Paclitaxel (1-hour infusion) plus carboplatin in the treatment of advanced non-small cell lung cancer: results of a multicenter phase II trial.

This study was performed to determine the activity and toxicity of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) given by 1-hour infusion plus carboplatin in the treatment of patients with advanced non-small cell lung cancer when used in a multicenter, community-based setting. The study population included 100 chemotherapy-naive patientswith stage IIIB or IV non-small cell lung cancer, Karnofsky performance status 70 to 100, measurable disease, and adequate kidney, liver, and bone marrow function. All patients received paclitaxel 225 mg/m2 intravenously by 1-hour infusion followed immediately by carboplatin at a targeted area under the concentration-time curve of 6.0 (Calvert formula). Cycles were repeated every 21 days. Colony-stimulating factors were not used routinely. Thirty-eight (38%) of 100 patients had objective responses (38 [40%] of 94 evaluable patients) to treatment (three complete responses, 35 partial responses). Thirty-two other patients had stable disease at initial re-evaluation. Weight gain during treatment occurred in 47% of those patients with objective response or stable disease. The median survival among all 100 patients was 8 months, with a 1-year survival rate of 42%. Leukopenia was common, but hospitalization for treatment of neutropenia and fever occurred in only 3% of courses. Cumulative peripheral neuropathy occurred consistently, but usually after the third or fourth course; it was severe (grade 3) in only 15% of patients. Other grade 3 and 4 toxicity was uncommon. One patient died as a result of treatment due to sepsis. This large, multicenter, community-based phase II trial demonstrates the efficacy of paclitaxel/carboplatin combination chemotherapy in advanced non-small cell lung cancer. This regimen is relatively well tolerated and when paclitaxel is given by 1-hour infusion, this treatment is easily administered in the outpatient setting.