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We conducted a phase II study of combination chemotherapy with carboplatin (Cb) and pemetrexed (Pem) followed by gefitinib (Gef) to determine the effects and toxicities in patients with non-small cell lung cancer (NSCLC) harboring sensitive EGFR mutation. Eligible patients received four courses of Cb at a dose corresponding to a target area under the curve equal to 6 mg/mL·min and 500 mg/m2 Pem on day 1 every three to four weeks followed by sequential Gef 250 mg once a day until tumor progression. Sixteen of registered 28 patients responded to Cb and Pem combination. Twenty-seven patients received sequential Gef and 8 non-responders to Cb and Pem achieved PR. The overall response rate was 85.7%. Among the major toxicities, grade 3 SGPT elevation, nausea and thrombosis were observed in 3, 3 and 1 patients, respectively, who received Cb and Pem, and grade 3 SGPT elevation and dry skin were observed in 5 and 1 patients, respectively, who received Gef. There was no febrile neutropenia and no treatment-related death. The median progression-free survival time was 19.1 months. Among 21 patients who were followed up for more than 2 years, 14 survived during that time. Cb and Pem followed by Gef maintenance are recommended for further evaluation for patients with metastatic NSCLC harboring sensitive EGFR mutation.

journal of cancer therapy

Phase II Study of Carboplatin and Pemetrexed Followed by Gefitinib for Patients with Advanced Non-Small Cell Lung Cancer Harboring Sensitive EGFR Mutation