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: