In a nutshell
This analysis evaluated the efficacy and safety of ipilimumab in treatment of patients with metastatic uveal melanoma.
Some background
Ocular melanoma or uveal melanoma is a cancer of the eye. Tumors arise from the pigment cells (melanocytes) that reside within the uvea giving color to the eye. Once metastasis (spread of the cancer from the eye to other organs) has occurred the prognosis is poor, and treatment options are limited. Ipilimumab (Yervoy) is a new treatment option for advanced uveal melanoma. T-cells (a type of white blood cell) help to fight cancer and disease by detecting unfamiliar or abnormal proteins on the surface of a cancer cell and respond by destroying the abnormal cell. Ipilimumab blocks a protein on T-cells that stops them from destroying cancer cells. The study assessed the safety and efficacy of this drug.
Methods & findings
The analysis involved 83 pre-treated patients who were subjected to doses of ipilimumab (3mg/kg). The main parameters of analysis were progression-free survival (the amount of time until the cancer worsens or progresses after treatment), immune-related response criteria (changes in tumor size), overall survival (the period from the first occurrence of metastasis to the time the patient dies) and adverse effects (undesirable effects of the drug).
Disease control was achieved in 34% of patients. 4 (5%) of patients had a partial response (over 50% reduction in tumor size), while 24 (29%) patients achieved stable disease (no change in tumor size).
The median overall survival for the patients was 6.0 months and median progression-free survival was 3.6 months. The patients had an estimated 1-year overall survival rate of 31% and progression-free survival rate of 11%. 42% of patients had adverse effects related to the drug. The most common adverse effects were related to the skin, but 6% of patients experienced drug-related adverse effects of liver toxicity or diarrhea.
The bottom line
Ipilimumab had manageable toxic effects and improved overall survival, demonstrating safety and efficacy.
The fine print
Some of the funding for the analysis was obtained from Bristol-Myers Squibb Company, the manufacturer of ipilimumab.
Published By :
Annals of oncology
Date :
Sep 25, 2013
