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Title: Addition of Oxaliplatin to FOLFIRI Regimen Increases Survival of Patients With Metastatic Colon Cancer: Presented at ASCO-GI

"Addition of Oxaliplatin to FOLFIRI Regimen Increases Survival of Patients With Metastatic Colon Cancer: Presented at ASCO-GI"

By Ed Susman SAN FRANCISCO, CA -- January 30, 2006 -- Researchers said that the addition of the third cytotoxic anticancer drug oxaliplatin to a standard regimen can extend survival in patients with metastatic colon cancer by 6 months -- to 22.6 months after diagnosis. Doctors in the Gruppo Oncologico Nord Ovest in Italy said that by adding oxaliplatin to FOLFIRI (5-fluorouracil and leucovorin with irinotecan) -- creating the combination called FOLFOXIRI -- the gain in survival could be achieved with manageable increases in toxicities. "Overall survival improved with FOLFOXIRI with a relative reduction in the risk of death of 30% and absolute improvement in median survival of 5.9 months," said Alfredo Falcone, MD, professor of medical oncology, University of Pisa, Pisa, Italy, at the 42[^nd Annual Meeting of the American Society of Clinical Oncology - Gastrointestinal Cancer Symposium (ASCO-GI).

In the trial, the researchers randomly assigned 122 patients to receive FOLFIRI. This regimen includes irinotecan 180 mg/m² in a 1-hour infusion on the first day of a cycle; leucovorin 100 mg/m² in a 2-hour infusion on days 1 and 2 of the cycle; 5-FU 400 mg/m² in a bolus on days 1 and 2; 5-FU 600 mg/m² in a 22-hour infusion on days 1 and 2. The treatment was repeated every 2 weeks and patients received 12 cycles of treatment.

A second group of 122 patients were randomly assigned to receive FOLFOXIRI. This regimen included irinotecan 165 mg/m² on day 1; oxaliplatin 85 mg/m² on day 1; leucovorin 200 mg/m² on day 1; 5-FU 3200 mg/m² by continuous infusion over 48 hours. Each cycle was repeated every 2 week for 12 cycles.

The researchers defined partial responses as at least a 50% reduction in tumor size.

About 6% of FOLFIRI patients and 8% of FOLFOXIRI patients experienced complete responses; 35% of the FOLFIRI patients and 58% of the FOLFOXIRI patients achieved partial responses.

The response rate was 66% in the FOLFOXIRI arm and 41% in the FOLFIRI arm, a difference that reached statistically significance at the P = .0002 level, Dr. Falcone said.

Disease-free progression average 9.8 months for patients getting oxaliplatin compared with 6.9 months for patients who did not receive this drug. That difference reached statistical significance at the P = .0006 level, Dr. Falcone said.

Overall survival at 30 months was 34% in the FOLFOXIRI arm and 21% in the FOLFIRI arm, and the median overall survival rates were 22.6 months and 16.7 months, respectively. Those differences also reached statistical significance at the P = .032 level.

The study protocol allowed patients who progressed on the FOLFIRI regimen to switch to a FOLFOX regimen.

Dr. Falcone noted that since the study was initiated in November 2001, doctors have begun using the targeted agent bevacizumab in treatment protocols. "I think it would be feasible to add bevacizumab to FOLFOXIRI without a major increase in side effects," he said at a press briefing January 28^th, where he discussed his study.

The symposium is cosponsored by the American Society of Clinical Oncology, the American Gastrointestinal Association, the Society of Surgical Oncology, and the American Society for Therapeutic Radiology and Oncology.

[Presentation title: Biweekly Irinotecan, Oxaliplatin and Infusional 5FU/LV (FOLFOXIRI) Versus FOLFIRI as First-Line Treatment of Metastatic Colorectal Cancer: Results of a Randomized, Phase III Trial by Gruppo Oncologico Nord Ovest. Abstract 227]

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