Combination of paclitaxel and etoposide in the treatment of advanced non-small cell lung cancer: A phase I-II study

Thirty-six patients (pts) with unpretreated advanced non-small cell lung ca ncer (NSCLC) stages IIIB and IV were enrolled in this two-stage phase I-II study aimed to establish the maximum tolerated dose (MTD) of paclitaxel and to evaluate the efficacy and safety of paclitaxel combined with etoposide every 3 weeks for a maximum of 6 courses, increasing the dose of paclitaxel according to a modified Fibonacci scheme. Nineteen pts were enrolled in th e first stage and 17 pts in the second stage. The characteristics of the pt s were as bellows: median age 56 years (40-70), median Karnofsky's Performa nce Status 80% (70-80), 11 pts were stage IIIB and 25 pts stage IV. The dos es of etoposide administered were 50 mg/m(2) for 15 pts and 100 mg/m(2) for 22 pts. MTD has not been reached and the study proceeded with the dose of paclitaxel 250 mg/m(2). We obtained 9 (25%) partial remissions (PR) and 11 (31%) stable disease (SD) in 33 objectively evaluable pts. Median time to p rogression (TTP) was 4 months (0.3-21), median survival was 9.3 months (0.3 -27). The main toxicity was neutropenia and neurotoxicity, while the gastro intestinal toxicity was mild. Two pts deceased after the first course. The causes of death were necrotizing enteritis in the first pt and congestive h eart failure in the second pt. A total of 156 courses were administered at 7 dose levels, with a median of 4 courses per patient (1-6). The results se em to support the use of this combination in advanced non-small cell lung c ancer.