Van der Kwast Theodorus H, Bolla Michel, Van Poppel Hein, Van Cangh Paul, Vekemans Kris, Da Pozzo Luigi, Bosset Jean-Francois, Kurth Karl H, Schröder Fritz H, Collette Laurence
Department of Pathology and Laboratory Medicine, Mount Sinai Hospital and University Health Network, Toronto, Canada.
J Clin Oncol. 2007 Sep 20;25(27):4178-86. doi: 10.1200/JCO.2006.10.4067.
The randomized controlled European Organisation for Research and Treatment of Cancer (EORTC) trial 22911 studied the effect of radiotherapy after prostatectomy in patients with adverse risk factors. Review pathology data of specimens from participants in this trial were analyzed to identify which factors predict increased benefit from adjuvant radiotherapy.
After prostatectomy, 1,005 patients with stage pT3 and/or positive surgical margins were randomly assigned to a wait-and-see (n = 503) and an adjuvant radiotherapy (60 Gy conventional irradiation) arm (n = 502). Pathologic review data were available for 552 patients from 11 participating centers. The interaction between the review pathology characteristics and treatment benefit was assessed by log-rank test for heterogeneity (P < .05).
Margin status assessed by review pathology was the strongest predictor of prolonged biochemical disease-free survival with immediate postoperative radiotherapy (heterogeneity, P < .01): by year 5, immediate postoperative irradiation could prevent 291 events/1,000 patients with positive margins versus 88 events/1,000 patients with negative margins. The hazard ratio for immediate irradiation was 0.38 (95% CI, 0.26 to 0.54) and 0.88 (95% CI, 0.53 to 1.46) in the groups with positive and negative margins, respectively. We could not identify a significant impact of the positive margin localization.
Provided careful pathology of the prostatectomy is performed, our results suggest that immediate postoperative radiotherapy might not be recommended for prostate cancer patients with negative surgical margins. These findings require validation on an independent data set.
欧洲癌症研究与治疗组织（EORTC）的随机对照试验22911研究了前列腺切除术后放疗对具有不良风险因素患者的影响。对该试验参与者标本的回顾性病理数据进行分析，以确定哪些因素可预测辅助放疗能带来更大益处。
前列腺切除术后，1005例pT3期和/或手术切缘阳性的患者被随机分为等待观察组（n = 503）和辅助放疗组（60 Gy常规照射，n = 502）。来自11个参与中心的552例患者有病理回顾数据。通过对数秩检验评估回顾性病理特征与治疗获益之间的相互作用（P < 0.05）。
回顾性病理评估的切缘状态是术后立即放疗延长生化无病生存期的最强预测因素（异质性，P < 0.01）：到第5年，术后立即放疗可预防每1000例切缘阳性患者发生291例事件，而每1000例切缘阴性患者发生88例事件。切缘阳性组和阴性组立即放疗的风险比分别为0.38（95% CI，0.26至0.54）和0.88（95% CI，0.53至1.46）。我们未发现切缘阳性部位有显著影响。
如果前列腺切除术的病理检查仔细，我们的结果表明，对于手术切缘阴性的前列腺癌患者，可能不建议术后立即放疗。这些发现需要在独立数据集上进行验证。
