Abstract
BACKGROUND
The current doseโoptimizing Phase II study evaluated the effect of weekly paclitaxel and gemcitabine on the response rate and survival of patients with nonโsmall cell lung carcinoma (NSCLC) using dose modifications that permitted optimal treatment intensity.
METHODS
Fortyโfive patients (40 with TNM Stage IV and 5 with TNM Stage IIIB NSCLC) were treated with gemcitabine at 1000 mg/m^2^ via a 30โminute intravenous (i.v.) infusion and with paclitaxel at 100 mg/m^2^ via a 60โminute i.v. infusion. The first 3 patients received chemotherapy on Days 1, 8, and 15 every 4 weeks; the next 42 patients, participating in the Phase II trial, received chemotherapy on Days 1 and 8 every 3 weeks.
RESULTS
The 3 patients who received paclitaxel and gemcitabine on Days 1, 8, and 15 every 4 weeks tolerated the treatment poorly. One patient died suddenly after Day 15 treatment during the first cycle, and the other 2 patients discontinued the treatment because of unacceptable toxicity before the third cycle of chemotherapy. The next 42 patients, 40 of whom were evaluable, entered this trial between May 2000 and April 2001. They received paclitaxel at 100 mg/m^2^ i.v. followed by gemcitabine at 1000 mg/m^2^ i.v. on Days 1 and 8 every 3 weeks. Two patients (5%) achieved complete response, 20 (50%) achieved partial response, and 8 (20%) had stable disease. Median survival (MS) was 9.8 months; and 1โyear survival was 35%. The 32 patients with performance status (PS) 0 or 1 had an MS of 11 months; the 8 patients with PS 2 had an MS of 3 months. Toxicity (especially hematologic toxicity, neuropathy, and alopecia) was minimal.
CONCLUSION
A weekly paclitaxel and gemcitabine regimen that incorporated the authors' dose modifications resulted in good efficacy with minimal toxicity. Cancer 2003;97:2242โ7. ยฉ 2003 American Cancer Society.
DOI 10.1002/cncr.11319