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Xeloda (Capecitabine) Appears To Reduce Risk Of Colon Cancer Recurrence, Lessen Side Effects At Lower Cost Than Current Standard Treatment: Presented at ESMO

VIENNA, AUSTRIA -- November 15, 2004 -- New data has shown Xeloda (capecitabine), a targeted oral chemotherapy, improves disease outcomes and saves money when used as post surgery (adjuvant therapy) colon cancer treatment. This analysis shows that not only does Xeloda reduce the risk of the cancer coming back by an impressive 14% but it also cuts the cost burden to healthcare systems of post surgery colon cancer treatment compared to the current standard therapy, the Mayo Clinic regimen (intravenous 5-FULV).

The new pharmacoeconomic analysis of the overall cost of treatment with oral Xeloda compared to intravenous 5-FU/LV (i.v. 5-FU/LV) was presented at the 29th European Society for Medical Oncology meeting in Vienna. The results of the study showed that staggeringly, for every 100 patients treated with Xeloda, a doctor could save approximately one year (400 days) in consultation time compared to i.v. 5-FU/LV. The consultation time was shown to decrease as oral Xeloda patients spend 85% less time visiting the doctor's office or hospital for treatment. In addition, previous studies have shown that patients prefer oral treatment options as they feel hospital-administered chemotherapy restricts their daily lives and prevents them from carrying on as normally as possible.

"It has already been shown that Xeloda is more effective and is more tolerable compared to the Mayo Clinic Regimen." Professor Jean-Yves Douillard, Head of the Department of Medical Oncology at the Gauducheau Centre in St-Herblain, France and primary author of the pharmacoeconomic data, said, "Now we know it can significantly decrease the cost imposed on healthcare systems, whilst saving enough consultation time to allow more time for other patients. This clearly marks Xeloda as a dominant treatment option in adjuvant colon cancer therapy * a dominant treatment being one that both improves outcomes and saves money."

Xeloda, called the 'smart pill' by the media, creates less of the side-effects usually associated with chemotherapy due to its targeted approach. Additionally, side-effects can easily be managed by altering the dose, without compromising efficacy,. The analysis showed that costs for medicines to treat these illnesses, such as nausea, and diarrhoea, were cut by nearly 75% compared to i.v. 5-FU/LV. Based on its survival rates, side-effect profile and newly announced economic benefits, Xeloda has been referred to as a 'dominant' treatment option for post surgery colon cancer treatment, and is expected to replace i.v. 5FU/LV.

This news follows the successful results of the X-ACT trial (Xeloda in Adjuvant Colon Cancer Therapy) showing that the trial met its primary endpoint of demonstrating at least equivalent disease free survival compared to i.v. 5-FU/LV. Moreover, the trial demonstrated that Xeloda reduced the risk of the cancer coming back (relapse-free survival) by an impressive 14%. The X-ACT trial results mean that every year, if treated with Xeloda, nearly 4,000 additional patients throughout Europe would not hear the dreaded words "Your cancer has come back."2

In 2002, colorectal cancer was the third most commonly reported cancer with 1,023,000 new cases worldwide. It is estimated that over 50% of people diagnosed with colorectal cancer will die of the disease, and it is one of the most common cancers in developed countries. Chemotherapy following surgery (adjuvant therapy) is one of the most common treatment approaches in patients diagnosed with the disease.

In August this year, Roche filed an additional indication in Europe and the US for Xeloda to treat colon cancer patients after surgery, based on the successful results of the X-ACT trial. The results for the filing are expected to be announced in mid-2005.

All Trademarks used or mentioned in this release are legally protected.

References:

Borner M, et al. Eur J Cancer 2002; 38: 349-58
Liu G, Franssen E, Fitch MI et al. J Clin Oncol 1997: 15: 110-115
Cassidy J, et al. Annals of Oncology 2002; 13: 566-575
Blum J, et al. Cancer 2001; 92(7): 1759-1768




SOURCE: Roche

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