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Merck at ASCO 2007: New Data Demonstrate the Value of UFT as an,Important Treatment Option for Patients With Metastatic Colorectal,Cancer

CHICAGO/DARMSTADT, Germany, June 4, 2007 – Data presented today at this year’s American Society of Clinical Oncology (ASCO) meeting in Chicago show that a novel combination regimen based on Merck KGaA’s oral 5-fluorouracil (5-FU) therapy UFT (tegafur–uracil) plus leucovorin (LV) has shown an excellent response rate in the first-line treatment of metastatic colorectal cancer (mCRC).

In the SCOUT study (Study of CPT-11 with Oxaliplatin combined with UFT plus leucovorin Therapy), the feasibility of UFT plus LV with alternating irinotecan and oxaliplatin was investigated in a phase I/II open-label trial in patients with mCRC (n=45). The objective response rate was 66% and, at a median follow-up of 14.9 months, the median time to progression was 8.7 months and the overall survival was 16.8 months Neurotoxicity and alopecia were minimal and there were no cases of hand–foot syndrome reported in this study.

Study author, Dr. Hamid Y. Sheikh of the Christie Hospital in Manchester, UK, commented: “Our findings point to the potential of this regimen in the first-line management of patients with metastatic colorectal cancer. In our opinion, UFT is an effective alternative to 5-FU in this disease.”

In a second study presented at ASCO, the first-line combination of UFT with LV plus irinotecan and Merck KGaA’s targeted monoclonal antibody therapy cetuximab (Erbitux®) was investigated in 61 patients with metastatic colorectal cancer (mCRC). The overall response rate was 47% in 53 evaluable patients, which was considered “attractive” by the authors alongside its acceptable safety profile. It is comparable with the response rate achieved with Erbitux combined with the intravenous 5-FU-based FOLFIRI regimen.(1) This combination regimen, termed CETUFTIRI, represents the first teaming of UFT and Erbitux (cetuximab) and is expected to be studied mor
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