title: Treatment patterns of adjuvant interferon-α2b for high-risk melanoma: a retrospective study of the Grupo Español Multidisciplinar de Melanoma - Prima study.
abstract: Adjuvant interferon-α2b (IFN-α2b) has been studied extensively in clinical trials, but there have been few studies of real-world use. The aim of this study is to describe the IFN-α2b real-world patterns in patients with high-risk melanoma in Spain. This was a retrospective and multicentre chart review study of an unselected cohort of patients with melanoma at high risk for relapse (stage IIB/IIC/III) treated with IFN-α2b. Patterns were assessed in terms of dose and compliance to planned treatment. A survival analysis was carried out for the full population and according to Kirkwood scheme compliance and the presence of ulceration. Of 327 patients treated with IFN-α2b, 318 received a high-dose regimen following the standard Kirkwood scheme; thus, patterns are described for this regimen. A total of 121 (38%) and 88 (28%) patients had at least one dose reduction during the induction and maintenance phases, respectively. Dose delay was required in fewer than 10% of patients. A total of 78, 40 and 38% of the patients completed the induction phase, maintenance phase and completed treatment, respectively. The median progression-free and overall survival for the full population were 3.2 and 10.5 years, respectively. There were no differences in progression-free survival and overall survival according to Kirkwood scheme compliance and the presence of ulceration. The most frequent adverse events were neutropenia (31%) and fatigue (30%). High-dose IFN-α2b is the most frequently used regimen in Spain as an adjuvant systemic treatment for high-risk melanoma. Despite poor compliance, in this retrospective study, IFN-α2b treatment provided a benefit consistent with that described previously.
authors.affiliation: aMedical Oncology Service, Hospital Universitario La Paz bMedical Oncology Service, Hospital Ramón y Cajal cMedical Oncology Service, Instituto de Investigación Sanitaria Gregorio Marañon dMedical Oncology Service, Hospital La Princesa eMedical Affairs, Merck Sharp & Dohme, Madrid fMedical Oncology Service, Instituto Valenciano de Oncología gMedical Oncology Service, Hospital General Universitario de Valencia hMedical Oncology Service, Hospital La Fe, Valencia iMedical Oncology Service, Hospital Clinic de Barcelona, Barcelona jMedical Oncology Service, Hospital de Basurto, Bilbao kMedical Oncology Service, Hospital Teresa Herrera, La Coruña lMedical Oncology Service, Hospital Central de Asturias, Oviedo mMedical Oncology Service, Hospital General Universitario Santa Lucía, Cartagena nMedical Oncology Service, Hospital de Cruces, San Vicente de Baracaldo oMedical Oncology Service, Hospital Universitario Virgen de la Victoria, Málaga pDermatology Service, Complejo Asistencial Universitario de León, León qMedical Oncology Service, Hospital Miguel Servet, Zaragoza rMedical Oncology Service, Hospital Virgen de la Macarena, Sevilla sMedical Oncology Service, Hospital Clínico Universitario de Valladolid, Valladolid tMedical Oncology Service, Hospital Clínico Universitario de Santiago, Santiago de Compostela uMedical Oncology Service, Clínica Universitaria de Navarra, Pamplona, Spain vGlobal Health Outcomes Research, Merck Sharp & Dohme, Kenilworth, New Jersey, USA.
authors.forename: Enrique
authors.initials: E
authors.lastname: Espinosa
authors.forename: Virtudes
authors.initials: V
authors.lastname: Soriano
authors.forename: Josep
authors.initials: J
authors.lastname: Malvehy
authors.forename: Alfonso
authors.initials: A
authors.lastname: Berrocal
authors.forename: Purificación
authors.initials: P
authors.lastname: Martínez de Prado
authors.forename: María
authors.initials: M
authors.lastname: Quindós
authors.forename: Ainara
authors.initials: A
authors.lastname: Soria
authors.forename: Iván
authors.initials: I
authors.lastname: Márquez-Rodas
authors.forename: Isabel
authors.initials: I
authors.lastname: Palacio
authors.forename: Pablo
authors.initials: P
authors.lastname: Cerezuela
authors.forename: Guillermo
authors.initials: G
authors.lastname: López-Vivanco
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Alonso
authors.forename: Elia
authors.initials: E
authors.lastname: Samaniego
authors.forename: Ana
authors.initials: A
authors.lastname: Ballesteros
authors.forename: Teresa
authors.initials: T
authors.lastname: Puértolas
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Díaz-Beveridge
authors.forename: Luis
authors.initials: L
authors.lastname: de la Cruz-Merino
authors.forename: Rafael
authors.initials: R
authors.lastname: López Castro
authors.forename: Rafael
authors.initials: R
authors.lastname: López López
authors.forename: Kendall
authors.initials: K
authors.lastname: Stevinson
authors.forename: Patricia
authors.initials: P
authors.lastname: Del Barrio
authors.forename: Maria V
authors.initials: MV
authors.lastname: Tornamira
authors.forename: Vicente
authors.initials: V
authors.lastname: Guillém
authors.forename: Salvador
authors.initials: S
authors.lastname: Martín-Algarra
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017024:Chemotherapy, Adjuvant; D015331:Cohort Studies; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D008875:Middle Aged; D012189:Retrospective Studies; D016019:Survival Analysis; D055815:Young Adult
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; C000614170:Interferon-alpha2b