Annals of Oncology Advance Access published online on February 9, 2006
Annals of Oncology, doi:10.1093/annonc/mdl007
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1 Medical Oncology Unit 2, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan
* To whom correspondence should be addressed. 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- 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- 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.
Received November 9, 2005
Revised December 30, 2005
Accepted January 9, 2006
original article
Multicenter phase III randomized trial of polychemotherapy (CVD regimen) versus the same chemotherapy (CT) plus subcutaneous interleukin-2 and interferon-
E. Bajetta 1 *,
M. Del Vecchio 1,
P. Nova 1,
A. Fusi 1,
A. Daponte 2,
M. R. Sertoli 3,
P. Queirolo 4,
P. Taveggia 4,
M. G. Bernengo 5,
S. S. Legha 6,
B. Formisano 1,
and
N. Cascinelli 7
2b in metastatic melanoma
2 Unit of Medical Oncology A, Istituto Nazionale Tumori Fondazione Pascale, Naples
3 Unit of Medical Oncology, National Cancer Research Institute, Genoa; University of Genoa
4 Unit of Medical Oncology, National Cancer Research Institute, 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
E. Bajetta, E-mail: emilio.bajetta{at}istitutotumori.mi.it
Abstract 
2b.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.
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