Abstract
e18048 Background: ASCO and Friends of Cancer Research have proposed that cancer clinical trials must ease eligibility criteria to make the trials more generalizable in “real-world” patient populations. The specific items in exclusion criteria included presence of brain metastasis (BM), which is commonly seen in small cell lung cancer patients. Frequency and trend of BM as exclusion criteria in extensive-stage (ES) SCLC trials is unknown. Methods: We conducted a comprehensive search to identify prospective clinical trials in patients with ES-SCLC. Pubmed search was conducted with key words “small cell lung cancer” and “extensive” in title. Websites of 20 oncology journals were also searched by their online archives. Recent review articles in ES-SCLC were also investigated for additional articles. Eligible studies must have enrolled primarily ES-SCLC and been published in English. Studies involving brain/chest radiation and brain metastasis specific trials were excluded. Studies were categorized into allowed/undefined, conditional, or complete exclusion of BM. Chi-squire test was used for categorial group comparison. Results: A total of 491 published studies were identified by Pubmed (240), journal websites (198), and review articles (53). Early publication year (1970-1999) and first-line/maintenance setting were associated with higher incidence of complete exclusion of cases with BM (p < 0.0001, 0.0233, respectively). Studies in the 1990s had the highest incidence (27%) of exclusion. In 2010, only 12% allowed or undefined BM. There is no correlation between complete exclusion of BMs and other clinical characteristics including journal impact factor, region, trial phase, randomization, sample size, patient performance status, and age limit. Conclusions: A significant number of ES-SCLC trials continue to exclude patients with BM. Future studies need to ease eligibility regarding BM according to ASCO/Friends recommendations.[Table: see text]
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