Docetaxel and vinorelbine plus GM-CSF in malignant melanoma

Patients having locoregional or metastatic melanoma have a poor prognosis, with 50% to 100% of patients dying from the disease within 5 years. Current chemotherapy regimens offer limited benefits to these patients, and more effective and less toxic treatments are needed. We therefore piloted a study of docetaxel (Taxotere), vinorelbine (Navelbine), granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim [Leukine]), or the DVS regimen, in patients with stage IV melanoma. Eight patients were treated after previous biochemotherapy and two patients were given the regimen as an initial treatment. The DVS regimen consisted of docetaxel at 40 mg/m2 i.v. over 1 hour, vinorelbine at 30 mg/m2 i.v. over 6 to 10 minutes every 14 days, and GM-CSF at 250 mg/m2 SC on days 2 to 12. No grade 3 or 4 toxicities were encountered. Of the 10 patients evaluable for response, 5 were partial responders (50% response rate). Time to progression for the 10 cases ranged from 2 to 26+ months (median: 8 months). The DVS regimen was active against advanced melanoma in both previously treated and untreated patients. A larger study to confirm the activity of the DVS regimen for stage IV melanoma is currently under way.