A phase I/II trial of weekly docetaxel and gefitinib in elderly patients with stage IIIB/IV non-small cell lung cancer

SummaryBackgroundPhase III trials in elderly patients with advanced (stage IIIB/IV) non-small cell lung cancer (NSCLC) reveal treatment with single agent chemotherapy improves survival. The role of double agent therapy in this patient population is an area of investigation.MethodsA phase I/II trial was performed in elderly patients (age ≥70 years) with stage IIIB/IV disease and Eastern Cooperative Oncology Group (ECOG) performance status of 0–2. Patients were treated with gefitinib 250 mg daily. Patients received docetaxel on a treatment schedule of days 1, 8, 15 of an every 28 days schedule. The phase I portion of the trial consisted of dose escalation docetaxel from 30 to 36 mg/m2 using a three patient cohort design. The trial design contained continuous monitoring for excessive toxicity with pre-selected toxicity boundaries.ResultsTwenty-six patients were evaluable for efficacy and toxicity analysis. The median age was 75.5 years. The majority of the patients had stage IV disease (85%), ECOG functional status of 0–1 (81%), were male (65%), and current or former smokers (88%). Eleven patients experienced National Cancer Institute Common Toxicity Criteria grades 3–5 non-hematologic toxicity during the first cycle. The toxicity was determined to be unexpected, and the trial was discontinued. Overall response rate (complete + partial responses) was 31%, and the median survival was 6.5 months (95% confidence interval (CI) (3.6–9.0)), and estimated 1-year survival rate was 27% (95% CI (13–55%)).ConclusionsThe combination of weekly docetaxel and gefitinib had activity; however, unexpected toxicity was observed in the elderly patient population.