Journal
LANCET ONCOLOGY
Volume 14, Issue 10, Pages 953-961Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/S1470-2045(13)70355-3
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Funding
- Zhejiang Beta Pharma
- Chinese Government grant from the Key Special Program for Innovative Drugs [2008ZX09101, 2008ZX09312]
- 863 Project [2006AA02Z4A3]
- Zhejiang Provincial Key Special Program [2007C13003]
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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.
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