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Melanoma treatment details. Biologic therapy. Immunotherapy. Dana–Farber Cancer Institute, Boston, MA, United States



Survival: 10.0 months
   
Toxicity Grade: 5
   
Treatments: Biologic therapy
Immunotherapy
   
Drugs:
Country: United States
   
City/State/Province: Boston, MA
   
Hospital: Dana–Farber Cancer Institute
   
Journal: Link
   
Date: 8/2010

Description:
Patients:
This study involved metastatic melanoma patients that were positive for HLA-A*0201, which is a specific version of a gene involved in the immune response. Patients were divided into three treatment groups. Group A consisted of 403 patients with a median age of 55.6 years and 61.3% male. Group B had 137 patients with a median age of 56.8 years and 59.1% male. Group C consisted of 136 patients with a median age of 57.4 years and 53.7% were male.

Treatment:
Group A was treated with the biologic therapy ipilimumab (a monoclonal antibody that blocks a protein called CTLA-4 and helps the immune system target cancer cells) and the immunotherapy gp100 (a cancer vaccine that stimulates the immune system to target and kill cancer cells). Group B received ipilimumab alone. Group C received gp100 alone.

Toxicities:
The maximum level of toxicity reported in this study was grade 5 (treatment-related death), which included 2.1% of patients – although the specific treatment group(s) in which these deaths occurred was not given. Half of these deaths were due to unspecified immune-related adverse events. In fact, most adverse events in this study were immune-related, most commonly diarrhea. Grade 3-4 fatigue and anemia were also reported.

Results:
The median overall survival for groups A, B, and C were 10.0, 10.1, and 6.4 months, respectively.

Support:
This study was supported by Bristol-Myers Squibb and Medarex, makers of ipilimumab.

Correspondence: Dr. Stephen Hodi; email: stephen_hodi@dfci.harvard.edu

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