Arnold L. Potosky, Huei-Ting Tsai, George Luta, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC; Reina Haque, Kaiser Permanente Southern California, Pasadena; Stephen K. Van Den Eeden, Kaiser Permanente Northern California, Oakland, CA; Andrea E. Cassidy-Bushrow, Henry Ford Hospital, Detroit, MI; Marianne Ulcickas Yood, Boston University School of Public Health; Nancy L. Keating, Brigham and Women's Hospital and Harvard Medical School; Matthew R. Smith, Massachusetts General Hospital, Boston, MA; Miao Jiang, Harvey L. Neiman Health Policy Institute, Reston, VA.
J Clin Oncol. 2014 May 1;32(13):1324-30. doi: 10.1200/JCO.2013.52.5782. Epub 2014 Mar 17.
Primary androgen-deprivation therapy (PADT) is often used to treat clinically localized prostate cancer, but its effects on cause-specific and overall mortality have not been established. Given the widespread use of PADT and the potential risks of serious adverse effects, accurate mortality data are needed to inform treatment decisions.
We conducted a retrospective cohort study using comprehensive utilization and cancer registry data from three integrated health plans. All men were newly diagnosed with clinically localized prostate cancer. Men who were diagnosed between 1995 and 2008, were not treated with curative intent therapy, and received follow-up through December 2010 were included in the study (n = 15,170). We examined all-cause and prostate cancer-specific mortality as our main outcomes. We used Cox proportional hazards models with and without propensity score analysis.
Overall, PADT was associated with neither a risk of all-cause mortality (hazard ratio [HR], 1.04; 95% CI, 0.97 to 1.11) nor prostate-cancer-specific mortality (HR, 1.03; 95% CI, 0.89 to 1.19) after adjusting for all sociodemographic and clinical characteristics. PADT was associated with decreased risk of all-cause mortality but not prostate-cancer-specific mortality. PADT was associated with decreased risk of all-cause mortality only among the subgroup of men with a high risk of cancer progression (HR, 0.88; 95% CI, 0.78 to 0.97).
We found no mortality benefit from PADT compared with no PADT for most men with clinically localized prostate cancer who did not receive curative intent therapy. Men with higher-risk disease may derive a small clinical benefit from PADT. Our study provides the best available contemporary evidence on the lack of survival benefit from PADT for most men with clinically localized prostate cancer.
雄激素剥夺疗法（PADT）常用于治疗临床局限性前列腺癌，但尚未确定其对特定病因和总体死亡率的影响。鉴于 PADT 的广泛应用以及严重不良反应的潜在风险，需要准确的死亡率数据来为治疗决策提供信息。
我们使用来自三个综合健康计划的全面利用和癌症登记数据进行了回顾性队列研究。所有男性均被诊断为临床局限性前列腺癌。符合以下条件的男性被纳入研究：1995 年至 2008 年被诊断，未接受根治性治疗，且随访至 2010 年 12 月（n = 15170）。我们将全因死亡率和前列腺癌特异性死亡率作为主要结局进行研究。我们使用 Cox 比例风险模型进行分析，同时还进行了倾向评分分析。
总体而言，在调整了所有社会人口统计学和临床特征后，PADT 与全因死亡率（风险比 [HR]，1.04；95%置信区间 [CI]，0.97 至 1.11）或前列腺癌特异性死亡率（HR，1.03；95% CI，0.89 至 1.19）均无相关性。PADT 与全因死亡率风险降低相关，但与前列腺癌特异性死亡率无关。仅在癌症进展风险较高的男性亚组中，PADT 与全因死亡率风险降低相关（HR，0.88；95%CI，0.78 至 0.97）。
我们发现，对于大多数未接受根治性治疗的临床局限性前列腺癌男性，与未接受 PADT 相比，接受 PADT 并不能带来死亡率的获益。高危疾病的男性可能会从 PADT 中获得较小的临床获益。本研究提供了目前关于大多数临床局限性前列腺癌男性接受 PADT 无生存获益的最佳现有证据。
