Miyake Hideaki, Hara Takuto, Terakawa Tomoaki, Ozono Seiichiro, Fujisawa Masato
Division of Urology, Kobe University Graduate School of Medicine, Kobe, Japan; Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Division of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.
Clin Genitourin Cancer. 2017 Apr;15(2):313-319. doi: 10.1016/j.clgc.2016.06.010. Epub 2016 Jun 23.
The objective of the present study was to comprehensively compare the clinical outcomes between abiraterone acetate (AA) and enzalutamide (Enz) in Japanese patients with docetaxel-naive metastatic castration-resistant prostate cancer (mCRPC).
The present study retrospectively included 280 consecutive mCRPC patients, consisting of 113 and 167 who had received AA and Enz, respectively, without previous treatment with docetaxel.
Of the several baseline characteristics examined, some parameters, including performance status (PS), prostate-specific antigen (PSA) value, and incidence of lymph node metastasis, significantly favored the Enz over the AA group. The PSA response rate in the Enz group was significantly greater than that in the AA group, and the PSA progression-free survival in the Enz group was significantly superior to that in the AA group. Multivariate analyses of several parameters identified the following independent predictors of PSA progression-free survival: duration of androgen deprivation therapy and PS for the AA group, age and PS for the Enz group, and PS but not the introduced agent (ie, AA vs. Enz) for the overall patients. The common adverse events observed in the present series were fatigue (19.4%) and liver toxicity (11.5%) in the AA group and fatigue (32.3%) and appetite loss (19.2%) in the Enz group. In addition, the proportion of patients with adverse events grade ≥ 3 in the Enz group (11.4%) was significantly greater than that in the AA group (4.4%).
Both AA and Enz were effective and tolerable for patients with docetaxel-naive mCRPC in the routine clinical setting.
本研究的目的是全面比较醋酸阿比特龙（AA）和恩杂鲁胺（Enz）在未经多西他赛治疗的日本转移性去势抵抗性前列腺癌（mCRPC）患者中的临床疗效。
本研究回顾性纳入了280例连续的mCRPC患者，其中分别有113例和167例接受了AA和Enz治疗，此前未接受多西他赛治疗。
在所检查的几个基线特征中，一些参数，包括体能状态（PS）、前列腺特异性抗原（PSA）值和淋巴结转移发生率，恩杂鲁胺组显著优于阿比特龙组。恩杂鲁胺组的PSA缓解率显著高于阿比特龙组，恩杂鲁胺组的PSA无进展生存期显著优于阿比特龙组。对多个参数进行多变量分析，确定了以下PSA无进展生存期的独立预测因素：阿比特龙组为雄激素剥夺治疗持续时间和PS，恩杂鲁胺组为年龄和PS，总体患者为PS而非所使用的药物（即AA与Enz）。本系列中观察到的常见不良事件为阿比特龙组的疲劳（19.4%）和肝毒性（11.5%）以及恩杂鲁胺组的疲劳（32.3%）和食欲减退（19.2%）。此外，恩杂鲁胺组不良事件≥3级的患者比例（11.4%）显著高于阿比特龙组（4.4%）。
在常规临床环境中，AA和Enz对未经多西他赛治疗的mCRPC患者均有效且耐受性良好。
