.02) among higher consumers of nitrates from food additives, especially with potassium nitrate consumption (HR = 1.25 [1.04-1.50], P = 0.01). Elevated prostate cancer risk was associated with nitrites (HR = 1.58 [1.14-2.18], P = 0.008), specifically for sodium nitrite (HR = 1.62 [1.17-2.25], P = 0.004). Nitrates and nitrites from natural sources were not associated significantly with higher cancer risk, Dr. Chazelas said.

He and his team found that food additive nitrates were positively associated with breast cancer risk, and food additive nitrites were positively associated with prostate cancer risk. “While these results need confirmation in other large-scale prospective studies, they provide new insights in a context of lively debate around the ban of nitrite additives in the food industry,” said Dr. Chazelas, who is a doctoral candidate at Sorbonne Paris Nord University.

In “Breast and prostate cancer risk associated with nitrites and nitrates from food additives (P1-09-01),” the study included 102,046 adults from the French NutriNet-Santé prospective cohort (2009-2021). It examined associations between artificial sweetener intakes (total from all dietary sources, the most frequently consumed ones [aspartame e951, acesulfame-K e950 and sucralose e955]) and cancer risk (overall and by sites: breast, prostate and obesity-related cancers).

Overall cancer risk in people who consumed higher amounts of total sweeteners (i.e. above the median exposure in consumers) was elevated (n = 2,527 cases, hazard ratio = 1.12, 95 percent confidence interval = 1.00-1.25, P-trend=0.005), especially for aspartame (HR = 1.20 [1.05-1.38] P = 0.001) and acesulfame-K (HR = 1.18 [1.04-1.34] P = 0.003). Elevated breast cancer risks (among 723 cases) were observed for total sweeteners (HR = 1.25 [1.02-1.53] P = 0.01), for aspartame (HR = 1.33 [1.05-1.69] P = 0.007), and for acesulfame-K (HR = 1.39 [1.11-1.74] P = 0.003). Also, obesity-related cancers (1,509 cases) were increased for total sweeteners (HR = 1.16 [1.00-1.33] P = 0.02), for aspartame (HR = 1.22 [1.02-1.45] P = 0.01) and for acesulfame-K (HR = 1.23 [1.04-1.45] P = 0.01).

Artificial sweeteners are found in more than 10,000 foods and beverages, said Charlotte Debras, a doctoral candidate in nutritional epidemiology at Sorbonne Paris Nord University. “These findings provide important and novel insights for the ongoing re-evaluation of food additive sweeteners by the European Food Safety Authority and other health agencies globally,” she said.
 

Trans fatty acid intakes and cancer risk

Investigating associations between trans fatty acid intake (total ruminant [rTFAs], industrial [iTFAs], and corresponding specific isomers and cancer risk), the analysis of Gaëlle Wendeu-Foyet, PhD, Sorbonne Paris Nord University, found a total of 3,374 incident cancer cases (982 breast, 405 prostate) in an overall population of 104,909. Dietary intake of total TFAs was associated with higher prostate cancer risk (hazard ration for quartile 4 versus 1: 1.27, 1.11-1.77 P-trend = 0.005). Also, rTFAs were associated with increased overall cancer risk (1.16, 1.02-1.32 P-trend = 0.07), in particular the conjugated linoleic acid isomers (CLA) (1.19, 1.04-1.36 P-trend = 0.04). These associations were specifically observed for breast cancer (rTFAs: 1.35, 1.06-1.72 P-trend = 0.01; CLA: 1.29, 1.00-1.66 P-trend = 0.048), in particular before menopause (rTFAs: 1.68, 1.06-2.67 P-trend = 0.02; CLA: 2.013, 1.25-3.23 P-trend = 0.003). Several iTFAs were associated with overall (1.18, 1.06-1.31 P-trend = 0.02 for transdocosenoic acid), breast (isomer 18:2t: 1.30, 1.06-1.58 P-trend = 0.01; hexadecenoic acid: 1.28, 1.05-1.56 P-trend = 0.02) and prostate (transdocosenoic acid: 1.52, 1.09-2.12 P-trend = 0.07) cancer risks.

“These results support the WHO’s goal of achieving elimination from food supplies of industrially produced TFAs,” Dr. Foyet said. “The consumption of food products containing partially hydrogenated oils should be avoided.”

Nutrition, along with avoiding tobacco intake, is one of the main modifiable risk factors for chronic diseases. “There is a lot at stake in terms of prevention. This requires a combination of actions at the individual level to the public level by informing the public through food labeling,” Ms. Debras said.

It also requires influencing the context in which citizens evolve by encouraging manufacturers to improve their products (pricing policies, commitment charters for product reformulation, etc.), and limiting advertising and marketing for products of poor nutritional quality (especially among children),” she said.

SAN ANTONIO – In a large prospective, international cohort, food additive nitrates and nitrites, artificial sweeteners (especially aspartame and acesulfame-K), and dietary trans fatty acids were found to be associated with increased cancer risks.

The findings were reported in three poster presentations (P1-09-01, P1-09-02 and P3-12-35) at the 2021 San Antonio Breast Cancer Symposium from the ongoing French NutriNet-Santé web-based study of 171,000 people that was launched in France in 2009 to investigate nutrition and health relationships. The authors of the analyses note that while evidence of deleterious health effects has been established for the dietary focus of their studies, and cancer risks have been suspected, strong evidence of a cancer association has been lacking.

Nitrates and nitrites are used in processed meats to increase shelf life and to avoid bacterial growth, said Eloi Chazelas, PhD, Nutritional Epidemiology Research Team (EREN) at Sorbonne Paris Nord University. Dr. Chazelas looked at consumption of nitrites and nitrates through repeated 24 hour dietary records, linked to a comprehensive food composition database. The study’s main outcome measure was adjusted associations between nitrite and nitrate exposures and the risk of cancer (overall and by main cancer sites).

During follow-up, 966 breast and 400 prostate cancers were diagnosed among 3,311 first incident cancer cases. Breast cancer risk was elevated (HR = 1.24 [1.03-1.48], P = 0.02) among higher consumers of nitrates from food additives, especially with potassium nitrate consumption (HR = 1.25 [1.04-1.50], P = 0.01). Elevated prostate cancer risk was associated with nitrites (HR = 1.58 [1.14-2.18], P = 0.008), specifically for sodium nitrite (HR = 1.62 [1.17-2.25], P = 0.004). Nitrates and nitrites from natural sources were not associated significantly with higher cancer risk, Dr. Chazelas said.

He and his team found that food additive nitrates were positively associated with breast cancer risk, and food additive nitrites were positively associated with prostate cancer risk. “While these results need confirmation in other large-scale prospective studies, they provide new insights in a context of lively debate around the ban of nitrite additives in the food industry,” said Dr. Chazelas, who is a doctoral candidate at Sorbonne Paris Nord University.

In “Breast and prostate cancer risk associated with nitrites and nitrates from food additives (P1-09-01),” the study included 102,046 adults from the French NutriNet-Santé prospective cohort (2009-2021). It examined associations between artificial sweetener intakes (total from all dietary sources, the most frequently consumed ones [aspartame e951, acesulfame-K e950 and sucralose e955]) and cancer risk (overall and by sites: breast, prostate and obesity-related cancers).

Overall cancer risk in people who consumed higher amounts of total sweeteners (i.e. above the median exposure in consumers) was elevated (n = 2,527 cases, hazard ratio = 1.12, 95 percent confidence interval = 1.00-1.25, P-trend=0.005), especially for aspartame (HR = 1.20 [1.05-1.38] P = 0.001) and acesulfame-K (HR = 1.18 [1.04-1.34] P = 0.003). Elevated breast cancer risks (among 723 cases) were observed for total sweeteners (HR = 1.25 [1.02-1.53] P = 0.01), for aspartame (HR = 1.33 [1.05-1.69] P = 0.007), and for acesulfame-K (HR = 1.39 [1.11-1.74] P = 0.003). Also, obesity-related cancers (1,509 cases) were increased for total sweeteners (HR = 1.16 [1.00-1.33] P = 0.02), for aspartame (HR = 1.22 [1.02-1.45] P = 0.01) and for acesulfame-K (HR = 1.23 [1.04-1.45] P = 0.01).

Artificial sweeteners are found in more than 10,000 foods and beverages, said Charlotte Debras, a doctoral candidate in nutritional epidemiology at Sorbonne Paris Nord University. “These findings provide important and novel insights for the ongoing re-evaluation of food additive sweeteners by the European Food Safety Authority and other health agencies globally,” she said.
 

Trans fatty acid intakes and cancer risk

Investigating associations between trans fatty acid intake (total ruminant [rTFAs], industrial [iTFAs], and corresponding specific isomers and cancer risk), the analysis of Gaëlle Wendeu-Foyet, PhD, Sorbonne Paris Nord University, found a total of 3,374 incident cancer cases (982 breast, 405 prostate) in an overall population of 104,909. Dietary intake of total TFAs was associated with higher prostate cancer risk (hazard ration for quartile 4 versus 1: 1.27, 1.11-1.77 P-trend = 0.005). Also, rTFAs were associated with increased overall cancer risk (1.16, 1.02-1.32 P-trend = 0.07), in particular the conjugated linoleic acid isomers (CLA) (1.19, 1.04-1.36 P-trend = 0.04). These associations were specifically observed for breast cancer (rTFAs: 1.35, 1.06-1.72 P-trend = 0.01; CLA: 1.29, 1.00-1.66 P-trend = 0.048), in particular before menopause (rTFAs: 1.68, 1.06-2.67 P-trend = 0.02; CLA: 2.013, 1.25-3.23 P-trend = 0.003). Several iTFAs were associated with overall (1.18, 1.06-1.31 P-trend = 0.02 for transdocosenoic acid), breast (isomer 18:2t: 1.30, 1.06-1.58 P-trend = 0.01; hexadecenoic acid: 1.28, 1.05-1.56 P-trend = 0.02) and prostate (transdocosenoic acid: 1.52, 1.09-2.12 P-trend = 0.07) cancer risks.

“These results support the WHO’s goal of achieving elimination from food supplies of industrially produced TFAs,” Dr. Foyet said. “The consumption of food products containing partially hydrogenated oils should be avoided.”

Nutrition, along with avoiding tobacco intake, is one of the main modifiable risk factors for chronic diseases. “There is a lot at stake in terms of prevention. This requires a combination of actions at the individual level to the public level by informing the public through food labeling,” Ms. Debras said.

It also requires influencing the context in which citizens evolve by encouraging manufacturers to improve their products (pricing policies, commitment charters for product reformulation, etc.), and limiting advertising and marketing for products of poor nutritional quality (especially among children),” she said.

SAN ANTONIO – In a large prospective, international cohort, food additive nitrates and nitrites, artificial sweeteners (especially aspartame and acesulfame-K), and dietary trans fatty acids were found to be associated with increased cancer risks.

The findings were reported in three poster presentations (P1-09-01, P1-09-02 and P3-12-35) at the 2021 San Antonio Breast Cancer Symposium from the ongoing French NutriNet-Santé web-based study of 171,000 people that was launched in France in 2009 to investigate nutrition and health relationships. The authors of the analyses note that while evidence of deleterious health effects has been established for the dietary focus of their studies, and cancer risks have been suspected, strong evidence of a cancer association has been lacking.

Nitrates and nitrites are used in processed meats to increase shelf life and to avoid bacterial growth, said Eloi Chazelas, PhD, Nutritional Epidemiology Research Team (EREN) at Sorbonne Paris Nord University. Dr. Chazelas looked at consumption of nitrites and nitrates through repeated 24 hour dietary records, linked to a comprehensive food composition database. The study’s main outcome measure was adjusted associations between nitrite and nitrate exposures and the risk of cancer (overall and by main cancer sites).

During follow-up, 966 breast and 400 prostate cancers were diagnosed among 3,311 first incident cancer cases. Breast cancer risk was elevated (HR = 1.24 [1.03-1.48], P = 0.02) among higher consumers of nitrates from food additives, especially with potassium nitrate consumption (HR = 1.25 [1.04-1.50], P = 0.01). Elevated prostate cancer risk was associated with nitrites (HR = 1.58 [1.14-2.18], P = 0.008), specifically for sodium nitrite (HR = 1.62 [1.17-2.25], P = 0.004). Nitrates and nitrites from natural sources were not associated significantly with higher cancer risk, Dr. Chazelas said.

He and his team found that food additive nitrates were positively associated with breast cancer risk, and food additive nitrites were positively associated with prostate cancer risk. “While these results need confirmation in other large-scale prospective studies, they provide new insights in a context of lively debate around the ban of nitrite additives in the food industry,” said Dr. Chazelas, who is a doctoral candidate at Sorbonne Paris Nord University.

In “Breast and prostate cancer risk associated with nitrites and nitrates from food additives (P1-09-01),” the study included 102,046 adults from the French NutriNet-Santé prospective cohort (2009-2021). It examined associations between artificial sweetener intakes (total from all dietary sources, the most frequently consumed ones [aspartame e951, acesulfame-K e950 and sucralose e955]) and cancer risk (overall and by sites: breast, prostate and obesity-related cancers).

Overall cancer risk in people who consumed higher amounts of total sweeteners (i.e. above the median exposure in consumers) was elevated (n = 2,527 cases, hazard ratio = 1.12, 95 percent confidence interval = 1.00-1.25, P-trend=0.005), especially for aspartame (HR = 1.20 [1.05-1.38] P = 0.001) and acesulfame-K (HR = 1.18 [1.04-1.34] P = 0.003). Elevated breast cancer risks (among 723 cases) were observed for total sweeteners (HR = 1.25 [1.02-1.53] P = 0.01), for aspartame (HR = 1.33 [1.05-1.69] P = 0.007), and for acesulfame-K (HR = 1.39 [1.11-1.74] P = 0.003). Also, obesity-related cancers (1,509 cases) were increased for total sweeteners (HR = 1.16 [1.00-1.33] P = 0.02), for aspartame (HR = 1.22 [1.02-1.45] P = 0.01) and for acesulfame-K (HR = 1.23 [1.04-1.45] P = 0.01).

Artificial sweeteners are found in more than 10,000 foods and beverages, said Charlotte Debras, a doctoral candidate in nutritional epidemiology at Sorbonne Paris Nord University. “These findings provide important and novel insights for the ongoing re-evaluation of food additive sweeteners by the European Food Safety Authority and other health agencies globally,” she said.
 

Trans fatty acid intakes and cancer risk

Investigating associations between trans fatty acid intake (total ruminant [rTFAs], industrial [iTFAs], and corresponding specific isomers and cancer risk), the analysis of Gaëlle Wendeu-Foyet, PhD, Sorbonne Paris Nord University, found a total of 3,374 incident cancer cases (982 breast, 405 prostate) in an overall population of 104,909. Dietary intake of total TFAs was associated with higher prostate cancer risk (hazard ration for quartile 4 versus 1: 1.27, 1.11-1.77 P-trend = 0.005). Also, rTFAs were associated with increased overall cancer risk (1.16, 1.02-1.32 P-trend = 0.07), in particular the conjugated linoleic acid isomers (CLA) (1.19, 1.04-1.36 P-trend = 0.04). These associations were specifically observed for breast cancer (rTFAs: 1.35, 1.06-1.72 P-trend = 0.01; CLA: 1.29, 1.00-1.66 P-trend = 0.048), in particular before menopause (rTFAs: 1.68, 1.06-2.67 P-trend = 0.02; CLA: 2.013, 1.25-3.23 P-trend = 0.003). Several iTFAs were associated with overall (1.18, 1.06-1.31 P-trend = 0.02 for transdocosenoic acid), breast (isomer 18:2t: 1.30, 1.06-1.58 P-trend = 0.01; hexadecenoic acid: 1.28, 1.05-1.56 P-trend = 0.02) and prostate (transdocosenoic acid: 1.52, 1.09-2.12 P-trend = 0.07) cancer risks.

“These results support the WHO’s goal of achieving elimination from food supplies of industrially produced TFAs,” Dr. Foyet said. “The consumption of food products containing partially hydrogenated oils should be avoided.”

Nutrition, along with avoiding tobacco intake, is one of the main modifiable risk factors for chronic diseases. “There is a lot at stake in terms of prevention. This requires a combination of actions at the individual level to the public level by informing the public through food labeling,” Ms. Debras said.

It also requires influencing the context in which citizens evolve by encouraging manufacturers to improve their products (pricing policies, commitment charters for product reformulation, etc.), and limiting advertising and marketing for products of poor nutritional quality (especially among children),” she said.