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

Journal of Translational Medicine

Paolo Antonio Ascierto⁹  Giuseppe Comella⁹  Ciro Gallo^1,11  Nicola Mozzillo⁹  Pasquale Aprea^1,10  Ernesta Cavalcanti⁵  Secondo Lastoria²  Antonella Petrillo⁸  Gerardo Botti⁶  Antonio Cossu⁴  Giuseppe Palmieri¹  Corrado Caracò⁹  Antonio Maria Grimaldi⁹  Ester Simeone⁹  Bruno Massidda⁷  Luigi Maiorino³  Simona Signoriello^1,11  Antonio Daponte⁹ 

[1] Unit of Cancer Genetics, Institute of Biomolecular Chemistry, C.N.R., Sassari, Italy;Department of Nuclear Medicine, Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy;Medical Oncology, S.Gennaro Hospital Napoli, Naples, Italy;Department of Pathology, Azienda Ospedaliero Universitaria, Sassari, Italy;Laboratory Medicine Unit, Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy;Department of Pathology, Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy;Medical Oncology, University of Cagliari, Cagliari, Italy;Department of Radiology, Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy;Department of Melanoma, Istituto Nazionale Tumori Fondazione Pascale, Via Mariano Semmola, 80131, Naples, Italy;Vascular Access Unit, Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy;Medical Statistics, Second University, Naples, Italy

关键词: Interferon-α;    Dacarbazine;    Fotemustine;    Melanoma;   

Others  :  828080
DOI  :  10.1186/1479-5876-11-38

 received in 2012-12-16, accepted in 2013-02-11,  发布年份 2013

【 摘 要 】

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

【 授权许可】

   
2013 Daponte et al; licensee BioMed Central Ltd.

【 图 表 】

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