Phase II trial of gemcitabine-carboplatin-paclitaxel as neoadjuvant chemotherapy for operable non-small cell lung cancer

Background: The aim of this single-arm phase II study was to evaluate the efficacy, feasibility. and safety of the genicitabine-carboplatin-paclitaxel combination as neoadjuvant chemotherapy in patients with operable non-small cell lung cancer (NSCLC). Methods: Patients with stage IB, II. or IIIA NSCLC were given three cycles of chemotherapy followed by tumor resection. Each 21-day cycle consisted of gemcitabine 1000 mg/m(2) on days 1 and 8. carboplatin AUC 5 oil day 1, and paclitaxel 175 mg/m(2) oil day 1. Results: Forty-four patients were enrolled: 18.2% of patients had stage IB, 15.9% had stage II, and 65.9% had stage IIIA NSCLC. All patients received three cycles of treatment. The clinical tumor response rate was 76.2% (32 of 42 patients; 95% Cl. 60.5-87.9%). Thirty-six patients had a complete tumor resection, five of whom had a complete pathological response with no viable tumor cells in the resected tumor oil histological examination. Median time to progression was 13.6 months (95% CI. 8.9, > 16 months), and 26 of 44 patients (59.1%) had progressed. The 1-year disease-free survival rate was 53.6% (95% Cl, 38.7-68.5%), and the 1-year survival rate was 86.0% (95% CI, 75.7-96.4%). Grade 3 and 4 neutropenia each occurred in 38.6% of patients, and grade 3 infection occurred in 2.3% of patients; grade 3 and 4 thrombocytopenia occurred in 25.0% and 0% of patients, respectively. Conclusion: The gemcitabine-carboplatin-paclitaxel combination showed promising efficacy and seemed to be safe and feasible as neoadjuvant chemotherapy in patients with operable-stage NSCLC.