AVAHO

The United States Food and Drug Administration (FDA) has expanded the approval for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) to include adults with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC), who have received androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.

The radioligand therapeutic agent was previously approved for the treatment of PSMA-positive mCRPC in patients who have already received ARPI therapy and taxane-based chemotherapy. Approval for the expanded indication was based on efficacy demonstrated in the randomized, open-label, phase 3 PSMAfore trial.

Treatment in 468 patients who progressed on one ARPI and who were deemed appropriate for delay of taxane-based chemotherapy was associated with improved radiographic progression-free survival (rPFS) and overall survival (OS) vs a different ARPI.

Patients were randomized 1:1 to receive lutetium Lu 177 vipivotide tetraxetan (7.4 GBq [200 mCi] every 6 weeks for six doses) or to receive a different ARPI, according to a statement from the FDA. Those who progressed on the new ARPI were allowed to cross over to the experimental therapy arm after progression, and 60% did so.

Median rPFS was 9.3 vs 5.6 months in the experimental and control arms, respectively (hazard ratio [HR], 0.41). Median OS durations were 24.5 and 23.1 months, respectively (HR, 0.91), but the difference in OS did not reach statistical significance.

Adverse reactions were consistent with the known safety profile of lutetium Lu 177 vipivotide tetraxetan, which includes possible radiation exposure, myelosuppression, and renal toxicity.

The recommended dose, according to prescribing information, is 7.4 GBq (200 mCi) administered intravenously every 6 weeks for six doses or until disease progression or unacceptable toxicity.

“The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC. It offers a targeted therapy that better delays disease progression compared to a second ARPI,” Michael Morris, MD, of Memorial Sloan Kettering Cancer Center, New York, and the principal investigator of the study in the United States stated in a Novartis press release. “This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy.”

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

The United States Food and Drug Administration (FDA) has expanded the approval for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) to include adults with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC), who have received androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.

The radioligand therapeutic agent was previously approved for the treatment of PSMA-positive mCRPC in patients who have already received ARPI therapy and taxane-based chemotherapy. Approval for the expanded indication was based on efficacy demonstrated in the randomized, open-label, phase 3 PSMAfore trial.

Treatment in 468 patients who progressed on one ARPI and who were deemed appropriate for delay of taxane-based chemotherapy was associated with improved radiographic progression-free survival (rPFS) and overall survival (OS) vs a different ARPI.

Patients were randomized 1:1 to receive lutetium Lu 177 vipivotide tetraxetan (7.4 GBq [200 mCi] every 6 weeks for six doses) or to receive a different ARPI, according to a statement from the FDA. Those who progressed on the new ARPI were allowed to cross over to the experimental therapy arm after progression, and 60% did so.

Median rPFS was 9.3 vs 5.6 months in the experimental and control arms, respectively (hazard ratio [HR], 0.41). Median OS durations were 24.5 and 23.1 months, respectively (HR, 0.91), but the difference in OS did not reach statistical significance.

Adverse reactions were consistent with the known safety profile of lutetium Lu 177 vipivotide tetraxetan, which includes possible radiation exposure, myelosuppression, and renal toxicity.

The recommended dose, according to prescribing information, is 7.4 GBq (200 mCi) administered intravenously every 6 weeks for six doses or until disease progression or unacceptable toxicity.

“The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC. It offers a targeted therapy that better delays disease progression compared to a second ARPI,” Michael Morris, MD, of Memorial Sloan Kettering Cancer Center, New York, and the principal investigator of the study in the United States stated in a Novartis press release. “This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy.”

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

The United States Food and Drug Administration (FDA) has expanded the approval for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) to include adults with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC), who have received androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.

The radioligand therapeutic agent was previously approved for the treatment of PSMA-positive mCRPC in patients who have already received ARPI therapy and taxane-based chemotherapy. Approval for the expanded indication was based on efficacy demonstrated in the randomized, open-label, phase 3 PSMAfore trial.

Treatment in 468 patients who progressed on one ARPI and who were deemed appropriate for delay of taxane-based chemotherapy was associated with improved radiographic progression-free survival (rPFS) and overall survival (OS) vs a different ARPI.

Patients were randomized 1:1 to receive lutetium Lu 177 vipivotide tetraxetan (7.4 GBq [200 mCi] every 6 weeks for six doses) or to receive a different ARPI, according to a statement from the FDA. Those who progressed on the new ARPI were allowed to cross over to the experimental therapy arm after progression, and 60% did so.

Median rPFS was 9.3 vs 5.6 months in the experimental and control arms, respectively (hazard ratio [HR], 0.41). Median OS durations were 24.5 and 23.1 months, respectively (HR, 0.91), but the difference in OS did not reach statistical significance.

Adverse reactions were consistent with the known safety profile of lutetium Lu 177 vipivotide tetraxetan, which includes possible radiation exposure, myelosuppression, and renal toxicity.

The recommended dose, according to prescribing information, is 7.4 GBq (200 mCi) administered intravenously every 6 weeks for six doses or until disease progression or unacceptable toxicity.

“The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC. It offers a targeted therapy that better delays disease progression compared to a second ARPI,” Michael Morris, MD, of Memorial Sloan Kettering Cancer Center, New York, and the principal investigator of the study in the United States stated in a Novartis press release. “This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy.”

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

In the largest head-to-head randomized trial of its kind, UK researchers found transperineal prostate biopsies using local anesthesia (LATP) superior to the transrectal approach in detecting clinically significant cancers.

The TRANSLATE study, with more than 1100 patients, found LATP identified 5.7% more cases of clinically significant prostate cancer, defined as Grade Group 2 or higher, than biopsies using transrectal ultrasonography (TRUS).

Previous research comparing the two techniques has focused mainly on rates of infection rather than cancer detection, said Richard Bryant, PhD, a consultant urologist at Nuffield Department of Surgical Sciences, University of Oxford in Oxford, England, who led the trial.

“We decided that the most important thing to look at is the detection rate of clinically significant prostate cancer, because that is why the man is having the biopsy in the first place, rather than to avoid infection, although avoiding infection is of course also important,” Bryant said.

Bryant presented the findings at the 2025 annual congress of the European Association of Urology and his group published the results in The Lancet Oncology.

The TRANSLATE trial was powered to identify a difference in the rate of cancer detection but not factors such as pain and sepsis. Hospitalization after biopsies served as a proxy for sepsis.

Men in the trial were nearly twice as likely to report LATP to be problematic immediately after the procedure than those who underwent transrectal biopsies. These issues included pain, discomfort, and embarrassment.

Two of the 562 men in the LATP group were hospitalized within 35 days of the procedure compared with nine of the 564 in the TRUS group. Bryant said this trend favored LATP, but the difference did not reach statistical significance.

The data on infection and other secondary outcomes were encouraging, but not conclusive, Bryant’s group reported.

Richard Szabo, MD, a prostate biopsy researcher at University of California Irvine, said the reduction in post-biopsy sepsis has been “an additional major advantage” of transperineal over transrectal prostate biopsy.

Almost 90% of men who received LATP had the biopsies without antibiotics — a “bonus,” Bryant said.

Antibiotic stewardship is a major factor in research and policies regarding biopsies in Europe. Transperineal biopsies avoid the rectum and pass needles through the perineum between the anus and the testicles, reducing risk for infection.

Jim Hu, MD, a urologic oncology researcher at Weill Cornell in New York City and the principal investigator on the 2024 PREVENT trial, said three of four randomized trials reported in the past year, including PREVENT and TRANSLATE, have found transperineal biopsies resulted in fewer infections than the transrectal method.

European guidelines call transperineal biopsy the preferred approach based on infection concerns, whereas guidance from the American Urological Association gives equal weight to transperineal and transrectal biopsies.

Badar Mian, MD, a urologist at Albany Med Health System in Albany, New York, said the field should “shift our focus from picking a winner to instead focus on whether prostate biopsy procedures are safe and effective. Patients should be reassured that, while there are trade-offs, both procedures can be performed safely and with a high degree of accuracy.”

The UK’s National Institute for Health and Care Research funded TRANSLATE. Bryant received support from BXTAccelyon to attend biopsy training provided by Guys’ Hospital, in London, England.

Howard Wolinsky is a Chicago-based freelance writer.

A version of this article appeared at Medscape.com.

In the largest head-to-head randomized trial of its kind, UK researchers found transperineal prostate biopsies using local anesthesia (LATP) superior to the transrectal approach in detecting clinically significant cancers.

The TRANSLATE study, with more than 1100 patients, found LATP identified 5.7% more cases of clinically significant prostate cancer, defined as Grade Group 2 or higher, than biopsies using transrectal ultrasonography (TRUS).

Previous research comparing the two techniques has focused mainly on rates of infection rather than cancer detection, said Richard Bryant, PhD, a consultant urologist at Nuffield Department of Surgical Sciences, University of Oxford in Oxford, England, who led the trial.

“We decided that the most important thing to look at is the detection rate of clinically significant prostate cancer, because that is why the man is having the biopsy in the first place, rather than to avoid infection, although avoiding infection is of course also important,” Bryant said.

Bryant presented the findings at the 2025 annual congress of the European Association of Urology and his group published the results in The Lancet Oncology.

The TRANSLATE trial was powered to identify a difference in the rate of cancer detection but not factors such as pain and sepsis. Hospitalization after biopsies served as a proxy for sepsis.

Men in the trial were nearly twice as likely to report LATP to be problematic immediately after the procedure than those who underwent transrectal biopsies. These issues included pain, discomfort, and embarrassment.

Two of the 562 men in the LATP group were hospitalized within 35 days of the procedure compared with nine of the 564 in the TRUS group. Bryant said this trend favored LATP, but the difference did not reach statistical significance.

The data on infection and other secondary outcomes were encouraging, but not conclusive, Bryant’s group reported.

Richard Szabo, MD, a prostate biopsy researcher at University of California Irvine, said the reduction in post-biopsy sepsis has been “an additional major advantage” of transperineal over transrectal prostate biopsy.

Almost 90% of men who received LATP had the biopsies without antibiotics — a “bonus,” Bryant said.

Antibiotic stewardship is a major factor in research and policies regarding biopsies in Europe. Transperineal biopsies avoid the rectum and pass needles through the perineum between the anus and the testicles, reducing risk for infection.

Jim Hu, MD, a urologic oncology researcher at Weill Cornell in New York City and the principal investigator on the 2024 PREVENT trial, said three of four randomized trials reported in the past year, including PREVENT and TRANSLATE, have found transperineal biopsies resulted in fewer infections than the transrectal method.

European guidelines call transperineal biopsy the preferred approach based on infection concerns, whereas guidance from the American Urological Association gives equal weight to transperineal and transrectal biopsies.

Badar Mian, MD, a urologist at Albany Med Health System in Albany, New York, said the field should “shift our focus from picking a winner to instead focus on whether prostate biopsy procedures are safe and effective. Patients should be reassured that, while there are trade-offs, both procedures can be performed safely and with a high degree of accuracy.”

The UK’s National Institute for Health and Care Research funded TRANSLATE. Bryant received support from BXTAccelyon to attend biopsy training provided by Guys’ Hospital, in London, England.

Howard Wolinsky is a Chicago-based freelance writer.

A version of this article appeared at Medscape.com.

In the largest head-to-head randomized trial of its kind, UK researchers found transperineal prostate biopsies using local anesthesia (LATP) superior to the transrectal approach in detecting clinically significant cancers.

The TRANSLATE study, with more than 1100 patients, found LATP identified 5.7% more cases of clinically significant prostate cancer, defined as Grade Group 2 or higher, than biopsies using transrectal ultrasonography (TRUS).

Previous research comparing the two techniques has focused mainly on rates of infection rather than cancer detection, said Richard Bryant, PhD, a consultant urologist at Nuffield Department of Surgical Sciences, University of Oxford in Oxford, England, who led the trial.

“We decided that the most important thing to look at is the detection rate of clinically significant prostate cancer, because that is why the man is having the biopsy in the first place, rather than to avoid infection, although avoiding infection is of course also important,” Bryant said.

Bryant presented the findings at the 2025 annual congress of the European Association of Urology and his group published the results in The Lancet Oncology.

The TRANSLATE trial was powered to identify a difference in the rate of cancer detection but not factors such as pain and sepsis. Hospitalization after biopsies served as a proxy for sepsis.

Men in the trial were nearly twice as likely to report LATP to be problematic immediately after the procedure than those who underwent transrectal biopsies. These issues included pain, discomfort, and embarrassment.

Two of the 562 men in the LATP group were hospitalized within 35 days of the procedure compared with nine of the 564 in the TRUS group. Bryant said this trend favored LATP, but the difference did not reach statistical significance.

The data on infection and other secondary outcomes were encouraging, but not conclusive, Bryant’s group reported.

Richard Szabo, MD, a prostate biopsy researcher at University of California Irvine, said the reduction in post-biopsy sepsis has been “an additional major advantage” of transperineal over transrectal prostate biopsy.

Almost 90% of men who received LATP had the biopsies without antibiotics — a “bonus,” Bryant said.

Antibiotic stewardship is a major factor in research and policies regarding biopsies in Europe. Transperineal biopsies avoid the rectum and pass needles through the perineum between the anus and the testicles, reducing risk for infection.

Jim Hu, MD, a urologic oncology researcher at Weill Cornell in New York City and the principal investigator on the 2024 PREVENT trial, said three of four randomized trials reported in the past year, including PREVENT and TRANSLATE, have found transperineal biopsies resulted in fewer infections than the transrectal method.

European guidelines call transperineal biopsy the preferred approach based on infection concerns, whereas guidance from the American Urological Association gives equal weight to transperineal and transrectal biopsies.

Badar Mian, MD, a urologist at Albany Med Health System in Albany, New York, said the field should “shift our focus from picking a winner to instead focus on whether prostate biopsy procedures are safe and effective. Patients should be reassured that, while there are trade-offs, both procedures can be performed safely and with a high degree of accuracy.”

The UK’s National Institute for Health and Care Research funded TRANSLATE. Bryant received support from BXTAccelyon to attend biopsy training provided by Guys’ Hospital, in London, England.

Howard Wolinsky is a Chicago-based freelance writer.

A version of this article appeared at Medscape.com.

Micro-ultrasound–guided biopsies were found for the first time to be “noninferior” to MRI-guided procedures, according to new research presented at the 2025 annual congress of the European Association of Urology.

The OPTIMUM study found 4.5% more clinically significant cancers among men who underwent micro-ultrasound–guided biopsies of the prostate than in those scanned using MRI.

“The take-home message is that men being worked up for an elevated PSA [prostate-specific antigen] or an abnormal digital rectal examination who are at increased risk of prostate cancer may safely undergo a micro-ultrasound–guided biopsy rather than an MRI-guided biopsy,” said Adam Kinnaird, MD, PhD, the Frank and Carla Sojonky Chair in Prostate Cancer Research at the University of Alberta, Edmonton, Alberta, Canada, and principal investigator of the study.

Micro-ultrasound can image to as small as 70 μm, ie, the width of a human hair.

OPTIMUM was an international, open-label, randomized, noninferiority trial in 20 centers in eight countries of men with clinical suspicion of prostate cancer, elevated PSAs, abnormal digital rectal exams, or a combination of these risk factors. None of the men previously had undergone biopsies.

The study had three arms to which men were assigned randomly: Micro-ultrasound–guided biopsy (n = 121); biopsies guided by micro-ultrasound and fusion MRI (n = 226), and MRI plus conventional ultrasound–guided biopsy (n = 331).

Subjects had a median age of 65 years and a median PSA level of 6.9 ng/mL; 83% self-identified as White individuals.

“Micro-ultrasound was found to be no worse than MRI at the detection of clinically significant prostate cancer. We don’t show it is equivalent. We don’t show it better. We show it is not worse,” Kinnaird said.

The study, funded by Exact Imaging, which makes the ExactVu micro-ultrasound platform, appeared simultaneously in JAMA.

Laurence Klotz, MD, the Sunnybrook Chair of Prostate Cancer Research at the University of Toronto Sunnybrook Health Sciences Centre, and senior researcher on the OPTIMUM trial, said as the incidence of prostate cancer rises globally, micro-ultrasound may be of particular value in low-income and middle-income countries where MRI is not widely available. 

“It’s extremely appealing in places that can’t offer MRI to everyone, but I think it also will have a role going forward in regions where there is no problem about getting access to MRI,” Klotz told Medscape Medical News.

This group is next studying the financial aspects of the technology, he added.

Gerald Andriole, MD, then urology chief at Washington University in St. Louis, St. Louis, Missouri, designed the original studies of the ExactVu system, which the US Food and Drug Administration approved in 2017.

Andriole, now chief medical officer of Prostatype Genomics, said MRIs are costly, subjective, and uncomfortable for many patients, due to claustrophobia and obesity, requiring complicated co-registration procedures to perform an accurate targeted biopsy into the most worrisome regions of the prostate. “Proceeding directly to a micro-ultrasound study avoids these impediments to discovering whether the patient has clinically significant cancer,” he said.

Micro-ultrasound testing involves a single visit to a urologist whereas MRI requires two trips for the patient — one to the urologist and the other to a radiologist, Klotz said. “It’s one-stop shopping,” he said. “So, the patient has his micro-ultrasound. If there’s a target found, he then does the targeted biopsy.”

Klotz said micro-ultrasound helps patients avoid the expense and health risks of gadolinium in contrast with MRIs.

“I don’t think micro-ultrasound is going to replace MRIs,” he said. “I think they’re somewhat complementary. You get cases where they’re visible on MRI and not visible on micro-ultrasound and vice versa.”

The researchers received a grant from Exact Imaging. 

A version of this article appeared at Medscape.com.

Howard Wolinsky is a Chicago-based freelance writer.

Micro-ultrasound–guided biopsies were found for the first time to be “noninferior” to MRI-guided procedures, according to new research presented at the 2025 annual congress of the European Association of Urology.

The OPTIMUM study found 4.5% more clinically significant cancers among men who underwent micro-ultrasound–guided biopsies of the prostate than in those scanned using MRI.

“The take-home message is that men being worked up for an elevated PSA [prostate-specific antigen] or an abnormal digital rectal examination who are at increased risk of prostate cancer may safely undergo a micro-ultrasound–guided biopsy rather than an MRI-guided biopsy,” said Adam Kinnaird, MD, PhD, the Frank and Carla Sojonky Chair in Prostate Cancer Research at the University of Alberta, Edmonton, Alberta, Canada, and principal investigator of the study.

Micro-ultrasound can image to as small as 70 μm, ie, the width of a human hair.

OPTIMUM was an international, open-label, randomized, noninferiority trial in 20 centers in eight countries of men with clinical suspicion of prostate cancer, elevated PSAs, abnormal digital rectal exams, or a combination of these risk factors. None of the men previously had undergone biopsies.

The study had three arms to which men were assigned randomly: Micro-ultrasound–guided biopsy (n = 121); biopsies guided by micro-ultrasound and fusion MRI (n = 226), and MRI plus conventional ultrasound–guided biopsy (n = 331).

Subjects had a median age of 65 years and a median PSA level of 6.9 ng/mL; 83% self-identified as White individuals.

“Micro-ultrasound was found to be no worse than MRI at the detection of clinically significant prostate cancer. We don’t show it is equivalent. We don’t show it better. We show it is not worse,” Kinnaird said.

The study, funded by Exact Imaging, which makes the ExactVu micro-ultrasound platform, appeared simultaneously in JAMA.

Laurence Klotz, MD, the Sunnybrook Chair of Prostate Cancer Research at the University of Toronto Sunnybrook Health Sciences Centre, and senior researcher on the OPTIMUM trial, said as the incidence of prostate cancer rises globally, micro-ultrasound may be of particular value in low-income and middle-income countries where MRI is not widely available. 

“It’s extremely appealing in places that can’t offer MRI to everyone, but I think it also will have a role going forward in regions where there is no problem about getting access to MRI,” Klotz told Medscape Medical News.

This group is next studying the financial aspects of the technology, he added.

Gerald Andriole, MD, then urology chief at Washington University in St. Louis, St. Louis, Missouri, designed the original studies of the ExactVu system, which the US Food and Drug Administration approved in 2017.

Andriole, now chief medical officer of Prostatype Genomics, said MRIs are costly, subjective, and uncomfortable for many patients, due to claustrophobia and obesity, requiring complicated co-registration procedures to perform an accurate targeted biopsy into the most worrisome regions of the prostate. “Proceeding directly to a micro-ultrasound study avoids these impediments to discovering whether the patient has clinically significant cancer,” he said.

Micro-ultrasound testing involves a single visit to a urologist whereas MRI requires two trips for the patient — one to the urologist and the other to a radiologist, Klotz said. “It’s one-stop shopping,” he said. “So, the patient has his micro-ultrasound. If there’s a target found, he then does the targeted biopsy.”

Klotz said micro-ultrasound helps patients avoid the expense and health risks of gadolinium in contrast with MRIs.

“I don’t think micro-ultrasound is going to replace MRIs,” he said. “I think they’re somewhat complementary. You get cases where they’re visible on MRI and not visible on micro-ultrasound and vice versa.”

The researchers received a grant from Exact Imaging. 

A version of this article appeared at Medscape.com.

Howard Wolinsky is a Chicago-based freelance writer.

Micro-ultrasound–guided biopsies were found for the first time to be “noninferior” to MRI-guided procedures, according to new research presented at the 2025 annual congress of the European Association of Urology.

The OPTIMUM study found 4.5% more clinically significant cancers among men who underwent micro-ultrasound–guided biopsies of the prostate than in those scanned using MRI.

“The take-home message is that men being worked up for an elevated PSA [prostate-specific antigen] or an abnormal digital rectal examination who are at increased risk of prostate cancer may safely undergo a micro-ultrasound–guided biopsy rather than an MRI-guided biopsy,” said Adam Kinnaird, MD, PhD, the Frank and Carla Sojonky Chair in Prostate Cancer Research at the University of Alberta, Edmonton, Alberta, Canada, and principal investigator of the study.

Micro-ultrasound can image to as small as 70 μm, ie, the width of a human hair.

OPTIMUM was an international, open-label, randomized, noninferiority trial in 20 centers in eight countries of men with clinical suspicion of prostate cancer, elevated PSAs, abnormal digital rectal exams, or a combination of these risk factors. None of the men previously had undergone biopsies.

The study had three arms to which men were assigned randomly: Micro-ultrasound–guided biopsy (n = 121); biopsies guided by micro-ultrasound and fusion MRI (n = 226), and MRI plus conventional ultrasound–guided biopsy (n = 331).

Subjects had a median age of 65 years and a median PSA level of 6.9 ng/mL; 83% self-identified as White individuals.

“Micro-ultrasound was found to be no worse than MRI at the detection of clinically significant prostate cancer. We don’t show it is equivalent. We don’t show it better. We show it is not worse,” Kinnaird said.

The study, funded by Exact Imaging, which makes the ExactVu micro-ultrasound platform, appeared simultaneously in JAMA.

Laurence Klotz, MD, the Sunnybrook Chair of Prostate Cancer Research at the University of Toronto Sunnybrook Health Sciences Centre, and senior researcher on the OPTIMUM trial, said as the incidence of prostate cancer rises globally, micro-ultrasound may be of particular value in low-income and middle-income countries where MRI is not widely available. 

“It’s extremely appealing in places that can’t offer MRI to everyone, but I think it also will have a role going forward in regions where there is no problem about getting access to MRI,” Klotz told Medscape Medical News.

This group is next studying the financial aspects of the technology, he added.

Gerald Andriole, MD, then urology chief at Washington University in St. Louis, St. Louis, Missouri, designed the original studies of the ExactVu system, which the US Food and Drug Administration approved in 2017.

Andriole, now chief medical officer of Prostatype Genomics, said MRIs are costly, subjective, and uncomfortable for many patients, due to claustrophobia and obesity, requiring complicated co-registration procedures to perform an accurate targeted biopsy into the most worrisome regions of the prostate. “Proceeding directly to a micro-ultrasound study avoids these impediments to discovering whether the patient has clinically significant cancer,” he said.

Micro-ultrasound testing involves a single visit to a urologist whereas MRI requires two trips for the patient — one to the urologist and the other to a radiologist, Klotz said. “It’s one-stop shopping,” he said. “So, the patient has his micro-ultrasound. If there’s a target found, he then does the targeted biopsy.”

Klotz said micro-ultrasound helps patients avoid the expense and health risks of gadolinium in contrast with MRIs.

“I don’t think micro-ultrasound is going to replace MRIs,” he said. “I think they’re somewhat complementary. You get cases where they’re visible on MRI and not visible on micro-ultrasound and vice versa.”

The researchers received a grant from Exact Imaging. 

A version of this article appeared at Medscape.com.

Howard Wolinsky is a Chicago-based freelance writer.

BOSTON — Solid intraductal carcinoma of the prostate (IDC-P) is associated with significantly worse outcomes compared with conventional Gleason grade 5 prostate cancers and is more commonly present in metastatic than nonmetastatic cancers, according to two studies presented this week at the United States and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting.

“Our findings suggest that solid IDC-P is more aggressive than Gleason grade 5 conventional prostate adenocarcinoma or cribriform IDC-P,” and it may therefore be better not to consider it as a grade 5 pattern, said first author of one of the studies, Hangchuan Shi, MD, PhD, of the University of Rochester Medical Center, in Rochester, New York.

Although IDC-P — reported in about 20% of men with prostate cancer — is known to be associated with poorer response to treatment, there is a debate over whether to grade the entity with Gleason scoring or not.

The International Society of Urological Pathology recommends incorporating IDC-P into the Gleason score, while the Genitourinary Pathology Society does not.

To evaluate the prognostic significance of solid IDC-P compared with Gleason grade 5 conventional prostate cancer, Shi and his colleagues identified 115 cases in the surgical pathology database at the University of Rochester Medical Center between 2008 and 2015 involving Gleason grade 5 conventional prostatic adenocarcinoma as a primary, secondary, or tertiary pattern, as well as cribriform IDC-P.

The researchers excluded cases showing comedonecrosis within IDC-P, due to the potential for worse outcomes.

Of the grade 5 conventional prostate cancer cases with cribriform carcinoma, 28 (24.3%) had solid nest pattern IDC-P. Patients with and without solid IDC-P had a matching mean age of about 64 years, and their mean preoperative PSA was about 12.27 ng/mL.

Adjuvant therapy prior to recurrence was significantly more common in those who had solid IDC-P (60.7% vs 34.5%; P = .016).

Compared with the conventional prostate cancer cases, those with solid IDC-P had a significantly higher incidence of lymph node metastasis (P = .014) and had larger estimated tumor volume (P = .011).

There were no significant differences in other clinicopathologic features, such as preoperative prostate-specific antigen, grade group, pT stage, and surgical margin status.

After adjustment for key factors in a multivariable analysis, solid IDC-P was significantly associated with poorer recurrence-free survival (P = .007), and poorer cancer-specific survival (P = .004).

Finally, solid IDC-P was an independent predictor of recurrence (hazard ratio [HR] 1.960; P = .031), whereas other measures, including prostate-specific antigen (PSA), cancer grade, pT, lymph node metastasis, surgical and tumor volume were not significant factors.

“We found the solid IDC-P patients had almost two-times the risk of recurrence compared with the patients without solid IDC-P in our study,” Shi said.

The findings underscore the importance of accurately identifying IDC-P, senior author Hiroshi Miyamoto, MD, PhD, director of Genitourinary Pathology at School of Medicine and Dentistry, University of Rochester, Rochester, New York, told Medscape Medical News.

“It may be difficult for some pathologists, especially those who have no specific training in genitourinary pathology, to adequately recognize” this form of cancer, he said.

Although it is recognized as an aggressive form of prostate cancer, “based on our studies, we believe that it is inadequate to grade IDC-P” as a Gleason grade 5 cancer, Miyamoto added.

IDC More Common in Metastases 

Poorer outcomes associated with IDC-P were further described in a post hoc sub-analysis of the phase 3, prospective PATRON clinical trial that is evaluating prostate-specific membrane antigen (PSMA) PET-CT–guided intensification of therapy.

In the multicenter trial, 825 patients were stratified into three cohorts: High-risk patients receiving radiation therapy (45%), high-risk patients receiving salvage radiation therapy post-radical prostatectomy (47%), and those receiving a radical prostatectomy (8%).

The patients in all three cohorts were randomized 1:1 to receive imaging with or without PSMA PET-CT.

IDC-P and/or cribriform carcinoma were present among 342 patients in the PSMA PET-CT group including 48% of high-risk patients receiving radiotherapy, 42% of high-risk patients receiving salvage radiation therapy post-radical prostatectomy, and 40% of those receiving a radical prostatectomy.

IDC-P was reported in 64% of cases with metastases detected by PSMA PET-CT compared with just 36% of cases without metastasis (P = .008), with the ratios being similar in each individual patient cohort.

Of note, the association between the presence of IDC-P and metastases was not observed when IDC-P and cribriform carcinoma were combined — IDC-P and/or cribriform carcinoma was detected in 54% of cases with PSMA PET-CT–detectable metastasis and in 46% of cases without metastasis (P = .362).

The first author Dominique Trudel, MD, PhD, of the Centre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada, said the findings add to understanding of IDC-P’s relationship with poorer outcomes.

“As pathologists, we know that IDC is associated with poor outcomes and that men with IDC who are treated with standard therapies do benefit from them, but they never benefit as much as men without IDC,” she told Medscape Medical News.

As the study is ongoing, “in approximately 4-5 years, we will know how much of a difference IDC-P makes in outcomes after treatment,” Trudel noted.

The take-home message from the collective research should be that “IDC-P matters,” she said.

“I think that if your patient has IDC-P and [cribriform carcinoma], it is worth at least asking someone from an academic center to see what the treatment options are. We know that some radiation oncologists are increasing doses for IDC-P. It is empiric, but they’re doing it,” she explained.

The authors had no disclosures to report.

The article first appeared in Medscape.com.

BOSTON — Solid intraductal carcinoma of the prostate (IDC-P) is associated with significantly worse outcomes compared with conventional Gleason grade 5 prostate cancers and is more commonly present in metastatic than nonmetastatic cancers, according to two studies presented this week at the United States and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting.

“Our findings suggest that solid IDC-P is more aggressive than Gleason grade 5 conventional prostate adenocarcinoma or cribriform IDC-P,” and it may therefore be better not to consider it as a grade 5 pattern, said first author of one of the studies, Hangchuan Shi, MD, PhD, of the University of Rochester Medical Center, in Rochester, New York.

Although IDC-P — reported in about 20% of men with prostate cancer — is known to be associated with poorer response to treatment, there is a debate over whether to grade the entity with Gleason scoring or not.

The International Society of Urological Pathology recommends incorporating IDC-P into the Gleason score, while the Genitourinary Pathology Society does not.

To evaluate the prognostic significance of solid IDC-P compared with Gleason grade 5 conventional prostate cancer, Shi and his colleagues identified 115 cases in the surgical pathology database at the University of Rochester Medical Center between 2008 and 2015 involving Gleason grade 5 conventional prostatic adenocarcinoma as a primary, secondary, or tertiary pattern, as well as cribriform IDC-P.

The researchers excluded cases showing comedonecrosis within IDC-P, due to the potential for worse outcomes.

Of the grade 5 conventional prostate cancer cases with cribriform carcinoma, 28 (24.3%) had solid nest pattern IDC-P. Patients with and without solid IDC-P had a matching mean age of about 64 years, and their mean preoperative PSA was about 12.27 ng/mL.

Adjuvant therapy prior to recurrence was significantly more common in those who had solid IDC-P (60.7% vs 34.5%; P = .016).

Compared with the conventional prostate cancer cases, those with solid IDC-P had a significantly higher incidence of lymph node metastasis (P = .014) and had larger estimated tumor volume (P = .011).

There were no significant differences in other clinicopathologic features, such as preoperative prostate-specific antigen, grade group, pT stage, and surgical margin status.

After adjustment for key factors in a multivariable analysis, solid IDC-P was significantly associated with poorer recurrence-free survival (P = .007), and poorer cancer-specific survival (P = .004).

Finally, solid IDC-P was an independent predictor of recurrence (hazard ratio [HR] 1.960; P = .031), whereas other measures, including prostate-specific antigen (PSA), cancer grade, pT, lymph node metastasis, surgical and tumor volume were not significant factors.

“We found the solid IDC-P patients had almost two-times the risk of recurrence compared with the patients without solid IDC-P in our study,” Shi said.

The findings underscore the importance of accurately identifying IDC-P, senior author Hiroshi Miyamoto, MD, PhD, director of Genitourinary Pathology at School of Medicine and Dentistry, University of Rochester, Rochester, New York, told Medscape Medical News.

“It may be difficult for some pathologists, especially those who have no specific training in genitourinary pathology, to adequately recognize” this form of cancer, he said.

Although it is recognized as an aggressive form of prostate cancer, “based on our studies, we believe that it is inadequate to grade IDC-P” as a Gleason grade 5 cancer, Miyamoto added.

IDC More Common in Metastases 

Poorer outcomes associated with IDC-P were further described in a post hoc sub-analysis of the phase 3, prospective PATRON clinical trial that is evaluating prostate-specific membrane antigen (PSMA) PET-CT–guided intensification of therapy.

In the multicenter trial, 825 patients were stratified into three cohorts: High-risk patients receiving radiation therapy (45%), high-risk patients receiving salvage radiation therapy post-radical prostatectomy (47%), and those receiving a radical prostatectomy (8%).

The patients in all three cohorts were randomized 1:1 to receive imaging with or without PSMA PET-CT.

IDC-P and/or cribriform carcinoma were present among 342 patients in the PSMA PET-CT group including 48% of high-risk patients receiving radiotherapy, 42% of high-risk patients receiving salvage radiation therapy post-radical prostatectomy, and 40% of those receiving a radical prostatectomy.

IDC-P was reported in 64% of cases with metastases detected by PSMA PET-CT compared with just 36% of cases without metastasis (P = .008), with the ratios being similar in each individual patient cohort.

Of note, the association between the presence of IDC-P and metastases was not observed when IDC-P and cribriform carcinoma were combined — IDC-P and/or cribriform carcinoma was detected in 54% of cases with PSMA PET-CT–detectable metastasis and in 46% of cases without metastasis (P = .362).

The first author Dominique Trudel, MD, PhD, of the Centre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada, said the findings add to understanding of IDC-P’s relationship with poorer outcomes.

“As pathologists, we know that IDC is associated with poor outcomes and that men with IDC who are treated with standard therapies do benefit from them, but they never benefit as much as men without IDC,” she told Medscape Medical News.

As the study is ongoing, “in approximately 4-5 years, we will know how much of a difference IDC-P makes in outcomes after treatment,” Trudel noted.

The take-home message from the collective research should be that “IDC-P matters,” she said.

“I think that if your patient has IDC-P and [cribriform carcinoma], it is worth at least asking someone from an academic center to see what the treatment options are. We know that some radiation oncologists are increasing doses for IDC-P. It is empiric, but they’re doing it,” she explained.

The authors had no disclosures to report.

The article first appeared in Medscape.com.

BOSTON — Solid intraductal carcinoma of the prostate (IDC-P) is associated with significantly worse outcomes compared with conventional Gleason grade 5 prostate cancers and is more commonly present in metastatic than nonmetastatic cancers, according to two studies presented this week at the United States and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting.

“Our findings suggest that solid IDC-P is more aggressive than Gleason grade 5 conventional prostate adenocarcinoma or cribriform IDC-P,” and it may therefore be better not to consider it as a grade 5 pattern, said first author of one of the studies, Hangchuan Shi, MD, PhD, of the University of Rochester Medical Center, in Rochester, New York.

Although IDC-P — reported in about 20% of men with prostate cancer — is known to be associated with poorer response to treatment, there is a debate over whether to grade the entity with Gleason scoring or not.

The International Society of Urological Pathology recommends incorporating IDC-P into the Gleason score, while the Genitourinary Pathology Society does not.

To evaluate the prognostic significance of solid IDC-P compared with Gleason grade 5 conventional prostate cancer, Shi and his colleagues identified 115 cases in the surgical pathology database at the University of Rochester Medical Center between 2008 and 2015 involving Gleason grade 5 conventional prostatic adenocarcinoma as a primary, secondary, or tertiary pattern, as well as cribriform IDC-P.

The researchers excluded cases showing comedonecrosis within IDC-P, due to the potential for worse outcomes.

Of the grade 5 conventional prostate cancer cases with cribriform carcinoma, 28 (24.3%) had solid nest pattern IDC-P. Patients with and without solid IDC-P had a matching mean age of about 64 years, and their mean preoperative PSA was about 12.27 ng/mL.

Adjuvant therapy prior to recurrence was significantly more common in those who had solid IDC-P (60.7% vs 34.5%; P = .016).

Compared with the conventional prostate cancer cases, those with solid IDC-P had a significantly higher incidence of lymph node metastasis (P = .014) and had larger estimated tumor volume (P = .011).

There were no significant differences in other clinicopathologic features, such as preoperative prostate-specific antigen, grade group, pT stage, and surgical margin status.

After adjustment for key factors in a multivariable analysis, solid IDC-P was significantly associated with poorer recurrence-free survival (P = .007), and poorer cancer-specific survival (P = .004).

Finally, solid IDC-P was an independent predictor of recurrence (hazard ratio [HR] 1.960; P = .031), whereas other measures, including prostate-specific antigen (PSA), cancer grade, pT, lymph node metastasis, surgical and tumor volume were not significant factors.

“We found the solid IDC-P patients had almost two-times the risk of recurrence compared with the patients without solid IDC-P in our study,” Shi said.

The findings underscore the importance of accurately identifying IDC-P, senior author Hiroshi Miyamoto, MD, PhD, director of Genitourinary Pathology at School of Medicine and Dentistry, University of Rochester, Rochester, New York, told Medscape Medical News.

“It may be difficult for some pathologists, especially those who have no specific training in genitourinary pathology, to adequately recognize” this form of cancer, he said.

Although it is recognized as an aggressive form of prostate cancer, “based on our studies, we believe that it is inadequate to grade IDC-P” as a Gleason grade 5 cancer, Miyamoto added.

IDC More Common in Metastases 

Poorer outcomes associated with IDC-P were further described in a post hoc sub-analysis of the phase 3, prospective PATRON clinical trial that is evaluating prostate-specific membrane antigen (PSMA) PET-CT–guided intensification of therapy.

In the multicenter trial, 825 patients were stratified into three cohorts: High-risk patients receiving radiation therapy (45%), high-risk patients receiving salvage radiation therapy post-radical prostatectomy (47%), and those receiving a radical prostatectomy (8%).

The patients in all three cohorts were randomized 1:1 to receive imaging with or without PSMA PET-CT.

IDC-P and/or cribriform carcinoma were present among 342 patients in the PSMA PET-CT group including 48% of high-risk patients receiving radiotherapy, 42% of high-risk patients receiving salvage radiation therapy post-radical prostatectomy, and 40% of those receiving a radical prostatectomy.

IDC-P was reported in 64% of cases with metastases detected by PSMA PET-CT compared with just 36% of cases without metastasis (P = .008), with the ratios being similar in each individual patient cohort.

Of note, the association between the presence of IDC-P and metastases was not observed when IDC-P and cribriform carcinoma were combined — IDC-P and/or cribriform carcinoma was detected in 54% of cases with PSMA PET-CT–detectable metastasis and in 46% of cases without metastasis (P = .362).

The first author Dominique Trudel, MD, PhD, of the Centre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada, said the findings add to understanding of IDC-P’s relationship with poorer outcomes.

“As pathologists, we know that IDC is associated with poor outcomes and that men with IDC who are treated with standard therapies do benefit from them, but they never benefit as much as men without IDC,” she told Medscape Medical News.

As the study is ongoing, “in approximately 4-5 years, we will know how much of a difference IDC-P makes in outcomes after treatment,” Trudel noted.

The take-home message from the collective research should be that “IDC-P matters,” she said.

“I think that if your patient has IDC-P and [cribriform carcinoma], it is worth at least asking someone from an academic center to see what the treatment options are. We know that some radiation oncologists are increasing doses for IDC-P. It is empiric, but they’re doing it,” she explained.

The authors had no disclosures to report.

The article first appeared in Medscape.com.

SAN FRANCISCO (Reuters) — Joey Cortez, who served 24 years in the US Air Force, had been waiting since August to see a mental health specialist from the Department of Veterans’ Affairs, when he experienced a fresh jolt of anxiety.

Cortez was fired last month from his human resources job at the agency - one of about 2400 employees who lost their jobs at Veterans’ Affairs (VA) in the first wave of President Donald Trump’s efforts to shrink the federal workforce.

“Once the firings happened and I was terminated, I started having panic attacks to the point where I black out,” Cortez, who suffers from post-traumatic stress disorder, told Reuters. The layoff is also making it harder to maintain his sobriety, as a recovering alcoholic.

“Not a day has gone by since I was fired that I haven’t thought about picking up a bottle,” said Cortez.

After losing his job, Cortez asked the VA to expedite his wait for a therapist and was told there was no record of his request, he said. After a month of calls to the agency, he got an appointment for this August, one year after he started the process. Then the VA offered him an appointment next week because another patient had canceled.

The VA provides health care to 9.31 million US veterans at hundreds of medical centers, clinics, and nursing homes across the country.

It also faces complex problems.

“The VA has bloat. There are redundancies. There are places where we have questioned the administration of care and asked, does it need to be the way it is?” Pat Murray, the legislative director for the Veterans of Foreign Wars, which represents Americans who have fought overseas, said in an interview.

The Trump administration plans additional cuts to the VA of more than 80,000 personnel, according to an internal memo obtained by Reuters. The agency has also announced it is phasing out telework.

Reuters spoke to nine current and former VA employees in California, Oregon, Texas, and the Washington D.C. area who said the changes were further disrupting some mental health services and fueling anxieties among those who provide and rely on them.

The VA employees — who include six mental health professionals and three people in leadership positions — described cancellations of some in-person and telehealth appointments; confusion over staffing of a crisis hot-line; and professionals conducting telehealth visits in makeshift meeting rooms inside VA buildings.

They spoke on the condition of anonymity, because they were not authorized to speak with the media.

 

STAFFING SHORTAGES

A former employee at the VA’s Office of Inspector General, who is also a veteran, said any future large-scale staffing cuts would likely worsen shortages and impact the quality of care.

“There’s no way to take a scalpel and do it appropriately that quickly,” he said.

VA spokesperson Peter Kasperowicz told Reuters mental health professionals, such as psychologists and social workers, were not included in February’s staffing cuts, and the agency is working to recruit mental health providers and improve wait times.

He did not specify how many support staff for these providers had been affected.

Last week, two federal judges ordered the VA and other federal agencies to reinstate thousands of fired probationary workers. Cortez’s pay was reinstated but he was told not to return to work.

The Veterans Health Administration, the branch of the VA that provides healthcare, has experienced severe staffing shortages since 2015, especially among mental health professionals, according to an OIG report last year.

Veterans often benefit from specialized services to treat anxiety, trauma, depression and substance abuse. The proportion of veterans receiving mental health services rose to 31% in 2022 from 20% in 2007, according to the VA. Suicide among veterans is twice the rate of Americans overall.

The VFW’s Murray said his organization supports a thorough review of the VA’s mental health services, but it needs to be done carefully, “not with a chainsaw.”

 

‘THE MOOD IS SO LOW’

In recent years, the agency had encouraged remote work to help expand access to telehealth services and reduce wait times, especially in rural areas where recruiting providers is difficult.

The VA’s Kasperowicz said that, while providers will need to return to VA facilities, veterans will be able to access telehealth appointments.

He did not directly address questions about why mental health providers needed to return to the office.

“The VA will make accommodations as needed to ensure employees have enough space to work and will always ensure that Veterans’ access to benefits and services remains uninterrupted as employees return to in-person work,” Kasperowicz said.

In the last few weeks, demand for services among veterans who are VA employees has also risen, one of the mental health professionals, a social worker, told Reuters. A quarter of VA employees are veterans.

The social worker said he is meeting with two to three VA employees a week who are seeking access to mental health care, citing stress and the fear that they will lose their jobs.

“People are calling out sick. People are ill with stress and worry. The mood is so low.”

A mental health supervisor in California described scrambling to cover the caseload of a remote worker who had to cancel appointments with more than a dozen veterans, because she could not access a VA facility.

VA employees in the Washington area and in Oregon said mental health professionals were unsure if they were allowed to answer calls from the VA’s crisis hot-line if they were not physically in an office, because they had been instructed not to conduct work outside of a facility.

“People are nervous to be on-call,” said a supervisor of mental health providers in the Washington area. “The system is under a lot of duress.”

The VA told Reuters that crisis line workers are exempt from the return-to-office policy, and that staff continue to respond quickly to nearly 3000 calls daily.

Therapists returning to the office are struggling to find private meeting rooms at some VA facilities, according to four of the mental health professionals interviewed by Reuters.

They described medical and mental health professionals converting closets and conference rooms into offices to comply with the mandate to conduct telehealth visits from VA facilities. They expressed concerns that the crowded rooms could violate patient privacy rights.

“We are scrambling to find space,” said a provider in California. “Veterans are going without until we can find spaces for these providers.”

Reuters was unable to independently verify the accounts of overcrowding. Kasperowicz said the agency’s “policy is to bring as many employees back to the office as space permits.”

(Reporting by Robin Respaut in San Francisco; additional reporting by Julia Harte in New York and Gabriella Borter in D.C.; Editing by Michele Gershberg and Suzanne Goldenberg)

SAN FRANCISCO (Reuters) — Joey Cortez, who served 24 years in the US Air Force, had been waiting since August to see a mental health specialist from the Department of Veterans’ Affairs, when he experienced a fresh jolt of anxiety.

Cortez was fired last month from his human resources job at the agency - one of about 2400 employees who lost their jobs at Veterans’ Affairs (VA) in the first wave of President Donald Trump’s efforts to shrink the federal workforce.

“Once the firings happened and I was terminated, I started having panic attacks to the point where I black out,” Cortez, who suffers from post-traumatic stress disorder, told Reuters. The layoff is also making it harder to maintain his sobriety, as a recovering alcoholic.

“Not a day has gone by since I was fired that I haven’t thought about picking up a bottle,” said Cortez.

After losing his job, Cortez asked the VA to expedite his wait for a therapist and was told there was no record of his request, he said. After a month of calls to the agency, he got an appointment for this August, one year after he started the process. Then the VA offered him an appointment next week because another patient had canceled.

The VA provides health care to 9.31 million US veterans at hundreds of medical centers, clinics, and nursing homes across the country.

It also faces complex problems.

“The VA has bloat. There are redundancies. There are places where we have questioned the administration of care and asked, does it need to be the way it is?” Pat Murray, the legislative director for the Veterans of Foreign Wars, which represents Americans who have fought overseas, said in an interview.

The Trump administration plans additional cuts to the VA of more than 80,000 personnel, according to an internal memo obtained by Reuters. The agency has also announced it is phasing out telework.

Reuters spoke to nine current and former VA employees in California, Oregon, Texas, and the Washington D.C. area who said the changes were further disrupting some mental health services and fueling anxieties among those who provide and rely on them.

The VA employees — who include six mental health professionals and three people in leadership positions — described cancellations of some in-person and telehealth appointments; confusion over staffing of a crisis hot-line; and professionals conducting telehealth visits in makeshift meeting rooms inside VA buildings.

They spoke on the condition of anonymity, because they were not authorized to speak with the media.

 

STAFFING SHORTAGES

A former employee at the VA’s Office of Inspector General, who is also a veteran, said any future large-scale staffing cuts would likely worsen shortages and impact the quality of care.

“There’s no way to take a scalpel and do it appropriately that quickly,” he said.

VA spokesperson Peter Kasperowicz told Reuters mental health professionals, such as psychologists and social workers, were not included in February’s staffing cuts, and the agency is working to recruit mental health providers and improve wait times.

He did not specify how many support staff for these providers had been affected.

Last week, two federal judges ordered the VA and other federal agencies to reinstate thousands of fired probationary workers. Cortez’s pay was reinstated but he was told not to return to work.

The Veterans Health Administration, the branch of the VA that provides healthcare, has experienced severe staffing shortages since 2015, especially among mental health professionals, according to an OIG report last year.

Veterans often benefit from specialized services to treat anxiety, trauma, depression and substance abuse. The proportion of veterans receiving mental health services rose to 31% in 2022 from 20% in 2007, according to the VA. Suicide among veterans is twice the rate of Americans overall.

The VFW’s Murray said his organization supports a thorough review of the VA’s mental health services, but it needs to be done carefully, “not with a chainsaw.”

 

‘THE MOOD IS SO LOW’

In recent years, the agency had encouraged remote work to help expand access to telehealth services and reduce wait times, especially in rural areas where recruiting providers is difficult.

The VA’s Kasperowicz said that, while providers will need to return to VA facilities, veterans will be able to access telehealth appointments.

He did not directly address questions about why mental health providers needed to return to the office.

“The VA will make accommodations as needed to ensure employees have enough space to work and will always ensure that Veterans’ access to benefits and services remains uninterrupted as employees return to in-person work,” Kasperowicz said.

In the last few weeks, demand for services among veterans who are VA employees has also risen, one of the mental health professionals, a social worker, told Reuters. A quarter of VA employees are veterans.

The social worker said he is meeting with two to three VA employees a week who are seeking access to mental health care, citing stress and the fear that they will lose their jobs.

“People are calling out sick. People are ill with stress and worry. The mood is so low.”

A mental health supervisor in California described scrambling to cover the caseload of a remote worker who had to cancel appointments with more than a dozen veterans, because she could not access a VA facility.

VA employees in the Washington area and in Oregon said mental health professionals were unsure if they were allowed to answer calls from the VA’s crisis hot-line if they were not physically in an office, because they had been instructed not to conduct work outside of a facility.

“People are nervous to be on-call,” said a supervisor of mental health providers in the Washington area. “The system is under a lot of duress.”

The VA told Reuters that crisis line workers are exempt from the return-to-office policy, and that staff continue to respond quickly to nearly 3000 calls daily.

Therapists returning to the office are struggling to find private meeting rooms at some VA facilities, according to four of the mental health professionals interviewed by Reuters.

They described medical and mental health professionals converting closets and conference rooms into offices to comply with the mandate to conduct telehealth visits from VA facilities. They expressed concerns that the crowded rooms could violate patient privacy rights.

“We are scrambling to find space,” said a provider in California. “Veterans are going without until we can find spaces for these providers.”

Reuters was unable to independently verify the accounts of overcrowding. Kasperowicz said the agency’s “policy is to bring as many employees back to the office as space permits.”

(Reporting by Robin Respaut in San Francisco; additional reporting by Julia Harte in New York and Gabriella Borter in D.C.; Editing by Michele Gershberg and Suzanne Goldenberg)

SAN FRANCISCO (Reuters) — Joey Cortez, who served 24 years in the US Air Force, had been waiting since August to see a mental health specialist from the Department of Veterans’ Affairs, when he experienced a fresh jolt of anxiety.

Cortez was fired last month from his human resources job at the agency - one of about 2400 employees who lost their jobs at Veterans’ Affairs (VA) in the first wave of President Donald Trump’s efforts to shrink the federal workforce.

“Once the firings happened and I was terminated, I started having panic attacks to the point where I black out,” Cortez, who suffers from post-traumatic stress disorder, told Reuters. The layoff is also making it harder to maintain his sobriety, as a recovering alcoholic.

“Not a day has gone by since I was fired that I haven’t thought about picking up a bottle,” said Cortez.

After losing his job, Cortez asked the VA to expedite his wait for a therapist and was told there was no record of his request, he said. After a month of calls to the agency, he got an appointment for this August, one year after he started the process. Then the VA offered him an appointment next week because another patient had canceled.

The VA provides health care to 9.31 million US veterans at hundreds of medical centers, clinics, and nursing homes across the country.

It also faces complex problems.

“The VA has bloat. There are redundancies. There are places where we have questioned the administration of care and asked, does it need to be the way it is?” Pat Murray, the legislative director for the Veterans of Foreign Wars, which represents Americans who have fought overseas, said in an interview.

The Trump administration plans additional cuts to the VA of more than 80,000 personnel, according to an internal memo obtained by Reuters. The agency has also announced it is phasing out telework.

Reuters spoke to nine current and former VA employees in California, Oregon, Texas, and the Washington D.C. area who said the changes were further disrupting some mental health services and fueling anxieties among those who provide and rely on them.

The VA employees — who include six mental health professionals and three people in leadership positions — described cancellations of some in-person and telehealth appointments; confusion over staffing of a crisis hot-line; and professionals conducting telehealth visits in makeshift meeting rooms inside VA buildings.

They spoke on the condition of anonymity, because they were not authorized to speak with the media.

 

STAFFING SHORTAGES

A former employee at the VA’s Office of Inspector General, who is also a veteran, said any future large-scale staffing cuts would likely worsen shortages and impact the quality of care.

“There’s no way to take a scalpel and do it appropriately that quickly,” he said.

VA spokesperson Peter Kasperowicz told Reuters mental health professionals, such as psychologists and social workers, were not included in February’s staffing cuts, and the agency is working to recruit mental health providers and improve wait times.

He did not specify how many support staff for these providers had been affected.

Last week, two federal judges ordered the VA and other federal agencies to reinstate thousands of fired probationary workers. Cortez’s pay was reinstated but he was told not to return to work.

The Veterans Health Administration, the branch of the VA that provides healthcare, has experienced severe staffing shortages since 2015, especially among mental health professionals, according to an OIG report last year.

Veterans often benefit from specialized services to treat anxiety, trauma, depression and substance abuse. The proportion of veterans receiving mental health services rose to 31% in 2022 from 20% in 2007, according to the VA. Suicide among veterans is twice the rate of Americans overall.

The VFW’s Murray said his organization supports a thorough review of the VA’s mental health services, but it needs to be done carefully, “not with a chainsaw.”

 

‘THE MOOD IS SO LOW’

In recent years, the agency had encouraged remote work to help expand access to telehealth services and reduce wait times, especially in rural areas where recruiting providers is difficult.

The VA’s Kasperowicz said that, while providers will need to return to VA facilities, veterans will be able to access telehealth appointments.

He did not directly address questions about why mental health providers needed to return to the office.

“The VA will make accommodations as needed to ensure employees have enough space to work and will always ensure that Veterans’ access to benefits and services remains uninterrupted as employees return to in-person work,” Kasperowicz said.

In the last few weeks, demand for services among veterans who are VA employees has also risen, one of the mental health professionals, a social worker, told Reuters. A quarter of VA employees are veterans.

The social worker said he is meeting with two to three VA employees a week who are seeking access to mental health care, citing stress and the fear that they will lose their jobs.

“People are calling out sick. People are ill with stress and worry. The mood is so low.”

A mental health supervisor in California described scrambling to cover the caseload of a remote worker who had to cancel appointments with more than a dozen veterans, because she could not access a VA facility.

VA employees in the Washington area and in Oregon said mental health professionals were unsure if they were allowed to answer calls from the VA’s crisis hot-line if they were not physically in an office, because they had been instructed not to conduct work outside of a facility.

“People are nervous to be on-call,” said a supervisor of mental health providers in the Washington area. “The system is under a lot of duress.”

The VA told Reuters that crisis line workers are exempt from the return-to-office policy, and that staff continue to respond quickly to nearly 3000 calls daily.

Therapists returning to the office are struggling to find private meeting rooms at some VA facilities, according to four of the mental health professionals interviewed by Reuters.

They described medical and mental health professionals converting closets and conference rooms into offices to comply with the mandate to conduct telehealth visits from VA facilities. They expressed concerns that the crowded rooms could violate patient privacy rights.

“We are scrambling to find space,” said a provider in California. “Veterans are going without until we can find spaces for these providers.”

Reuters was unable to independently verify the accounts of overcrowding. Kasperowicz said the agency’s “policy is to bring as many employees back to the office as space permits.”

(Reporting by Robin Respaut in San Francisco; additional reporting by Julia Harte in New York and Gabriella Borter in D.C.; Editing by Michele Gershberg and Suzanne Goldenberg)

New findings on radiation plus adjuvant chemotherapy in patients with intermediate-risk cervical cancer seem to spell the end for the dual therapy in this group. 

Results from a phase 3 clinical trial of 316 women who’d had radical hysterectomies found that adjuvant chemotherapy as treatment for their early-stage, intermediate-risk cervical carcinoma did not improve outcomes but did increase toxicity. The results were the inverse of the study’s intention. 

The NRG-GOG 0263 (NCT01101451) study failed to reach its endpoint of improving recurrence-free survival through the addition of cisplatin chemotherapy, confirming instead that cisplatin chemotherapy given adjuvantly with radiotherapy is not a superior alternative in this cohort. The results were presented during a plenary session of the Society of Gynecologic Oncology Annual Meeting on Women’s Cancers in Seattle, Washington.

The current standard of care in this cohort is for radiotherapy alone, although the National Comprehensive Cancer Network (NCCN) guidelines place adjuvant chemotherapy in category 2B recommendations. 

“Perhaps the NCCN guidelines will have to change what it says here,” Andrew Berchuck, MD, chief of gynecologic oncology and professor of obstetrics and gynecology at Duke University School of Medicine in Durham, North Carolina, told this news organization. Berchuck was not involved in the clinical trial.

The National Cancer Institute lists adjuvant chemotherapy first in its guidelines for this group.

Another study published online this month in JAMA Oncology concluded that morbidity in these patients could be reduced if the use of chemoradiotherapy were de-escalated. 

This population-based cohort study of 1116 women, conducted by Núria Agustí Garcia, MD, postdoctoral fellow at The University of Texas MD Anderson Cancer Center in Houston, and colleagues, found no significant overall survival benefit of adjuvant chemotherapy in intermediate-risk cervical cancer, and that when it was given, patients tended to have larger tumors and nonsquamous cell history. 

The 5-year survival rate in patients who received chemoradiotherapy was 87%, compared with an 87% 5-year survival rate in those who received radiotherapy alone (hazard ratio = 0.85; 95% CI, 0.59-1.23; P =.38).

If the standard of care in this cohort is radiation only, and outcomes are not better in adjuvant treatment, then why is there a controversy at all, and why are some investigators such as Agustí Garcia attempting to clarify adjuvant treatment’s effects?

Experts say it’s because of the history of adjuvant chemotherapy in more advanced cervical cancer and the extrapolations clinicians made when treating patients with intermediate risk.

 

What Is the History of Adjuvant Treatment in Cervical Cancer?

Concomitant therapies in intermediate-risk cervical cancer began in the late 1990s, at a time when it was found effective in more advanced disease, according to Berchuck, who also was not involved in the population study.

“Say back then, you had a stage IIIb cervical cancer. With external radiation alone, followed by brachytherapy internally, the cure rate for something like that would have been maybe 50 or 60%,” Berchuck said in an interview. “Adding cisplatin improved the cure rate by about 15%.”

That cisplatin improved survival rates in advanced disease, led to using it in less advanced cases, according to Berchuck. “The idea here was that if the pathology report indicated a larger tumor involving the lymphatics, the risk of recurrence went up to about 20%, so by adding chemo to postsurgical radiotherapy, you could improve things more than with just radiation alone,” Berchuck said. 

Studies of adjuvant chemotherapy in advanced cervical cancers confused the matter, according to Agustí Garcia. 

“The theoretical benefit of adding chemotherapy to radiotherapy for patients with intermediate-risk cervical cancer has been extrapolated from studies on locally advanced or high-risk cases, for example, those with parametrial or lymph node metastases,” Agustí Garcia said in an interview.

“However, before its implementation, there was no solid evidence supporting this approach in intermediate-risk patients,” she said. “The oncologic behavior of this subgroup may differ, and in the absence of parametrial or lymph node metastasis, chemotherapy may not be necessary.”

 

Do Both Studies Suggest That Radiotherapy Has Become More Effective Recently?

“Probably. Modern radiation techniques, such as IMRT [intensity-modulated radiation therapy] and IGRT [image-guided radiation therapy] are more effective than historical techniques,” said Amer Karam, MD, a clinical professor of obstetrics and gynecology at Stanford University in Palo Alto, California. Karam was not involved in either study mentioned previously.

Agustí Garcia said that while it’s true radiotherapy techniques have improved, these advancements primarily impact morbidity rather than survival outcomes.

“The lack of survival benefit from concomitant chemotherapy in intermediate-risk patients suggests that such benefit may never have existed in this subgroup,” she said.

 

What Explains Why Overall Survival Did Not Significantly Differ Between Patients Who Received Radiotherapy Alone and Those Who Received Chemoradiotherapy?

For Karam, there is a question as to whether chemosensitization mechanisms in radiation therapy, such as reactive oxygen species, inhibition of DNA repair, modulating tumor microenvironment, and cell cycle arrest — all used to induce apoptosis — are as efficacious as once thought.

“Also, systemic chemosensitization may not be as effective at controlling systemic disease beyond the pelvis and radiation field,” he said.

“Radiation is extremely effective in cervical cancer,” said Berchuck. “When you’re giving radiation in a situation like this where there is none, to only microscopic disease, it makes sense that radiation could be effective by itself.”

 

Why in the JAMA Oncology Study Were Larger Tumor Size and Nonsquamous Histology Associated With the Use of Chemoradiotherapy?

All experts agreed this is likely because this subgroup of patients with larger tumors is typically seen as being at higher risk for recurrence. This might be due to what Karam called an “unfavorable histology” and certain tumor characteristics, including depth of invasion.

Yet Agustí Garcia said, in her study, even after propensity score matching, adjuvant chemotherapy did not demonstrate any survival benefit in this subgroup.

“The importance of performing propensity score matching in our analysis was to ensure that populations with comparable baseline recurrence and death risks were being evaluated fairly,” she told this news organization.

 

Do These Findings Change Clinical Practice for Intermediate-Risk Cervical Cancer Treatment?

For Karam, the new evidence in intermediate-risk cervical cancer confirms rather than changes clinical practice. “The standard of care was radiation therapy alone, which is now confirmed, based on the results of GOG 263,” Karam said. “The standard of care for these patients will remain the same.”

Agustí Garcia said her study results can help “refine” clinical practice.

“The results suggest that adjuvant therapy could be safely de-escalated in intermediate-risk cervical cancer,” Agustí Garcia said. 

“We should avoid chemotherapy when there is no evidence-based benefit, reserving its use for locally advanced or high-risk cases, refining clinical guidelines to ensure treatment recommendations are based on higher-quality evidence, thereby standardizing care and reducing overtreatment,” she continued. “Current guidelines lack consensus and rely on lower-quality evidence.”

Agustí Garcia reported grants from Fundación Alfonso Martín Escudero. Berchuck has no disclosures. Karam reported royalties from UpToDate and that he is a speaker for AstraZeneca.

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

New findings on radiation plus adjuvant chemotherapy in patients with intermediate-risk cervical cancer seem to spell the end for the dual therapy in this group. 

Results from a phase 3 clinical trial of 316 women who’d had radical hysterectomies found that adjuvant chemotherapy as treatment for their early-stage, intermediate-risk cervical carcinoma did not improve outcomes but did increase toxicity. The results were the inverse of the study’s intention. 

The NRG-GOG 0263 (NCT01101451) study failed to reach its endpoint of improving recurrence-free survival through the addition of cisplatin chemotherapy, confirming instead that cisplatin chemotherapy given adjuvantly with radiotherapy is not a superior alternative in this cohort. The results were presented during a plenary session of the Society of Gynecologic Oncology Annual Meeting on Women’s Cancers in Seattle, Washington.

The current standard of care in this cohort is for radiotherapy alone, although the National Comprehensive Cancer Network (NCCN) guidelines place adjuvant chemotherapy in category 2B recommendations. 

“Perhaps the NCCN guidelines will have to change what it says here,” Andrew Berchuck, MD, chief of gynecologic oncology and professor of obstetrics and gynecology at Duke University School of Medicine in Durham, North Carolina, told this news organization. Berchuck was not involved in the clinical trial.

The National Cancer Institute lists adjuvant chemotherapy first in its guidelines for this group.

Another study published online this month in JAMA Oncology concluded that morbidity in these patients could be reduced if the use of chemoradiotherapy were de-escalated. 

This population-based cohort study of 1116 women, conducted by Núria Agustí Garcia, MD, postdoctoral fellow at The University of Texas MD Anderson Cancer Center in Houston, and colleagues, found no significant overall survival benefit of adjuvant chemotherapy in intermediate-risk cervical cancer, and that when it was given, patients tended to have larger tumors and nonsquamous cell history. 

The 5-year survival rate in patients who received chemoradiotherapy was 87%, compared with an 87% 5-year survival rate in those who received radiotherapy alone (hazard ratio = 0.85; 95% CI, 0.59-1.23; P =.38).

If the standard of care in this cohort is radiation only, and outcomes are not better in adjuvant treatment, then why is there a controversy at all, and why are some investigators such as Agustí Garcia attempting to clarify adjuvant treatment’s effects?

Experts say it’s because of the history of adjuvant chemotherapy in more advanced cervical cancer and the extrapolations clinicians made when treating patients with intermediate risk.

 

What Is the History of Adjuvant Treatment in Cervical Cancer?

Concomitant therapies in intermediate-risk cervical cancer began in the late 1990s, at a time when it was found effective in more advanced disease, according to Berchuck, who also was not involved in the population study.

“Say back then, you had a stage IIIb cervical cancer. With external radiation alone, followed by brachytherapy internally, the cure rate for something like that would have been maybe 50 or 60%,” Berchuck said in an interview. “Adding cisplatin improved the cure rate by about 15%.”

That cisplatin improved survival rates in advanced disease, led to using it in less advanced cases, according to Berchuck. “The idea here was that if the pathology report indicated a larger tumor involving the lymphatics, the risk of recurrence went up to about 20%, so by adding chemo to postsurgical radiotherapy, you could improve things more than with just radiation alone,” Berchuck said. 

Studies of adjuvant chemotherapy in advanced cervical cancers confused the matter, according to Agustí Garcia. 

“The theoretical benefit of adding chemotherapy to radiotherapy for patients with intermediate-risk cervical cancer has been extrapolated from studies on locally advanced or high-risk cases, for example, those with parametrial or lymph node metastases,” Agustí Garcia said in an interview.

“However, before its implementation, there was no solid evidence supporting this approach in intermediate-risk patients,” she said. “The oncologic behavior of this subgroup may differ, and in the absence of parametrial or lymph node metastasis, chemotherapy may not be necessary.”

 

Do Both Studies Suggest That Radiotherapy Has Become More Effective Recently?

“Probably. Modern radiation techniques, such as IMRT [intensity-modulated radiation therapy] and IGRT [image-guided radiation therapy] are more effective than historical techniques,” said Amer Karam, MD, a clinical professor of obstetrics and gynecology at Stanford University in Palo Alto, California. Karam was not involved in either study mentioned previously.

Agustí Garcia said that while it’s true radiotherapy techniques have improved, these advancements primarily impact morbidity rather than survival outcomes.

“The lack of survival benefit from concomitant chemotherapy in intermediate-risk patients suggests that such benefit may never have existed in this subgroup,” she said.

 

What Explains Why Overall Survival Did Not Significantly Differ Between Patients Who Received Radiotherapy Alone and Those Who Received Chemoradiotherapy?

For Karam, there is a question as to whether chemosensitization mechanisms in radiation therapy, such as reactive oxygen species, inhibition of DNA repair, modulating tumor microenvironment, and cell cycle arrest — all used to induce apoptosis — are as efficacious as once thought.

“Also, systemic chemosensitization may not be as effective at controlling systemic disease beyond the pelvis and radiation field,” he said.

“Radiation is extremely effective in cervical cancer,” said Berchuck. “When you’re giving radiation in a situation like this where there is none, to only microscopic disease, it makes sense that radiation could be effective by itself.”

 

Why in the JAMA Oncology Study Were Larger Tumor Size and Nonsquamous Histology Associated With the Use of Chemoradiotherapy?

All experts agreed this is likely because this subgroup of patients with larger tumors is typically seen as being at higher risk for recurrence. This might be due to what Karam called an “unfavorable histology” and certain tumor characteristics, including depth of invasion.

Yet Agustí Garcia said, in her study, even after propensity score matching, adjuvant chemotherapy did not demonstrate any survival benefit in this subgroup.

“The importance of performing propensity score matching in our analysis was to ensure that populations with comparable baseline recurrence and death risks were being evaluated fairly,” she told this news organization.

 

Do These Findings Change Clinical Practice for Intermediate-Risk Cervical Cancer Treatment?

For Karam, the new evidence in intermediate-risk cervical cancer confirms rather than changes clinical practice. “The standard of care was radiation therapy alone, which is now confirmed, based on the results of GOG 263,” Karam said. “The standard of care for these patients will remain the same.”

Agustí Garcia said her study results can help “refine” clinical practice.

“The results suggest that adjuvant therapy could be safely de-escalated in intermediate-risk cervical cancer,” Agustí Garcia said. 

“We should avoid chemotherapy when there is no evidence-based benefit, reserving its use for locally advanced or high-risk cases, refining clinical guidelines to ensure treatment recommendations are based on higher-quality evidence, thereby standardizing care and reducing overtreatment,” she continued. “Current guidelines lack consensus and rely on lower-quality evidence.”

Agustí Garcia reported grants from Fundación Alfonso Martín Escudero. Berchuck has no disclosures. Karam reported royalties from UpToDate and that he is a speaker for AstraZeneca.

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

New findings on radiation plus adjuvant chemotherapy in patients with intermediate-risk cervical cancer seem to spell the end for the dual therapy in this group. 

Results from a phase 3 clinical trial of 316 women who’d had radical hysterectomies found that adjuvant chemotherapy as treatment for their early-stage, intermediate-risk cervical carcinoma did not improve outcomes but did increase toxicity. The results were the inverse of the study’s intention. 

The NRG-GOG 0263 (NCT01101451) study failed to reach its endpoint of improving recurrence-free survival through the addition of cisplatin chemotherapy, confirming instead that cisplatin chemotherapy given adjuvantly with radiotherapy is not a superior alternative in this cohort. The results were presented during a plenary session of the Society of Gynecologic Oncology Annual Meeting on Women’s Cancers in Seattle, Washington.

The current standard of care in this cohort is for radiotherapy alone, although the National Comprehensive Cancer Network (NCCN) guidelines place adjuvant chemotherapy in category 2B recommendations. 

“Perhaps the NCCN guidelines will have to change what it says here,” Andrew Berchuck, MD, chief of gynecologic oncology and professor of obstetrics and gynecology at Duke University School of Medicine in Durham, North Carolina, told this news organization. Berchuck was not involved in the clinical trial.

The National Cancer Institute lists adjuvant chemotherapy first in its guidelines for this group.

Another study published online this month in JAMA Oncology concluded that morbidity in these patients could be reduced if the use of chemoradiotherapy were de-escalated. 

This population-based cohort study of 1116 women, conducted by Núria Agustí Garcia, MD, postdoctoral fellow at The University of Texas MD Anderson Cancer Center in Houston, and colleagues, found no significant overall survival benefit of adjuvant chemotherapy in intermediate-risk cervical cancer, and that when it was given, patients tended to have larger tumors and nonsquamous cell history. 

The 5-year survival rate in patients who received chemoradiotherapy was 87%, compared with an 87% 5-year survival rate in those who received radiotherapy alone (hazard ratio = 0.85; 95% CI, 0.59-1.23; P =.38).

If the standard of care in this cohort is radiation only, and outcomes are not better in adjuvant treatment, then why is there a controversy at all, and why are some investigators such as Agustí Garcia attempting to clarify adjuvant treatment’s effects?

Experts say it’s because of the history of adjuvant chemotherapy in more advanced cervical cancer and the extrapolations clinicians made when treating patients with intermediate risk.

 

What Is the History of Adjuvant Treatment in Cervical Cancer?

Concomitant therapies in intermediate-risk cervical cancer began in the late 1990s, at a time when it was found effective in more advanced disease, according to Berchuck, who also was not involved in the population study.

“Say back then, you had a stage IIIb cervical cancer. With external radiation alone, followed by brachytherapy internally, the cure rate for something like that would have been maybe 50 or 60%,” Berchuck said in an interview. “Adding cisplatin improved the cure rate by about 15%.”

That cisplatin improved survival rates in advanced disease, led to using it in less advanced cases, according to Berchuck. “The idea here was that if the pathology report indicated a larger tumor involving the lymphatics, the risk of recurrence went up to about 20%, so by adding chemo to postsurgical radiotherapy, you could improve things more than with just radiation alone,” Berchuck said. 

Studies of adjuvant chemotherapy in advanced cervical cancers confused the matter, according to Agustí Garcia. 

“The theoretical benefit of adding chemotherapy to radiotherapy for patients with intermediate-risk cervical cancer has been extrapolated from studies on locally advanced or high-risk cases, for example, those with parametrial or lymph node metastases,” Agustí Garcia said in an interview.

“However, before its implementation, there was no solid evidence supporting this approach in intermediate-risk patients,” she said. “The oncologic behavior of this subgroup may differ, and in the absence of parametrial or lymph node metastasis, chemotherapy may not be necessary.”

 

Do Both Studies Suggest That Radiotherapy Has Become More Effective Recently?

“Probably. Modern radiation techniques, such as IMRT [intensity-modulated radiation therapy] and IGRT [image-guided radiation therapy] are more effective than historical techniques,” said Amer Karam, MD, a clinical professor of obstetrics and gynecology at Stanford University in Palo Alto, California. Karam was not involved in either study mentioned previously.

Agustí Garcia said that while it’s true radiotherapy techniques have improved, these advancements primarily impact morbidity rather than survival outcomes.

“The lack of survival benefit from concomitant chemotherapy in intermediate-risk patients suggests that such benefit may never have existed in this subgroup,” she said.

 

What Explains Why Overall Survival Did Not Significantly Differ Between Patients Who Received Radiotherapy Alone and Those Who Received Chemoradiotherapy?

For Karam, there is a question as to whether chemosensitization mechanisms in radiation therapy, such as reactive oxygen species, inhibition of DNA repair, modulating tumor microenvironment, and cell cycle arrest — all used to induce apoptosis — are as efficacious as once thought.

“Also, systemic chemosensitization may not be as effective at controlling systemic disease beyond the pelvis and radiation field,” he said.

“Radiation is extremely effective in cervical cancer,” said Berchuck. “When you’re giving radiation in a situation like this where there is none, to only microscopic disease, it makes sense that radiation could be effective by itself.”

 

Why in the JAMA Oncology Study Were Larger Tumor Size and Nonsquamous Histology Associated With the Use of Chemoradiotherapy?

All experts agreed this is likely because this subgroup of patients with larger tumors is typically seen as being at higher risk for recurrence. This might be due to what Karam called an “unfavorable histology” and certain tumor characteristics, including depth of invasion.

Yet Agustí Garcia said, in her study, even after propensity score matching, adjuvant chemotherapy did not demonstrate any survival benefit in this subgroup.

“The importance of performing propensity score matching in our analysis was to ensure that populations with comparable baseline recurrence and death risks were being evaluated fairly,” she told this news organization.

 

Do These Findings Change Clinical Practice for Intermediate-Risk Cervical Cancer Treatment?

For Karam, the new evidence in intermediate-risk cervical cancer confirms rather than changes clinical practice. “The standard of care was radiation therapy alone, which is now confirmed, based on the results of GOG 263,” Karam said. “The standard of care for these patients will remain the same.”

Agustí Garcia said her study results can help “refine” clinical practice.

“The results suggest that adjuvant therapy could be safely de-escalated in intermediate-risk cervical cancer,” Agustí Garcia said. 

“We should avoid chemotherapy when there is no evidence-based benefit, reserving its use for locally advanced or high-risk cases, refining clinical guidelines to ensure treatment recommendations are based on higher-quality evidence, thereby standardizing care and reducing overtreatment,” she continued. “Current guidelines lack consensus and rely on lower-quality evidence.”

Agustí Garcia reported grants from Fundación Alfonso Martín Escudero. Berchuck has no disclosures. Karam reported royalties from UpToDate and that he is a speaker for AstraZeneca.

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

TOPLINE:

Adjuvant therapy with camrelizumab significantly improved 3-year event-free survival in patients with locoregionally advanced nasopharyngeal carcinoma compared with observation, according to findings from the phase 3 DIPPER trial.

METHODOLOGY:

• About 20%-30% of patients with locoregionally advanced nasopharyngeal carcinoma experience disease relapse after definitive chemoradiotherapy. Camrelizumab plus chemotherapy can improve progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma, but its effectiveness as adjuvant therapy in locoregionally advanced disease remains unclear.
• Researchers conducted the randomized phase 3 DIPPER trial at 11 centers in China, enrolling 450 patients with T4N1M0 or T1-4N2-3M0 nasopharyngeal carcinoma who had completed induction-concurrent chemoradiotherapy.
• Participants were randomly assigned to receive either adjuvant camrelizumab (200 mg intravenously every 3 weeks for 12 cycles; n = 226) or observation (n = 224). The median follow-up duration was 39 months.
• The primary endpoint was event-free survival, defined as freedom from distant metastasis, locoregional relapse, or death due to any cause; secondary endpoints included distant metastasis–free survival, locoregional relapse–free survival, overall survival, and safety.

TAKEAWAY:

• Patients who received camrelizumab had a higher 3-year event-free survival rate than those who underwent observation (86.9% vs 77.3%; stratified hazard ratio [HR], 0.56; P = .01).
• The 3-year distant metastasis–free survival was also higher in the camrelizumab group (92.4% vs 84.5%; stratified HR, 0.54; P = .04).
• Patients in the camrelizumab group had higher locoregional relapse–free survival at 3 years than those in the observation group (92.8% vs 87.0%; stratified HR, 0.53; P = .046). However, the difference in overall survival between the groups was not significant.
• The safety analysis included 426 patients; 97.1% of those who received camrelizumab experienced at least one adverse event of any grade, the most common being reactive capillary endothelial proliferation compared with 85.5% of those in the observation group. Further, 11.2% of patients taking camrelizumab reported grade 3 or 4 events, including leukopenia and neutropenia compared with 3% in the observation group.

IN PRACTICE:

“The DIPPER trial demonstrated that adjuvant camrelizumab following induction-concurrent chemoradiotherapy significantly improved event-free survival by 9.6% with a favorable safety profile in patients with locoregionally advanced [nasopharyngeal carcinoma],” the authors wrote.

“If survival is eventually proven to be improved with induction chemoimmunotherapy, can we begin asking about de-escalation of chemoradiotherapy” for patients with nasopharyngeal carcinoma? “This question is exceptionally important, given the significant long-term consequences of radiotherapy on survivors,” the author of an accompanying editorial wrote.

SOURCE:

The study was led by Ye-Lin Liang, MD, Sun Yat-sen University Cancer Center in Guangzhou, China, and was published online in JAMA.

LIMITATIONS:

The study included patients from an endemic region where nasopharyngeal carcinoma is predominantly linked to Epstein-Barr virus infection, potentially affecting the generalizability of the findings to nonendemic populations. The open-label design may have introduced bias. Additionally, combined positive scores for programmed cell death ligand 1 (PD-L1) were unavailable for some patients, potentially affecting the analysis of the correlation between PD-L1 expression and clinical outcomes.

DISCLOSURES:

The study was supported by the Noncommunicable Chronic Diseases-National Science and Technology Major Project, National Natural Science Foundation of China, Guangzhou Municipal Health Commission, Key Area Research and Development Program of Guangdong Province, Overseas Expertise Introduction Project for Discipline Innovation, and Cancer Innovative Research Program of Sun Yat-sen University Cancer Center. The authors reported no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Adjuvant therapy with camrelizumab significantly improved 3-year event-free survival in patients with locoregionally advanced nasopharyngeal carcinoma compared with observation, according to findings from the phase 3 DIPPER trial.

METHODOLOGY:

• About 20%-30% of patients with locoregionally advanced nasopharyngeal carcinoma experience disease relapse after definitive chemoradiotherapy. Camrelizumab plus chemotherapy can improve progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma, but its effectiveness as adjuvant therapy in locoregionally advanced disease remains unclear.
• Researchers conducted the randomized phase 3 DIPPER trial at 11 centers in China, enrolling 450 patients with T4N1M0 or T1-4N2-3M0 nasopharyngeal carcinoma who had completed induction-concurrent chemoradiotherapy.
• Participants were randomly assigned to receive either adjuvant camrelizumab (200 mg intravenously every 3 weeks for 12 cycles; n = 226) or observation (n = 224). The median follow-up duration was 39 months.
• The primary endpoint was event-free survival, defined as freedom from distant metastasis, locoregional relapse, or death due to any cause; secondary endpoints included distant metastasis–free survival, locoregional relapse–free survival, overall survival, and safety.

TAKEAWAY:

• Patients who received camrelizumab had a higher 3-year event-free survival rate than those who underwent observation (86.9% vs 77.3%; stratified hazard ratio [HR], 0.56; P = .01).
• The 3-year distant metastasis–free survival was also higher in the camrelizumab group (92.4% vs 84.5%; stratified HR, 0.54; P = .04).
• Patients in the camrelizumab group had higher locoregional relapse–free survival at 3 years than those in the observation group (92.8% vs 87.0%; stratified HR, 0.53; P = .046). However, the difference in overall survival between the groups was not significant.
• The safety analysis included 426 patients; 97.1% of those who received camrelizumab experienced at least one adverse event of any grade, the most common being reactive capillary endothelial proliferation compared with 85.5% of those in the observation group. Further, 11.2% of patients taking camrelizumab reported grade 3 or 4 events, including leukopenia and neutropenia compared with 3% in the observation group.

IN PRACTICE:

“The DIPPER trial demonstrated that adjuvant camrelizumab following induction-concurrent chemoradiotherapy significantly improved event-free survival by 9.6% with a favorable safety profile in patients with locoregionally advanced [nasopharyngeal carcinoma],” the authors wrote.

“If survival is eventually proven to be improved with induction chemoimmunotherapy, can we begin asking about de-escalation of chemoradiotherapy” for patients with nasopharyngeal carcinoma? “This question is exceptionally important, given the significant long-term consequences of radiotherapy on survivors,” the author of an accompanying editorial wrote.

SOURCE:

The study was led by Ye-Lin Liang, MD, Sun Yat-sen University Cancer Center in Guangzhou, China, and was published online in JAMA.

LIMITATIONS:

The study included patients from an endemic region where nasopharyngeal carcinoma is predominantly linked to Epstein-Barr virus infection, potentially affecting the generalizability of the findings to nonendemic populations. The open-label design may have introduced bias. Additionally, combined positive scores for programmed cell death ligand 1 (PD-L1) were unavailable for some patients, potentially affecting the analysis of the correlation between PD-L1 expression and clinical outcomes.

DISCLOSURES:

The study was supported by the Noncommunicable Chronic Diseases-National Science and Technology Major Project, National Natural Science Foundation of China, Guangzhou Municipal Health Commission, Key Area Research and Development Program of Guangdong Province, Overseas Expertise Introduction Project for Discipline Innovation, and Cancer Innovative Research Program of Sun Yat-sen University Cancer Center. The authors reported no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Adjuvant therapy with camrelizumab significantly improved 3-year event-free survival in patients with locoregionally advanced nasopharyngeal carcinoma compared with observation, according to findings from the phase 3 DIPPER trial.

METHODOLOGY:

• About 20%-30% of patients with locoregionally advanced nasopharyngeal carcinoma experience disease relapse after definitive chemoradiotherapy. Camrelizumab plus chemotherapy can improve progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma, but its effectiveness as adjuvant therapy in locoregionally advanced disease remains unclear.
• Researchers conducted the randomized phase 3 DIPPER trial at 11 centers in China, enrolling 450 patients with T4N1M0 or T1-4N2-3M0 nasopharyngeal carcinoma who had completed induction-concurrent chemoradiotherapy.
• Participants were randomly assigned to receive either adjuvant camrelizumab (200 mg intravenously every 3 weeks for 12 cycles; n = 226) or observation (n = 224). The median follow-up duration was 39 months.
• The primary endpoint was event-free survival, defined as freedom from distant metastasis, locoregional relapse, or death due to any cause; secondary endpoints included distant metastasis–free survival, locoregional relapse–free survival, overall survival, and safety.

TAKEAWAY:

• Patients who received camrelizumab had a higher 3-year event-free survival rate than those who underwent observation (86.9% vs 77.3%; stratified hazard ratio [HR], 0.56; P = .01).
• The 3-year distant metastasis–free survival was also higher in the camrelizumab group (92.4% vs 84.5%; stratified HR, 0.54; P = .04).
• Patients in the camrelizumab group had higher locoregional relapse–free survival at 3 years than those in the observation group (92.8% vs 87.0%; stratified HR, 0.53; P = .046). However, the difference in overall survival between the groups was not significant.
• The safety analysis included 426 patients; 97.1% of those who received camrelizumab experienced at least one adverse event of any grade, the most common being reactive capillary endothelial proliferation compared with 85.5% of those in the observation group. Further, 11.2% of patients taking camrelizumab reported grade 3 or 4 events, including leukopenia and neutropenia compared with 3% in the observation group.

IN PRACTICE:

“The DIPPER trial demonstrated that adjuvant camrelizumab following induction-concurrent chemoradiotherapy significantly improved event-free survival by 9.6% with a favorable safety profile in patients with locoregionally advanced [nasopharyngeal carcinoma],” the authors wrote.

“If survival is eventually proven to be improved with induction chemoimmunotherapy, can we begin asking about de-escalation of chemoradiotherapy” for patients with nasopharyngeal carcinoma? “This question is exceptionally important, given the significant long-term consequences of radiotherapy on survivors,” the author of an accompanying editorial wrote.

SOURCE:

The study was led by Ye-Lin Liang, MD, Sun Yat-sen University Cancer Center in Guangzhou, China, and was published online in JAMA.

LIMITATIONS:

The study included patients from an endemic region where nasopharyngeal carcinoma is predominantly linked to Epstein-Barr virus infection, potentially affecting the generalizability of the findings to nonendemic populations. The open-label design may have introduced bias. Additionally, combined positive scores for programmed cell death ligand 1 (PD-L1) were unavailable for some patients, potentially affecting the analysis of the correlation between PD-L1 expression and clinical outcomes.

DISCLOSURES:

The study was supported by the Noncommunicable Chronic Diseases-National Science and Technology Major Project, National Natural Science Foundation of China, Guangzhou Municipal Health Commission, Key Area Research and Development Program of Guangdong Province, Overseas Expertise Introduction Project for Discipline Innovation, and Cancer Innovative Research Program of Sun Yat-sen University Cancer Center. The authors reported no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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