Charles N. Catton, Peter W.M. Chung, Patrick Cheung, Padraig Warde, and Tim K. Craig, University of Toronto, Toronto; Himu Lukka, Chu-Shu Gu, Theodoros Tsakiridis, Tom B. Corbett, Ian S. Dayes, Jim A. Julian, and Mark N. Levine, McMaster University, Hamilton; Glenn S. Bauman, University of Western Ontario, London, Ontario; Jean-Paul Bahary, University of Montreal, Montreal, Quebec; Shahida Ahmed, University of Manitoba, Winnipeg, Manitoba; Jackson S. Wu, University of Calgary, Calgary; Matthew B. Parliament, University of Alberta, Edmonton, Alberta, Canada; Jarad M. Martin, University of Newcastle, Newcastle, New South Wales; Keen Hun Tai, University of Melbourne, Melbourne, Victoria; Colin Tang, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia; and Stéphane Supiot, University of Nantes, Nantes, France.
J Clin Oncol. 2017 Jun 10;35(17):1884-1890. doi: 10.1200/JCO.2016.71.7397. Epub 2017 Mar 15.
Purpose Men with localized prostate cancer often are treated with external radiotherapy (RT) over 8 to 9 weeks. Hypofractionated RT is given over a shorter time with larger doses per treatment than standard RT. We hypothesized that hypofractionation versus conventional fractionation is similar in efficacy without increased toxicity. Patients and Methods We conducted a multicenter randomized noninferiority trial in intermediate-risk prostate cancer (T1 to 2a, Gleason score ≤ 6, and prostate-specific antigen [PSA] 10.1 to 20 ng/mL; T2b to 2c, Gleason ≤ 6, and PSA ≤ 20 ng/mL; or T1 to 2, Gleason = 7, and PSA ≤ 20 ng/mL). Patients were allocated to conventional RT of 78 Gy in 39 fractions over 8 weeks or to hypofractionated RT of 60 Gy in 20 fractions over 4 weeks. Androgen deprivation was not permitted with therapy. The primary outcome was biochemical-clinical failure (BCF) defined by any of the following: PSA failure (nadir + 2), hormonal intervention, clinical local or distant failure, or death as a result of prostate cancer. The noninferiority margin was 7.5% (hazard ratio, < 1.32). Results Median follow-up was 6.0 years. One hundred nine of 608 patients in the hypofractionated arm versus 117 of 598 in the standard arm experienced BCF. Most of the events were PSA failures. The 5-year BCF disease-free survival was 85% in both arms (hazard ratio [short v standard], 0.96; 90% CI, 0.77 to 1.2). Ten deaths as a result of prostate cancer occurred in the short arm and 12 in the standard arm. No significant differences were detected between arms for grade ≥ 3 late genitourinary and GI toxicity. Conclusion The hypofractionated RT regimen used in this trial was not inferior to conventional RT and was not associated with increased late toxicity. Hypofractionated RT is more convenient for patients and should be considered for intermediate-risk prostate cancer.
局限性前列腺癌患者常接受 8 至 9 周的外照射放疗（RT）。与标准 RT 相比，短程放疗的剂量更大，每次治疗的剂量更大。我们假设短程放疗与常规放疗在疗效上相似，而毒性不增加。
我们在中危前列腺癌（T1 至 2a，Gleason 评分≤6，前列腺特异性抗原[PSA]10.1 至 20ng/ml；T2b 至 2c，Gleason≤6，PSA≤20ng/ml；或 T1 至 2，Gleason=7，PSA≤20ng/ml）中进行了一项多中心随机非劣效性试验。患者被分配接受常规 RT，78Gy 分 39 次，8 周完成；或接受短程放疗，60Gy 分 20 次，4 周完成。治疗期间不允许进行雄激素剥夺。主要结局是生化临床失败（BCF），定义为以下任何一种情况：PSA 失败（最低值+2）、激素干预、临床局部或远处失败或前列腺癌导致的死亡。非劣效性边界为 7.5%（风险比，<1.32）。
中位随访时间为 6.0 年。短程放疗组 608 例患者中有 109 例发生 BCF，标准组 598 例患者中有 117 例发生 BCF。大多数事件是 PSA 失败。两组 5 年 BCF 无病生存率均为 85%（短程与标准臂的风险比[short v standard]，0.96；90%CI，0.77 至 1.2）。短程组有 10 例前列腺癌相关死亡，标准组有 12 例。两组间≥3 级晚期泌尿生殖系统和胃肠道毒性无显著差异。
本试验中使用的短程放疗方案并不劣于常规 RT，且与晚期毒性增加无关。短程放疗对患者更方便，应考虑用于中危前列腺癌。
