Ipilimumab in pretreated patients with metastatic uveal melanoma: safety and clinical efficacy View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2012-01

AUTHORS

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

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. More... »

PAGES

41-48

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00262-011-1089-0

DOI

http://dx.doi.org/10.1007/s00262-011-1089-0

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1046605974

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/21833591


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