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Melanoma treatment details. Alternative. Biologic therapy. Moffitt Cancer Center, Tampa, FL, United States



Survival: 17.7 months
   
Toxicity Grade: 4
   
Treatments: Alternative
Biologic therapy
   
Drugs:
Country: United States
   
City/State/Province: Tampa, FL
   
Hospital: Moffitt Cancer Center
   
Journal: Link
   
Date: 9/2009

Description:
Patients:
This phase 2 study involved patients with advanced melanoma. Patients were divided into two separate treatments groups. Group A consisted of 58 patients with a median age of 58 years, 74% being male. Group B involved 57 patients with a median age of 61 years and 67% male.

Treatment:
Patients in group A were given the biologic therapy ipilimumab and the prophylactic corticosteroid budesonide to prevent diarrhea associated with ipilimumab treatment. Ipilimumab is a monoclonal antibody that targets a protein called CTLA-4 to enhance the immune response against cancer cells.

Patients in group B were given ipilimumab and a placebo (no prophylactic).

Toxicities:
The highest toxicity level reported for both groups was grade 4, consisting of gastrointestinal and liver toxicities. Specific symptoms were not given. Most adverse events were immune-related events. Immune reactions in the skin of any grade were reported by 60% of patients in group A and 68% of group B.

Results:
The median overall survival in group A was 17.7 months. For group B, the medial overall survival was 19.3 months.

Support:
Some of the authors of this study were employed by, or received funding from Bristol-Myers Sqibb, makers of ipilimumab.

Correspondence: Dr. Jeffrey Weber; email: Jeffrey.Weber@moffitt.org

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