Treatment Patterns of Adjuvant Interferon Alfa-2B (Ifn-&Agr;2B) for High-Risk Melanoma. a Retrospective Study of the Grupo Español Multidisciplinar De Melanoma (Gem)

• DOI: 10.1093/annonc/mdu344.39
• Publication Date: 2017-02-03T12:08:04Z
• Authors: S. Martin-Algarra; V. Soriano; J. Malvehy; A. Berrocal; M. Quindos; P. Martinez Del P...; A. Soria; I. Márquez-Rodas; I. Palacio; P. Cerezuela; L. Alonso; G. López-Vivanco; G. Nocea; K. Stevinson; P. Del Barrio; M.V. Tornamira; V. Guillem Porta; E. Espinosa
• Keywords: Breslow Thickness; Interferon alfa; Adjuvant Therapy

ABSTRACT Aim: To describe patterns of use of adjuvant Interferon alfa-2b (IFN-a2b): dose, schedule, duration, adherence to therapy as well as others factors, in an unselected cohort of patients with high-risk melanoma, treated in different hospitals of Spain between January 2000 and December 2009. Methods: A multi-institutional retrospective clinical trial, including a statistically predefined sample of 325 melanoma patients with stage IIB, IIC or III and treated with adjuvant IFN-a2b was considered feasible to fulfill the study objective. Eligibility criteria include: 1) Pathologically confirmed diagnosis of cutaneous melanoma in the established period; 2) Complete resection of disease; 3) Adjuvant therapy with at least one dose of IFN-a2b; 4) Complete treatment details and follow-up data available; 5) Written informed consent in all patients that were alive at the time of review. Results: From June 2013 to January 2014, a total of 347 patients were included. As of April 2014, data analysis has been performed for 126 patients. Preliminary results in this cohort are presented: Median age: 59 years, male/female: 58%/42%. Pathological stage (AJCC 2009): IIB 15%, IIC 7%, IIIA 30%, IIIB 33% and IIIC 15%. Breslow thickness: 4mm 39%. Ulceration: 51.4%. 90% of patients received high-dose IFN-a2b and 10% either low or intermediate doses. High-dose IFN-a2b induction phase was completed by 88% of patients, and 70% completed the maintenance phase, although dose delay and dose reduction due to toxicity were common in both periods. Sixty percent of patients have relapsed as per investigator's review. Final analysis including disease-free and overall survival will be completed in July 2014. Conclusions: Most patients included in this preliminary analysis receive both, high dose IFN-a2b induction and maintenance phases, although dose delay and dose reduction are common. The complete analysis of this study will provide relevant and detailed information about the feasibility of IFN-a2b adjuvant treatment programs used for high-risk melanoma in Spain. These results will be relevant for the design and interpretation of future trials of adjuvant therapy. Disclosure: S. Martin-Algarra: In the past 36 months I have participated in Advisory Boards of MSD, BMS, Roche, GSK and Novartis. In the past 36 months have given lectures in events organized/sponsorized by BMS, Roche and GSK; G. Nocea: Employee of Merck Sharp and Dohme Spain; K. Stevinson: Employee of Merck US; P. Del Barrio: Employee of Merck Sharp and Dohme Spain; M.V. Tornamira: Employee of Merck Sharp and Dohme Spain; E. Espinosa: I am participated in the Advisory Board of MSD (Merck Sharp and Dohme). All other authors have declared no conflicts of interest.