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Androgen Depriv..

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In the neoadjuvant setting for men with clinically advanced localized prostate cancer, concurrent androgen deprivation and radiation therapy is considered an effective treatment. This treatment option, with an emphasis on short-term androgen deprivation, is supported by National Comprehensive Cancer Network.1 Roach et al demonstrated short-term androgen deprivation therapy reduced mortality from localized prostate cancer.2 However, long-term androgen deprivation therapy also has rigorous trial data demonstrating improved overall survival and disease free survival compared to no androgen deprivation therapy.3 Since androgen deprivation therapy can cause a decrease in quality of life, fatal myocardial infarction, and fractures, it would be ideal if a shorter course of androgen deprivation would be comparable in patient outcomes to the longer term therapy.

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Bolla et al recently published the results of multi-center, randomized, controlled trial conducted by European Organization for Research and Treatment of Cancer (EORTC) to determine if short-term androgen suppression (AS) would preserve quality of life while maintaining the same overall survival rate obtained with long-term androgen suppression.4 Eligible patients (histologically confirmed prostate adenocarcinoma T1c to T2a-b, pathological nodal stage N1 or N2 or clinical tumor stages T2c to T4, clinical nodal stages N0 to N2, and no evidence of metastatic spread) received external beam radiation therapy (EBRT) and AS for 6 months and then were randomized to either receive no further AS or an additional 2.5 years for a total of 3 years of AS. The primary endpoint was noninferiority of overall survival for short-term AS compared to long-term AS and required a hazard ratio of more than 1.35, with a one-sided alpha level of 0.05. Quality of life was assessed with use of EORTC core quality-of-life questionnaire (QLC-C30).

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In the study, 1113 patients were registered and 970 received EBRT plus 6 months of complete androgen blockade (triptorelin and antiandrogen). The luteinizing hormone-releasing hormone (LHRH) analogue used in this study was triptorelin (depot formulation was administered every month until new formulation was released and administered every 3 months). Antiandrogen (flutamide or bicalutamide allowed) was initiated 1 week prior to LHRH. Then, 483 patients were randomly assigned to no further treatment and 487 patients were randomly assigned to an additional 2.5 years of AS. Antiandrogen agent was not continued for those patients assigned to the additional 2.5 years of AS. Baseline characteristics were similar between the two groups. After a median follow-up of 6.4 years, 132 patients in short-term AS and 98 in the long-term AS had died; prostate cancer was cause of death in 47 patients in the short-term group and 29 patients in the long-term group. The 5-year overall mortality for short-term and long-term suppression was 19.0% and 15.2%, respectively. The observed hazard ratio was 1.42 for overall survival, which exceeded the predefined limits. Overall quality of life between the two groups did not differ significantly. The authors conclude combination of radiotherapy plus 6 months of androgen suppression provides inferior overall survival compared to radiotherapy plus long-term suppression (3 years) for men with ...

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