Nonplatinum Doublet Vinorelbine/ Gemcitabine Effective in NSCLC

NEW YORK- A combinationof vinorelbine (Navelbine) andgemcitabine (Gemzar) showed similarefficacy to the standard platinumbasedregimen for advanced non-small-cell lung cancer (NSCLC) and adifferent toxicity profile in a phase IIstudy presented at the Mount SinaiSchool of Medicine ChemotherapyFoundation Symposium XX.Rogerio C. Lilenbaum, MD, clinicalassociate professor of medicine,University of Miami School of Medicine,and director, Thoracic OncologyProgram, Mount Sinai ComprehensiveCancer Center, Miami Beach,presented preliminary results from amulticenter randomized trial that enrolled164 lung cancer patients.Patients With BrainMets EligibleAll patients had histologically provenstage IIIB or IV NSCLC and hadnot received chemotherapy. Patientswith brain metastases were eligible ifthey were neurologically stable."Most patients had stage IV disease,"Dr. Lilenbaum said, "and mosthad performance status 0 to 1. About15% had performance status 2."Patients were randomized to receivecarboplatin (Paraplatin) at a doseof AUC 6 and paclitaxel (Taxol) at200 mg/m² on the first day of eachcycle or vinorelbine at 25 mg/m² andgemcitabine at 1,000 mg/m² on days 1and 8 of each cycle. For both regimens,the cycles were 21 days and wererepeated up to a maximum of sixtimes. The median number of cyclescompleted was approximately four.Results and ToxicityOutcomes were similar in botharms, with no significant differences.Partial responses were achieved in14.6% of patients in the vinorelbine/gemcitabine arm and 17.1% in thecarboplatin/paclitaxel arm. Stable diseasewas recorded in 37.8% and 35.4%,and disease progression was seen in34.1% and 31.7%, respectively. Themedian time to progression was 2.1months in both groups.Median survival was 7.3 monthswith vinorelbine/gemcitabine and8.4 months with the platinum-basedtherapy.Grade 3/4 hematologic toxicity wasmore common in the platinum-basedarm, occurring in 11% of thevinorelbine/gemcitabine patients vs28% of the carboplatin/paclitaxel group. The difference in neutropenia,but not thrombocytopenia, was statisticallysignificant, Dr. Lilenbaumnoted.Among nonhematologic toxicities,alopecia (grade 1 to 4) was significantlyless common in the vinorelbine/gemcitabine arm, 7.5% vs 36.6% forthe platinum-based regimen.'There was less peripheral neuropathyin the vinorelbine/gemcitabinearm, compared with the carboplatin/paclitaxel regimen," Dr. Lilenbaumsaid. Quality of life was similar in botharms.As a result of the findings in thephase II trial, Dr. Lilenbaum now seesvinorelbine/gemcitabine as "an attractivealternative" to carboplatin/paclitaxel in patients with advancedNSCLC who, in the physician's judgment,are not likely to tolerate suchtherapy well."Just as we work to extend the lives ofpeople with late-stage disease, we will alsocontinue to investigate new approachesthat improve the tolerability of treatmentfor these patients," he said.