Roche Pharmaceuticals

New Data Shows Bowel Cancer Patients Live Longer on Xeloda

    Barcelona, Spain (ots/PRNewswire) -

    Abstract no: 1LB, being presented at ECCO "Gastrointestinal malignancies - colorectal cancer 1" session in room 110, starting at 09.00 on Tuesday 25 September 2007

BARCELONA, Spain, September 25 /PRNewswire/ --

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

    Five-year follow-up data from the X-ACT trial presented today at the 14th European Cancer Conference (ECCO) show that patients with stage III colon cancer live longer when taking the oral chemotherapy Xeloda (capecitabine) compared to the injections of bolus 5-FU/FA(i), the Mayo Clinic regimen. Patients were followed up for a median of 7 years, 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 also showed that patients taking Xeloda were as likely to be relapse-free and disease-free at five years as those having bolus i.v. treatment.

    "These results are very encouraging, as the data show patients living longer with Xeloda monotherapy." said Professor Chris Twelves, University of Leeds and St. James University Hospital, Leeds. "We have long-term evidence now that clearly supports Xeloda's superiority over the Mayo Clinic regimen. There is no reason we should ask colon cancer patients to endure the burdens associated with bolus i.v. treatment, visiting the clinic 5 consecutive days for an injection, when there is a highly effective option with fewer side-effects that patients can take in the comfort of their home."

    "This adds to the growing body of evidence supporting the fact that Xeloda can replace 5-FU in colorectal cancer regimens." Prof Twelves said.

    Earlier results from the X-ACT study show that Xeloda is also more cost-effective than the Mayo Clinic regimen. Xeloda patients spend 85% less time visiting their doctor or hospital for treatment and 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/FA.

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

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

    Based on the initial results of the X-ACT study, Xeloda was 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. The results seen in the five-year follow up data with single agent Xeloda are broadly similar to those previously seen in the Mosaic study with continuous infusion 5FU/FA and the addition of oxaliplatin.

    Earlier this year Roche applied for a label extension in Europe to broaden 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 third most commonly reported cancer worldwide, and it is estimated that over 50% of people diagnosed with colorectal cancer will die of the disease.

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

    Chemotherapy following surgery (adjuvant therapy) is one of the most common treatment approaches in patients diagnosed with the disease.

    (i) FA: Folinic Acid

    Notes to editors:

    Highlights from the new X-ACT data

    - Overall Survival -- With a median follow-up of 7 years, the 5-year overall survival rates were 71.4% (95% CI 68-74%) in the Xeloda 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 3.8 years, 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 Cancer Therapy) was to evaluate the safety and efficacy of Xeloda(R) (capecitabine), a targeted oral chemotherapy, versus the old global standard of care, bolus intravenous 5-FU/FA (also known as the Mayo Clinic regimen), in patients who recently have had colon cancer surgery (adjuvant therapy).

    The X-ACT trial randomly assigned 1987 patients with resected stage III colon cancer to oral capecitabine (n=1004) or bolus 5-FU/FA (Mayo Clinic regimen; n=983) over 24 weeks. The primary efficacy endpoint was at least equivalence in disease-free survival (DFS); other efficacy endpoints included relapse-free survival (RFS) and overall 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 of capecitabine vs. 5-FU/LV as adjuvant treatment for stage III colon cancer

    Abstract #1LB

    About Roche

    Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. Additional information is available on 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 patient interviews 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. version 2.0,  IARCPress, Lyon, 2004

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch

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



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