Weekly docetaxel with either gemcitabine or vinorelbine as second-line treatment in patients with advanced nonsmall cell lung carcinoma - Phase II trials of the Minnie Pearl Cancer Research Network

BACKGROUND. The current study was conducted to evaluate the feasibility, to xicity, and efficacy of weekly docetaxel when paired with either gemcitabin e or vinorelbine as the second-line treatment of patients with advanced non small cell lung carcinoma. METHODS. Patients with progressive nonsmall cell lung carcinoma after one p revious chemotherapeutic regimen, an Eastern Cooperative Oncology Group per formance status of 0-2, and measurable lesions were eligible for treatment in these Phase II trials. Patients who had not received gemcitabine previou sly were treated with docetaxel, 30 mg/m(2), and gemcitabine, 800 mg/m(2), both of which were administered intravenously (i.v.) on Days 1, 8, and 15 o f a 28-day cycle. if the patients had received gemcitabine as part of first -line therapy, they were treated with docetaxel, 30 mg/m(2), and vinorelbin e, 20 mg/m(2) i.v., on Days 1, 8, and 15 of a 28-day cycle. Patients were r eevaluated after two courses of treatment, and responding patients continue d treatment for six courses or until disease progression. RESULTS. Forty patients were treated with a combination of docetaxel and ge mcitabine, and 23 patients received docetaxel and vinorelbine. The docetaxe l/gemcitabine combination was reasonably well tolerated, with moderate myel osuppression and a few nonhematologic toxicities reported. The objective re sponse rate was 10%, with a 1-year survival rate of 20%. The docetaxel/vino relbine combination was found to be poorly tolerated, with Grade 3/4 leukop enia reported in 71% of patients and neutropenic fever reported in 70% of p atients despite frequent dose reductions and omission of the Day 15 doses. Enrollment onto this regimen was stopped prematurely due to toxicity, and a fter no major responses were observed in the first 20 evaluable patients. CONCLUSIONS. The combination of weekly docetaxel/gemcitabine appears to be feasible and relatively well tolerated as second-line treatment in patients with advanced nonsmall cell lung carcinoma, whereas a weekly combination o f docetaxel and vinorelbine did not appear to be tolerable at the doses and schedule used in the current study. Neither regimen showed a level of acti vity that suggested any advantage compared with the results obtained with s ingle-agent docetaxel in this setting. (C) 2001 American Cancer Society.