First Line chemotherapy with weekly docetaxel and cisplatin in elderly patients with advanced non-small cell lung cancer; A multicenter phase II study

Abstract

Introduction: We report outcomes for a phase II study of the combination of weekly docetaxel and cisplatin in elderly patients with advanced non-small cell lung cancer. Methods: Patients with chemotherapy-naive, stage IIIB/IV, an Eastern Cooperative Oncology Group performance status of 0 or 1, ages 70 years or older, were eligible. Chemotherapy consisted of cisplatin (25 mg/m 2) on days 1, 8, and 15 and docetaxel (20 mg/m2) on days 1, 8, and 15 every 4 weeks. Results: Forty-six (95.8%) of the 48 patients were assessable for response, 1 case of complete response and 18 cases of partial response were confirmed, giving an overall response rate of 39.6% (95% confidence interval [CI], 25.7-53.5%). The median time to progression and overall survival for all patients was 5.0 months (95% CI, 4.1-5.7 months) and 10.9 months (95% CI, 9.6 -12.2 months), respectively. The most severe hematologic adverse event was anemia, which occurred with grade 3 intensity in 6 (13.0%) patients and grade 4 in 2 (4.3%) patients. Neutropenia occurred with grade 3 intensity in 4 (8.7%) patients. Grade 3 asthenia, diarrhea, neuropathy, stomatitis, and nausea/vomiting were observed in 2 (4.3%), 5 (10.9%), 5 (10.9%), 5 (10.9%), and 3 (6.5%) patients, respectively. Yet, no grade 4 nonhematologic toxicity was observed. Conclusions: The combination of weekly docetaxel and cisplatin is a well-tolerated treatment modality with encouraging activity and survival outcome in previously untreated elderly patients with advanced non-small cell lung cancer. © 2009 by the International Association for the Study of Lung Cancer.