Prostate-Only Versus Whole-Pelvic Radiation Therapy in High-Risk and Very High-Risk Prostate Cancer (POP-RT): Outcomes From Phase III Randomized Controlled Trial
Prostate-Only Versus Whole-Pelvic Radiation Therapy in High-Risk and Very High-Risk Prostate Cancer (POP-RT): Outcomes From Phase III Randomized Controlled Trial
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DOI：
10.1200/jco.20.03282
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发表时间：
2021-04-10
影响因子：
45.3
通讯作者：
Mahantshetty, Umesh
中科院分区：
文献类型：
--
作者：
Murthy, Vedang;Maitre, Priyamvada;Mahantshetty, Umesh
目的我们报告一项随机试验的临床结果，该试验比较了高风险前列腺癌的预防性全盆腔淋巴结放疗与单纯前列腺放疗（PORT）。方法这项 III 期、单中心、随机对照试验纳入了接受淋巴结阴性前列腺癌根治性放疗的合格患者，估计淋巴结风险 >= 20%。随机化为 1:1 进行 PORT（68 Gy/25# 前列腺）或全盆腔放疗（WPRT，68 Gy/25# 前列腺，50 Gy/25# 盆腔淋巴结，包括髂总），采用计算机分层区组随机化，按格里森评分、雄激素剥夺类型、诊断时前列腺特异性抗原和既往经尿道前列腺切除术进行分层。所有患者均接受影像引导调强放射治疗和至少 2 年的雄激素剥夺治疗。主要终点为5年生化无失败生存期（BFFS），次要终点为无病生存期（DFS）和总生存期（OS）。 结果2011年11月至2017年8月，共有224例患者被随机分配（PORT = 114，WPRT = 110）。中位随访时间为 68 个月，记录了 36 例生化失败（PORT = 25，WPRT = 7）和 24 例死亡（PORT = 13，WPRT = 11）。 WPRT 组的五年 BFFS 为 95.0%（95% CI，88.4 至 97.9），而 PORT 组为 81.2%（95% CI，71.6 至 87.8），未经调整的风险比 (HR) 为 0.23（95% CI，0.10 至 0.52；P < .0001）。 WPRT 还显示出较高的 5 年 DFS（89.5% vs 77.2%；HR，0.40；95% CI，0.22 至 0.73；P = 0.002），但 5 年 OS 似乎没有差异（92.5% vs 90.8%；HR，0.92；95% CI，0.41 至 2.05；P = .83）。 WPRT 组的远处无转移生存率也较高（95.9% vs 89.2%；HR，0.35；95% CI，0.15 至 0.82；P = 0.01）。 BFFS 和 DFS 的益处在各个预后亚组中得以维持。 结论 与 PORT 相比，针对高风险、局部晚期前列腺癌的预防性盆腔放疗可改善 BFFS 和 DFS，但 OS 似乎没有差异。
PURPOSEWe report the clinical outcomes of a randomized trial comparing prophylactic whole-pelvic nodal radiotherapy to prostate-only radiotherapy (PORT) in high-risk prostate cancer.METHODSThis phase III, single center, randomized controlled trial enrolled eligible patients undergoing radical radiotherapy for node-negative prostate adenocarcinoma, with estimated nodal risk >= 20%. Randomization was 1:1 to PORT (68 Gy/25# to prostate) or whole-pelvic radiotherapy (WPRT, 68 Gy/25# to prostate, 50 Gy/25# to pelvic nodes, including common iliac) using computerized stratified block randomization, stratified by Gleason score, type of androgen deprivation, prostate-specific antigen at diagnosis, and prior transurethral resection of the prostate. All patients received image-guided, intensity-modulated radiotherapy and minimum 2 years of androgen deprivation therapy. The primary end point was 5-year biochemical failure-free survival (BFFS), and secondary end points were disease-free survival (DFS) and overall survival (OS).RESULTSFrom November 2011 to August 2017, a total of 224 patients were randomly assigned (PORT = 114, WPRT = 110). At a median follow-up of 68 months, 36 biochemical failures (PORT = 25, WPRT = 7) and 24 deaths (PORT = 13, WPRT = 11) were recorded. Five-year BFFS was 95.0% (95% CI, 88.4 to 97.9) with WPRT versus 81.2% (95% CI, 71.6 to 87.8) with PORT, with an unadjusted hazard ratio (HR) of 0.23 (95% CI, 0.10 to 0.52; P < .0001). WPRT also showed higher 5-year DFS (89.5% v 77.2%; HR, 0.40; 95% CI, 0.22 to 0.73; P = .002), but 5-year OS did not appear to differ (92.5% v 90.8%; HR, 0.92; 95% CI, 0.41 to 2.05; P = .83). Distant metastasis-free survival was also higher with WPRT (95.9% v 89.2%; HR, 0.35; 95% CI, 0.15 to 0.82; P = .01). Benefit in BFFS and DFS was maintained across prognostic subgroups.CONCLUSIONProphylactic pelvic irradiation for high-risk, locally advanced prostate cancer improved BFFS and DFS as compared with PORT, but OS did not appear to differ.