Xeloda (capecitabine) Shown to be Superior to IV 5-FU in Advanced Stomach and Oesophageal Cancer
15/09/2008 07:02
PR Newswire
STOCKHOLM, September 12 /PRNewswire/ --
- Patients Live Longer After Treatment With Capecitabine Chemotherapy
Combinations Compared With Standard IV 5-FU/FA
- For Non-US and Non-UK Media Only
Pooled results of two phase III trials have shown that stomach
and oesophageal cancer patients treated with oral chemotherapy Xeloda
(capecitabine) lived approximately one month longer than those that were
treated with infused intravenous (IV) 5FU/FA.*(1) The individual trials
compared capecitabine with the previous standard IV 5-FU/FA, in chemotherapy
combinations for the treatment of incurable stomach and oesophageal cancer.
The results were presented today at the European Society of Medical Oncology
(ESMO).
"The fact that this analysis shows capecitabine to be superior
for overall survival to IV 5-FU in chemotherapy combinations for advanced
oesophageal and stomach cancers is welcome news for patients," said Professor
David Cunningham, Department of Medicine, The Royal Marsden Hospital, Surrey,
United Kingdom. "Intravenous 5-FU based regimens can be burdensome for
patients because they require additional hospital visits during the treatment
cycle and are usually given via a pump that the patient has to wear at home.
Capecitabine appears to offer a survival advantage in addition to the
convenience of a tablet that can be taken at home. These data provide further
evidence that capecitabine can replace IV 5-FU in combination chemotherapy
regimens in the treatment of stomach and oesophageal cancers."
Stomach cancer is a particularly aggressive and debilitating
type of cancer. It is the second leading cause of cancer worldwide, after
lung cancer, causing an estimated 866,000 deaths worldwide each year,(2) and
nearly 140,000 deaths in Europe alone.(3)
Further Evidence
Data from a separate study of capecitabine trials was
presented at the World Congress of Gastrointestinal Cancers in Barcelona in
June. The study involved analysing data from six phase III trials and showed
that patients taking oral capecitabine actually lived longer than those
receiving IV 5-FU/FA for the treatment of a range of gastrointestinal cancers
including colon, colorectal and stomach.(4)
"These new data from ESMO confirm what we have seen in
previous studies: that capecitabine can replace intravenous 5-FU in the
treatment of a number of serious gastrointestinal cancers because it may
offer better survival coupled with improved patient acceptability," Prof
Cunningham concluded.
Xeloda is approved in Europe in combination with platinum based
chemotherapy in first-line treatment of advanced stomach cancer.(5) The most
commonly reported treatment-related adverse reactions are gastrointestinal
disorders (especially diarrhoea, nausea, vomiting, abdominal pain,
stomatitis), fatigue and hand-foot syndrome (palmar-plantar
erythrodysaesthesia).(5)
Since its first licence for advanced breast cancer in 1998, capecitabine
has been proven to be a highly effective and well tolerated treatment for
over 1.5 million breast, colon, colorectal and stomach cancer patients
worldwide.
* FA: Folinic Acid
Notes to editors:
About the meta-analysis
- Pooled data on 1318 patients from the ML17032 and REAL 2
studies showed oral chemotherapy pill Xeloda is superior to intravenous
(IV) 5-FU within doublet and triplet combination chemotherapy regimens
for overall survival in the treatment of advanced stomach and
oesophageal cancer.
- The individual trials compared the efficacy of Xeloda with
previous standard infused IV 5-FU/FA chemotherapy treatment in two
trials:
- REAL 2: A trial of 1002 patients with previously untreated
advanced oesophagogastric cancer in a two-by-two design. Patients
received either triple combination therapy with epirubicin and
cisplatin plus IV 5-FU/FA or Xeloda, or epirubicin and oxaliplatin
plus IV 5-FU or Xeloda.
- ML17032: A trial of 316 patients with untreated advanced
stomach cancer who received cisplatin and either infused IV 5-FU/FA
or Xeloda as part of double combination chemotherapy.
- The primary endpoint of the meta-analysis was overall survival
and secondary endpoints were progression free survival and response
rate.
- Results of the meta-analysis showed that overall survival was
superior in the 654 patients treated with Xeloda combinations compared
to the 664 patients treated with IV 5-FU combinations. (adjusted
HR 0.87; 95% CI 0.77-0.98, p=0.02).
- Differences in progression free survival were not statistically
significant (HR 0.91 (95% CI 0.81-1.02, P=0.095).
- Patients with measurable disease who were treated with Xeloda
based combinations were more likely to have an objective response than
those treated with IV 5-FU/FA combinations.
About Xeloda
Xeloda is a highly effective targeted oral chemotherapy offering patients
a survival advantage when taken on its own or in combination with other
anticancer drugs. Xeloda uniquely activates the cancer-killing agent 5-FU
(5-fluorouracil) directly inside the cancer cells so avoiding damage to
healthy cells. Xeloda tablets can be taken by patients in their own home,
reducing the number of hospital visits.
Licensed in more than 100 countries worldwide, Xeloda has over ten years
proven clinical experience providing an effective and flexible treatment
option to over 1.5 million people with cancer. Xeloda is currently approved
in:
- Metastatic Colorectal Cancer
- Monotherapy 1st line (US & EU) - 2001
- In combination with any chemotherapy in all lines of treatment with or
without Avastin (EU) - 2008
- Metastatic Breast Cancer
- Monotherapy 1st line in patients with tumours resistant to other
chemotherapy drugs such as paclitaxel and anthracyclines - (US) 1998
and (EU) 2002
- In combination with docetaxel in patients whose disease has progressed
following I.V. chemotherapy with anthracyclines - (US) 2001 and (EU)
2002
- In patients with inoperable or recurrent breast cancer - (Japan) 2003
- Adjuvant Colon Cancer
- Monotherapy (US & EU) - 2005
- Monotherapy (Japan) - 2007
- Advanced Gastric Cancer
- 1st line treatment (South Korea) 2002 and (China) 2008
- In combination with platinum-based chemotherapy 1st line (EU) - 2007
- Metastatic Pancreatic Cancer
- In combination with gemcitabine 1st line (South Korea) - 2006
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. As the world's biggest biotech company and an innovator of
products and services for the early detection, prevention, diagnosis and
treatment of diseases, the Group contributes on a broad range of fronts to
improving people's health and quality of life. Roche is the world leader in
in-vitro diagnostics and drugs for cancer and transplantation, and is a
market leader in virology. It is also active in other major therapeutic areas
such as autoimmune diseases, inflammatory and metabolic disorders and
diseases of the central nervous system. In 2007 sales by the Pharmaceuticals
Division totalled 36.8 billion Swiss francs, and the Diagnostics Division
posted sales of 9.3 billion francs. Roche has R? agreements and strategic
alliances with numerous partners, including majority ownership interests in
Genentech and Chugai, and invested over 8 billion Swiss francs in R? in
2007. Worldwide, the Group employs about 80,000 people. Additional
information is available on the Internet at http://www.roche.com.
About The Royal Marsden
The Royal Marsden Hospital was the first hospital in the world dedicated
to cancer treatment and research into the causes of cancer. Today the
hospital with its academic partner, The Institute of Cancer Research, forms
the largest comprehensive cancer centre in Europe with over 40,000 patients
from the UK and abroad seen each year. It provides inpatient, day care and
outpatient services for all areas of cancer treatment. For further
information please contact: Catherine O'Mara on +44(0)207-808-2605 or
catherine.omara@rmh.nhs.uk
http://www.royalmarsden.nhs.uk
All trademarks used or mentioned in this release are protected by law.
Further information available:
- Xeloda in stomach 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. Meta-analysis of the REAL 2 and ML17032 Trials Comparing Capecitabine
with 5-FU in Advanced Gastroesophageal Cancer. Presented at the European
Society for Medical Oncology, 2008. Poster no. 513PD
2. Word Health Organisation: Cancer Fact Sheet No. 297.
http://www.who.int/mediacentre/factsheets/fs297/en/index.html Accessed July
2008
3. Boyle, P & Ferlay, J. Cancer incidence and mortality in Europe 2004.
Annals of Oncology 2005; 16(3):481-4883.
4. Meta-analysis of overall survival in 6 randomised phase III clinical
trials of capecitabine vs. 5-FU in colorectal and gastric cancer. Presented
at the World Congress of Gastrointestinal Cancers 2008.
5. Xeloda European Summary of Product Characteristics. E-medicines
Compendium: http://emc.medicines.org.uk. Accessed August 2008
For further information please contact: Catherine O'Mara on +44(0)20-7808-2605 or catherine.omara@rmh.nhs.uk; Julia Pipe, International Communications Manager - Xeloda, F.Hoffmann-La Roche, Mob: +41-79-263-9715, Email: julia.pipe@roche.com; Nerea Hinzpeter, OgilvyHealthPR, Tel: +1-646-407-9015, Email: nerea.hinzpeter@ohpr.com
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