Clinical experience with ipilimumab 10 mg/kg in patients with melanoma treated at Italian centres as part of a European expanded ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2013-12

AUTHORS

Maresa Altomonte, Anna Maria Di Giacomo, Paola Queirolo, Paolo Antonio Ascierto, Francesco Spagnolo, Emilio Bajetta, Luana Calabrò, Riccardo Danielli, Francesco de Rosa, Michela Maur, Vanna Chiarion-Sileni, Pier Francesco Ferrucci, Diana Giannarelli, Alessandro Testori, Ruggero Ridolfi, Michele Maio

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. More... »

PAGES

82

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/1756-9966-32-82

DOI

http://dx.doi.org/10.1186/1756-9966-32-82

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1006895592

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/24423086


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