First-Line Icotinib Versus Cisplatine/Pemetrexed Plus Pemetrexed Maintenance Therapy In Lung Adenocarcinoma Patients With Sensitizing Egfr Mutation (Convince).

ANNALS OF ONCOLOGY(2016)

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摘要
9041Background: Icotinib is an oral, selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), which is non-inferior to gefitinib in treating unselected or EGFR-mutated advanced non-small cell lung cancer (NSCLC) patients as second-line therapy. We assess icotinib as first-line therapy in lung adenocarcinoma patients with EGFR mutation. Methods: This phase 3, open-label, randomized study (CONVINCE, NCT01719536) was conducted at 18 sites in China. Eligible patients (pathologically confirmed lung adenocarcinoma, 19/21 EGFR mutation, treatment naive) were 1:1 randomized to receive icotinib (125 mg, three times daily) or pemetrexed (500 mg/m2, day 1) plus cisplatine (75 mg/m2, day 1), non-progressive patients after 4-cycle chemotherapy continue to receive pemetrexed (500 mg/m2, day 1) as maintenance therapy until disease progression or intolerable toxicity. Randomization was stratified by performance status, smoking status, disease stage, and mutation type. The primary endpoint was prog...
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