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Xeloda plus Oxaliplatin (Xelox) Dramatically Reduces Hospital Visits by Over 60%

Xeloda provides patients with early colon cancer the freedom to live a normal life

BASEL, SWITZERLAND -- November 2, 2005 -- New data confirm that Xelox, a combination of Xeloda(R) (capecitabine) and oxaliplatin, is as safe as the current standard treatment of intravenous 5-fluorouracil/leucovorin (i.v. 5-FU/LV) in adjuvant colon cancer patients (post-surgery). Moreover, Xelox reduces the number of hospital visits by more than 60% compared to the current standard therapy, providing them the freedom to live as normal a life as possible.1

"Being diagnosed with colon cancer shook me to the core. Having discussed treatment options with my doctor, I was thankful to be offered a combination treatment, including oral Xeloda, as it would mean much less time spent in hospital, so that I could get on with my life and return to work sooner," said Andy Griffin, a patient with colon cancer from the UK. "At such a difficult time in my life, it was important for me to be able to spend as much quality time with my family as possible."

In 2004, colorectal cancer was one of the leading cancers and accounted for 13% of all cancers.2

It is estimated that over 394,000 people die worldwide from colorectal cancer each year.3

Xeloda was approved in the EU for post-surgery treatment of colorectal cancer in April 2005. Approval was based on data (X-ACT study) that showed Xeloda to be at least equal to 5-FU/LV in terms of effectiveness with a strong trend towards improvement with fewer severe side-effects.4

"It's great to know that physicians have a new treatment option that will truly benefit patients that cannot tolerate current therapies. This option gives patients the freedom to live their lives while providing similar safety benefits to the current standard intravenous treatment in the post-surgery setting," said Professor Hans-Joachim Schmoll, MD, PhD, Martin Luther University, Halle, Germany, and lead author of the new study. "This study confirms that Xeloda shows potential in combination treatment in colorectal cancer."

Previous Xelox studies, conducted in patients where the disease has spread have shown that it is well tolerated with similar efficacy to the FOLFOX (oxaliplatin + 5-FU/LV) combination.5,6,7 Xelox is also being investigated in the largest ever phase III clinical trial programme for the treatment of colorectal cancer, with over 4,000 patients from more than 30 countries involved.

Xeloda in colorectal cancer
Abstract Number 617 -- Initial safety findings from XeloxA: a randomized phase III trial of capecitabine plus oxaliplatin vs. bolus 5-FU/LV as adjuvant therapy for patients (pts) with stage III colon cancer:1 In early Phase III safety findings, from the largest population of patients treated with Xelox to date, compared with the current standard of therapy, i.v. 5-FU/LV, Xelox demonstrates benefits for the patient in terms of side-effects:

• Xelox led to less myelosuppression (reduced production of red and white blood cells and platelets) and stomatitis (mouth inflammation / ulcers)

Presented at ECCO on Wednesday, 2 November, 11.30 CET (poster discussion)

About Xelox
An abbreviation for a type of combination chemotherapy used to treat colorectal cancer; it contains Xeloda (capecitabine) and oxaliplatin.

About Xeloda
Xeloda is licensed in more than 90 countries worldwide including the EU, USA, Japan, Australia and Canada.

Roche received marketing authorisation for Xeloda as a first-line monotherapy (by itself) in the treatment of metastatic colorectal cancer (colorectal cancer that has spread to other parts of the body) in most countries (including the EU and USA) in 2001. Xeloda has also been approved by the European Medicines Agency (EMEA) and U.S. Food and Drug Administration (FDA) for adjuvant (post-surgery) treatment of colon cancer in March and June 2005, respectively.

Xeloda is licensed in combination with Taxotere(R) (docetaxel) in women with metastatic breast cancer (breast cancer that has spread to other parts of the body) and whose disease has progressed following intravenous (i.v.) chemotherapy with anthracyclines. Xeloda monotherapy is also indicated for treatment of patients with metastatic breast cancer that is resistant to other chemotherapy drugs such as paclitaxel and anthracyclines. Xeloda is licensed for the first-line treatment of stomach cancer that has spread, in South Korea.

REFERENCES:
1. Schmoll HJ et al. Initial safety findings from XeloxA: a randomised phase III trial of capecitabine plus oxaliplatin vs. bolus 5-FU/LV as adjuvant therapy for patients (pts) with stage III colon cancer. Abstract 617 presented at the 13th European Cancer Conference, Paris, 2005.
2. Boyle P, Ferlay J. Cancer incidence and mortality in Europe, 2004. Annals of Oncology 2005;16:481-488
3. Boyle P, Langman JS. ABC of colorectal cancer. Epidemiology. BMJ 2000;321:805-808
4. Twelves C et al. Capecitabine as adjuvant treatment for stage III colon cancer. New Eng Journ Med 2005; vol 352: no.26: 2696-2704.
5. Arkenau HT et al. Infusional 5-fluorouracil/folinic acid plus oxaliplatin (FUFOX) versus capecitabine plus oxaliplatin (CAPOX) as first line treatment of metastatic colorectal cancer (MCRC): Results of the safety and efficacy analysis. Proc ASCO 2005 (Abst 3507).
6. Sastre J et al. Preliminary results of a randomized phase III trial of the TTD Group comparing Capecitabine and Oxaliplatin (CapeOx) vs. Oxaliplatin and 5-Fluorouracil in continuous infusion (5-FU CI) as first line treatment in advanced or metastatic colorectal cancer (CRC). Proc ASCO 2005 (Abst 3524).
7. Hochster HS et al. Safety and efficacy of bevacizumab (Bev) when added to oxaliplatin/fluoropyrimidine (O/F) regimens as first-line treatment of metastatic colorectal cancer (mCRC): TREE 1 & 2 Studies. Proc ASCO 2005 (Abst 3515).

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SOURCE: Roche

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