title: Ipilimumab in real-world clinical practice: efficacy and safety data from a multicenter observational study.
abstract: In patients with metastatic melanoma, ipilimumab has been shown to improve long-term survival. This observational multicenter study reports clinical outcomes of 418 patients treated with second-line ipilimumab from February 2013 to August 2014. Median overall survival (OS) was 6.43 months (95%CI: 5.45-7.42; n = 300), while median progression-free survival (PFS) was 3.7 months (95%CI: 3.23-4.17; n = 188). Demographic factors, such as sex or number of previous therapies did not affect OS. Survival was shorter in patients with ECOG > 0 (Eastern Cooperative Oncology Group, Performance Status) (p < 0.001), while a longer OS was found in patients who completed all four therapy cycles (p < 0.001). Adverse events of any grade were reported for 66% of patients (mainly cutaneous and gastrointestinal), but most were low grade and easily managed. Adverse events of grades 3-4 were observed in 13% of patients. This study confirmed the efficacy and safety of this treatment in real practice.
authors.affiliation: a Hospital Pharmacy , Veneto Institute of Oncology - IRCCS , Padua , Italy.
authors.forename: Alberto
authors.identifier: http://orcid.org/0000-0003-1962-908X
authors.initials: A
authors.lastname: Russi
authors.affiliation: b School of Hospital Pharmacy , University of Padua , Padua , Italy.
authors.forename: Vera
authors.identifier: http://orcid.org/0000-0002-3685-6789
authors.initials: V
authors.lastname: Damuzzo
authors.affiliation: c Italian Society for Clinical Pharmacy and Therapeutics , Milan , Italy.
authors.forename: Marco
authors.identifier: http://orcid.org/0000-0002-0943-6746
authors.initials: M
authors.lastname: Chiumente
authors.affiliation: d Melanoma and Esophageal Oncology Unit, Veneto Institute of Oncology IOV - IRCCS , Padua , Italy.
authors.forename: Jacopo
authors.initials: J
authors.lastname: Pigozzo
authors.affiliation: a Hospital Pharmacy , Veneto Institute of Oncology - IRCCS , Padua , Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Cesca
authors.affiliation: d Melanoma and Esophageal Oncology Unit, Veneto Institute of Oncology IOV - IRCCS , Padua , Italy.
authors.forename: Vanna
authors.identifier: http://orcid.org/0000-0001-9191-9124
authors.initials: V
authors.lastname: Chiarion-Sileni
authors.affiliation: a Hospital Pharmacy , Veneto Institute of Oncology - IRCCS , Padua , Italy.
authors.forename: Angelo Claudio
authors.initials: AC
authors.lastname: Palozzo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000074322:Antineoplastic Agents, Immunological / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000074324:Ipilimumab / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000188:drug therapy*; D008875:Middle Aged; D011379:Prognosis; D012189:Retrospective Studies; D012449:Safety; D012878:Skin Neoplasms / Q000188:drug therapy*; D015996:Survival Rate
chemical_list: D000074322:Antineoplastic Agents, Immunological; D000074324:Ipilimumab
keywords: Ipilimumab; Melanoma; Monoclonal antibodies; Oncology; Registries; Retrospective studies