Nonplatinum Doublet Vinorelbine/ Gemcitabine Effective in NSCLC

NEW YORK- A combination of vinorelbine (Navelbine) and gemcitabine(Drug information on gemcitabine) (Gemzar) showed similar efficacy to the standard platinumbased regimen for advanced non-small-cell lung cancer (NSCLC) and a different toxicity profile in a phase II study presented at the Mount Sinai School of Medicine Chemotherapy Foundation Symposium XX. Rogerio C. Lilenbaum, MD, clinical associate professor of medicine, University of Miami School of Medicine, and director, Thoracic Oncology Program, Mount Sinai Comprehensive Cancer Center, Miami Beach, presented preliminary results from a multicenter randomized trial that enrolled 164 lung cancer patients. Patients With Brain Mets Eligible All patients had histologically proven stage IIIB or IV NSCLC and had not received chemotherapy. Patients with brain metastases were eligible if they were neurologically stable. "Most patients had stage IV disease," Dr. Lilenbaum said, "and most had performance status 0 to 1. About 15% had performance status 2." Patients were randomized to receive carboplatin(Drug information on carboplatin) (Paraplatin) at a dose of AUC 6 and paclitaxel(Drug information on paclitaxel) (Taxol) at 200 mg/m² on the first day of each cycle or vinorelbine at 25 mg/m² and gemcitabine at 1,000 mg/m² on days 1 and 8 of each cycle. For both regimens, the cycles were 21 days and were repeated up to a maximum of six times. The median number of cycles completed was approximately four. Results and Toxicity Outcomes were similar in both arms, with no significant differences. Partial responses were achieved in 14.6% of patients in the vinorelbine/ gemcitabine arm and 17.1% in the carboplatin/paclitaxel arm. Stable disease was recorded in 37.8% and 35.4%, and disease progression was seen in 34.1% and 31.7%, respectively. The median time to progression was 2.1 months in both groups. Median survival was 7.3 months with vinorelbine/gemcitabine and 8.4 months with the platinum-based therapy. Grade 3/4 hematologic toxicity was more common in the platinum-based arm, occurring in 11% of the vinorelbine/gemcitabine patients vs 28% of the carboplatin/paclitaxel group. The difference in neutropenia, but not thrombocytopenia, was statistically significant, Dr. Lilenbaum noted. Among nonhematologic toxicities, alopecia (grade 1 to 4) was significantly less common in the vinorelbine/ gemcitabine arm, 7.5% vs 36.6% for the platinum-based regimen. 'There was less peripheral neuropathy in the vinorelbine/gemcitabine arm, compared with the carboplatin/ paclitaxel regimen," Dr. Lilenbaum said. Quality of life was similar in both arms. As a result of the findings in the phase II trial, Dr. Lilenbaum now sees vinorelbine/gemcitabine as "an attractive alternative" to carboplatin/ paclitaxel in patients with advanced NSCLC who, in the physician's judgment, are not likely to tolerate such therapy well. "Just as we work to extend the lives of people with late-stage disease, we will also continue to investigate new approaches that improve the tolerability of treatment for these patients," he said.