VA Clinical Epidemiology Research Center, VA Connecticut Healthcare System, West Haven, CT 06516, USA.
J Investig Med. 2010 Mar;58(3):566-8. doi: 10.231/JIM.0b013e3181cf9002.
Randomized controlled trials (RCTs) evaluate the potential benefits of chemotherapy regimens and guide clinical care for patients with cancer. Inclusion criteria for RCTs are usually stringent and may exclude many patients seen in clinical practice. Our objective was to determine the proportion of men with castrate-resistant prostate cancer (CRPC) in a clinical setting that would have been excluded from major phase 3 RCTs.
We reviewed eligibility criteria from 24 phase 3 clinical trials evaluating chemotherapy for CRPC active from January, 2004, through April, 2008. We created a common list of criteria used in at least 3 studies and separately considered the criteria from a prominent RCT (TAX 327). We applied these criteria to a population of patients with CRPC treated during 2004 to 2006 at the Veterans Affairs Connecticut Healthcare System.
Among 106 patients with CRPC, 99 (93%) had complete medical records, and 45 (45%) of the 99 would have been excluded from RCTs. Common reasons for exclusion were abnormal laboratory values, other malignancies, and other serious medical conditions including cardiac disease.
Almost half of the CRPC patients examined in a clinical setting would have been ineligible for phase 3 RCTs, highlighting that such trials may not be applicable to general oncology practice.
随机对照试验（RCT）评估化疗方案的潜在益处，并为癌症患者的临床治疗提供指导。RCT 的纳入标准通常较为严格，可能会排除许多在临床实践中观察到的患者。我们的目的是确定在临床环境中患有去势抵抗性前列腺癌（CRPC）的男性中，会有多少比例会被排除在主要的 3 期 RCT 之外。
我们回顾了 2004 年 1 月至 2008 年 4 月期间评估化疗治疗 CRPC 的 24 项 3 期临床试验的纳入标准。我们创建了一个至少有 3 项研究使用的共同标准列表，并分别考虑了一项重要 RCT（TAX 327）的标准。我们将这些标准应用于 2004 年至 2006 年期间在退伍军人事务康涅狄格医疗保健系统治疗的 CRPC 患者人群中。
在 106 名 CRPC 患者中，99 名（93%）有完整的医疗记录，其中 45 名（45%）患者将被排除在 RCT 之外。排除的常见原因是实验室值异常、其他恶性肿瘤和其他严重疾病，包括心脏病。
在临床环境中检查的 CRPC 患者中，近一半可能不符合 3 期 RCT 的纳入标准，这表明此类试验可能不适用于普通肿瘤学实践。
