title: Clinical experience with ipilimumab 10 mg/kg in patients with melanoma treated at Italian centres as part of a European expanded access programme.
abstract: BACKGROUND
  Patients with advanced melanoma are faced with a poor prognosis and, until recently, limited treatment options. Ipilimumab, a novel immunotherapy that blocks cytotoxic T-lymphocyte-associated antigen-4, was the first agent to improve survival of patients with advanced melanoma in a randomised, controlled phase 3 trial. We used data from an expanded access programme (EAP) at Italian centres to evaluate the clinical activity and safety profile of ipilimumab 10 mg/kg in patients with advanced melanoma in a setting more similar to that of daily practice.
  
  
  METHODS
  Data were collected from patients enrolled in an ipilimumab EAP across eight participating Italian centres. As per the EAP protocol, patients had life-threatening, unresectable stage III/IV melanoma, had failed or did not tolerate previous treatments and had no other therapeutic option available. Treatment comprised ipilimumab 10 mg/kg every 3 weeks for a total of four doses. If physicians believed patients would continue to derive benefit from ipilimumab treatment, maintenance therapy with ipilimumab 10 mg/kg was provided every 12 weeks. Tumour responses were assessed every 12 weeks using modified World Health Organization criteria and safety continuously monitored.
  
  
  RESULTS
  Seventy-four pretreated patients with advanced melanoma were treated with ipilimumab 10 mg/kg. Of these, 9 (13.0%) had an objective response, comprising 3 patients with a complete response and 6 with a partial response. Median overall survival was 7.0 months (95% confidence interval, 5.3-8.7) and 16.6% of patients were alive after 3 years. Forty-five patients (60.8%) reported treatment-related adverse events of any grade, which were most commonly low-grade pruritus, pain, fever and diarrhoea. Grade 3 or 4 treatment-related AEs were reported in 8 patients (10.8%).
  
  
  CONCLUSIONS
  The clinical activity and safety profile of ipilimumab 10 mg/kg in the EAP was similar to that seen in previous clinical trials of ipilimumab in pretreated patient populations.
authors.forename: Maresa
authors.initials: M
authors.lastname: Altomonte
authors.forename: Anna
authors.initials: A
authors.lastname: Di Giacomo
authors.forename: Paola
authors.initials: P
authors.lastname: Queirolo
authors.forename: Paolo
authors.initials: P
authors.lastname: Ascierto
authors.forename: Francesco
authors.initials: F
authors.lastname: Spagnolo
authors.forename: Emilio
authors.initials: E
authors.lastname: Bajetta
authors.forename: Luana
authors.initials: L
authors.lastname: Calabrò
authors.forename: Riccardo
authors.initials: R
authors.lastname: Danielli
authors.forename: Francesco
authors.initials: F
authors.lastname: de Rosa
authors.forename: Michela
authors.initials: M
authors.lastname: Maur
authors.forename: Vanna
authors.initials: V
authors.lastname: Chiarion-Sileni
authors.forename: Pier
authors.initials: P
authors.lastname: Ferrucci
authors.forename: Diana
authors.initials: D
authors.lastname: Giannarelli
authors.forename: Alessandro
authors.initials: A
authors.lastname: Testori
authors.forename: Ruggero
authors.initials: R
authors.lastname: Ridolfi
authors.forename: Michele
authors.initials: M
authors.lastname: Maio
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D057176:Compassionate Use Trials / Q000379:methods*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D000074324:Ipilimumab; D007558:Italy; D008297:Male; D008545:Melanoma / Q000188:drug therapy*; D008875:Middle Aged; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012878:Skin Neoplasms; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult; D000096142:Cutaneous Malignant Melanoma
chemical_list: D000911:Antibodies, Monoclonal; D000074324:Ipilimumab