Department of Urology, Lund University, Skåne University Hospital, Sweden.
Department of Oncology, Lund University, Skåne University Hospital, Sweden.
Eur Urol. 2018 Jun;73(6):870-876. doi: 10.1016/j.eururo.2018.01.012. Epub 2018 Feb 1.
Adjuvant chemotherapy is standard treatment for other solid tumours, but to date has not proven effective in prostate cancer.
o evaluate whether six cycles of docetaxel alone improve biochemical disease-free survival after radical prostatectomy for high-risk prostate cancer.
DESIGN, SETTING, AND PARTICIPANTS: Open-label, randomised multinational phase 3 trial. Enrolment of 459 patients after prostatectomy.
high-risk pT2 margin positive or pT3a Gleason score ≥4+3, pT3b, or lymph node positive disease Gleason score ≥3+4. Patients assigned (1:1) to either six cycles of adjuvant docetaxel 75mg/m every 3 wk without daily prednisone (Arm A) or surveillance (Arm B) until endpoint was reached. Primary endpoint was prostate-specific antigen progression ≥0.5 ng/ml.
Docetaxel treatment after prostatectomy.
Median time to progression, death, or last follow-up was 56.8 mo. Primary endpoint was reached in 190/459 patients-the risk of progression at 5 yr being 41% (45% in Arm A and 38% in Arm B). There was evidence of nonproportional hazards in Kaplan-Meier analysis, so we used the difference in restricted mean survival time as the primary estimate of effect. Restricted mean survival time to endpoint was 43 mo in Arm A versus 46 mo in Arm B (p=0.06), a nonsignificant difference of 3.2 mo (95% confidence interval: 6.7 to -1.5 mo). A total of 116 serious adverse events were recorded in Arm A and 41 in Arm B with no treatment-related deaths. Not all patients received docetaxel by protocol. The endpoint is biochemical progression and some patients received radiation treatment before the endpoint.
Docetaxel without hormonal therapy did not significantly improve biochemical disease-free survival after radical prostatectomy.
In this randomised trial, we tested whether chemotherapy after surgery for high-risk prostate cancer decreases the risk of a rising prostate-specific antigen. We found no benefit from docetaxel given after radical prostatectomy.
辅助化疗是治疗其他实体瘤的标准治疗方法，但迄今为止，在前列腺癌中并未证明有效。
评估单独使用 6 个周期多西他赛是否能改善高危前列腺癌根治术后的生化无病生存期。
设计、地点和参与者：开放标签、随机、多中心 3 期试验。在前列腺切除术后入组 459 例患者。
高风险 pT2 切缘阳性或 pT3a Gleason 评分≥4+3、pT3b 或淋巴结阳性疾病 Gleason 评分≥3+4。患者按 1:1 随机分配至接受 6 个周期辅助多西他赛 75mg/m2，每 3 周一次，不使用泼尼松（A 组）或监测（B 组），直至达到终点。主要终点为前列腺特异性抗原进展≥0.5ng/ml。
前列腺切除术后的多西他赛治疗。
中位无进展、死亡或末次随访时间为 56.8 个月。主要终点在 459 例患者中的 190 例中达到，5 年进展风险为 41%（A 组为 45%，B 组为 38%）。在 Kaplan-Meier 分析中存在非比例风险，因此我们使用受限平均生存时间差异作为主要的效果估计。A 组终点的受限平均生存时间为 43 个月，B 组为 46 个月（p=0.06），差异无统计学意义为 3.2 个月（95%置信区间：6.7 至-1.5 个月）。A 组共记录 116 例严重不良事件，B 组为 41 例，无治疗相关死亡。并非所有患者均按方案接受多西他赛治疗。该终点为生化进展，部分患者在终点前接受了放射治疗。
根治性前列腺切除术后不联合激素治疗的多西他赛并未显著改善生化无病生存期。
在这项随机试验中，我们测试了高危前列腺癌手术后化疗是否能降低前列腺特异性抗原升高的风险。我们发现根治性前列腺切除术后使用多西他赛没有获益。
