New Data Shows Bowel Cancer Patients Live Longer on Xeloda
25/09/2007 09:06
PR Newswire
BARCELONA, Spain, September 25 /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
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