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Short-Term vs. Long-Term Hormone Therapy for Prostate Cancer

Six months (vs. 3 years) of androgen suppression provided inferior survival for patients with locally advanced disease.

Given emerging data about the potential harms of androgen-deprivation therapy (ADT), the need is growing to define the optimal duration of ADT plus external beam radiotherapy for patients with locally advanced prostate cancer. Although level 1 evidence suggests that radiotherapy plus short-term (6 months) ADT attenuates disease mortality in patients with clinically localized prostate cancer, no current data support this approach in patients with higher-risk disease.

To examine this issue, European investigators assessed 970 men with locally advanced prostate cancer. Patients received external beam radiotherapy (70 Gy) plus ADT for 6 months. Those with no evidence of disease progression were then randomized to receive either no additional ADT (short-term group) or 2.5 years of additional ADT (long-term group). Quality of life was assessed using a validated questionnaire. The primary endpoint was overall survival assessed with a modified log-rank test for noninferiority.

During median follow-up of 6.4 years, 132 deaths (47 from prostate cancer) occurred in the short-term group, and 98 deaths (29 from prostate cancer) occurred in the long-term group. Five-year overall mortality was 19.0% in the short-term group and 15.2% in the long-term group; these results did not fit with the hypothesis that the outcomes would be similar between the short-term and long-term groups. The investigators noted no serious long-term genitourinary or gastrointestinal toxicity from radiotherapy and no elevated risk for fatal cardiovascular events. Insomnia, hot flushes, and diminished sexual interest and activity were more common in the long-term group. However, no between-group differences in overall quality of life were seen. The authors concluded that the combination of radiotherapy plus 6 months of ADT is inferior to radiotherapy plus 3 years of ADT.

Comment: One benefit of widespread prostate cancer screening in the U.S. is that the number of men who present with locally advanced disease has decreased during the past 10 to 15 years. The findings from this trial provide convincing evidence that these patients would benefit from 3 years of ADT (vs. a shorter course) plus radiotherapy. The results do not address the management of low- or intermediate-risk patients nor can they be extrapolated to patients who are managed with brachytherapy.

— Robert Dreicer, MD, MS, FACP

Published in Journal Watch Oncology and Hematology June 10, 2009

Citation(s):

Bolla M et al. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med 2009 Jun 11; 360:2516.

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• Medline abstract (Free)

Albertsen P. Androgen deprivation in prostate cancer — Step by step. N Engl J Med 2009 Jun 11; 360:2572.

• Original article (Subscription may be required)
• Medline abstract (Free)

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• Duration of ADT in PC
  SB Strum, Ashland, OREGON, 15 Jun 2009 7:25 AM EST
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