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A multicenter, phase III study of carboplatin/paclitaxel versus oral uracil-tegafur as the adjuvant chemotherapy in resected non-small cell lung cancer (NSCLC): Planned interim analyses.

7560 Background: Recent studies have demonstrated that adjuvant chemotherapy provides a survival benefit in patients with resected NSCLC. In Japan, uracil-tegafur has been recognized as a standard adjuvant strategy for resected NSCLC, however, carboplatin based adjuvant chemotherapy has not been fully evaluated for the treatment of NSCLC patients in an adjuvant setting. The present phase III study assessed the efficacy and safety of carboplatin/paclitaxel and oral uracil-tegafur as the first study to compare intravenous and oral drugs in resected stage IB-IIIA NSCLC.


METHODS
The patients with pathological stage IB-IIIA NSCLC who underwent complete resection were randomized 1:1 to carboplatin (AUC 5) /paclitaxel (175 mg/m2) every 3 week for 4 cycles (A arm) or uracil-tegafur (250 mg/m2) daily for 2 years (B arm). The primary endpoint was overall survival (OS) and secondary endpoints were disease-free survival and toxicity. The accrual of 200 patients per arm is required to demonstrate an improvement of OS (15% increase) in the A arm compared to B arm. Randomization was stratified by histology and tumor stage. An interim analysis was planned to perform on the first 200 patients recruited and data of survival and toxicity were examined in the first 100 patients.


RESULTS
Between November 2004 and November 2008, 200 patients from 31 Japanese centers were randomized and the first 100 patients were included for interim analysis. Median age was 69 (range; 50-80) years. Ninety-eight patients had PS of 0-1 and 2 patients had PS of 2. Sixty-seven patients were male and 23 patients were female. Sixty patients had adenocarcinoma, 30 had squamous cell carcinoma, and 10 had other histologies. Disease stage was IB in 53, IIA in 14, IIB in 19, and IIIA in 14 patients. Toxicities observed during adjuvant chemotherapy were well tolerable. There was no toxic death. The median survival time of A and B arms combined was 4.1 year. Monitoring Committees approved to continue the present study.


CONCLUSIONS
The present phase III trial with carboplatin/paclitaxel or uracil-tegafur is feasible with manageable toxicity. The study is on course to achieve its primary endpoint. [Table: see text].