Multicenter phase III randomized trial of polychemotherapy (CVD regimen) versus the same chemotherapy (CT) plus subcutaneous interleukin-2 and interferon-α2b in metastatic melanoma

Emilio Bajetta, M. Del Vecchio, P. Nova, A. Fusi, A. Daponte, M. R. Sertoli, P. Queirolo, P. Taveggia, M. G. Bernengo, S. S. Legha, B. Formisano, N. Cascinelli

Research output: Contribution to journalArticle

Abstract

Background: The addition of cytokines to chemotherapy (CT) has obtained encouraging but contradictory results in metastatic melanoma. In this phase III trial, we compared the effects of CT [cisplatin, vindesine and dacarbazine (CVD)] with those of concurrent biochemotherapy (bioCT) consisting of CVD plus interleukin-2 and interferon-α2b. Patients and methods: A total of 151 untreated metastatic melanoma patients were randomized, 75 on arm A (cisplatin 30 mg/m2 on days 1-3, vindesine 2.5 mg/m2 on days 1-3), and 76 on arm B (same CVD scheme plus interferon-α2b on days 1-5 and interleukin-2 on days 1-5 and 8-15, both administered subcutaneously), either recycled every 3 weeks. Response was assessed every two cycles. Results: Ten percent of the patients were alive at a median of 52 months from start of therapy. We observed a response rate (RR) of 21% on arm A versus 33% on arm B; three patients (4%) given bioCT had complete responses (CRs). Median time to progression (TTP) was identical; median overall survival (OS) time was 12 months on arm A and 11 months on arm B. Conclusions: BioCT is not better than CT alone; the trend in favor of the bioCT in terms of RR did not translate into better TTP or OS. Therefore, bioCT cannot be recommended as standard first-line therapy for metastatic melanoma.

Original languageEnglish
Pages (from-to)571-577
Number of pages7
JournalAnnals of Oncology
Volume17
Issue number4
DOIs
Publication statusPublished - Apr 2006

Keywords

  • Chemotherapy
  • Cytokines
  • Immunotherapy
  • Metastatic melanoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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