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. © 2013 Daponte et al; licensee BioMed Central Ltd.

Phase III randomized study of fotemustine and dacarbazine versus dacarbazine with or without interferon-α in advanced malignant melanoma / Daponte, A.; Signoriello, S.; Maiorino, L.; Massidda, B.; Simeone, E.; Grimaldi, A. M.; Caraco, C.; Palmieri, G.; Cossu, A.; Botti, G.; Petrillo, A.; Lastoria, S.; Cavalcanti, E.; Aprea, P.; Mozzillo, N.; Gallo, C.; Comella, G.; Ascierto, P. A.. - In: JOURNAL OF TRANSLATIONAL MEDICINE. - ISSN 1479-5876. - 11:1(2013), p. 38. [10.1186/1479-5876-11-38]

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

Palmieri G.;Cossu A.;
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. © 2013 Daponte et al; licensee BioMed Central Ltd.
Phase III randomized study of fotemustine and dacarbazine versus dacarbazine with or without interferon-α in advanced malignant melanoma / Daponte, A.; Signoriello, S.; Maiorino, L.; Massidda, B.; Simeone, E.; Grimaldi, A. M.; Caraco, C.; Palmieri, G.; Cossu, A.; Botti, G.; Petrillo, A.; Lastoria, S.; Cavalcanti, E.; Aprea, P.; Mozzillo, N.; Gallo, C.; Comella, G.; Ascierto, P. A.. - In: JOURNAL OF TRANSLATIONAL MEDICINE. - ISSN 1479-5876. - 11:1(2013), p. 38. [10.1186/1479-5876-11-38]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11388/241271
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