All authors: Regina Elena National Cancer Institute, Rome, Italy.
J Clin Oncol. 2017 Jun 10;35(17):1891-1897. doi: 10.1200/JCO.2016.70.4189. Epub 2017 Mar 29.
Purpose To report the final results on treatment outcomes of a randomized trial comparing conventional and hypofractionated radiotherapy in high-risk, organ-confined prostate cancer (PCa). Patients and Methods This single-institution, randomized clinical trial, conducted from January 2003 to December 2007, enrolled 168 patients with high-risk PCa who were randomly assigned in a 1:1 ratio to conventional (80 Gy in 40 fractions in 8 weeks) or hypofractionated radiotherapy (62 Gy in 20 fractions in 5 weeks) to prostate and seminal vesicles. The primary outcome measure was late toxicity. Additional outcomes were freedom from biochemical failure (FFBF), prostate cancer-specific survival (PCaSS), and overall survival (OS), evaluated on an intention-to-treat basis. Results A total of 85 patients were assigned to conventional and 83 to hypofractionated radiotherapy. At a median follow-up of 9 years (interquartile range, 7.5 to 10.1 years), no differences was observed in physician-assessed late gastro intestinal and genitourinary toxicity greater than or equal to grade 2 ( P = .68 and .57, respectively) were found between the two arms. The 10-year FFBF rate was 72% in the hypofractionation group and 65% in the conventional fractionation group ( P = .148). Ten-year OS rates were 75% in the hypofractionation group and 64% in the conventional group, respectively ( P = .22). The same features for 10-year PCaSS were 95% and 88%, respectively ( P = .066). Hypofractionation, pretreatment prostate-specific antigen level, Gleason score, and clinical tumor stage for FFBF, and hypofractionation and Gleason score for PCaSS were significant prognostic variables on the multivariate analysis. Conclusion Long-term findings showed that hypofractionated radiotherapy failed the intent of either reducing physician-assessed late toxicity or maintaining the same efficacy. A postrandomization analysis, however, revealed that hypofractionation was a significant prognostic factor for FFBF and PCaSS, when adjusted for clinical prognostic variables.
报告比较常规分割和适形低分割放疗治疗高危局限性前列腺癌（PCa）的随机临床试验的最终结果。
该单中心、随机临床试验于 2003 年 1 月至 2007 年 12 月进行，纳入了 168 例高危 PCa 患者，按照 1:1 的比例随机分配至常规分割（8 周内 40 次 80Gy）或适形低分割（5 周内 20 次 62Gy）放疗组，照射前列腺和精囊。主要观察终点为晚期毒性。次要终点包括生化无失败生存率（FFBF）、前列腺癌特异性生存率（PCaSS）和总生存率（OS），均采用意向治疗分析。
共有 85 例患者被分配至常规分割组，83 例患者被分配至适形低分割组。中位随访 9 年（四分位距 7.5-10.1 年），两组间医生评估的≥2 级晚期胃肠道和泌尿生殖系统毒性发生率无差异（分别为 P =.68 和.57）。适形低分割组和常规分割组的 10 年 FFBF 率分别为 72%和 65%（P =.148）。10 年 OS 率分别为 75%和 64%（P =.22）。10 年 PCaSS 率分别为 95%和 88%（P =.066）。多变量分析显示，适形低分割、治疗前前列腺特异抗原水平、Gleason 评分和临床肿瘤分期是 FFBF 的显著预后因素，适形低分割和 Gleason 评分是 PCaSS 的显著预后因素。
长期随访结果显示，适形低分割放疗未能降低医生评估的晚期毒性或保持相同的疗效。但是，在进行随机分组后分析发现，在调整了临床预后因素后，适形低分割是 FFBF 和 PCaSS 的显著预后因素。
