Dose-response in radiotherapy for localized prostate cancer: Results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy
Dose-response in radiotherapy for localized prostate cancer: Results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy
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DOI：
10.1200/jco.2005.05.2530
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发表时间：
2006-05-01
影响因子：
45.3
通讯作者：
Lebesque, AV
中科院分区：
文献类型：
--
作者：
Peeters, STH;Heemsbergen, WD;Lebesque, AV
目的确定是否78戈伊的剂量改善结果相比，传统的剂量为68戈伊的前列腺癌患者治疗与三维适形radiotherapy.Patients和方法之间1997年6月和2003年2月，阶段T1 b-4前列腺癌患者参加了一个多中心随机试验比较68戈伊与78戈伊。患者按机构、年龄、（新）辅助激素治疗（HT）和治疗组分层。根据精囊受累的概率定义了4个治疗组（具有特定的辐射体积）。主要终点是无失败（FFF）。根据美国放射治疗肿瘤学会的定义，失败被定义为临床失败或生化失败。其他终点是无临床失败（FFCF），总生存期（OS），和toxicity.Results中位随访时间为51个月。在669例入组患者中，664例被纳入分析。143名患者接受了HT治疗。与68-戈伊组相比，78-戈伊组的FFF显著更好（5年FFF率分别为64%和54%），调整后的风险比为0.74（P= 0.02）。治疗组之间的FFCF或OS无显著差异。放射治疗肿瘤组和欧洲组织的研究和治疗癌症2级或以上的晚期泌尿生殖系统毒性没有差异，2级或以上的晚期胃肠道毒性的发生率略高，无显著性差异。结论本多中心随机试验显示，前列腺癌患者接受更高剂量的放射治疗后，FFF得到显著改善。
Purpose To determine whether a dose of 78 Gy improves outcome compared with a conventional dose of 68 Gy for prostate cancer patients treated with three-dimensional conformal radiotherapy.Patients and Methods Between June 1997 and February 2003, stage T1b-4 prostate cancer patients were enrolled onto a multicenter randomized trial Comparing 68 Gy with 78 Gy. Patients were stratified by institution, age, (neo)adjuvant hormonal therapy (HT), and treatment group. Four treatment groups (with specific radiation volumes) were defined based on the probability of seminal vesicle involvement. The primary end point was freedom from failure (FFF). Failure was defined as clinical failure or biochemical failure, according to the American Society of Therapeutic Radiation Oncology definition. Other end points were freedom from clinical failure (FFCF), overall survival (OS), and toxicity.Results Median follow-up time was 51 months. Of the 669 enrolled patients, 664 were included in the analysis. HT was prescribed for 143 patients. FFF was significantly better in the 78-Gy arm compared with the 68-Gy arm (5-year FFF rate, 64% v 54%, respectively), with an adjusted hazard ratio of 0.74 (P=.02). No significant differences in FFCF or OS were seen between the treatment arms. There was no difference in late genitourinary toxicity of Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer grade 2 or more and a slightly higher nonsignificant incidence of late gastrointestinal toxicity of grade 2 or more.Conclusion This multicenter randomized trial shows a significantly improved FFF in prostate cancer patients treated with a higher dose of radiotherapy.