Data Reinforce The Value Of UFT As An Important Treatment Option For Patients With Metastatic Colorectal Cancer

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology
Article Date: 27 Sep 2007 - 18:00 PDT

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Data presented at this year's European Congress of Clinical Oncology (ECCO) demonstrate that a novel combination regimen based on Merck Serono's oral 5-fluorouracil (5-FU) therapy UFT® (tegafur-uracil) plus leucovorin (LV) results in a high response rate in the first-line treatment of metastatic colorectal cancer (mCRC).

In the SCOUTa study, a phase I/II open-label trial in patients with mCRC (n=45), the feasibility of combining UFT plus LV with alternating irinotecan and oxaliplatin was investigated in 45 patients. 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 (HFS) of any grade, which is a significant side effect often associated with other FU-based chemotherapies.

In this advanced disease setting, the low incidence of significant side effects with UFT is beneficial, not only from a quality of life perspective, but also because the tolerability of the therapy allows patients whose disease progresses to receive second-line treatment.

Study author, Dr Hamid Y. Sheikh of the Christie Hospital in Manchester, UK, commented: "Our findings highlight the value of this regimen in the first-line management of patients with metastatic colorectal cancer. As an oral therapy, UFT provides a convenient alternative to intravenous 5-FU, as patients are able to take the medication at home, saving both their time and hospital resources. The regimen was well tolerated with no disabling side effects, such as hand-foot syndrome, and minimal neurotoxicity. In addition, as this is an advanced disease setting, it is valuable that patients were able to go on to receive second-line therapy."

UFT is an oral 5-FU therapy that is used in clinical practice in combination with LV for first-line treatment of patients with mCRC and is being investigated in other settings. Phase II data of the CETUFTIRIb trial presented at ASCO 2007,1 a congress held earlier this year, highlighted that a new regimen of UFT with LV, irinotecan and Erbitux® (cetuximab) in first-line mCRC was comparable in efficacy (47% overall response rate) with the results seen in the CRYSTALc trial, which investigated FOLFIRI (5-FU/LV and irinotecan) plus Erbitux (also a 47% overall response rate).2 In addition, there was no reported HFS in the CETUFTIRI trial using UFT.1

More than 370,000 people develop colorectal cancer in Europe each year, accounting for 13% of the total cancer burden and around 200,000 deaths.3 Approximately 25% of patients present with metastatic disease and their prognosis is poor;4 five-year survival rates for patients with mCRC are as low as 5%.5

a. SCOUT: Study of CPT-11 with Oxaliplatin combined with UFT plus leucovorin Therapy
b. CETUFTIRI: Combination of CETuximab, UFT, leucovorin and IRInotecan
c. CRYSTAL: Cetuximab combined with iRinotecan in first line therapY for metaSTatic colorectAL cancer

About UFT

UFT has marketing authorizations in more than 50 countries. In the majority of these countries, UFT is registered in combination with folinic acid (leucovorin, LV) as a first-line treatment for metastatic colorectal cancer (mCRC). In some countries, UFT is also approved as a treatment for other tumors. In Japan, for example, UFT is approved for the treatment of a variety of cancer types, including tumors of the colon/rectum, lung, breast, stomach, head and neck, liver, gallbladder, bile duct, pancreas, bladder, prostate, and cervix. Since 1984, more than 30 million cancer patients have been treated with UFT.6

References

1. Bennouna J, et al. J Clin Oncol 2007;25: Abstract 4087.
2. Douillard J-Y, et al. Lancet 2000; 355: 1041-7
3. Parkin DM, et al. CA Cancer J Clin 2005; 55: 72-108.
4. GLOBOCAN. http://www-dep.iarc.fr/.
5. Argiris A, et al. Cancer 2004; 101: 2222-2229.
6. Hospital Pharmacy Europe, March/April 2006

About 'Merck Serono'

Merck Serono, the new division for innovative small molecules and biopharmaceuticals of Merck was established following the acquisition of Serono and the integration of its business with the former Merck Ethicals Division. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, produces and commercializes innovative products to help patients with diseases with unmet needs. Our North American business operates in the United States and Canada under EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), metabolic and cardiometabolic disorders (Glucophage®, Concor®, Saizen®, Serostim®), as well as psoriasis (Raptiva®). With an annual R&D investment of €1bn, we are committed to growing our business in specialist-focused therapeutic areas, such as Neurology and Oncology, as well as new therapeutic areas potentially arising out of our research and development in autoimmune and inflammatory diseases.

For more information, please visit http://www.merckserono.net or http://www.merck.de

About Merck KGaA

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Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 35,214 employees in 63 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

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