Twenty years of phase III trials for patients with extensive-stage small-cell lung cancer: Perceptible progress
Twenty years of phase III trials for patients with extensive-stage small-cell lung cancer: Perceptible progress
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DOI：
10.1200/jco.1999.17.6.1794
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发表时间：
1999-06-01
影响因子：
45.3
通讯作者：
Johnson, BE
中科院分区：
文献类型：
--
作者：
Chute, JP;Chen, T;Johnson, BE
目的：对过去20年间在北美进行的所有广泛期小细胞肺癌(SCLC)患者的合作小组研究进行评估，以确定临床试验的模式和患者的结果。在监测、流行病学和最终结果(SEER)数据库中列出的相似雾化间隔期间治疗的广泛期小细胞肺癌患者也被检查。结果：1972-1990年间，21例广泛期小细胞肺癌患者开始了III期临床试验。在1972至1981年间开始的III期试验中，在对照试验组接受治疗的患者的中位生存期为7.0个月；而在1982至1990年间纳入对照试验组的患者的中位生存期为8.9个月(P=.001)。对同一时间段广泛期小细胞肺癌患者的SEER数据库的分析显示，中位生存期延长了类似的2个月。结论：对北美启动的21项III期试验和1972年至1994年的SEER数据库的分析表明，昂贵期小细胞肺癌患者的生存时间有轻微的改善。(C)1999年，由美国临床肿瘤学会主办。
Purpose: All cooperative group studies performed in North America for patients with extensive-stage small-cell lung cancer (SCLC) were evaluated to determine the pattern of the clinical trials and the outcome of patients over the past 20 years.Patient and Methods: Phase III trials for patients with extensive-stage SCLC were identified through a search of the National Cancer Institute Cancer Therapy Evaluation Program database from 1972 to 1993. Patients with extensive-stage SCLC treated during a similar rime interval listed in the Surveillance, Epidemiology, and End Results (SEER) database were also examined. Trends were tested in the number of trials over time, the number and sex of patients entered onto the trials, and the survival time of patients treated over time,Results: Twenty-one phase III trials far patients with extensive-stage SCLC were initiated between 1972 and 1990. The median of the median survival times of patients treated on the control arms of the phase III trials initiated between 1972 and 1981 was 7.0 months; for those patients enrolled onto control arms between 1982 and 1990, the median survival rime was 8.9 months (P = .001). Analysis of the SEER database of patients with extensive-stage SCLC over the same time period shows a similar 2-month prolongation in median survival time.Conclusion: Analysis of 21 phase III trials initiated in North America and the SEER database from 1972 Po 1994 demonstrates that there has been a modest improvement in the survival time of patients with expensive-stage SCLC. (C) 1999 by American Society of Clinical Oncology.