Twenty-two years of phase III trials for patients with advanced non-small-cell lung cancer: Sobering results
Twenty-two years of phase III trials for patients with advanced non-small-cell lung cancer: Sobering results
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DOI：
10.1200/jco.2001.19.6.1734
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发表时间：
2001-03-15
影响因子：
45.3
通讯作者：
Johnson, BE
中科院分区：
文献类型：
--
作者：
Breathnach, OS;Freidlin, B;Johnson, BE
目的：通过检索1973年至1994年美国国家癌症研究所癌症治疗评估计划数据库，联系合作组织，通过文献检索MEDLINE，确定1973年至1994年在北美启动的III期随机试验中晚期非小细胞肺癌(NSCLC)患者的临床试验和结果的变化。在类似时间间隔内接受治疗的晚期非小细胞肺癌患者也在SEER数据库中接受检查。对试验的数量、参加试验的患者的数量和性别以及随时间推移的存活率进行了趋势检验。结果：在1973至1994年间启动了33个III期试验。24项试验(73%)是在这段时间的前半段(1973-1983)内启动的，占8,434名符合条件的患者中的5,359项(%)。试验中每支手臂接受治疗的患者的中位数从77人(1973年至1983年)上升到121人(1984年至1994年)(P<；.001)。5个试验(15%)显示治疗侧间的生存差异有统计学意义，中位生存期延长2个月(范围为0.7至2.7个月)。结论：对过去北美试验的分析表明，随机研究的两侧间的中位生存期延长很少超过2个月。需要为晚期非小细胞肺癌患者的第三阶段随机治疗试验开发改善患者资源使用和适当试验设计的技术。2001年由美国临床肿瘤学会主办。
Purpose: To determine the changes in clinical trials and outcomes of patients with advanced-stage nonsmall-cell lung cancer (NSCLC) treated on phase III randomized trials initiated in North America from 1973 to 1994,Patients and Methods: Phase III trials for patients with advanced-stage NSCLC were identified through a search of the National Cancer Institute's Cancer Therapy Evaluation Program database from 1973 to 1994, contact with Cooperative Groups, and by literature search of MEDLINE. Patients with advanced NSCLC treated during a similar time interval were also examined in the SEER database. Trends were tested in the number of trials, in the number and sex of patients entered on the trials, and in survival over time,Results: Thirty-three phase III trials were initiated between 1973 and 1994. Twenty-four trials (73%) were initiated within the first half of this period (1973 to 1983) and accounted for 5,359 (64%) of the 8,434 eligible patients. The median number of patients treated per arm of the trials rose from 77 (1973 to 1983) to 121 (1984 to 1994) (P < .001). five trials (15%) showed a statistically significant difference in survival between treatment arms, with a median prolongation of the median survival of 2 months (range, 0.7 to 2.7 months).Conclusion: Analysis of past trials in North America shows that the prolongation in median survival between two arms of a randomized study was rarely in excess of 2 months. Techniques for improved use of patient resources and appropriate trial design for phase III randomized therapeutic trials with patients with advanced NSCLC need to be developed. 2001 by American Society of Clinical Oncology.