PHASE-II TRIAL OF A 3-HOUR INFUSION OF PACLITAXEL IN PREVIOUSLY UNTREATED PATIENTS WITH ADVANCED NON-SMALL-CELL LUNG-CANCER

Purpose: To determine the antitumor activity and toxicity of paclitaxe l administered as a 3-hour infusion in patients with advanced non-smal l-cell lung cancer (NSCLC). Patients and Methods: Fifty-one patients w ith advanced measurable or assessable NSCLC and performance status 0 t o 2 who had not received prior chemotherapy were treated with paclitax el 175 mg/m(2) over 3 hours with premedication, Cycles were repeated e very 3 weeks for a maximum of nine cycles, Most patients had prior rad iotherapy (57%), extrathoracic metastatic disease (65%), and measurabl e disease (75%). Twenty-two percent had previously untreated stage III disease. Results: The objective response rate was five of 51 (10%; 95 % confidence interval, 3% to 21%). No subgroup with a higher response rate could be identified, There were no complete responses (CRs) and a ll responses lasted less than 5 months, Treatment was well tolerated w ith brief World Health Organization (WHO) grade IV neutropenia in only 16% of patients, Grade III/IV myalgia/arthralgia occurred in 22% of p atients. No significant hypersensitivity reactions occurred. Conclusio n: The antitumor activity of this dose and schedule appears inferior t o that reported in previously published phase II trials in NSCLC that used higher doses of paclitaxel infused over 24 hours, although confid ence intervals for response overlap. Determining the optimal dose and schedule for using paclitaxel in NSCLC requires further investigation, and these results should caution against using shorter infusions outs ide appropriate clinical trials. (C) 1996 by American Society of Clini cal Oncology.