Single-agent paclitaxel as a 3-hour infusion

This ongoing phase II trial of patients with inoperable stage IIIB-IV non-small cell lung cancer is seeking to determine the efficacy and toxicity of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) when administered as a 3-hour infusion. The 58 patients now evaluable met standard eligibility requirements, including no prior chemotherapy. Paclitaxel 225 mg/m2 was delivered every 3 weeks for up to 10 courses, depending on patient response. All patients were evaluable for toxicity and 50 were evaluable for response. There were no complete responses, 12 patients had partial responses, 12 had progressive disease, and 26 had no change. The median time to response was 8.7 weeks; the median survival was 10 months. Leukopenia, when observed, was grade 1 or 2 in all but one case. Likewise, all nonhematologic effects were mild, with the exception of one case of grade 3 gastrointestinal toxicity. The 3-hour infusion schedule is more convenient, and the authors feel that the safety of the schedule is confirmed by these results. However, the efficacy of the shortened schedule, compared with a 24-hour infusion, remains to be proven.