title: Efficacy of flutamide-combined androgen blockade therapy in advanced prostate cancer patients: a phase III randomized, comparative trial.
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].
authors.affiliation: Dept. of Nephro-Urology, Nagasaki University Graduate School of Biomedical Sciences.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kanetake
authors.forename: Michiyuki
authors.initials: M
authors.lastname: Usami
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Ijima
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Akaza
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000008:administration & dosage / Q000009:adverse effects; D000728:Androgens / Q000378:metabolism; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D005485:Flutamide / Q000008:administration & dosage / Q000009:adverse effects; D020249:Hormone Replacement Therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000188:drug therapy*
chemical_list: D000726:Androgen Antagonists; D000728:Androgens; D005485:Flutamide