Lee W Robert, Dignam James J, Amin Mahul B, Bruner Deborah W, Low Daniel, Swanson Gregory P, Shah Amit B, D'Souza David P, Michalski Jeff M, Dayes Ian S, Seaward Samantha A, Hall William A, Nguyen Paul L, Pisansky Thomas M, Faria Sergio L, Chen Yuhchyau, Koontz Bridget F, Paulus Rebecca, Sandler Howard M
W. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
J Clin Oncol. 2016 Jul 10;34(20):2325-32. doi: 10.1200/JCO.2016.67.0448. Epub 2016 Apr 4.
Conventional radiotherapy (C-RT) treatment schedules for patients with prostate cancer typically require 40 to 45 treatments that take place from > 8 to 9 weeks. Preclinical and clinical research suggest that hypofractionation-fewer treatments but at a higher dose per treatment-may produce similar outcomes. This trial was designed to assess whether the efficacy of a hypofractionated radiotherapy (H-RT) treatment schedule is no worse than a C-RT schedule in men with low-risk prostate cancer.
A total of 1,115 men with low-risk prostate cancer were randomly assigned 1:1 to C-RT (73.8 Gy in 41 fractions over 8.2 weeks) or to H-RT (70 Gy in 28 fractions over 5.6 weeks). This trial was designed to establish (with 90% power and an α of .05) that treatment with H-RT results in 5-year disease-free survival (DFS) that is not worse than C-RT by more than 7.65% (H-RT/C-RT hazard ratio [HR] < 1.52).
A total of 1,092 men were protocol eligible and had follow-up information; 542 patients were assigned to C-RT and 550 to H-RT. Median follow-up was 5.8 years. Baseline characteristics were not different according to treatment assignment. The estimated 5-year DFS was 85.3% (95% CI, 81.9 to 88.1) in the C-RT arm and 86.3% (95% CI, 83.1 to 89.0) in the H-RT arm. The DFS HR was 0.85 (95% CI, 0.64 to 1.14), and the predefined noninferiority criterion that required that DFS outcomes be consistent with HR < 1.52 was met (P < .001). Late grade 2 and 3 GI and genitourinary adverse events were increased (HR, 1.31 to 1.59) in patients who were treated with H-RT.
In men with low-risk prostate cancer, the efficacy of 70 Gy in 28 fractions over 5.6 weeks is not inferior to 73.8 Gy in 41 fractions over 8.2 weeks, although an increase in late GI/genitourinary adverse events was observed in patients treated with H-RT.
前列腺癌患者的传统放射治疗（C-RT）方案通常需要进行40至45次治疗，疗程超过8至9周。临床前和临床研究表明，大分割放疗——治疗次数减少但每次剂量增加——可能产生相似的疗效。本试验旨在评估在低危前列腺癌男性患者中，大分割放射治疗（H-RT）方案的疗效是否不劣于C-RT方案。
总共1115例低危前列腺癌男性患者被随机1:1分配至C-RT组（8.2周内分41次给予73.8 Gy）或H-RT组（5.6周内分28次给予70 Gy）。本试验旨在确定（检验效能为90%，α为0.05）H-RT治疗导致的5年无病生存率（DFS）不比C-RT差超过7.65%（H-RT/C-RT风险比[HR]<1.52）。
总共1092例男性符合方案要求并具有随访信息；542例患者被分配至C-RT组，550例被分配至H-RT组。中位随访时间为5.8年。根据治疗分配，基线特征无差异。C-RT组的估计5年DFS为85.3%（95%CI，81.9至88.1），H-RT组为86.3%（95%CI，83.1至89.0）。DFS HR为0.85（95%CI，0.64至1.14），满足预先设定的非劣效性标准，即DFS结果需符合HR<1.52（P<0.001）。接受H-RT治疗的患者中，2级和3级胃肠道及泌尿生殖系统晚期不良事件有所增加（HR，1.31至1.59）。
在低危前列腺癌男性患者中，5.6周内分28次给予70 Gy的疗效不劣于8.2周内分41次给予73.8 Gy，尽管接受H-RT治疗的患者中观察到胃肠道/泌尿生殖系统晚期不良事件有所增加。
