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Ipilimumab for advanced melanoma: experience from the Spanish Expanded Access Program

Berrocal, Alfonsoa; Arance, Anac; Lopez Martin, Jose Antonioe; Soriano, Virtudesb; Muñoz, Evad; Alonso, Lorenzoh; Espinosa, Enriquef; Lopez Criado, Pilarg; Valdivia, Javieri; Martin Algarra, Salvadorj; on behalf of the Spanish Melanoma Group

doi: 10.1097/CMR.0000000000000108
ORIGINAL ARTICLES: Clinical research
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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.

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

Correspondence to Alfonso Berrocal, MD, Servicio de Oncología Médica, Consorcio Hospital General Universitario, Avda. Tres Cruces S/N, 46014 Valencia, Spain Tel: +34 96 313 18 00×437642; fax: +34 96 197 21 23; e-mail:

Received February 12, 2014

Accepted June 6, 2014

© 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins