Phase III Postoperative Adjuvant Radiotherapy After Radical Prostatectomy Compared With Radical Prostatectomy Alone in pT3 Prostate Cancer With Postoperative Undetectable Prostate-Specific Antigen: ARO 96-02/AUO AP 09/95
Phase III Postoperative Adjuvant Radiotherapy After Radical Prostatectomy Compared With Radical Prostatectomy Alone in pT3 Prostate Cancer With Postoperative Undetectable Prostate-Specific Antigen: ARO 96-02/AUO AP 09/95
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DOI：
10.1200/jco.2008.18.9563
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发表时间：
2009-06-20
影响因子：
45.3
通讯作者：
Miller, Kurt
中科院分区：
文献类型：
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作者：
Wiegel, Thomas;Bottke, Dirk;Miller, Kurt
根治性膀胱切除术（RP）后的局部失败常见于肿瘤超出包膜的患者。两项随机试验证明了辅助放疗（RT）与观望政策相比的优势。我们进行了一项随机对照临床试验，比较RP，然后立即RT与RP单独的患者与PT 3前列腺癌和检测不到的前列腺特异性抗原（PSA）水平后RP。MethodsAfter RP，192名男子被随机分配到一个等待和观望的政策，和193名男子被分配到立即术后RT。符合条件的患者有PT 3 pN 0肿瘤。根据随机分配（n = 78; 20%），RP后未达到不可检测PSA的患者从治疗中排除。在其余307例患者中，RT组34例患者未接受RT，观望组5例患者接受RT。因此，114例患者接受RT，154例患者接受观望政策治疗。主要终点是生化无进展生存率。结果RP后PSA检测不到的患者5年后的生化无进展生存率在RT组显著改善（72%; 95% CI，65%至81%; v 54%，95% CI，45%至63%;风险比= 0.53; 95% CI，0.37至0.79; P = 0.0015）。在单因素分析中，Gleason评分大于6且小于7、RP前PSA、肿瘤分期和手术切缘阳性是预后的预测因素。3 ~ 4级晚期不良反应发生率为0.3%。结论术后PSA检测阴性的pT 3前列腺癌患者行辅助放疗可显著降低生化进展的风险。需要进一步随访以评估对无瘤生存率和总生存率的影响。J Clin Oncol 27：2924-2930. (C)2009年美国临床肿瘤学会
PurposeLocal failure after radical prostatectomy (RP) is common in patients with cancer extending beyond the capsule. Two randomized trials demonstrated an advantage for adjuvant radiotherapy (RT) compared with a wait-and-see policy. We conducted a randomized, controlled clinical trial to compare RP followed by immediate RT with RP alone for patients with pT3 prostate cancer and an undetectable prostate-specific antigen (PSA) level after RP.MethodsAfter RP, 192 men were randomly assigned to a wait-and-see policy, and 193 men were assigned to immediate postoperative RT. Eligible patients had pT3 pN0 tumors. Patients who did not achieve an undetectable PSA after RP were excluded from treatment according to random assignment (n = 78; 20%). Of the remaining 307 patients, 34 patients on the RT arm did not receive RT and five patients on the wait-and-see arm received RT. Therefore, 114 patients underwent RT and 154 patients were treated with a wait-and-see policy. The primary end point was biochemical progression-free survival.ResultsBiochemical progression-free survival after 5 years in patients with undetectable PSA after RP was significantly improved in the RT group (72%; 95% CI, 65% to 81%; v 54%, 95% CI, 45% to 63%; hazard ratio = 0.53; 95% CI, 0.37 to 0.79; P = .0015). On univariate analysis, Gleason score more than 6 and less than 7, PSA before RP, tumor stage, and positive surgical margins were predictors of outcome. The rate of grade 3 to 4 late adverse effects was 0.3%.ConclusionAdjuvant RT for pT3 prostate cancer with postoperatively undetectable PSA significantly reduces the risk of biochemical progression. Further follow-up is needed to assess the effect on metastases-free and overall survival. J Clin Oncol 27: 2924-2930. (C) 2009 by American Society of Clinical Oncology