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Rectal Cancer treatment details. Biologic therapy. Chemotherapy. Fox Chase Cancer Center, Philadelphia, PA, United States

Survival: 12.9 months
Toxicity Grade: 5
Treatments: Biologic therapy
Drugs: Leucovorin
Country: United States
City/State/Province: Philadelphia, PA
Hospital: Fox Chase Cancer Center
Journal: Link
Date: 4/2007

Patients: This phase III study involved 829 patients with metastatic colorectal cancer. They had previously been treated with fluoropyrimidine and irinotecan. They ranged in age from 21 to 85 years old. About 40% were female. The patients were divided randomly into three different treatment groups, receiving chemotherapy with and without immunotherapy, or the immunotherapy alone.

Treatment: One group received FOLFOX4 (the drug combination oxaliplatin, fluorouracil, and leucovorin) and the monoclonal antibody bevacizumab, while the other two group of patients received either the FOLFOX4 combination alone or bevacizumab alone. These groups consisted of 286 patients (FOLOFOX4 and bevacizumab), 291 patients (FOLFOX4 only) and 243 patients (bevacizumab only).

Toxicity: Two patients died from bleeding in the central nervous system (hemorrhage). Both of these patients were receiving bevacizumab. Also, six patients suffered from a bowel perforation, and two died as a result. No bowel perforations were reported in patients receiving FOLFOX4 alone. Overall, patients receiving the combination of FOLFOX4 and bevacizumab had higher rates of grade 3 or 4 toxicities, including neuropathy, hypertension, bleeding and vomiting. Of the patients receiving FLOFOX4 and bevacizumab, 25.8% had a grade 4 toxic event and 5 deaths occurred. Grade 4 adverse events occurred in 24.9% of those receiving FOLFOX4 alone and in 8.1% of patients receiving bevacizumab alone. Four deaths and six deaths occurred in the FOLFOX4 only and bevacizumab only groups, respectively.

Results: The median overall survival for patients receiving FLOFOX4 and bevacizumab was 12.9 months. The median overall survival for patients receiving FOLFOX4 only was 10.8 months. Patients treated with bevacizumab only had a median overall survival of 10.2 months.

Support: Three authors received research funds from Genentech, Sanofi-Aventis Pfizer, or Genentech Pfizer, companies that produce and/or market FOLFOX4 and bevacizumab.

Correspondence: Bruce J. Giantonio, M.D.

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