Kanetake Hiroshi, Usami Michiyuki, Ohashi Yasuo, Ijima Toshiyuki, Akaza Hideyuki
Dept. of Nephro-Urology, Nagasaki University Graduate School of Biomedical Sciences.
Gan To Kagaku Ryoho. 2014 Dec;41(13):2591-7.
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].
在日本未经治疗的晚期前列腺癌（临床分期为D期）患者中，研究了由非甾体类抗雄激素药物氟他胺加促黄体生成素释放激素（LH-RH）激动剂组成的联合雄激素阻断疗法（F-CAB）的疗效。主要终点是总生存期（OS），次要终点包括疾病特异性生存期（DSS）、无进展生存期（PFS）、前列腺特异性抗原（PSA）降低、抗肿瘤效果、生活质量（QOL）和药物不良反应（ADR）。截至1293.5天的中位观察期，与LH-RH单一疗法相比，F-CAB显著延长了DSS和PFS（对数秩检验：p分别为0.0343和0.0017）。本研究结果表明F-CAB作为未经治疗的晚期前列腺癌的一种有效治疗方法具有潜力。尽管认为有必要进行进一步研究以确定氟他胺的日剂量，但本研究获得的抗肿瘤效果表明，375毫克/天作为日剂量是合适的，当担心出现并发症或发生包括肝功能障碍在内的药物不良反应时，也可考虑250毫克/天。[由日本化药株式会社资助，Japic CTI-050101]
