RESUMEN
BACKGROUND: The combination cisplatin/gemcitabine is one of the most active and well-tolerated regimens in advanced non-small-cell lung cancer (NSCLC). We undertook this pilot study to evaluate postoperative drug delivery and toxicity of cisplatin plus gemcitabine in patients with radically resected stage IB-III NSCLC. PATIENTS AND METHODS: Twenty-two consecutive patients were treated with cisplatin 80 mg/m2 on day 1 and gemcitabine 1200 mg/m2 on days 1 and 8 every 3 weeks for 4 planned courses. Most patients (50%) had pathologic stage IIIA disease; all had an Eastern Cooperative Oncology Group performance status score of 0 or 1. The median age was 63 years (range, 56-73 years). Six out of 22 patients (27.3%) had undergone pneumonectomy. RESULTS: A total of 85 courses of chemotherapy were administered, and the median number of courses was 4 (range, 1-4 courses); twenty-one out of 22 patients received the planned 4 courses of chemotherapy. Chemotherapy caused grade 3 anemia in 1 patient, grade 3 thrombocytopenia in another patient, and grade 3/4 neutropenia in 4 patients; grade 3 vomiting was observed in 3 patients, and grade 3 anorexia and grade 3 asthenia were both observed in 1 patient. No treatment-related deaths occurred. The median delivered dose intensities of cisplatin and gemcitabine were 24.3 mg/m2/week (97.2%) and 700.9 mg/m2 weekly (87.5%), respectively. CONCLUSION: The combination of cisplatin/gemcitabine is a feasible and well-tolerated regimen in the adjuvant setting. Future trials should better define the best strategy in terms of efficacy, toxicity, and quality of life between this combination and the standard regimen, cisplatin plus vinorelbine.