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Colon Cancer treatment details. Biologic therapy. Chemotherapy. Royal Marsden Hospital, Surrey, United Kingdom

Survival: 15.2 months
Toxicity Grade: 4
Treatments: Biologic therapy
Drugs: Adrucil
Country: United Kingdom
City/State/Province: Surrey
Hospital: Royal Marsden Hospital
Journal: Link
Date: 11/2005

Patients: This Phase III study involved 630 patients with previously untreated metastatic colorectal cancer. The patients were randomized into two groups. Group B had 208 patients (149 men, 59 women) with a median age of 63 years. Of the 208 patients, 149 had colon cancer and 59 had rectal cancer.

Treatment: The treatment consisted of two chemotherapeutic agents: fluorouracil and leucovorin. In addition, Group A received a biological therapy agent 3H1, a monoclonal antibody against the carcinoembryonic antigen (CEA); Group B received a placebo.

Toxicity: For Group B, grade 3-4 toxicities included neutropenia, diarrhea, dehydration, and abdominal pain.

Results: The median overall survival was 14.7 months for Group A and 15.2 months for Group B. The authors observed that while,"3H1 is safe and effectively induces immune responses to CEA", the "addition of 3H1 to 5-FU and LV was not shown to improve overall patient outcomes."

Support: Several of the authors were employees of Titan Pharmaceuticals. Titan Pharmaceuticals develops and manufactures the 3H1 monoclonal antibody used in this study.

Correspondence: Dr. D. Cunningham

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