title: Ipilimumab for advanced melanoma: experience from the Spanish Expanded Access Program.
abstract: Ipilimumab, a fully human, recombinant, monoclonal antibody to cytotoxic T-lymphocyte antigen 4 improves overall survival (OS) in previously treated and untreated metastatic melanoma. This retrospective analysis reports data gathered by a questionnaire on the demographics, outcomes, and toxicity of ipilimumab administered through an Expanded Access Program (EAP). Ipilimumab 3 mg/kg was administered intravenously every 3 weeks for four cycles to adults with metastatic melanoma. Efficacy outcomes included complete response, partial response (PR), progressive disease, stabilized disease, and OS. EAP data were collected from EAP physicians. A subgroup analysis examined efficacy in elderly patients (≥70 years) and factors predictive of survival were identified. Of 355 requests for ipilimumab, resulting in 288 treatments, completed questionnaires were received for 153 ipilimumab recipients (median age 58 years, 57.2% men). Efficacy was evaluated in 144 patients: complete response in 1.3%, PR in 9.6%, PR with previous progression 8.4%, stabilized disease in 14.5%, and progressive disease in 66.2%. The median OS was 6.5 months (199 days); 1-year survival was 32.9%. Predictive survival factors included lymphocytes over 1000/ml (P=0.0008) and lactate dehydrogenase more than 1.5×upper limit of normal (P=0.003). Cutaneous, hepatic, and gastrointestinal toxicities were mild. In 30 patients aged more than 70 years, ipilimumab efficacy and tolerability was similar to that of the overall population. In the clinical practice setting, ipilimumab is effective and well tolerated in patients with advanced melanoma, including elderly patients, when administered at the recommended dosage. Ipilimumab improves treatment options for patients who, until recently, have had little hope of an improved prognosis.
authors.affiliation: aMedical Oncology, Hospital General Valencia bMedical Oncology, Instituto Valenciano de Oncologia, Valencia cMedical Oncology, Hospital Clinic i Provincial dMedical Oncology, Hospital Vall d´Hebron, Barcelona eMedical Oncology, Hospital 12 de Octubre fMedical Oncology, Hospital La Paz gMedical Oncology, Hospital MD Anderson Cancer Center, Madrid hMedical Oncology, Hospital ClinicoVirgen de la Victoria, Malaga iMedical Oncology, Hospital Virgen de las Nieves, Granada jMedical Oncology, Clinica Universitaria de Navarra, Pamplona, Spain.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Berrocal
authors.forename: Ana
authors.initials: A
authors.lastname: Arance
authors.forename: Jose Antonio
authors.initials: JA
authors.lastname: Lopez Martin
authors.forename: Virtudes
authors.initials: V
authors.lastname: Soriano
authors.forename: Eva
authors.initials: E
authors.lastname: Muñoz
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Alonso
authors.forename: Enrique
authors.initials: E
authors.lastname: Espinosa
authors.forename: Pilar
authors.initials: P
authors.lastname: Lopez Criado
authors.forename: Javier
authors.initials: J
authors.lastname: Valdivia
authors.forename: Salvador
authors.initials: S
authors.lastname: Martin Algarra
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D057176:Compassionate Use Trials; D018450:Disease Progression; D005260:Female; D006297:Health Services Accessibility; D006801:Humans; D000074324:Ipilimumab; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D008875:Middle Aged; D012189:Retrospective Studies; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D013030:Spain / Q000453:epidemiology; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D000074324:Ipilimumab