Vinorelbine (Navelbine)/carboplatin combination therapy: dose intensification with granulocyte colony-stimulating factor.

Treatment with platinum agents or the new vinca alkaloid vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France) results in prolonged survival in patients with advanced non-small cell lung cancer (NSCLC). To determine whether a unique combination of these agents might enhance activity against NSCLC, a combination chemotherapy regimen consisting of intravenous carboplatin, administered on days 1 and 29, and intravenous vinorelbine, given once weekly, was evaluated. Because the dose-limiting toxicity of both agents is myelosuppression, an additional study goal was to assess the ability of granulocyte colony-stimulating factor to alleviate hematologic toxicity and allow on-time, full-dose vinorelbine therapy. To this end, a phase I/II study was begun. Phase I of the study included 22 patients (15 men and seven women) with a median age of 63 years (age range, 39 to 77 years) who had stage IV NSCLC and no prior chemotherapy. Phase I consisted of 28-day cycles in which intravenous carboplatin was administered at an area under the curve of 7 by the Calvert formula, dose range 350 to 450 mg/m2, and intravenous vinorelbine was administered weekly. Granulocyte colony-stimulating factor was administered if dose-limiting neutropenia developed. Four cohorts of patients were studied, ranging from those who received no vinorelbine to those who received drug doses of up to 30 mg/m2. Patients were able to tolerate the highest dose of vinorelbine, but the majority required granulocyte colony-stimulating factor support to do so. No novel toxicities were observed in patients treated with the combination of carboplatin and vinorelbine.(ABSTRACT TRUNCATED AT 250 WORDS)

Duke Scholars

Author Jeffrey Crawford Medicine, Medical Oncology