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Shi, Yuankai, MD; Zhang, Li, MD; Liu, Xiaoqing, MD; Zhou, Caicun, MD; Zhang, Shucai, MD; Wang, Dong, MD; Li, Qiang, MD; Qin, Shukui, MD; Hu, Chunhong, MD; Zhang, Yiping, MD; Chen, Jianhua, MD; Cheng, Ying, MD; Feng, Jifeng, MD; Zhang, Helong, MD; Song, Yong, MD; Wu, Yi-Long, MD; Xu, Nong, MD; Zhou, Jianying, MD; Luo, Rongcheng, MD; Bai, Chunxue, MD; Jin, Yening, MD; Liu, Wenchao, MD; Wei, Zhaohui, PhD; Tan, Fenlai, MD; Wang, Yinxiang, PhD; Ding, Lieming, MD; Dai, Hong, MD; Jiao, Shunchang, MD; Wang, Jie, MD; Liang, Li, MD; Zhang, Weimin, MD; Sun, Yan, Prof
The lancet oncology, 09/2013, Letnik: 14, Številka: 10Journal Article
Summary Background Icotinib, an oral EGFR tyrosine kinase inhibitor, had shown antitumour activity and favourable toxicity in early-phase clinical trials. We aimed to investigate whether icotinib is non-inferior to gefitinib in patients with non-small-cell lung cancer. Methods In this randomised, double-blind, phase 3 non-inferiority trial we enrolled patients with advanced non-small-cell lung cancer from 27 sites in China. Eligible patients were those aged 18–75 years who had not responded to one or more platinum-based chemotherapy regimen. Patients were randomly assigned (1:1), using minimisation methods, to receive icotinib (125 mg, three times per day) or gefitinib (250 mg, once per day) until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival, analysed in the full analysis set. We analysed EGFR status if tissue samples were available. All investigators, clinicians, and participants were masked to patient distribution. The non-inferiority margin was 1·14; non-inferiority would be established if the upper limit of the 95% CI for the hazard ratio (HR) of gefitinib versus icotinib was less than this margin. This study is registered with ClinicalTrials.gov , number NCT01040780 , and the Chinese Clinical Trial Registry, number ChiCTR-TRC-09000506. Findings 400 eligible patients were enrolled between Feb 26, 2009, and Nov 13, 2009; one patient was enrolled by mistake and removed from the study, 200 were assigned to icotinib and 199 to gefitinib. 395 patients were included in the full analysis set (icotinib, n=199; gefitinib, n=196). Icotinib was non-inferior to gefitinib in terms of progression-free survival (HR 0·84, 95% CI 0·67–1·05; median progression-free survival 4·6 months 95% CI 3·5–6·3 vs 3·4 months 2·3–3·8; p=0·13). The most common adverse events were rash (81 41% of 200 patients in the icotinib group vs 98 49% of 199 patients in the gefitinib group) and diarrhoea (43 22% vs 58 29%). Patients given icotinib had less drug-related adverse events than did those given gefitinib (121 61% vs 140 70%; p=0·046), especially drug-related diarrhoea (37 19% vs 55 28%; p=0·033). Interpretation Icotinib could be a new treatment option for pretreated patients with advanced non-small-cell lung cancer. Funding Zhejiang Beta Pharma (China), the Chinese National Key Special Program for Innovative Drugs, the 863 Project, and Zhejiang Provincial Key Special Program.
