期刊
BRITISH JOURNAL OF CANCER
卷 116, 期 5, 页码 568-574出版社
NATURE PUBLISHING GROUP
DOI: 10.1038/bjc.2016.456
关键词
non-small cell lung cancer; EGFR mutation; exon 19; exon 21; erlotinib; gefitinib
类别
资金
- Guangdong Provincial Key Laboratory of Lung Cancer Translational Medicine [2012A061400006]
- special fund for National Health and Family Planning Commission of People's Republic of China [201402031]
- Guangzhou Science and Technology Bureau [2011Y200014, 2014Y2-00545]
- Project of the National Natural Science Funding of China [81472207]
Background: A phase III trial was conducted to compare the safety and efficacy of erlotinib with that of gefitinib in advanced non-small cell lung cancer harbouring epidermal growth factor receptor mutations in exon 19 or 21. Methods: Eligible patients were randomised to receive erlotinib (150mg per day) or gefitinib (250mg per day) orally until disease progression or unacceptable toxicity. We aimed to determine whether erlotinib is superior to gefitinib in efficacy. The primary end point was progression-free survival. Results: A total of 256 patients were randomised to receive erlotinib (N = 128) or gefitinib (N = 128). Median progression-free survival was not better with erlotinib than with gefitinib (13.0 vs 10.4 months, 95% confidence interval (CI) 0.62-1.05, P = 0.108). The corresponding response rates and median overall survival were 56.3% vs 52.3% (P = 0.530) and 22.9 vs 20.1 months (95% CI 0.63-1.13, P = 0.250), respectively. There were no significant differences in grade 3/4 toxicities between the two arms (P = 0.172). Conclusions: The primary end point was not met. Erlotinib was not significantly superior to gefitinib in terms of efficacy in advanced non-small cell lung cancer with epidermal growth factor receptor mutations in exon 19 or 21, and the two treatments had similar toxicities.
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