Affiliations of authors: Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, CT (NHLC, SJ, WJM, JBY); Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (SZG); Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, TX (DJS); Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, MA (AVD).
J Natl Cancer Inst. 2016 Dec 31;109(6). doi: 10.1093/jnci/djw281. Print 2017 Jun.
The purpose of this study is to determine the optimal strategy for men with newly diagnosed intermediate-risk prostate cancer by age and cardiac risk.
A Markov model was calibrated to the EORTC 22991 trial, which randomly assigned men with intermediate-risk prostate cancer to radiation therapy (RT) with or without six months of hormonal therapy (HT). We compared quality-adjusted life-years (QALYs) in men age 50, 60, and 70 years by age decile and cardiac risk group. Competing risks of cardiovascular mortality were estimated from the published literature. Sensitivity analyses were used to assess the impact of varying model assumptions.
HT was associated with a net decrease of 0.3 to 0.4 QALYs in men with a history of myocardial infarction. However, for all other men, HT improved QALYs (range = 0.4-2.6 QALYs). Younger men with fewer cardiac risk factors experienced the largest benefit from HT. In sensitivity analyses, the model was only found to be sensitive to the probability of biochemical failure. Men at low risk for biochemical failure (≤8.7% at five years) did not benefit from HT. Further, the benefits of HT did not begin to manifest until after 7.3 years of follow-up.
The optimal choice of therapy depends upon age, cardiac risk, and disease recurrence risk. Young men with intermediate-risk prostate cancer with no cardiac risk factors benefit most from HT. Men with a history of myocardial infarction who are at very low risk for biochemical failure may be negatively impacted by the addition of HT.
本研究旨在通过年龄和心脏风险确定新诊断为中危前列腺癌男性的最佳治疗策略。
我们使用 Markov 模型对 EORTC 22991 试验进行了校准，该试验随机将中危前列腺癌患者分配至接受放射治疗（RT）联合或不联合 6 个月激素治疗（HT）。我们按年龄十分位数和心脏风险组比较了 50、60 和 70 岁男性的质量调整生命年（QALYs）。心血管死亡率的竞争风险是根据已发表的文献估计的。敏感性分析用于评估模型假设变化的影响。
对于有心肌梗死病史的男性，HT 与 0.3 至 0.4 个 QALY 的净减少相关。然而，对于所有其他男性，HT 改善了 QALYs（范围为 0.4-2.6 QALYs）。心脏危险因素较少的年轻男性从 HT 中获益最大。在敏感性分析中，该模型仅对生化失败的概率敏感。生化失败风险较低（5 年内≤8.7%）的男性不能从 HT 中获益。此外，HT 的益处直到随访 7.3 年后才开始显现。
治疗的最佳选择取决于年龄、心脏风险和疾病复发风险。没有心脏危险因素的中危前列腺癌年轻男性从 HT 中获益最大。对于生化失败风险极低且有心肌梗死病史的男性，添加 HT 可能会产生负面影响。
