Paclitaxel plus carboplatin in advanced non-small-cell lung cancer: A phase II trial

Purpose: Studies conducted by the Eastern Cooperative Oncology Group (ECOG) indicate both paclitaxel and carboplatin are associated with an improvement in I-year survival in patients with stage IV non-small-cell rung cancer (NSCLC). Based on these findings, a phase II trial of these agents in combination was conducted in patients with advanced NSCLC. Patients and Methods: Eligibility included previously untreated stage IIIB or IV NSCLC patients with a good performance status (PS), Paclitaxel (135 or 175 mg/m(2)) was administered by 24-hour infusion on day 1, followed by a 1-hour infusion of carboplatin on day 2 (300 mg/m(2) or dosed to an area under the concentration-time curve [AUC] of 6 mg/mL . min). Treatment was repeated every 28 days for a total of six cycles. Hematopoietic growth factors were not routinely used, Results: Among 51 eligible patients, there were no complete and 14 partial responses, for an overall response rate of 27% (95% confidence interval [CI], 17% to 41%). The median progression-free survival time was 23.8 weeks (range, 12.1 to 73.9) and median survival time, 38 weeks. The survival rate at 1 year was 32%, Grade 3 or 4 granulocytopenia and thrombocytopenia were observed in 47% and 3%, respectively, of the 184 treatment cycles administered. The most common nonhematologic toxicities included nausea and emesis, neuropathy, and arthralgia/myalgia. Conclusion: Paclitaxel plus corboplatin is a moderately active regimen in patients with advanced NSCLC and warrants comparison with existing cisplatin-based regimens in a prospective randomized trial. The toxicities of this regimen are well tolerated in patients with a good PS. (C) 1996 by American Society of Clinical Oncology.