2007-09-25

New Data Shows Bowel Cancer Patients Live Longer on Xeloda


Barcelona, Spain (ots/PRNewswire) -

Abstract no: 1LB, being presented at ECCO "Gastrointestinalmalignancies - colorectal cancer 1" session in room 110, starting at09.00 on Tuesday 25 September 2007

BARCELONA, Spain, September 25 /PRNewswire/ --

- 5 Year Data Confirm Superiority of Xeloda Over the Mayo ClinicRegimen in Treating Colon Cancer

Five-year follow-up data from the X-ACT trial presented today atthe 14th European Cancer Conference (ECCO) show that patients withstage III colon cancer live longer when taking the oral chemotherapyXeloda (capecitabine) compared to the injections of bolus 5-FU/FA(i),the Mayo Clinic regimen. Patients were followed up for a median of 7years, with results confirming 5 year overall survival rates of 71.4%in the Xeloda group and 68.4% in the 5-FU/FA group. The trial alsoshowed that patients taking Xeloda were as likely to be relapse-freeand disease-free at five years as those having bolus i.v. treatment.

"These results are very encouraging, as the data show patientsliving longer with Xeloda monotherapy." said Professor Chris Twelves,University of Leeds and St. James University Hospital, Leeds. "Wehave long-term evidence now that clearly supports Xeloda'ssuperiority over the Mayo Clinic regimen. There is no reason weshould ask colon cancer patients to endure the burdens associatedwith bolus i.v. treatment, visiting the clinic 5 consecutive days foran injection, when there is a highly effective option with fewerside-effects that patients can take in the comfort of their home."

"This adds to the growing body of evidence supporting the factthat Xeloda can replace 5-FU in colorectal cancer regimens." ProfTwelves said.

Earlier results from the X-ACT study show that Xeloda is also morecost-effective than the Mayo Clinic regimen. Xeloda patients spend85% less time visiting their doctor or hospital for treatment and forevery 100 patients treated with Xeloda, a doctor could saveapproximately one year (400 days) in consultation time compared toi.v. 5-FU/FA.

Previous studies show that patients prefer oral treatment as itallows them to carry on their daily lives as normally aspossible(1),(2).

Earlier results also confirm that Xeloda's targeted approachcauses less of the side-effects usually associated with chemotherapy.Additionally, any side-effects can be easily managed by altering thedose without compromising efficacy(3),(4). This has a cost-savingbenefit with previous analyses of the X-ACT study showing that costsfor medicines to treat side effects such as nausea, vomiting anddiarrhoea, were cut by nearly 75% in patients taking Xeloda comparedto i.v. 5-FU/FA.

Based on the initial results of the X-ACT study, Xeloda wasapproved by the European Medicines Agency (EMEA) and U.S. Food andDrug Administration (FDA) for adjuvant (post-surgery) treatment ofcolon cancer in March and June 2005, respectively. The results seenin the five-year follow up data with single agent Xeloda are broadlysimilar to those previously seen in the Mosaic study with continuousinfusion 5FU/FA and the addition of oxaliplatin.

Earlier this year Roche applied for a label extension in Europe tobroaden the label for Xeloda in the form of Xeloda plus oxaliplatin(XELOX) with or without Avastin for the treatment of metastatic(advanced) colorectal cancer.

Colorectal cancer (cancer of the colon and rectum) is the thirdmost commonly reported cancer worldwide, and it is estimated thatover 50% of people diagnosed with colorectal cancer will die of thedisease.

This year will see 281,700 suffer with adjuvant colon cancer inthe majority of the developed world (UK, Spain, Italy, France,Germany, Japan, Canada and the USA), and its incidence is likely toincrease, with over 286,500 patients expected in 2008(5).

Chemotherapy following surgery (adjuvant therapy) is one of themost common treatment approaches in patients diagnosed with thedisease.

(i) FA: Folinic Acid

Notes to editors:

Highlights from the new X-ACT data

- Overall Survival -- With a median follow-up of 7 years, the5-year overall survival rates were 71.4% (95% CI 68-74%) in theXeloda group and 68.4% (95% CI 65-71%) in the 5-FU/FA group,corresponding to a HR of 0.86 (95% CI 0.74-1.01).

- Disease-free Survival (DFS) -- At a median follow-up of 3.8years, DFS in the Xeloda group was at least equivalent to 5-FU/FA(intent-to-treat analysis, P

About the X-ACT Study:

The goal of the X-ACT trial (Xeloda in Adjuvant Colon CancerTherapy) was to evaluate the safety and efficacy of Xeloda(R)(capecitabine), a targeted oral chemotherapy, versus the old globalstandard of care, bolus intravenous 5-FU/FA (also known as the MayoClinic regimen), in patients who recently have had colon cancersurgery (adjuvant therapy).

The X-ACT trial randomly assigned 1987 patients with resectedstage III colon cancer to oral capecitabine (n=1004) or bolus 5-FU/FA(Mayo Clinic regimen; n=983) over 24 weeks. The primary efficacyendpoint was at least equivalence in disease-free survival (DFS);other efficacy endpoints included relapse-free survival (RFS) andoverall survival.

Results presented at ECCO:

2007-09-25 Tuesday, 09:00 "Gastrointestinal malignancies -colorectal cancer 1" Room 110

5-year overall survival update from the X-ACT trial ofcapecitabine vs. 5-FU/LV as adjuvant treatment for stage III coloncancer

Abstract #1LB

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. Additional information is availableon the Internet at http://www.roche.com.

Further information available:

- Colorectal cancer fact sheet

- Xeloda fact sheet

- Roche: http://www.roche.com

- Broadcast quality B-roll including doctor, caregiver and patientinterviews is available for download via http://www.thenewsmarket.com

References

(1). Borner M, et al. Eur J Cancer 2002; 38: 349-58

(2). Liu G, Franssen E, Fitch MI et al. J Clin Oncol 1997: 15:110-115

(3). Cassidy J, et al. Annals of Oncology 2002; 13: 566-575

(4). Blum J, et al. Cancer 2001; 92(7): 1759-1768

(5). Ferlay, J., Bray, J. et al. GLOBOCAN 2002: Cancer Incidence,Mortality and Prevalence Worldwide IARC CancerBase No. 5. version2.0, IARCPress, Lyon, 2004

ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de

Contact:For further information please contact: Julia Pipe, International Communications Manager - Xeloda, F.Hoffmann-La Roche, Mob: +41-79-263-9715, Email: julia.pipe@roche.com; Nerea Hinzpeter, ShireHealthPR, Mob: +1-646-407-9015, Email : nerea.hinzpeter@shirehealthpr.com

Roche Pharmaceuticals

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