Protocol
Phase III randomized study of fotemustine and dacarbazine versus dacarbazine with or without interferon-α in advanced malignant melanoma
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
Journal of Translational Medicine 2013, 11:38 doi:10.1186/1479-5876-11-38
Published: 13 February 2013Abstract
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
