Feasibility trial of adjuvant chemotherapy with paclitaxel and carboplatin after surgical resection in Japanese patients with non-small cell lung cancer: Report of the Lung Oncology Group in Kyushu (LOGIK) protocol 0501

Objectives. The present study was designed to determine whether adjuvant chemotherapy with paclitaxel (TXL) and carboplatin (CBDCA) after surgical resection is feasible in Japanese patients with non-small cell lung cancer (NSCLC) in a multiinstitutional trial. Methods. From August 2005 to March 2006, 34 patients received the following regimen: TXL (175 mg/m2) and CBDCA (AUC = 5) on day 1, every 3 weeks. The primary endpoint of this trial was the completion rate of four cycles. Results. The completion rate of four cycles was 79.4% [90% confidence interval (CI), 67.5%-91.3%]. Perfect completion rate of four cycles on schedule and full doses without delay was 50% (90% CI, 34.9%-65.1%). The reasons for incomplete cycles were hypersensitivity to TXL infusion during the first cycle in 3 patients, patients refusal in 2, and anemia and cerebral infarction in 1 patient each. As a consequence of delay and/or dose reductions, the relative dose intensity of TXL and CBDCA was 86.2% and 85.8%, respectively. Conclusion. Doublet chemotherapy with TXL and CBDCA in the planned doses and schedule was found to be a feasible treatment for Japanese patients following surgical resection for NSCLC.