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Xeloda (capecitabine) Shown to be Superior to IV 5-FU in Advanced Stomach and Oesophageal Cancer
Stockholm (ots/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)
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.
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
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&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D 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 email@example.com
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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
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. [Abstract no.: 1296]
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 firstname.lastname@example.org; Julia Pipe,
International Communications Manager - Xeloda, F.Hoffmann-La Roche,
Mob: +41-79-263-9715, Email: email@example.com; Nerea Hinzpeter,
OgilvyHealthPR, Tel: +1-646-407-9015, Email: firstname.lastname@example.org