Postoperative radiotherapy after radical prostatectomy:: a randomised controlled trial (EORTC trial 22911)
Postoperative radiotherapy after radical prostatectomy:: a randomised controlled trial (EORTC trial 22911)
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DOI：
10.1016/s0140-6736(05)67101-2
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发表时间：
2005-08-13
期刊：
影响因子：
168.9
通讯作者：
Piérart, M
中科院分区：
文献类型：
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作者：
Bolla, M;van Poppel, H;Piérart, M
背景 癌症超出包膜范围的患者，前列腺切除术后可能会出现局部失败。我们进行了一项随机对照试验，对手术切缘阳性或 pT3 前列腺癌患者的根治性前列腺切除术后即刻外照射与单纯前列腺切除术进行比较。方法在接受根治性耻骨后前列腺切除术后，503 名患者被随机分配接受观望治疗，502 名患者接受术后立即放疗（6 周内进行 60 Gy 常规照射）。符合条件的患者患有pN0M0肿瘤和一种或多种病理危险因素：包膜穿孔、手术切缘阳性、精囊侵犯。我们修改后的主要终点是生化无进展生存期。按意向治疗进行分析。结果 中位年龄为 65 岁 (IQR 61-69)。中位随访 5 年后，照射组的生化无进展生存率显着改善（74.0%，98% CI 68.7-79.3 vs 52.6%，46.6-58.5；p
Background Local failure after prostatectomy can arise in patients with cancer extending beyond the capsule. We did a randomised controlled trial to compare radical prostatectomy followed by immediate external irradiation with prostatectomy alone for patients with positive surgical margin or pT3 prostate cancer.Methods After undergoing radical retropubic prostatectomy, 503 patients were randomly assigned to a wait-and-see policy, and 502 to immediate postoperative radiotherapy (60 Gy conventional irradiation delivered over 6 weeks). Eligible patients had pN0M0 tumours and one or more pathological risk factors: capsule perforation, positive surgical margins, invasion of seminal vesicles. Our revised primary endpoint was biochemical progression-free survival. Analysis was by intention to treat.Findings The median age was 65 years (IQR 61-69). After a median follow-up of 5 years, biochemical progression-free survival was significantly improved in the irradiated group (74.0%, 98% CI 68.7-79.3 vs 52.6%, 46.6-58.5; p