Phase II study of neoadjuvant chemotherapy with gemcitabine and vinorelbine in resectable non-small cell lung cancer.

OBJECTIVE We assessed the efficacy of a non-platinum-containing doublet chemotherapy of gemcitabine and vinorelbine as induction therapy prior to surgical resection in patients with stage IB-IIIA and selected stage IIIB non-small cell lung cancer (NSCLC). The primary clinical end point was radiographic disease response rate, and the secondary end points were pathologic response rate, treatment-related toxicity, surgical resectability and outcome, and overall and disease-free survival. METHODS Patients underwent staging with CT of the chest and upper-abdomen, whole-body F-18 fluorodeoxyglucose positron emission tomography, bronchoscopy, and mediastinoscopy. The patients had to have medically and surgically resectable disease. Chemotherapy consisted of gemcitabine, 1,000 mg/m(2), and vinorelbine, 25 mg/m(2), administered on days 1, 8, 22, and 29. Imaging studies were repeated between days 43 and 50. Disease response was assessed by response evaluation criteria in solid tumors, and patients with resectable disease were offered surgery between days 50 and 70. Patients were followed up every 3 months for 2 years with chest CT. RESULTS Between January 2000 and March 2004, 27 patients with stage IB NSCLC, 15 patients with stage II NSCLC, and 20 patients with stage III NSCLC were entered. After induction chemotherapy 34% (95% confidence interval [CI], 23 to 48%) had an objective radiographic response, 2% had a complete pathologic response, 90% underwent thoracotomy, and 77% underwent a complete resection. There were four deaths in the 6-week period following surgery, and there were no deaths related to chemotherapy. There were no unexpected morbidities from surgery or chemotherapy. The 1-year and 2-year overall survival rates were 80% (95% CI, 68 to 88%) and 65% (95% CI, 50 to 76%), and the median overall survival was 38.2 months. CONCLUSIONS Induction chemotherapy with gemcitabine and vinorelbine results in 1-year and 2-year survival rates and a median survival time comparable to those obtained with platinum-containing doublets. However, it appears to be less efficacious in terms of radiographic and pathologic response rates compared with platinum-containing chemotherapy doublets.