Combination therapy with docetaxel and low dose of cisplatin in elderly patients with advanced non-small cell lung cancer: multicenter phase II study.

ABSTRACT

PURPOSE: To determine the efficacy and safety of the combination therapy with docetaxel and cisplatin (CDDP) at low doses in elderly patients with advanced NSCLC. PATIENTS AND METHODS: A total of 42 patients aged > or =70 years with previously untreated advanced NSCLC received docetaxel 75 mg/m(2) plus CDDP 50 mg/m(2) on day 1. The regimen was repeated every 21 days. Patients received a minimum of three courses unless progressive disease was detected. RESULTS: By intent-to-treat analysis, the overall response rate was 31% (95% CI, 17.8-47.2%). A total of 18 patients (43%) had stable disease and 11 (26%) progressed. Median time to progression was 5.2 months. Overall median survival was 8.9 months, with 1-year actuarial survival rate of 41%. Eastern Cooperative Oncology Group performance status was improved in 18 patients (43%). The chemotherapy regimen was well tolerated. A total of 11 patients (26%) had grade 3/4 adverse events 7 (17%) neutropenia (one of them was diagnosed with febrile neutropenia), 3 (7%) asthenia, 3 (7%) nausea/vomiting, 1 (2%) diarrhea, 1 (2%) thrombocytopenia and 1 (2%) neurotoxicity. No death due to toxicity was seen. CONCLUSION: The combination of low-dose CDDP and docetaxel for elderly patients with advanced NSCLC is an efficient and well-tolerated chemotherapeutic approach.