title: Efficacy and safety of ipilimumab therapy in patients with metastatic melanoma: a retrospective multicenter analysis.
abstract: OBJECTIVE
  The Patient Assistance Program, a type of expanded access program, was initiated for compassionate purposes to provide ipilimumab to patients with unresectable stage III or IV melanoma with failed previous treatment. The aim of this analysis is to evaluate efficacy, safety, and tolerability of ipilimumab therapy in daily clinical practice.
  
  
  METHODS
  We analyzed 50 patients (29 males, 21 females) aged 21 to 76 years (median: 49 years). An ipilimumab dose of 3 mg/kg was administered intravenously every 3 weeks for a total of 4 doses. Patients were assessed for response rate, progression-free survival and overall survival, and monitored for adverse events.
  
  
  RESULTS
  The objective response (complete or partial response) rate was 12%. Median overall survival was 8 months and median progression-free survival was 3 months. In patients with ECOG-PS 0, the median overall survival was 16 months. Immune-related adverse events (irAEs) occurred in 48% of the patients, grade 3 or 4 irAEs were reported in 8% of the patients, and there were no toxic deaths.
  
  
  CONCLUSIONS
  Ipilimumab demonstrated clinical benefit in previously treated advanced melanoma patients. Although clinical benefit is limited to a minority of the patients, there is a benefit in terms of overall survival in this group of patients.
authors.affiliation: Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Wiater
authors.affiliation: Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Switaj
authors.affiliation: Chair of Medical Biotechnology, University of Medical Sciences, Poznan, Poland ; Department of Diagnostics and Cancer Immunology, Greater Poland Cancer Centre, Poznan, Poland ; Medical Oncology Department, Malgorzata Medical Center, Śrem, Poland.
authors.forename: Jacek
authors.initials: J
authors.lastname: Mackiewicz
authors.affiliation: Department of Chemotherapy, Regional Cancer Center, Lodz, Poland.
authors.forename: Ewa
authors.initials: E
authors.lastname: Kalinka-Warzocha
authors.affiliation: Department of Oncology, Medical University, Comprehensive Cancer Center, Bialystok, Poland.
authors.forename: Marek
authors.initials: M
authors.lastname: Wojtukiewicz
authors.affiliation: Department of Oncology, Medical University, Comprehensive Cancer Center, Bialystok, Poland.
authors.forename: Paweł
authors.initials: P
authors.lastname: Szambora
authors.affiliation: Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.
authors.forename: Sławomir
authors.initials: S
authors.lastname: Falkowski
authors.affiliation: Department of Chemotherapy, Warmia and Mazury Oncological Center, Olsztyn, Poland.
authors.forename: Wojciech
authors.initials: W
authors.lastname: Rogowski
authors.affiliation: Chair of Medical Biotechnology, University of Medical Sciences, Poznan, Poland ; Department of Diagnostics and Cancer Immunology, Greater Poland Cancer Centre, Poznan, Poland.
authors.forename: Andrzej
authors.initials: A
authors.lastname: Mackiewicz
authors.affiliation: Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Rutkowski
keywords: CTLA-4; immunotherapy; ipilimumab; melanoma; outcome