Pommier Pascal, Chabaud Sylvie, Lagrange Jean Leon, Richaud Pierre, Lesaunier François, Le Prise Elisabeth, Wagner Jean Philippe, Hay Meng Huor, Beckendorf Veronique, Suchaud Jean Philippe, Pabot du Chatelard Pierre Marie, Bernier Valerie, Voirin Nicolas, Perol David, Carrie Christian
Centre Léon Bérard, Department of Radiotherapy, Lyon, France.
J Clin Oncol. 2007 Dec 1;25(34):5366-73. doi: 10.1200/JCO.2006.10.5171.
To assess the benefit and toxicity and quality-of-life (QOL) outcomes of pelvic nodes irradiation in nonmetastatic prostate carcinoma patients.
Between December 1998 and June 2004, 444 patients with T1b-T3, N0 pNx, M0 prostate carcinoma were randomly assigned to either pelvic and prostate radiotherapy or prostate radiotherapy only. Patients were stratified according to the prognostic factor of lymph node involvement (LNI). Short-term 6-month neoadjuvant and concomitant hormonal therapy was allowed only for patients in the high-risk group. The pelvic dose was 46 Gy. The total dose recommended to the prostate was changed during the course of the study from 66 Gy to 70 Gy. Criteria for progression-free survival (PFS) included biologic prostate-specific antigen recurrences or a local or metastatic evolution. Acute and late toxicities were recorded according to the Radiation Therapy Oncology Group and Late Effects in Normal Tissues Subjective, Objective, Management, and Analytic scales, respectively. The QOL outcome was recorded with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30, the International Prostatic Symptom Score, and the Sexual Function Index scales.
With a 42.1-month median follow-up time, the 5-year PFS and overall survival were similar in the two treatment arms for the whole series and for each stratified group. On multivariate analysis, low LNI risk and hormonal therapy were statistically associated with increased PFS. However, subgroup analyses based on these factors did not show any benefit for pelvic irradiation. There were no significant differences in acute and late digestive toxicities and in QOL outcomes.
Pelvic node irradiation was well tolerated but did not improve PFS.
评估盆腔淋巴结照射对非转移性前列腺癌患者的益处、毒性及生活质量（QOL）结果。
1998年12月至2004年6月期间，444例T1b - T3、N0 pNx、M0前列腺癌患者被随机分为盆腔及前列腺放疗组或仅前列腺放疗组。患者根据淋巴结受累（LNI）这一预后因素进行分层。仅高危组患者允许进行短期（6个月）新辅助及同步激素治疗。盆腔剂量为46 Gy。在研究过程中，推荐给前列腺的总剂量从66 Gy变为70 Gy。无进展生存期（PFS）标准包括生物学前列腺特异性抗原复发或局部或转移进展。急性和晚期毒性分别根据放射治疗肿瘤学组以及正常组织晚期效应主观、客观、管理和分析量表进行记录。使用欧洲癌症研究与治疗组织生活质量问卷C30、国际前列腺症状评分和性功能指数量表记录QOL结果。
中位随访时间为42.1个月，整个系列以及每个分层组中两个治疗组的5年PFS和总生存率相似。多因素分析显示，低LNI风险和激素治疗与PFS增加在统计学上相关。然而，基于这些因素的亚组分析未显示盆腔照射有任何益处。急性和晚期消化毒性以及QOL结果方面无显著差异。
盆腔淋巴结照射耐受性良好，但未改善PFS。
