晚期非小细胞肺癌患者参加靶向治疗临床试验的资格。
The eligibility of advanced non-small-cell lung cancer patients for targeted therapy clinical trials.
机构信息
Faculty of Medicine, University of Sydney, Sydney.
Faculty of Medicine, University of Sydney, Sydney; Department of Medical Oncology, Concord Repatriation General Hospital, Sydney.
出版信息
Ann Oncol. 2012 May;23(5):1229-1233. doi: 10.1093/annonc/mdr443. Epub 2011 Oct 10.
BACKGROUND
The selection criteria for phase III trials are often stringent. We aimed to determine how many advanced non-small-cell lung cancer (NSCLC) patients would have been eligible for phase III targeted therapy trials and the proportion receiving anticancer treatment.
PATIENTS AND METHODS
From March 2007 to May 2008, all advanced NSCLC patients presented at our lung cancer multidisciplinary team meeting were included to assess eligibility for the targeted therapy trials: ECOG-4599, AVAiL, FLEX, TALENT, INTACT-1, INTACT-2, ESCAPE, NEXUS and MONET1. Medical records were examined to determine treatment utilisation and overall survival.
RESULTS
A total of 62 patients were registered: 63% male; median age 71 years; 61% stage IIIB disease. Percentages that met criteria were: ECOG-4599 31%, AVAiL 24%, FLEX 69%, TALENT 27%, INTACT-1 50%, INTACT-2 42%, ESCAPE 39%, NEXUS 63% and MONET1 34%. Common reasons for ineligibility were insufficient life expectancy, poor performance status, abnormal bloods, proteinuria and associated cancer problems. Systemic therapies were received by 66% of patients and median survival was 10.3 months.
CONCLUSION
Only 24%-69% were eligible for targeted therapy trials but 66% received anticancer treatment. Clinical trials in patients with advanced NSCLC need to be more representative of the majority of patients.
背景
III 期临床试验的入选标准通常较为严格。本研究旨在明确有多少晚期非小细胞肺癌（NSCLC）患者有资格入组 III 期靶向治疗临床试验，以及有多少患者接受了抗肿瘤治疗。
方法
从 2007 年 3 月至 2008 年 5 月，所有在我院肺癌多学科团队会议上就诊的晚期 NSCLC 患者都接受了靶向治疗临床试验（ECOG-4599、AVAiL、FLEX、TALENT、INTACT-1、INTACT-2、ESCAPE、NEXUS 和 MONET1）的入组评估。我们查阅病历以明确治疗方法和总生存期。
结果
共有 62 例患者登记入组：男性占 63%；中位年龄 71 岁；61%为 IIIB 期疾病。符合入选标准的患者比例为：ECOG-4599 组为 31%，AVAiL 组为 24%，FLEX 组为 69%，TALENT 组为 27%，INTACT-1 组为 50%，INTACT-2 组为 42%，ESCAPE 组为 39%，NEXUS 组为 63%，MONET1 组为 34%。不符合入选标准的主要原因是预期寿命较短、体力状况差、血液检查异常、蛋白尿和合并其他癌症。66%的患者接受了全身治疗，中位生存期为 10.3 个月。
结论
仅有 24%-69%的患者有资格入组靶向治疗临床试验，但 66%的患者接受了抗肿瘤治疗。晚期 NSCLC 患者的临床试验需要更具代表性。
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