Paclitaxel, carboplatin, and vinorelbine in the treatment of advanced non-small cell lung cancer: A phase II trial of the Minnie Pearl Cancer Research Network

PURPOSE To evaluate the feasibility, toxicity, and efficacy of adding vinorelbine t o the paclitaxel/carboplatin combination in the treatment of advanced non-s mall cell lung cancer. PATIENTS AND METHODS Patients with advanced (stage IIIB/IV) non-small cell lung cancer who had r eceived no previous chemotherapy were treated with the following three-drug regimen: paclitaxel, 200 mg/m(2), 1-hour IV infusion, day 1; carboplatin, AUC 6.0 IV, day 1; and vinorelbine, 22.5 mg/m2 IV days 1 and either 8 or 15 . Treatment was repeated every 21 days. This phase II trial was conducted i n a multicenter, community-based setting. RESULTS Eighty-nine patients were treated with a median of four courses of therapy (range, one to eight). Thirty-one patients (35%) had major responses (two c omplete, 29 partial), and 36 patients (40%) had a minor response or stable disease. Actuarial median survival was 8.6 months; 1 year survival was 43%, Leukopenia was the major toxicity: 73% of patients had grade 3/4 toxicity, and 32 patients (36%) were hospitalized for neutropenia/fever (11% of tota l courses administered). Treatment-related death due to infection occurred in four patients (4%). CONCLUSIONS This three-drug regimen is feasible and efficacious in the treatment of adv anced non-small cell lung cancer, The addition of vinorelbine increases the incidence of severe leukopenia substantially when compared with the paclit axel/carboplatin regimen. However, other toxicities are not markedly increa sed. Ongoing randomized trials will define the role of this regimen in the treatment of non-small cell lung cancer.