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Ann Oncol. 2013 Nov;24(11):2911-5. doi: 10.1093/annonc/mdt376. Epub 2013 Sep 25.

Efficacy and safety of ipilimumab in patients with pre-treated, uveal melanoma.

Author information

1
Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena, Tuscan Cancer Institute, Siena.

Abstract

BACKGROUND:

Patients with advanced uveal melanoma have a poor prognosis and limited treatment options. Ipilimumab is approved for pre-treated adult patients with advanced melanoma. However, because previous clinical trials with ipilimumab have excluded patients with uveal melanoma, data in this patient population are limited.

PATIENTS AND METHODS:

Pre-treated patients with advanced uveal melanoma received ipilimumab 3 mg/kg through an expanded access programme, every 3 weeks for four doses. Tumour assessments were conducted at baseline and after completion of treatment and patients were monitored throughout for adverse events.

RESULTS:

Among 82 assessable patients, 4 (5%) had an immune-related objective response and 24 (29%) had immune-related stable disease lasting ≥3 months for an immune-related disease control rate of 34%. With a median follow-up of 5.6 months, median overall survival (OS) was 6.0 months and median progression-free survival (PFS) was 3.6 months. The 1-year rates of OS and PFS were 31% and 11%, respectively. The safety profile of ipilimumab was similar to that in patients with cutaneous melanoma.

CONCLUSIONS:

These data suggest ipilimumab 3 mg/kg is a feasible option in pre-treated patients with metastatic uveal melanoma. Evidence of disease control and a 1-year survival rate of 31% indicate the need for further investigation in randomised, controlled trials to determine the optimal timing and use of ipilimumab in this patient population.

KEYWORDS:

efficacy; expanded access programme; ipilimumab; metastatic melanoma; safety; uveal melanoma

PMID:
24067719
DOI:
10.1093/annonc/mdt376
[Indexed for MEDLINE]

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