Efficacy of flutamide-combined androgen blockade therapy in advanced prostate cancer patients: a phase III randomized, comparative trial.
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| Abstract |
The efficacy of combined androgen blockade therapy consisting of flutamide, a nonsteroidal antiandrogen, plus an LH-RH agonist (F-CAB) was investigated in Japanese patients with untreated advanced prostate cancer (clinical stage D). The primary endpoint was overall survival (OS), while the secondary endpoints were disease-specific survival (DSS), progression- free survival (PFS), reduction of prostate specific antigen (PSA), anti-tumor effects, quality of life (QOL), and adverse drug reactions (ADRs). As of the median observation period of 1,293.5 days, the F-CAB significantly prolonged DSS and PFS relative to LH-RH monotherapy (log rank test: p=0.0343 and 0.0017, respectively). The results of this study indicate the potential of F-CAB as a useful treatment for untreated advanced prostate cancer. Although additional study is considered necessary to determine the daily dosage of flutamide, the anti-tumor effects obtained from this study indicated that 375 mg/day is appropriate as a daily dosage, and 250 mg/day can also be considered when concern exists regarding the occurrence of complications or the development of ADRs, including liver function disorders. [Funded by Nippon Kayaku Co., Ltd., Japic CTI-050101].
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| Authors | Hiroshi Kanetake, Michiyuki Usami, Yasuo Ohashi, Toshiyuki Ijima, Hideyuki Akaza |
| Journal | Gan to kagaku ryoho. Cancer & chemotherapy (Gan To Kagaku Ryoho) Vol. 41 Issue 13 Pg. 2591-7 (Dec 2014) ISSN: 0385-0684 [Print] Japan |
| PMID | 25596054 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't) |
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