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Sep 18, 2019
Sep 18, 2020
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Long-term hormone therapy after prostate cancer surgery may not be needed in men with low PSA and may actually do more harm than good.
Patients who had PSA levels of 0.6 ng/mL or less were twice as likely to die from causes other than their cancer when long-term hormone therapy was added.
CHICAGO — Long-term hormone therapy for men after they’ve undergone surgery for prostate cancer may not be needed, despite current guidelines that recommend that all men be offered hormone therapy when they are receiving salvage radiotherapy (SRT).
In fact, according to research presented here at the annual meeting of the American Society of Radiation Oncology (ASTRO), long-term hormone therapy may do more harm than good in men with lower PSAs.
A secondary analysis of the NRG Oncology/RTOG 9601 randomized, phase III clinical trial determined that a subset of 389 patients with a PSA of 0.6 ng/mL or less were twice as likely to die from causes other than their cancer when hormone therapy was added (hazard ratio 1.94, 95% CI 1.17-3.20). And, according to Daniel Spratt, MD, of the University of Michigan in Ann Arbor, who presented the study, the greatest risk of death was for patients with the lowest PSA levels (0.2-0.3 ng/mL, n=148).
The NRG Oncology/RTOG 9601 trial initially reported in 2017 that the addition of 24 months of antiandrogen therapy to salvage radiation therapy (SRT) "resulted in significantly higher rates of long-term overall survival and lower incidences of metastatic prostate cancer and death from prostate cancer than radiation therapy plus placebo."
Referencing the results from RTOG 9601, ASTRO and the American Urological Association amended their Adjuvant and Salvage Radiotherapy After Prostatectomy Guideline to recommend that clinicians "encourage hormonal therapy to be offered to patients who are candidates for salvage radiotherapy."
However, according to Spratt and colleagues, "hormone therapy has well documented side effects and has been shown to increase cardiac event rates, and there remains no evidence of an overall survival benefit from hormone therapy for men treated with early SRT." Therefore, in this analysis, their objective was to determine whether pre-SRT PSA can serve as both a prognostic and predictive biomarker of benefit or harm from hormone therapy.
The researchers re-examined data from 760 patients who were treated between 1998 and 2003 and whose cancer returned after their prostate was surgically removed. In the original study patients were randomized to either post-surgical radiation therapy plus a nonsteroidal anti-androgen (bicalutamide 150 mg/day) or placebo for two years. In this re-analysis, Spratt and colleagues stratified the patients based on PSA levels prior to receiving radiation — those with PSAs greater than 1.5 ng/mL (n=118) and those with PSAs lower than 1.5 ng/mL (n=642).
They found that — as in the original trial — patients with PSAs higher than 1.5 ng/mL showed improved overall survival (HR 0.45 [0.25-0.81]). For men with PSA levels lower than 1.5 ng/mL, however, there was no survival benefit (HR 0.87 [0.66-1.16]).
Spratt and colleagues also assessed the data for the subset of patients with PSA levels less than or equal to 0.6 ng/mL, which they noted is closer to today’s standard for post-surgical radiation treatment (as opposed to the standard at the time the RTOG 9601 trial was enrolling patients, when PSA levels were allowed to rise before initiating radiation therapy). And that data, Spratt said, "demonstrates that men with lower PSAs are more harmed than helped by long-term hormone therapy."
"We have now 3 randomized trials with over 2,400 men that do not demonstrate that short- or long-term hormone therapy improves overall survival in men receiving early salvage radiotherapy at low PSAs," said Spratt. "PSA prior to salvage radiotherapy predicts who will benefit most from hormone therapy and guidelines should now be updated to reflect this finding."
Anthony Zietman, MD, of Massachusetts General Hospital in Boston, who moderated a press briefing on the study, noted that of the approximately 100,000 men who undergo radical prostatectomy for prostate cancer annually, about 30,00 subsequently see their PSA rise — "the first indicator that their cancer may be recurring."
"And the vast majority of these men would go on to get radiation," he pointed out. "But as a result of the early analysis of RTOG 9601, we’ve been giving them all hormone therapy, as well, for greater or shorter periods of time. This suggests we need to hold back a little."
"There are some people who really benefit, and some people who don’t benefit, and some people who just might be harmed," he added. "So, we can be much more thoughtful and cautious in the future. From here on out, I’m going to be a lot more cautious with my patients."
Spratt serves on the advisory board of Janssen and Blue Earth and has received funding from Janssen.