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May 29, 2014
PSA-Only Relapse Survival Not Affected By
Androgen-Deprivation Delay

Boston—Without standard guidelines for the timing of androgen-deprivation therapy initiation in patients with increased PSA levels but no symptoms or evidence of a tumor, it can be difficult to determine when to start treatment.

Now, a new study from the Harvard School of Public Health offers information to help make the decision.

Results indicate that patients who underwent immediate initiation of androgen-deprivation therapy at PSA-only relapse had a similar 5-year overall survival to those who deferred it.

Deferred initiation could help delay androgen-deprivation therapy by 2 or more years for some men, improving patients’ quality of life as well as lowering expenses, according to the authors of the study, which was presented in advance of the 2014 American Society of Clinical Oncology (ASCO) meeting, set for May 30-June 3 in Chicago. The study will be presented as abstract 5003.

“Rising PSA levels trigger a lot of anxiety, and many men want to start treatment as soon as possible,” said lead author Xabier Garcia-Albeniz, MD, a research associate at Harvard University School of Public Health in Boston. “These findings suggest that there may be no need to rush to androgen deprivation therapy. If our results are confirmed in randomized trials, patients could feel more comfortable waiting until they develop symptoms or signs of cancer that are seen on a scan, before initiating androgen deprivation therapy.”

The observational study offers new information about patients with PSA relapse, where PSA levels are increased but patients have no symptoms or tumor visible with computed tomography or a bone scan.

Using the national prospective registry data CaPSURE: Cancer of the Prostate Strategic Urologic Research Endeavor, based at the University of California, San Francisco, researchers focused on 2,012 patients who had a PSA relapse after radical prostatectomy or radiation therapy with curative intention. Patients were assigned to the “immediate” strategy if they received androgen-deprivation therapy within 3 months of PSA relapse or to the “deferred” strategy if they started androgen-deprivation therapy at least 2 years after the PSA relapse, or when they presented with metastasis, symptoms, or a short PSA doubling time.

Results indicate that the median time from primary treatment to PSA relapse was 27 months. After a relapse, patients were followed for a median period of 41 months. The estimated 5-year overall survival was found to be similar between the two androgen-deprivation therapy timing strategies: 87.2% for deferred androgen-deprivation therapy versus 85.1% for immediate androgen-deprivation therapy, suggesting that there was little or no survival benefit of immediate initiation compared with deferred initiation.

The authors cautioned that, as an observational study, some unmeasured characteristics affecting survival could not be determined.

The study notes, however, that delaying androgen deprivation therapy by 2 or more years could improve quality of live for patients, who often have side effects such as sexual dysfunction, osteoporosis and risk of bone fracture, hot flashes, decreased mental sharpness, fatigue, loss of muscle mass, increased cholesterol, weight gain, and depression. Some of the side effects worsen the longer a patient is on androgen-deprivation therapy.

“Hormone therapy is one of the oldest, most common, and most effective treatment approaches in prostate cancer, and these findings will influence the treatment of thousands of patients worldwide,” said Peter P. Yu, MD, ASCO president-elect. “This study is also a great example of how less aggressive treatment can sometimes offer patients optimal outcomes while sparing them from side effects that impair their quality of life.”





U.S. Pharmacist Social Connect