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Open Access Protocol

Phase III randomized study of fotemustine and dacarbazine versus dacarbazine with or without interferon-α in advanced malignant melanoma

Antonio Daponte1, Simona Signoriello2, Luigi Maiorino3, Bruno Massidda4, Ester Simeone1, Antonio Maria Grimaldi1, Corrado Caracò1, Giuseppe Palmieri5, Antonio Cossu6, Gerardo Botti7, Antonella Petrillo8, Secondo Lastoria9, Ernesta Cavalcanti10, Pasquale Aprea11, Nicola Mozzillo1, Ciro Gallo2, Giuseppe Comella1, Paolo Antonio Ascierto1* and on behalf of the Southern Italy Cooperative Oncology Group (SICOG)

Author Affiliations

1 Department of Melanoma, Istituto Nazionale Tumori Fondazione Pascale, Via Mariano Semmola, 80131, Naples, Italy

2 Medical Statistics, Second University, Naples, Italy

3 Medical Oncology, S.Gennaro Hospital Napoli, Naples, Italy

4 Medical Oncology, University of Cagliari, Cagliari, Italy

5 Unit of Cancer Genetics, Institute of Biomolecular Chemistry, C.N.R., Sassari, Italy

6 Department of Pathology, Azienda Ospedaliero Universitaria, Sassari, Italy

7 Department of Pathology, Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy

8 Department of Radiology, Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy

9 Department of Nuclear Medicine, Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy

10 Laboratory Medicine Unit, Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy

11 Vascular Access Unit, Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy

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Journal of Translational Medicine 2013, 11:38  doi:10.1186/1479-5876-11-38

Published: 13 February 2013

Abstract

Background

The effect of the addition of fotemustine and/or interferon (IFN) to standard therapy with dacarbazine alone in patients with advanced malignant melanoma was investigated in a multicenter, randomized 2x2 factorial design trial.

Methods

A total of 260 patients were randomly assigned to one of four treatment groups: (A) fotemustine and dacarbazine repeated on 3-week cycle; (B) same treatment as (A) plus IFN-α2b three times per week; (C) dacarbazine alone repeated on 3-week cycle; (D) same treatment as (C) plus IFN-α2b three times per week. Two comparisons were planned to assess the efficacy of fotemustine (groups A+B vs. C+D) and IFN-α2b (groups A+C vs. B+D).

Results

Addition of fotemustine did not significantly improve overall survival (OS) (p=0.28) or progression-free survival (PFS) (p=0.55); Hazard ratio (HR) for OS was 0.93 (95% CI 0.71-1.21). Similarly, addition of IFN-α2b did not improve OS (p=0.68) or PFS (p=0.65); HR for OS was 0.92 (95% CI 0.70-1.20). Overall response rate was not improved by the addition of either fotemustine (p=0.87) or IFN-α2b (p=0.57). The combination of all three drugs resulted in the highest occurrence of adverse events.

Conclusions

No significant improvement in outcomes were observed with the addition of either fotemustine or IFN-α2b to dacarbazine.

Trial registration

ClinicalTrials.gov: NCT01359956

Keywords:
Melanoma; Fotemustine; Dacarbazine; Interferon-α