1123P - Treatment patterns of adjuvant interferon alfa-2b (IFN-α2b) for high-risk melanoma. A retrospective study of the Grupo Español Multidisciplinar de...

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Cancer Immunology and Immunotherapy
Melanoma and other Skin Tumours
Presenter Salvador Martin-Algarra
Citation Annals of Oncology (2014) 25 (suppl_4): iv374-iv393. 10.1093/annonc/mdu344
Authors S. Martin-Algarra1, V. Soriano2, J. Malvehy3, A. Berrocal4, M. Quindos5, P. Martinez Del Prado6, A. Soria7, I. Márquez-Rodas8, I. Palacio9, P. Cerezuela10, L. Alonso11, G. Lopez-Vivanco12, G. Nocea13, K. Stevinson14, P. Del Barrio15, M.V. Tornamira15, V. Guillem Porta16, E. Espinosa17
  • 1Oncology, Clinica Universidad de Navarra, 31008 - Pamplona/ES
  • 2Medical Oncology, Fundación IVO, Valencia/ES
  • 3Dermatology, Hospital Clinic Barcelona, 08036 - Barcelona/ES
  • 4Medical Oncology, Hospital General Universitario, Valencia/ES
  • 5Oncology, Hospital Teresa Herrera, A Coruña/ES
  • 6Medical Oncology, Universitary Hospital of Basurto, 48013 - Bilbao/ES
  • 7Medical Oncology, Hospital Universitario Ramon y Cajal, Madrid/ES
  • 8Medical Oncology, Instituto Investigación Sanitaria Hospital Gregorio Marañón, 28007 - Madrid/ES
  • 9Medical Oncology, Hospital Central de Asturias, Oviedo/ES
  • 10Medical Oncology, Hospital General Universitario Santa Lucía, Cartagena/ES
  • 11Medical Oncology, Hospital Clínico Victoria, Málaga/ES
  • 12Department Of Oncology, University Hospital Cruces, San Vicente de Barakaldo, Vizcaya/ES
  • 13Outcomes Research Department, MSD, 28027 - Madrid/ES
  • 14Global Health Outcomes Research, Merck, NJ/US
  • 15Medical Department, MSD, 28027 - Madrid/ES
  • 16Oncology, Fundación Instituto Valenciano de Oncología, Valencia/ES
  • 17Medical Oncology, Hospital Universitario La Paz, 28046 - Madrid/ES

Abstract

Aim

To describe patterns of use of adjuvant Interferon alfa-2b (IFN-α2b): 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-α2b 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-α2b; 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: <1mm 4%, 1-2mm 20%, 2-4mm 37% and >4mm 39%. Ulceration: 51.4%. 90% of patients received high-dose IFN-α2b and 10% either low or intermediate doses. High-dose IFN-α2b 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-α2b 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-α2b 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.