Weekly chemotherapy with cisplatin and paclitaxel in advanced NSCLC: a phase II study

Background. This phase II study was designed to assess the activity and toxicity of administration of the cisplatin/ paclitaxel combination in advanced non-small cell lung cancer (NSCLC). Methods. Eligibility criteria included: age up to 70 years, pathological diagnosis of NSCLC, inoperable disease or post-operative tumour recurrence, performance status </=2, no severe co-morbidity, no previous chemotherapy, and informed consent. Treatment consisted of intravenous infusion of cisplatin, 25 mg/m2, and paclitaxel, 80 mg/m2, every week. Chemotherapy was continued until completion of a 22-week treatment plan, disease progression, persistent toxicity, or patient refusal. Results. Forty-nine patients entered the study. They received a median of 14 cycles (range 0-22). For both drugs, the median dose-intensity was 75% of projected. Toxicity was generally acceptable, and never life threatening. Alopecia was the most common side effect, followed by anemia, leukopenia, and nausea/vomiting. Twenty patients responded (40.8% response rate), with three complete, pathologically documented responses. The estimated median time to progression was 35 weeks (95% CI: 29-41); the median survival time was 56 weeks (95% CI: not calculable), with a 2-year survival rate of 46.1%. Conclusions. When given on a weekly basis, the cisplatin/ paclitaxel combination is well tolerated, active, and associated to remarkably long survivals.