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Rectal Cancer treatment details. Chemotherapy. University of Pisa, Livorno, Italy

Survival: 22.6 months
Toxicity Grade: 4
Treatments: Chemotherapy
Drugs: Leucovorin
Country: Italy
City/State/Province: Livorno
Hospital: University of Pisa
Journal: Link
Date: 5/2007

Patients: This phase III trial involved 244 patients with unresectable metastatic colorectal cancer. They were divided into two groups of 122. In arm 1, 57% were men and 43 were women. Similarly, in arm 2, 61% were men and 39% were women. The ages ranged from 21-75 years.

Treatment: Patients in one group received the chemotherapy drugs fluorouracil, leucovorin, oxaliplatin, and irinotecan (the FOLFOXIRI group) and the other group received the same drugs except no oxaliplatin (the FOLFIRI group).

Toxicity: Grade 4 toxicities were neutropenia, including neutropenia with fever, stomatitis, diarrhea, and vomiting. Grade 3 neurotoxicity, diarrhea, vomiting, astenia, thrombocytopenia and anemia also occurred. Neurotoxicity and neutropenia were more common in the group that received the FOLFOXIRI treatment regimen. Two patients died during the study because of rapidly progressive disease, not toxicity of the drugs.

Results: The median overall survival was 22.6 months in the FOLFOXIRI group and 16.7 months in the FOLFIRI group.

Support: One author acted as a consultant and received an honoraria from Roche, Sanofi-aventis, Pfizer, Baxter. Oxaliplatin is marketed by Sanofi-Aventis as ELOXATIN

Correspondence: Alfredo Falcone, M.D.

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