title: Ipilimumab retreatment in patients with pretreated advanced melanoma: the expanded access programme in Italy.
abstract: BACKGROUND
  Retreatment with ipilimumab has been shown to re-establish disease control in some patients with disease progression. Here, we report the efficacy and safety of retreatment with ipilimumab 3 mg kg(-1) among patients participating in an expanded access programme in Italy.
  
  
  METHODS
  Patients who achieved disease control during induction therapy were retreated with ipilimumab upon progression (3 mg kg(-1) every 3 weeks for up to four doses), providing they had not experienced toxicity that precluded further dosing. Tumour assessments were conducted after retreatment, and patients were monitored throughout for adverse events.
  
  
  RESULTS
  Of 855 patients treated with ipilimumab, 51 were retreated upon disease progression. Of these, 28 (55%) regained disease control upon retreatment and 42% were alive 2 years after the first induction dose of ipilimumab; median overall survival was 21 months. Eleven patients (22%) had a treatment-related adverse event of any grade during retreatment. These were generally mild-to-moderate and resolved within a median of 4 days. No new types of toxicity were reported.
  
  
  CONCLUSIONS
  For patients who meet predefined criteria, retreatment with ipilimumab is generally well tolerated and can translate into clinical benefit. This strategy should be compared with other therapeutic options in randomised controlled trials.
authors.affiliation: Melanoma Cancer Unit, Veneto Institute of Oncology IOV-IRCCS, Via Gattamelata, 64, 35128 Padua, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Chiarion-Sileni
authors.affiliation: Melanoma Cancer Unit, Veneto Institute of Oncology IOV-IRCCS, Via Gattamelata, 64, 35128 Padua, Italy.
authors.forename: J
authors.initials: J
authors.lastname: Pigozzo
authors.affiliation: Melanoma, Cancer Immunotherapy and Innovative Therapy Unit, Istituto Nazionale Tumori Fondazione 'G Pascale', Via Cappella dei Cangiani, 1, 80131 Naples, Italy.
authors.forename: P A
authors.initials: PA
authors.lastname: Ascierto
authors.affiliation: Melanoma, Cancer Immunotherapy and Innovative Therapy Unit, Istituto Nazionale Tumori Fondazione 'G Pascale', Via Cappella dei Cangiani, 1, 80131 Naples, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Simeone
authors.affiliation: Medical Oncology and Immunotherapy Unit, University Hospital of Siena, Istituto Toscano Tumori, Strada delle Scotte, 14, 53100 Siena, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Maio
authors.affiliation: Medical Oncology and Immunotherapy Unit, University Hospital of Siena, Istituto Toscano Tumori, Strada delle Scotte, 14, 53100 Siena, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Calabrò
authors.affiliation: 1] Medical Oncology, Dermopathic Institute of the Immaculate IDI-IRCCS, Via dei Monti di Creta, 104, 00167 Rome, Italy [2] Medical Oncology, Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa, 1035-39, 00189 Rome, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Marchetti
authors.affiliation: Medical Oncology, Dermopathic Institute of the Immaculate IDI-IRCCS, Via dei Monti di Creta, 104, 00167 Rome, Italy.
authors.forename: F
authors.initials: F
authors.lastname: De Galitiis
authors.affiliation: Divisione Melanoma, Istituto Europeo di Oncologia, Via Ripamonti, 435, 20141 Milan, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Testori
authors.affiliation: Oncology of Melanoma Unit, Istituto Europeo di Oncologia, Via Ripamonti, 435, 20141 Milan, Italy.
authors.forename: P F
authors.initials: PF
authors.lastname: Ferrucci
authors.affiliation: Department of Medical Oncology A, San Martino Hospital, National Institute for Cancer Research, L.go R. Benzi, 10, 16132 Genoa, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Queirolo
authors.affiliation: Department of Medical Oncology A, San Martino Hospital, National Institute for Cancer Research, L.go R. Benzi, 10, 16132 Genoa, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Spagnolo
authors.affiliation: Dermatologic Clinic, Department of Medical Sciences, University of Torino, San Giovanni Battista di Torino, Via Cherasco, 23, 10126 Turin, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Quaglino
authors.affiliation: Division of Medical Oncology, Institute for Cancer Research and Treatment, IRCC, Piedmont Oncology Foundation, Strada Provinciale, 142, 10060 Candiolo, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Carnevale Schianca
authors.affiliation: Unit of Medical Oncology, Papa Giovanni XXIII Hospital, Piazza OMS-Organizzazione Mondiale della Sanità, 1, 24127 Bergamo, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Mandalà
authors.affiliation: Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian, 1, 20133 Milan, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Di Guardo
authors.affiliation: Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian, 1, 20133 Milan, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Del Vecchio
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006284:Health Plan Implementation; D006297:Health Services Accessibility; D006801:Humans; D007167:Immunotherapy / Q000379:methods; D000074324:Ipilimumab; D007558:Italy; D008297:Male; D008545:Melanoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008875:Middle Aged; D016730:Program Development; D012074:Remission Induction; D019233:Retreatment; D012878:Skin Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016019:Survival Analysis; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D000074324:Ipilimumab