Obesity May Lower mCRPC Death Risk

Novel radiotherapy

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randomly assigned 551 men to receive 177Lu-PSMA-617 plus standard of care (SOC) and 280 to receive SOC alone. The median study follow-up duration was 20.9 months.

The men who received 177Lu-PSMA- 617 plus SOC experienced significantly longer radiographic progression-free survival (median 8.7 vs 3.4 months), overall survival (median 15.3 vs 11.3 months), and time to first symptomatic skeletal event (SSE, median 11.5 vs 6.8 months) compared with those who received SOC alone, Dr Morris reported. Patients in the radiotherapy-SOC arm had a significant 60% decreased risk for disease progression, 38% decreased risk for death, and 50% decreased risk for a first SSE compared with the SOC-only arm.

Although the radiotherapy arm experienced a higher rate of high-grade treatment-emergent adverse events (52.7% vs 38.0%), the combination of radiotherapy and SOC was well tolerated, Dr Morris and colleagues reported.

“These findings do warrant adoption of lutetium-PSMA as a new treatment option in this patient population, pending FDA review,” Dr Morris said, adding that 177Lu-PSMA-617 is being studied for use in patients with earlier-stage prostate cancer.

Commenting on the study’s findings, ASCO President Lori J. Pierce, MD, stated, “Use of this PSMA radioligand therapy, if it obtains regulatory approval, could indeed become an important treatment option for these patients with refractory disease.”

“I am excited about the future possibilities of combining this new therapy with other treatments and using it even earlier in the disease management,” said Stephen J. Freedland, MD, director of the Center for Integrated Research in Cancer and Lifestyle at CedarsSinai Medical Center in Los Angeles, California, who was not part of the study.

He pointed out, however, that not all men would qualify for the treatment because they would need to have a PSMA-positive PET scan.

Dr Freedland, who is affiliated with the Durham VA Medical Center in Durham, North Carolina, noted that the control arm of the study might not have been the best comparison group. Patients already had been treated with novel hormone therapy, such as enzalutamide, apalutamide, or abiraterone, and at least 1 chemotherapy, and SOC was not allowed to include chemotherapy or radium-223. “Thus, I am guessing most of the men received [an] alternative novel hormonal therapy, which multiple studies show is not a great choice.”

Endocyte, Inc., a Novartis company, provided funding for the VISION trial. ■

Metformin Possibly Beneficial in Advanced Prostate Cancer

USING METFORMIN in combination with standard of care (SOC) for highrisk locally advanced or metastatic hormone-sensitive prostate cancer (mHSPC) may improve outcomes in selected patients, according to investigators.

In a randomized controlled trial (RCT), patients who received the combination therapy experienced a significant delay in the development of castration-resistant disease compared with patients who received SOC alone, Reham Alghandour, MD, and colleagues from Mansoura University in Mansoura, Egypt, reported online in Urologic Oncology.

The trial included 124 patients randomly assigned to receive metformin 850 mg twice daily plus SOC (androgen deprivation therapy [ADT] or chemotherapy) or SOC alone. The primary endpoint was castration-resistant prostate cancer-free survival (CRPC-FS).

Over a median follow-up of 22 months, the metformin group had significantly longer median CRPC-FS compared with the SOC group (29 vs 20 months).

The investigators found a beneficial effect of metformin among some subgroups. For example, among patients with high-risk locally advanced disease, the median CRPC-FS was not reached in the metformin arm and 25 months in the SOC arm. Among patients with metastatic low-tumor-volume disease, the median CRPC-FS was not reached in the metformin arm and 15 months in the SOC arm. CRPC-FS did not differ significantly between study arms among patients with metastatic hightumor-volume disease.

The study arms did not differ significantly with regard to overall survival and PSA response.

Metformin did not show significant adverse events except self-limited diarrhea in 3 patients, according to the investigators.

Dr Alghandour and colleagues said that to the best of their knowledge, “our study is the first RCT that confirmed that metformin use in combination with ADT prolonged the CRPC-FS in HSPC.” ■

PCa care dip

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drop in March and recovery in June, Dr Cooperberg told Renal & Urology News.

“Clearly as a country we have struggled to restore access to cancer care to prepandemic levels, even more so in the

latter half of 2020 than in the first half,” he said. “We have multiple guidelines, developed in the past year, to help decide which patients’ cancer care can and cannot be safely deferred, but based largely on expert opinion. It will take time and attention to measure the impact of COVID-related delays on outcomes.”

For low-risk PCa, mean visits per day declined from 6.57 at week 10 to 4.49 at week 14, rebounded to a peak of 7.04, then declined again to a new low of 3.62 at week 44. Intermediaterisk PCa visits followed the same temporal trend. Mean visits per day declined from 9.68 at week 10 to 7.36 at week 14, rebounded to a peak of 10.04, then declined to 5.65 at week 44. High-risk PCa visits showed less fluctuation but also declined twice. Mean visits per day declined from 6.31 at week 10 to 5.24 at week 13, rebounded to a peak of 6.45, then dropped to 4.31 at week 41, Dr Cooperberg’s team reported.

Early Detection Critical “For urologists and genitourinary cancer patients, early detection and treatment are critical to successful outcomes,” David F. Penson, MD, MPH, chair of the AUA Science and Quality Council, stated in a news release from Verana Health and the AUA. “Thanks to our collaboration with Verana Health, we now have a better understanding about changes in care due to the COVID-19 pandemic that we can study to gauge the long-term impact of delayed diagnoses and treatments for prostate cancer.” ■

Visits to urologists declined twice from January to November 2020 vs 2019.

Pembro prolongs DFS

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rate was 77.3% among the patients treated with pembrolizumab compared with 68.1% for placebo recipients, lead investigator Toni K. Choueiri, MD, of the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute in Boston, Massachusetts, reported during an ASCO presscast. The estimated preliminary overall

survival rate at 24 months was 96.6% for those who received pembrolizumab and 93.5% for placebo.

Approximately half of patients who undergo surgery for kidney cancer experience disease recurrence, Dr Choueiri said, adding that there is no globally accepted standard adjuvant therapy to prevent recurrence supported by high-level evidence. “Pembrolizumab is a potential new standard of care for patients with renal cell cancer in the adjuvant setting,” Dr Choueiri said.

Grade 3 to 5 all-cause adverse events occurred among more patients in the pembrolizumab group (32.4%) compared with the placebo group (17.7%). No treatment-related deaths occurred in the pembrolizumab group, according to the investigators.

“Despite surgery, recurrence is common in clear cell renal cell carcinoma, and if it does recur, there are limited curative treatment options,” commented ASCO Chief Medical Officer and Executive Vice President Julie R. Gralow, MD. “The results of the KEYNOTE-564 trial support consideration of pembrolizumab as a potential new standard of care in the adjuvant setting to reduce disease recurrence in certain patients with kidney cancer.”

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, funded the trial. ■