Pisansky Thomas M, Hunt Daniel, Gomella Leonard G, Amin Mahul B, Balogh Alexander G, Chinn Daniel M, Seider Michael J, Duclos Marie, Rosenthal Seth A, Bauman Glenn S, Gore Elizabeth M, Rotman Marvin Z, Lukka Himanshu R, Shipley William U, Dignam James J, Sandler Howard M
Thomas M. Pisansky, Mayo Clinic, Rochester, MN; Daniel Hunt and James J. Dignam, Radiation Therapy Oncology Group Statistical Center; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center, Los Angeles; Daniel M. Chinn, John Muir Medical Center-Concord Campus, Concord; Seth A. Rosenthal, Sutter Medical Group, Sacramento, CA; Michael J. Seider, Akron City Hospital, Akron, OH; Elizabeth M. Gore, Zablocki Veterans Administration Medical Center-Wood, Milwaukee, WI; Marvin Z. Rotman, Brooklyn Minority-Based Community Clinical Oncology Program, State University of New York Downstate, Brooklyn, NY; William U. Shipley, Massachusetts General Hospital, Boston, MA; James J. Dignam, University of Chicago, Chicago, IL; Alexander G. Balogh, Tom Baker Cancer Centre, Calgary, Alberta; Marie Duclos, McGill University, Montreal, Quebec; Glenn S. Bauman, London Regional Cancer Program, London; and Himanshu R. Lukka, McMaster University, Hamilton, Ontario, Canada.
J Clin Oncol. 2015 Feb 1;33(4):332-9. doi: 10.1200/JCO.2014.58.0662. Epub 2014 Dec 22.
To determine whether prolonged androgen suppression (AS) duration before radiotherapy improves survival and disease control in prostate cancer.
One thousand five hundred seventy-nine men with intermediate-risk prostate cancer were randomly assigned to 8 weeks of AS followed by radiotherapy with an additional 8 weeks of concurrent AS (16 weeks total) or to 28 weeks of AS followed by radiotherapy with an additional 8 weeks of AS (36 weeks total). The trial sought primarily to detect a 33% reduction in the hazard of prostate cancer death in the 28-week assignment. Time-to-event end points are reported for up to 10 years of follow-up.
There were no between-group differences in baseline characteristics of 1,489 eligible patients with follow-up. For the 8- and 28-week assignments, 10-year disease-specific survival rates were 95% (95% CI, 93.3% to 97.0%) and 96% (95% CI, 94.6% to 98.0%; hazard ratio [HR], 0.81; P = .45), respectively, and 10-year overall survival rates were 66% (95% CI, 62.0% to 69.9%) and 67% (95% CI, 63.0% to 70.8%; HR, 0.95; P = .62), respectively. For the 8- and 28-week assignments, 10-year cumulative incidences of locoregional progression were 6% (95% CI, 4.3% to 8.0%) and 4% (95% CI, 2.5% to 5.7%; HR, 0.65; P = .07), respectively; 10-year distant metastasis cumulative incidences were 6% (95% CI, 4.0% to 7.7%) and 6% (95% CI, 4.0% to 7.6%; HR, 1.07; P = .80), respectively; and 10-year prostate-specific antigen-based recurrence cumulative incidences were 27% (95% CI, 23.1% to 29.8%) and 27% (95% CI, 23.4% to 30.3%; HR, 0.97; P = .77), respectively.
Extending AS duration from 8 weeks to 28 weeks before radiotherapy did not improve outcomes. A lower than expected prostate cancer death rate reduced ability to detect a between-group difference in disease-specific survival. The schedule of 8 weeks of AS before radiotherapy plus 8 weeks of AS during radiotherapy remains a standard of care in intermediate-risk prostate cancer.
确定放疗前延长雄激素抑制（AS）时间是否能提高前列腺癌患者的生存率并改善疾病控制情况。
1579例中度风险前列腺癌男性患者被随机分为两组，一组先接受8周的AS治疗，随后进行放疗，并在放疗期间额外进行8周的同步AS治疗（共16周）；另一组先接受28周的AS治疗，随后进行放疗，并在放疗期间额外进行8周的AS治疗（共36周）。该试验主要旨在检测28周治疗组前列腺癌死亡风险降低33%的情况。报告了长达10年随访期的事件发生时间终点。
1489例符合条件且有随访的患者，其基线特征在两组间无差异。对于8周和28周治疗组，10年疾病特异性生存率分别为95%（95%CI，93.3%至97.0%）和96%（95%CI，94.6%至98.0%；风险比[HR]，0.81；P = 0.45），10年总生存率分别为66%（95%CI，62.0%至69.9%）和67%（95%CI，63.0%至70.8%；HR，0.95；P = 0.62）。对于8周和28周治疗组，10年局部区域进展累积发生率分别为6%（95%CI，4.3%至8.0%）和4%（95%CI，2.5%至5.7%；HR，0.65；P = 0.07）；10年远处转移累积发生率分别为6%（95%CI，4.0%至7.7%）和6%（95%CI，4.0%至7.6%；HR，1.07；P = 0.80）；10年基于前列腺特异性抗原的复发累积发生率分别为27%（95%CI，23.1%至29.8%）和27%（95%CI，23.4%至30.3%；HR，0.97；P = 0.77）。
放疗前将AS时间从8周延长至28周并未改善治疗结果。前列腺癌死亡率低于预期降低了检测两组间疾病特异性生存率差异的能力。放疗前8周的AS治疗加上放疗期间8周的AS治疗方案仍是中度风险前列腺癌的标准治疗方案。
