Induction chemotherapy followed by gefitinib and concurrent thoracic radiotherapy for unresectable locally advanced adenocarcinoma of the lung: A multicenter feasibility study (JCOG 0402)

Abstract

Background: We conducted a feasibility study of induction chemotherapy followed by gefitinib and thoracic radiotherapy (TRT) for unresectable locally advanced adenocarcinoma of the lung. Patients and methods: Patients received induction chemotherapy with cisplatin (80 mg/m. 2, days 1 and 22) and vinorelbine (25 mg/m. 2, days 1, 8, 22, and 29) followed by gefitinib (250 mg daily, beginning on day 43, for 1 year) and TRT (60 Gy/30 fractions, days 57-98). The primary end point was feasibility, which was defined as the proportion of patients who completed 60 Gy of TRT and received >75% of the planned dose of gefitinib without developing grade 2 or worse pneumonitis. Results: Of the 38 enrolled patients, 23 patients [60.5%; 80% confidence interval (CI) 48.8-71.3] completed treatment without experiencing grade 2 or worse pneumonitis. During the chemoradiation phase, grade 3-4 alanine aminotransferase elevations were observed in 37.1% of the patients. The overall response rate was 73.0%. The median survival time was 28.5 months (95% CI 22.5-38.2), and the 2-year survival rate was 65.4%. Conclusions: Although the results did not meet our criterion for feasibility, the toxicity was acceptable. This treatment warrants further evaluation among patients with locally advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations. © The Author 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.