Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA 19111, USA.
Eur Urol. 2009 Oct;56(4):609-16. doi: 10.1016/j.eururo.2009.03.066. Epub 2009 Apr 1.
Primary androgen deprivation therapy (PADT) is frequently used as a sole modality of treatment in men with localized prostate cancer, despite a lack of clinical trial data supporting its use.
To measure the impact of treatment with PADT compared to observation on overall survival in men with organ-confined prostate cancer.
DESIGN, SETTING, AND PARTICIPANTS: The design was for an observational cohort from Surveillance, Epidemiology, and End Results (SEER) Medicare data. The cohort consisted of 16,535 men aged 65-80 yr at diagnosis with organ-confined well-differentiated or moderately differentiated prostate cancer who survived >1 yr past diagnosis and did not undergo treatment with prostatectomy or radiation therapy within 6 mo of diagnosis. They were diagnosed between 1991 and 1999 and followed until death or until the end of the study period (December 31, 2002).
Study subjects were selected to receive PADT alone if they received luteinizing hormone-releasing hormone agonists or bilateral orchiectomy in the first 6 mo after diagnosis, and they were selected to be observed if they did not have claims for PADT during the same interval.
Overall survival.
After adjusting for potential confounders (ie, tumor characteristics, comorbidities, and demographics), patients who received ADT had a worse overall survival rate than patients who were observed (hazard ratio: 1.20; 95% confidence interval: 1.13-1.27). In observational studies there may be unmeasured differences between the treated and untreated groups. The SEER database does not provide information on prostate-specific antigen levels.
This large, population-based study suggests that PADT did not improve survival in men with localized prostate cancer, but it suggests that PADT may instead result in worse outcomes compared with observation. Patients and physicians should be cognizant of the potential long-term side effects of ADT in a patient population for which expectant observation is an acceptable treatment strategy.
尽管缺乏临床试验数据支持，但原发性去势治疗（PADT）经常被用作局限性前列腺癌患者的单一治疗方式。
测量与观察相比，PADT 对局限于前列腺的癌症患者总生存的影响。
设计、地点和参与者：本研究为观察性队列研究，来自监测、流行病学和最终结果（SEER）医疗保险数据。该队列由 16535 名年龄在 65-80 岁之间、诊断为局限性高分化或中分化前列腺癌、诊断后存活超过 1 年且在诊断后 6 个月内未接受前列腺切除术或放疗的男性组成。他们的诊断时间在 1991 年至 1999 年之间，并随访至死亡或研究期结束（2002 年 12 月 31 日）。
如果研究对象在诊断后的前 6 个月内接受促黄体激素释放激素激动剂或双侧睾丸切除术，他们被选为单独接受 PADT；如果他们在同一时期没有接受 PADT 的索赔，他们被选为观察对象。
总生存率。
在调整潜在混杂因素（即肿瘤特征、合并症和人口统计学）后，接受 ADT 的患者的总生存率低于观察组（风险比：1.20；95%置信区间：1.13-1.27）。在观察性研究中，治疗组和未治疗组之间可能存在未测量的差异。SEER 数据库不提供前列腺特异性抗原水平的信息。
这项大规模的基于人群的研究表明，PADT 并未改善局限性前列腺癌患者的生存率，但它表明与观察相比，PADT 可能导致更差的结果。对于接受期待观察是一种可接受的治疗策略的患者人群，患者和医生应该意识到 ADT 的潜在长期副作用。
