title: Efficacy and safety of ipilimumab in patients with advanced melanoma and brain metastases.
abstract: Patients with melanoma brain metastases have a poor prognosis and historically have been excluded from clinical trials. The Expanded Access Program (EAP) provided an opportunity to evaluate the feasibility of ipilimumab (3 mg/kg every 3 weeks for four doses) in patients with stage 3 (unresectable) or 4 melanoma and asymptomatic brain metastases, who had failed or did not tolerate previous treatments and had no other therapeutic option available. Tumor assessments were conducted at baseline and week 12 using immune-related response criteria and patients were monitored for adverse events (AEs). Of 855 patients participating in the EAP in Italy, 146 had asymptomatic brain metastases. With a median follow-up of 4 months, the global disease control rate was 27%, including 4 patients with a complete response and 13 with a partial response. Median progression-free survival and overall survival were 2.8 and 4.3 months, respectively and approximately one-fifth of patients were alive 1 year after starting ipilimumab. In total, 29% of patients reported a treatment-related AE of any grade, which were grade 3/4 in 6% of patients. AEs were generally reversible with treatment as per protocol-specific guidelines. Ipilimumab shows durable benefits in some patients with advanced melanoma metastatic to the brain, with safety results consistent with those previously reported in clinical trials.
authors: Medical Oncology, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Largo Rosanna Benzi, 10, 16132, Genova, Italy, paola.queirolo@hsanmartino.it.
authors: Paola
authors: P
authors: Queirolo
authors: Francesco
authors: F
authors: Spagnolo
authors: Paolo Antonio
authors: PA
authors: Ascierto
authors: Ester
authors: E
authors: Simeone
authors: Paolo
authors: P
authors: Marchetti
authors: Alessandro
authors: A
authors: Scoppola
authors: Michele
authors: M
authors: Del Vecchio
authors: Lorenza
authors: L
authors: Di Guardo
authors: Michele
authors: M
authors: Maio
authors: Anna Maria
authors: AM
authors: Di Giacomo
authors: Andrea
authors: A
authors: Antonuzzo
authors: Francesco
authors: F
authors: Cognetti
authors: Virginia
authors: V
authors: Ferraresi
authors: Laura
authors: L
authors: Ridolfi
authors: Massimo
authors: M
authors: Guidoboni
authors: Michele
authors: M
authors: Guida
authors: Jacopo
authors: J
authors: Pigozzo
authors: Vanna
authors: V
authors: Chiarion Sileni
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D000074324:Ipilimumab; D053208:Kaplan-Meier Estimate; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology*; D008875:Middle Aged; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D007155:Immunologic Factors; D000074324:Ipilimumab