高危局限性前列腺癌患者选择性盆腔放疗的结果：GETUG 12 期 3 随机试验的二次分析。
Outcome According to Elective Pelvic Radiation Therapy in Patients With High-Risk Localized Prostate Cancer: A Secondary Analysis of the GETUG 12 Phase 3 Randomized Trial.
机构信息
Radiation Oncology, Gustave Roussy Cancer Center, Villejuif, France; University of Paris-Sud, Cancer Campus, Villejuif, France.
Biostatistics, Gustave Roussy Cancer Center, Villejuif, France.
出版信息
Int J Radiat Oncol Biol Phys. 2016 Jan 1;94(1):85-92. doi: 10.1016/j.ijrobp.2015.09.020. Epub 2015 Sep 25.
PURPOSE
The role of pelvic elective nodal irradiation (ENI) in the management of prostate cancer is controversial. This study analyzed the role of pelvic radiation therapy (RT) on the outcome in high-risk localized prostate cancer patients included in the Groupe d'Etude des Tumeurs Uro-Genitales (GETUG) 12 trial.
METHODS AND MATERIALS
Patients with a nonpretreated high-risk localized prostate cancer and a staging lymphadenectomy were randomly assigned to receive either goserelin every 3 months for 3 years and 4 cycles of docetaxel plus estramustine or goserelin alone. Local therapy was administered 3 months after the start of systemic treatment. Performance of pelvic ENI was left to the treating physician. Only patients treated with primary RT were included in this analysis. The primary endpoint was biochemical progression-free survival (bPFS).
RESULTS
A total of 413 patients treated from 2002 to 2006 were included, of whom 358 were treated using primary RT. A total of 208 patients received pelvic RT and 150 prostate-only RT. Prostate-specific antigen (PSA) concentration, Gleason score, or T stage did not differ according to performance of pelvic RT; pN+ patients more frequently received pelvic RT than pN0 patients (P<.0001). Median follow-up was 8.8 years. In multivariate analysis, bPFS was negatively impacted by pN stage (hazard ratio [HR]: 2.52 [95% confidence interval [CI]: 1.78-3.54], P<.0001), Gleason score 8 or higher (HR: 1.41 [95% CI: 1.03-1.93], P=.033) and PSA higher than 20 ng/mL (HR: 1.41 [95% CI: 1.02-1.96], P=.038), and positively impacted by the use of chemotherapy (HR: 0.66 [95% CI: 0.48-0.9], P=.009). There was no association between bPFS and use of pelvic ENI in multivariate analysis (HR: 1.10 [95% CI: 0.78-1.55], P=.60), even when analysis was restricted to pN0 patients (HR: 0.88 [95% CI: 0.59-1.31], P=.53). Pelvic ENI was not associated with increased acute or late patient reported toxicity.
CONCLUSIONS
This unplanned analysis of a randomized trial failed to demonstrate a benefit of pelvic ENI on bPFS in high-risk localized prostate cancer patients.
目的
盆腔选择性淋巴结照射（ENI）在前列腺癌治疗中的作用存在争议。本研究分析了高危局限性前列腺癌患者中盆腔放疗（RT）对 GETUG 12 试验中接受治疗的结果的影响。
方法和材料
对未经预处理的高危局限性前列腺癌且接受了分期淋巴结切除术的患者进行随机分组，分别接受戈舍瑞林每 3 个月治疗 3 年和 4 个周期的多西他赛加雌莫司汀或戈舍瑞林单药治疗。全身治疗开始后 3 个月进行局部治疗。盆腔 ENI 的实施由治疗医生决定。仅纳入接受原发 RT 治疗的患者进行本分析。主要终点是生化无进展生存期（bPFS）。
结果
共纳入 2002 年至 2006 年期间治疗的 413 例患者，其中 358 例接受了原发 RT 治疗。208 例患者接受了盆腔 RT，150 例患者接受了前列腺 RT。根据是否行盆腔 RT，前列腺特异性抗原（PSA）浓度、Gleason 评分或 T 分期无差异；pN+患者比 pN0 患者更常接受盆腔 RT（P<.0001）。中位随访时间为 8.8 年。多变量分析显示，bPFS 受 pN 分期（危险比[HR]：2.52[95%置信区间[CI]：1.78-3.54]，P<.0001）、Gleason 评分 8 或更高（HR：1.41[95% CI：1.03-1.93]，P=.033）和 PSA 高于 20ng/mL（HR：1.41[95% CI：1.02-1.96]，P=.038）的负面影响，受化疗（HR：0.66[95% CI：0.48-0.9]，P=.009）的正面影响。多变量分析中，bPFS 与盆腔 ENI 的使用之间无关联（HR：1.10[95% CI：0.78-1.55]，P=.60），甚至当分析仅限于 pN0 患者时（HR：0.88[95% CI：0.59-1.31]，P=.53）。盆腔 ENI 与急性或晚期患者报告的毒性增加无关。
结论
这项对随机试验的未计划分析未能证明高危局限性前列腺癌患者行盆腔 ENI 对 bPFS 的获益。
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