Department of Oncology, McMaster University and Ontario Clinical Oncology Group, Hamilton, Ontario, Canada.
Eur Urol. 2012 Feb;61(2):363-9. doi: 10.1016/j.eururo.2011.06.034. Epub 2011 Jun 22.
The optimal number of 3-wk docetaxel plus prednisone (DP) cycles for metastatic castration-resistant prostate cancer (mCRPC) is unclear.
A retrospective analysis of two clinical trials was performed to evaluate the association of the number of cycles with overall survival (OS).
DESIGN, SETTING, AND PARTICIPANTS: An exploratory analysis compared outcomes of 332 men who received DP in the TAX-327 trial, which stipulated up to 10 cycles, and 220 men who received DP in CS-205, a randomized phase 2 trial comparing DP plus AT-101 (bcl-2 inhibitor) versus DP plus placebo, which allowed up to 17 cycles.
Patients who completed 10 cycles of DP without progression in both trials were included. Men in both arms of CS-205 were combined for analysis, as no significant differences in outcomes were observed. OS was estimated from the date of cycle 10 docetaxel infusion.
The number of men receiving 10 cycles was similar (p=0.26) in the two trials (166 [50.0%] in TAX-327 vs 99 [45.0%] in CS-205; the latter group received a median of five additional cycles). Six- and 12-mo estimated survival after cycle 10 was 92.2% (95% confidence interval [CI], 86.9-95.4%) and 74.6% (CI, 67.2-80.5%) in TAX-327, compared with 92.8% (CI, 85.5-96.5) and 63.4% (CI, 51.8-72.9%) in CS-205. Subanalyses suggested that <10 cycles may have a negative impact and prostate-specific antigen (PSA) declines at cycle 10 may carry a favorable impact. The significance of continued PSA declines up to 17 cycles is unclear. Limitations of a retrospective analysis apply.
A survival benefit was not detected with >10 cycles of DP in men with mCRPC in this retrospective hypothesis-generating analysis.
转移性去势抵抗性前列腺癌（mCRPC）最佳的多西他赛加泼尼松（DP）治疗周期数尚不清楚。
对两项临床试验进行回顾性分析，以评估周期数与总生存（OS）的相关性。
设计、地点和参与者：对 TAX-327 试验中接受 DP 治疗的 332 例男性和 CS-205 中接受 DP 治疗的 220 例男性（比较 DP 加 AT-101（bcl-2 抑制剂）与 DP 加安慰剂的随机 2 期试验）进行了探索性分析。在这两项试验中，均规定最多接受 10 个周期 DP 治疗。在 CS-205 中，无进展的患者完成了 10 个 DP 周期，两个试验中完成 10 个 DP 周期的患者人数相似（p=0.26）。分析时将 CS-205 两个臂的患者合并，因为未观察到结局存在差异。OS 从第 10 周期多西他赛输注日期开始估算。
从第 10 周期 DP 开始的 6 个月和 12 个月的估计生存率分别为 92.2%（95%置信区间 [CI]，86.9-95.4%）和 74.6%（CI，67.2-80.5%）。
在这两项试验中，接受 10 个周期 DP 治疗的患者人数相似（p=0.26）（TAX-327 组为 166 [50.0%]，CS-205 组为 99 [45.0%]；后者组接受了中位数为 5 个额外周期的 DP 治疗）。TAX-327 组与 CS-205 组相比，第 10 周期后 6 个月和 12 个月的估计生存率分别为 92.8%（CI，85.5-96.5%）和 63.4%（CI，51.8-72.9%）。亚分析表明，<10 个周期可能会产生负面影响，第 10 周期时前列腺特异性抗原（PSA）下降可能具有有利影响。PSA 持续下降至 17 个周期的意义尚不清楚。该回顾性分析存在一定局限性。
在这项回顾性假设生成分析中，对于 mCRPC 男性，多西他赛加泼尼松治疗>10 个周期并未显示出生存获益。
