Department of Urology, Charité, University Medicine Berlin, Berlin, Germany.
Department of Urology, University Hospital Cologne, Cologne, Germany.
BJU Int. 2018 Nov;122(5):774-782. doi: 10.1111/bju.14239. Epub 2018 May 6.
To investigate non-inferiority of intermittent docetaxel compared to continuous docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC).
The investigator initiated randomised phase III study included 187 chemotherapy-naïve patients with mCRPC who were allocated to two treatment arms: intermittent docetaxel and continuous docetaxel. Docetaxel was applied in both arms as weekly (35 mg/m ) or 3-weekly (75 mg/m ). The primary endpoint was 1-year survival, which was tested for non-inferiority (margin δ = 0.125). The secondary endpoints were: overall survival (OS), progression-free survival (PFS), median time to treatment failure (TTF), and toxicity.
Of 156 eligible patients, 78 were allocated to each arm. The intermittent treatment met the non-inferiority criteria for 1-year survival (two-sided 95% confidence interval, -0.12, 18, P = 0.022), but not for OS, according to the result of a post hoc analysis. The differences between the study arms in PFS and TTF were not significant. The median (range) treatment holiday in the intermittent arm was 110 (13-486) days, or 38% of the overall treatment duration. Safety profiles of both study arms were comparable. The main limitation of this study was that the planned number of patients could not be recruited.
Intermittent docetaxel chemotherapy was non-inferior to continuous therapy for 1-year survival; non-inferiority in regard to OS was not reached.
研究转移性去势抵抗性前列腺癌（mCRPC）患者间歇性多西紫杉醇与连续多西紫杉醇相比的非劣效性。
研究者发起的随机 III 期研究纳入了 187 例化疗初治的 mCRPC 患者，他们被分配到两个治疗组：间歇性多西紫杉醇组和连续多西紫杉醇组。两个组中均应用每周（35mg/m ）或 3 周（75mg/m ）方案的多西紫杉醇。主要终点为 1 年生存率，检验非劣效性（边界 δ = 0.125）。次要终点为：总生存期（OS）、无进展生存期（PFS）、中位治疗失败时间（TTF）和毒性。
在 156 例合格患者中，78 例被分配到每个治疗组。间歇性治疗在 1 年生存率方面符合非劣效性标准（双侧 95%置信区间为-0.12，18，P = 0.022），但根据事后分析的结果，OS 不符合。两组间 PFS 和 TTF 差异无统计学意义。间歇性治疗组的中位（范围）治疗假期为 110 天（13-486 天），或占总治疗时间的 38%。两个研究组的安全性特征相当。本研究的主要局限性是计划的患者数量未能招募到。
间歇性多西紫杉醇化疗在 1 年生存率方面非劣效于连续治疗；OS 未达到非劣效性。
