Combination treatment with weekly docetaxel and gemcitabine for advanced non-small-cell lung cancer in elderly patients and patients with poor performance status: results of a Minnie Pearl Cancer Research Network phase II trial

The purpose of this study was to evaluate the feasibility, toxicity, and efficacy of the combination of weekly docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer (NSCLC) who are either elderly or have poor performance status (PS). Patients with stage IIIB or IV NSCLC who had received no previous chemotherapy and were = 70 years of age were eligible for this clinical trial. Patients < 70 years of age were also eligible if they had poor PS or were considered poor candidates for standard platinum-based combination chemotherapy regimens. All patients received chemotherapy with gemcitabine 800 mg/m2 and docetaxel 30 mg/m2, both drugs administered by 30-minute intravenous infusions on days 1, 8, and 15. Treatment courses were repeated every 28 days. Patients were reevaluated after completion of 2 treatment courses; responding patients continued treatment until disease progression or for a maximum of 6 courses. Between August 1999 and June 2000, 64 patients (73% with stage IV disease) were treated at 17 participating sites in the Minnie Pearl Cancer Research Network. Eighteen of 64 patients enrolled (28%) had objective response to treatment; an additional 25 patients (39%) had stable disease. Median survival was 7 months, with 1- and 2-year survival rates of 30% and 17%, respectively. Treatment was well tolerated by most patients. Grade 3/4 leukopenia occurred in 7 patients (11%), but no patient required hospitalization for neutropenia/fever. One patient developed fatal bilateral pneumonitis, which was possibly treatment-related. The combination of weekly docetaxel/gemcitabine is active and relatively well tolerated in most patients with advanced age or poor PS with advanced NSCLC. A randomized comparison of this regimen versus single-agent weekly docetaxel is in progress.