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Annals of Oncology Advance Access originally published online on February 9, 2006
Annals of Oncology 2006 17(4):571-577; doi:10.1093/annonc/mdl007
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© 2006 European Society for Medical Oncology

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

E. Bajetta1,*, M. Del Vecchio1, P. Nova1, A. Fusi1, A. Daponte2, M. R. Sertoli3,4, P. Queirolo3, P. Taveggia3, M. G. Bernengo5, S. S. Legha6, B. Formisano1 and N. Cascinelli7

1 Medical Oncology Unit 2, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan; 2 Unit of Medical Oncology A, Istituto Nazionale Tumori Fondazione Pascale, Naples; 3 Unit of Medical Oncology, National Cancer Research Institute, Genoa; 4 University of Genoa, 5 Institute of Dermatology, University of Turin; 6 Melanoma Center, St. Luke's Episcopal Hospital, Houston (USA); 7 Scientific Director, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan

* Correspondence to: Dr E. Bajetta, Oncologia Medica 2, Istituto Nazionale per lo Studio e la Cura dei Tumori, Via Venezian 1, 20133 Milan, Italy. Tel: +39-02-23902500; Fax: +39-02-23902149; E-mail: emilio.bajetta{at}istitutotumori.mi.it

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-{alpha}2b.

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 day 1 and dacarbazine 250 mg/m2 on days 1–3), and 76 on arm B (same CVD scheme plus interferon-{alpha}2b 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.

Key words: chemotherapy, cytokines, immunotherapy, metastatic melanoma


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