Ipilimumab in pretreated patients with metastatic uveal melanoma: Safety and clinical efficacy

Riccardo Danielli, Ruggero Ridolfi, Vanna Chiarion-Sileni, Paola Queirolo, Alessandro Testori, Ruth Plummer, Monica Boitano, Luana Calabrò, Costanza De Rossi, Anna Maria Di Giacomo, Pier Francesco Ferrucci, Laura Ridolfi, Maresa Altomonte, Clelia Miracco, Angelo Balestrazzi, Michele Maio

Research output: Contribution to journalArticle

80 Citations (Scopus)

Abstract

Current systemic treatments for metastatic uveal melanoma (UM) have not improved overall survival (OS). The fully human anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) monoclonal antibody, ipilimumab, improved OS of patients with advanced cutaneous melanoma in a phase 3 trial; however, UM patients were excluded. The aim of this subanalysis, performed by the ipilimumab-ocular melanoma expanded access program (I-OMEAP) study group, was to assess the activity and safety of ipilimumab in patients with UM in a setting similar to daily clinical practice. Patients participating in a multicenter expanded access program (EAP) received induction treatment with ipilimumab 10 mg/kg. Maintenance doses were administered in patients who experienced clinical benefit or at physicians' discretion. Tumor assessment was evaluated per modified World Health Organization criteria at baseline, Week 12, Week 24, and Week 36. Adverse events (AEs) and immune-related AEs (irAEs) were collected according to Common Terminology Criteria for Adverse Events version 3.0. Thirteen pretreated patients with metastatic UM were treated at 6 European institutions. All patients received at least one dose of ipilimumab. Overall, no objective responses were observed; however, two patients had stable disease (SD), with a third patient achieving SD after initial progressive disease. Median OS as of July 1, 2011, was 36 weeks (range 2-172+ weeks). No grade 3/4 AEs of non-immune origin were reported. Three patients (23%) experienced grade 3 irAEs (1 thrombocytopenia, 1 diarrhea, and 1 alanine/aspartate aminotransferase elevation) that resolved with steroid therapy. The results indicate UM is a potential indication for ipilimumab treatment that should be further investigated in clinical trials.

Original languageEnglish
Pages (from-to)41-48
Number of pages8
JournalCancer Immunology, Immunotherapy
Volume61
Issue number1
DOIs
Publication statusPublished - Jan 2012

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Safety
Survival
Melanoma
Uveal melanoma
ipilimumab
CTLA-4 Antigen
Therapeutics
Aspartate Aminotransferases
Alanine Transaminase
Terminology
Diarrhea
Steroids
Monoclonal Antibodies
Clinical Trials
Physicians
Skin
Neoplasms

Keywords

  • Cytotoxic T-lymphocyte antigen-4
  • Immunotherapy
  • Ipilimumab
  • Melanoma
  • Uveal melanoma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Immunology
  • Immunology and Allergy

Cite this

Ipilimumab in pretreated patients with metastatic uveal melanoma : Safety and clinical efficacy. / Danielli, Riccardo; Ridolfi, Ruggero; Chiarion-Sileni, Vanna; Queirolo, Paola; Testori, Alessandro; Plummer, Ruth; Boitano, Monica; Calabrò, Luana; De Rossi, Costanza; Giacomo, Anna Maria Di; Ferrucci, Pier Francesco; Ridolfi, Laura; Altomonte, Maresa; Miracco, Clelia; Balestrazzi, Angelo; Maio, Michele.

In: Cancer Immunology, Immunotherapy, Vol. 61, No. 1, 01.2012, p. 41-48.

Research output: Contribution to journalArticle

Danielli, R, Ridolfi, R, Chiarion-Sileni, V, Queirolo, P, Testori, A, Plummer, R, Boitano, M, Calabrò, L, De Rossi, C, Giacomo, AMD, Ferrucci, PF, Ridolfi, L, Altomonte, M, Miracco, C, Balestrazzi, A & Maio, M 2012, 'Ipilimumab in pretreated patients with metastatic uveal melanoma: Safety and clinical efficacy', Cancer Immunology, Immunotherapy, vol. 61, no. 1, pp. 41-48. https://doi.org/10.1007/s00262-011-1089-0
Danielli, Riccardo ; Ridolfi, Ruggero ; Chiarion-Sileni, Vanna ; Queirolo, Paola ; Testori, Alessandro ; Plummer, Ruth ; Boitano, Monica ; Calabrò, Luana ; De Rossi, Costanza ; Giacomo, Anna Maria Di ; Ferrucci, Pier Francesco ; Ridolfi, Laura ; Altomonte, Maresa ; Miracco, Clelia ; Balestrazzi, Angelo ; Maio, Michele. / Ipilimumab in pretreated patients with metastatic uveal melanoma : Safety and clinical efficacy. In: Cancer Immunology, Immunotherapy. 2012 ; Vol. 61, No. 1. pp. 41-48.
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