Hotta Katsuyuki, Ueoka Hiroshi, Kiura Katsuyuki, Tabata Masahiro, Tanimoto Mitsune
Department of Medicine II, Okayama University Medical School, 2-5-1 Shikata-cho, Okayama 700-8558, Japan.
Lung Cancer. 2004 Oct;46(1):61-76. doi: 10.1016/j.lungcan.2004.02.018.
The aim of the present study was to identify elderly-specific clinical trials for advanced non-small cell lung cancer (NSCLC) and to clarify the study design and patient characteristics entered of each of these trials.
We used the MEDLINE database to select prospective clinical trials evaluating the efficacy of chemotherapy in elderly patients with advanced NSCLC.
Our literature search yielded 48 prospective clinical trials between 1990 and 2003, involving a total of 2648 elderly patients with advanced NSCLC. The median number of patients treated per trial was 36. In 23 (48%) of the 48 trials, only the abstract was available. In 44 trials (92%), elderly patients were defined using their calendar age, and the age of 70 years was the most frequently used lower limit for inclusion. Vinorelbine was the most widely studied chemotherapy agent in elderly patients.
Our review revealed that (i) the definition of "elderly" varied from trial to trial, and elderly patients were simply defined using calendar age in the clinical trials; (ii) the quality of elderly-specific trials were generally poor, mainly because of their small sample size.
本研究旨在确定针对老年晚期非小细胞肺癌(NSCLC)的特定临床试验,并阐明这些试验的研究设计及纳入患者的特征。
我们使用MEDLINE数据库选择评估化疗对老年晚期NSCLC患者疗效的前瞻性临床试验。
我们的文献检索在1990年至2003年间产生了48项前瞻性临床试验,共涉及2648例老年晚期NSCLC患者。每项试验治疗的患者中位数为36例。在48项试验中的23项(48%)中,仅可获取摘要。在44项试验(92%)中,老年患者根据其实际年龄定义,70岁是最常用的纳入下限年龄。长春瑞滨是在老年患者中研究最广泛的化疗药物。
我们的综述显示:(i)“老年”的定义在不同试验中有所不同,在临床试验中,老年患者仅根据实际年龄定义;(ii)特定于老年患者的试验质量普遍较差,主要原因是样本量小。