Background

Adjuvant chemotherapy is standard treatment for other solid tumours, but to date has not proven effective in prostate cancer.

Objective

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. Inclusion criteria: 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 75 mg/m² 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.

Intervention

Docetaxel treatment after prostatectomy.

Results and limitations

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.

Conclusions

Docetaxel without hormonal therapy did not significantly improve biochemical disease-free survival after radical prostatectomy.

Patient summary

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.

中文翻译：

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高危前列腺癌根治性前列腺切除术后多西他赛与监测的比较：前瞻性随机，开放标签第3期斯堪的纳维亚前列腺癌第12组试验的结果

背景

辅助化疗是其他实体瘤的标准治疗方法，但迄今为止尚未证明对前列腺癌有效。

客观的

o评价高危前列腺癌根治性前列腺切除术后单独使用六个周期的多西他赛是否能改善无生化疾病的生存率。

设计，设置和参与者

开放标签，随机的跨国3期临床试验。前列腺切除术后459例患者入组。纳入标准：高危pT2边缘阳性或pT3a格里森评分≥4+ 3，pT3b或淋巴结阳性疾病格里森评分≥3+4。患者被分配为（1：1）六个周期的多西他赛辅助治疗75 mg / m每3周^2次，无每日泼尼松（Arm A）或监测（Arm B），直至达到终点。主要终点为前列腺特异性抗原进展≥0.5ng / ml。

干涉

前列腺切除术后多西他赛治疗。

结果与局限性

进展，死亡或最后一次随访的中位时间为56.8 mo。190/459位患者达到了主要终点-5年时进展的风险为41％（A组为45％，B组为38％）。在Kaplan-Meier分析中有非比例危险的证据，因此我们将受限平均生存时间的差异作为影响的主要估计。A组的至终点的平均生存时间受限，B组为46 mo（p  = 0.06），差异无统计学意义，为3.2 mo（95％置信区间：6.7至–1.5 mo），差异无统计学意义（p = 0.06）。在A组中记录了116起严重不良事件，在B组中记录了41次，没有与治疗相关的死亡。并非所有患者均按方案接受多西他赛治疗。终点是生化进程，一些患者在终点之前接受了放射治疗。

结论

不用激素治疗的多西他赛不能显着改善根治性前列腺切除术后的无生化疾病的生存期。

病人总结

在这项随机试验中，我们测试了高危前列腺癌手术后的化疗是否可以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给予多西他赛没有益处。