Miyamae Koichi, Kitani Kosuke, Hara Kazumasa, Nakakuma Kensuke, Hamada Shinsuke, Hamada Yasuyuki
Department of Urology, Kumamoto Chuo Hospital.
Nihon Hinyokika Gakkai Zasshi. 2017;108(2):74-79. doi: 10.5980/jpnjurol.108.74.
(Purpose) This study is to evaluate the efficacy and safety of sequential therapy with two novel drugs, abiraterone and enzalutamide after docetaxel (DOC) therapy for castration-resistant prostate cancer (CRPC). (Material and methods) Twenty-one patients were identified received sequential therapy with abiraterone and enzalutamide after DOC therapy at our institution. We investigated PSA response (decrease of 50% or more) to prior administered drug as primary endpoint, and overall survival rate and occurrence of adverse events as secondary endpoint. (Results) There were 12 patients in the group preliminarily administered enzalutamide (Group E) and 9 patients in the group preliminarily administered abiraterone (Group A). The novel drugs were administered immediately following DOC therapy in nearly all cases. Of the 9 patients in Group A, only one patient (11%) and of the 12 patients in Group E, only one patient (9%) achieved PSA decrease of 50% or more, thus resulting in a poor response rate. There was not significantly difference in both groups. The overall survival rates of Group A and E were not significantly difference. There were three adverse events which required change drug. Those were two cases (appetite loss and general fatigue) on enzalutamide and one case (edema) on abiraterone. (Conclusion) This study suggested that sequential therapy with abiraterone and enzalutamide after DOC therapy had poor clinical benefit regardless of the order of administration of both drugs.
（目的）本研究旨在评估多西他赛（DOC）治疗去势抵抗性前列腺癌（CRPC）后，使用两种新型药物阿比特龙和恩杂鲁胺序贯治疗的疗效和安全性。（材料与方法）在我们机构，确定有21例患者在接受DOC治疗后接受了阿比特龙和恩杂鲁胺的序贯治疗。我们将对先前使用药物的PSA反应（降低50%或更多）作为主要终点进行研究，并将总生存率和不良事件的发生作为次要终点。（结果）初步使用恩杂鲁胺的组（E组）有12例患者，初步使用阿比特龙的组（A组）有9例患者。几乎在所有情况下，新型药物均在DOC治疗后立即给药。A组的9例患者中，只有1例患者（11%），E组的12例患者中，只有1例患者（9%）的PSA降低了50%或更多，因此缓解率较低。两组之间没有显著差异。A组和E组的总生存率没有显著差异。有3例不良事件需要更换药物。恩杂鲁胺有2例（食欲减退和全身乏力），阿比特龙有1例（水肿）。（结论）本研究表明，DOC治疗后使用阿比特龙和恩杂鲁胺序贯治疗，无论两种药物的给药顺序如何，临床获益都较差。
