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Rectal Cancer treatment details. Biologic therapy. Chemotherapy. Ospedale San Martino, Genoa, Italy

Survival: 10.7 months
Toxicity Grade: 5
Treatments: Biologic therapy
Country: Italy
City/State/Province: Genoa
Hospital: Ospedale San Martino
Journal: Link
Date: 5/2008

Patients: This phase III study involved 1,298 patients with metastatic colorectal cancer. The median age was 62, ranging from 21 to 90 years of age. Almost 63% of these patients were men.

Treatment: Patients were treated with the chemotherapy drug irinotecan alone, or with irinotecan and the biological drug cetuximab.

Toxicity: Seven patients died from causes attributed to toxicity from the study drugs. Grade 3 or 4 neutropenia was reported in 31.8% of patients treated with cetuximab and irinotecan, and in 25.4% of those treated with only irinotecan. Other grade 3 or 4 toxicities were diarrha, acneforme rash, nausea, fatigue, vomiting, anorexia, abdominal pain, and asthenia. The most common of these was diarrhea, reported in 28.4% of patients treated with cetuximab and irinotecan and 15.7% of those treated with irinotecan only.

Results: The median overall survival of patients treated with cetuximab and irinotecan was 10.7 months, and 10 months in those treated with irinotecan alone.

Support: This study was supported by Merck, Bristol-Myers Squibb and ImClone Systems. Bristol-Myers and ImClone developed and cetuximab and market it as ERBITUX.

Correspondence: Dr. Alberto F. Sobrero

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