Multicenter phase II trial of docetaxel and carboplatin in patients with stage IIIB and IV non-small-cell lung cancer

Purpose: To evaluate the safety and efficacy of docetaxel and carboplatin a s first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods: In this multicenter, phase II trial, 33 patients with previously untreated stage IIIB (n = 8) or IV (n = 25) NSCLC received intr avenous infusions of docetaxel 80 mg/m(2) followed immediately by carboplat in dosed to AUC of 6 mg/ml/min (Calvert's formula) every three weeks. Patie nts also received dexamethasone 8 mg orally twice daily for three days begi nning one day before each docetaxel treatment. Filgrastim was not allowed d uring the first cycle and was added only if a patient experienced febrile n eutropenia or grade 4 neutropenia lasting greater than or equal to 7 days. Results: There were 1 complete and 11 partial responses for an objective re sponse rate of 43% (95% CI: 24%-63%) in 28 evaluable patients and 36% (95% CI: 20%-55%) in the intent-to-treat population. The median duration of resp onse was 5.5 months (range 3.0-12.5 months). The median survival was 13.9 m onths (range 1-35+ months); one-year survival was 52%. The most common toxi city was hematologic, which included grade 4 neutropenia (79% of patients a nd 7% percent of cycles) and febrile neutropenia (15% of patients); there w ere no episodes of grade 3 or 4 infection. The most common severe nonhemato logic toxicities were asthenia (24%) and myalgia (12%); there were no grade 3 or 4 neurologic effects. Conclusions: The combination of docetaxel and carboplatin has an acceptable toxicity profile and is active in the treatment of previously untreated pa tients with advanced NSCLC. This combination is being evaluated in a random ized phase III trial involving patients with advanced and metastatic NSCLC.