Adjuvant treatment with vindesine in comparison to observation alone in patients with metastasized melanoma after complete metastasectomy: a randomized multicenter trial of the German Dermatologic Cooperative Oncology Group.

Abstract

To evaluate the efficacy and safety of vindesine in patients with metastatic melanoma after complete metastasectomy. One hundred and forty-two patients with metastatic spread to regional sites, lymph nodes, and distant sites after complete metastasectomy were randomized to receive either treatment with vindesine for 2 years or observation alone. Vindesine 3 mg/m intravenously was administered biweekly for the first 26 weeks following 3-week intervals for an additional 26 weeks and thereafter every 4 weeks for 52 weeks. One hundred and thirty-nine patients were eligible for intent-to-treat analysis. Median follow-up time was 46 months. Median recurrence free survival was 7.9 months in the vindesine group and 7.6 months in the observational group (P=0.40). Three-year overall survival rate was 54.9% (37 patients) for patients receiving vindesine in comparison to 43.6% (31 patients) in the observation arm (P=0.07). No grade IV toxicity was observed. The two major side effects in the vindesine group were alopecia and peripheral neuropathy. Ten patients went off treatment because of grade III toxicity. Adjuvant treatment with vindesine did not significantly prolong disease free or overall survival in high-risk melanoma patients. Thus, this randomized trial did not confirm earlier reports of beneficial effects of adjuvant vindesine and can therefore not be recommended.

• Authors: Thomas K Eigentler, Peter Radny, Axel Hauschild, Ralf Gutzmer, Ruthild Linse, Claudia Pföhler, Stephan N Wagner, Dirk Schadendorf, Ulf Ellwanger, Claus Garbe, German Dermatologic Cooperative Oncology Group
• Journal: Melanoma research (Melanoma Res) Vol. 18 Issue 5 Pg. 353-8 (Oct 2008) ISSN: 1473-5636 [Electronic] England
• PMID: 18781134 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Phytogenic
• Vindesine

Topics

• Adult
• Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects, therapeutic use)
• Chemotherapy, Adjuvant
• Female
• Humans
• Lymph Node Excision
• Lymphatic Metastasis
• Male
• Melanoma (drug therapy, mortality, secondary, surgery)
• Middle Aged
• Skin Neoplasms (drug therapy, mortality)
• Survival Rate
• Vindesine (administration & dosage, adverse effects, therapeutic use)