Healthcare Industry News:  esophageal cancer 

Biopharmaceuticals Oncology

 News Release - June 5, 2006

New Xeloda Combination Allows Patients with Stomach Cancer to Live Significantly Longer

In Addition, Oral Chemotherapy Xeloda Reduces Treatment Time for Patients

BASEL, Switzerland, June 5 (Healthcare Sales & Marketing Network) -- Results of the largest-ever phase III study in advanced oesophagogastric cancer, the REAL 2 study, reveal that Xeloda can replace 5-fluorouracil (5-FU) and oxaliplatin can replace cisplatin for the first-line treatment of patients with advanced oesophagogastric (oesophagus and stomach) cancer. The standard treatment for this disease in the UK and much of Europe is the combination of epirubicin, cisplatin and 5-FU (known as ECF). In addition, the trial showed that patients treated with the combination of Xeloda plus oxaliplatin and epirubicin (known as 'EOX') live significantly longer, compared to patients treated with standard ECF chemotherapy. ECF is administered to patients via an infusion pump connected to their arm -- lasting all day and night, every day of the week, for the entire duration of their treatment. Oral Xeloda frees the patient from this schedule, is more convenient and provides greater patient autonomy.

A second study, presented by lead investigator Prof. Y K Kang of the Asan Medical Center, Seoul, South Korea, confirms that Xeloda can also effectively replace the old standard intravenous 5-FU, in combination with cisplatin, as first-line therapy for stomach cancer.

Xeloda in combination with other chemotherapy drugs is therefore an effective, safe, simpler and more convenient treatment option for stomach and oesophageal cancer patients compared to standard treatments.

Stomach cancer is the fourth most commonly diagnosed cancer and the second leading cause of cancer-related deaths worldwide.(1) In Europe alone, nearly 140,000 people die from stomach cancer each year.(2) Stomach cancer affects twice as many men as women and occurs more frequently in people aged over 55 years.(3) Amongst tumours of the upper GI tract, oesophagogastric cancer is more common in the West, whilst stomach cancer is predominant in the East.(4)

Annie Logan, a patient with stomach cancer, said "I wasn't prepared for how drastically my life would change after I'd been diagnosed with stomach cancer -- it was an absolute shock. The cancer felt like an intruder inside of me, and it left me very debilitated. The operation to remove the cancer involved being cut right across my stomach and it felt like being knitted up inside. Having now received therapy, I have a positive outlook for the future, and am able to enjoy spending time with my family".

Professor David Cunningham from the Royal Marsden Hospital, London, and lead investigator of the REAL 2 study, comments "Xeloda can now be considered as a treatment option for oesophagogastric cancer, replacing 5-FU, as it provides the optimal balance between efficacy, safety and convenience for patients".

Roche is filing for an indication in advanced stomach cancer with worldwide regulatory authorities, based on the results of the study presented by Prof. Y K Kang.

NOTES TO EDITORS:

About the Studies

The REAL 2 study is the largest-ever phase III study in advanced oesophagogastric cancer, and the study by Prof. Kang is a large international phase III study in advanced stomach cancer. These remarkable data were unveiled today as late-breaking abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting in Atlanta -- considered the premier educational and scientific event by the oncology community.

1. 'Randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric (OG) cancer: The REAL 2 trial' Cunningham D

(Presented at ASCO 2006, 05/06/2006, 11:30a.m.)
  • This study was conducted in 1002 advanced oesophagogastric cancer patients from 61 centres mainly in the UK.
  • The chemotherapy regimen ECF (epirubicin, cisplatin and 5-FU) is considered a standard treatment option for patients with oesophagogastric cancer in the UK and much of Europe.
  • The study aimed to establish the potential use of Xeloda (X) and oxaliplatin (O) in untreated patients, with the primary endpoint of overall survival.
  • Patients were randomised to one of four regimens: ECF, EOF, ECX or EOX. The primary comparison was overall survival between the Xeloda and 5-FU containing arms (ECX + EOX versus ECF + EOF) and the oxaliplatin and cisplatin containing arms (EOF + EOX versus ECF + ECX). A further comparison was survival between all four regimens.
  • Results: Xeloda was found to be as effective as 5-FU and oxaliplatin was shown to be as effective as cisplatin for the primary endpoint of overall survival. Patients who were on the Xeloda-containing arms lived at least as long as those on the 5-FU arms (HR for non-inferiority =0.86, 95% CI; 0.9-0.99 which was highly significant). Patients on the oxaliplatin containing arms lived at least as long as those on the cisplatin arms (HR for non-inferiority =0.92, 95% CI; 0.8-1.1 which was highly significant). Patients who were treated first-line with Xeloda plus oxaliplatin and epirubicin (EOX) had a longer overall survival which was significant when compared to standard ECF (median overall survival of 11.2 months on EOX versus 9.3 months on EOF, and 9.9 months on ECF and ECX). The toxicity profile for the Xeloda and oxaliplatin- containing arms appeared acceptable.
  • Xeloda and oxaliplatin can now replace 5-FU and cisplatin in triplet regimens used for the first-line treatment of advanced oesophagogastric cancer.
2. 'Randomised phase III trial of capecitabine/cisplatin vs. continuous infusion of 5-FU/cisplatin as first-line therapy in patients with advanced gastric cancer: efficacy and safety results' Kang Y.K. (Presented at ASCO 2006, 05/06/2006, 11:45a.m.)
  • This phase III study was conducted in 316 advanced gastric cancer patients who were enrolled in 46 centres across 13 countries.
  • The study compared the efficacy and safety of Xeloda and cisplatin (XP) with intravenous 5-FU and cisplatin (FP); FP is also a standard treatment of gastric cancer, and accepted by regulatory agencies as the reference regimen against which all other regimens should be compared.
  • The primary endpoint was non-inferiority in progression-free survival; patients receiving the XP combination therapy lived at least as long without the cancer progressing as those treated with FP (median progression-free survival 5.6 vs. 5 months, HR= 0.81, p=<0.001 showing strong evidence of non-inferiority), with acceptable and similar levels of toxicity.
  • XP patients also lived at least as long overall (10.5 vs. 9.3 months, HR=0.85, p=0.008 showing strong evidence of non-inferiority).
  • XP response rate was superior to FP - this is the first time that Xeloda has shown superiority to infusional 5-FU rather than bolus 5-FU (overall response rate 41 vs. 29%, p=0.030).
  • XP reduces the amount of time a patient needs to visit the clinic by 80% compared to FP (1 day vs. 5 days per 3 weeks).
About Xeloda (capecitabine)

Xeloda is licensed in more than 90 countries worldwide including the EU, USA, Japan, Australia and Canada and has been shown to be effective, safe, simple and convenient oral chemotherapy in treating over 1 million patients to date.

Roche received marketing authorisation for Xeloda as a first-line monotherapy (by itself) in the treatment of metastatic colorectal cancer (colorectal cancer that has spread to other parts of the body) in most countries (including the EU and USA) in 2001. Xeloda has also been 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.

Xeloda is licensed in combination with Taxotere(R) (docetaxel) in women with metastatic breast cancer (breast cancer that has spread to other parts of the body) and whose disease has progressed following intravenous (i.v.) chemotherapy with anthracyclines. Xeloda monotherapy is also indicated for treatment of patients with metastatic breast cancer that is resistant to other chemotherapy drugs such as paclitaxel and anthracyclines. Xeloda is licensed for the first-line treatment of stomach cancer that has spread, in South Korea.

The most commonly reported adverse events with Xeloda include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (palmar-plantar erythrodysesthaesia).

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 a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (http://www.roche.com).

All trademarks used or mentioned in this release are legally protected.

For further information please contact:

Julia Pipe International Communications Manager Tel: + 41 79 263 9715 Email: julia.pipe(at)roche.com

Peter Dixon Shire Health International, New York Tel: + 1 646 642 1224 Email: peter.dixon(at)newyork.shirehealth.com

Further Information Available from Media Relations Contacts:

-- Gastric and oesophageal cancer fact sheet
-- Xeloda in stomach cancer fact sheet
-- Xeloda fact sheet
-- Roche in oncology: www.roche.com/pages/downloads/company/pdf/mboncology05e_a.pdf
-- Roche: www.roche.com
-- Broadcast quality B-roll including doctor, caregiver and patient interviews is available for download via www.thenewsmarket.com

References:

1. Ajani, J. Evolving Chemotherapy for Advanced Gastric Cancer. The Oncologist, Oct. 2005; Vol. 10, Sup. 3, 49-58

2. Boyle, P & Ferlay, J. Cancer incidence and mortality in Europe. 2004. Annals of Oncology 2005; 16(3):481-488

3. Oncology Channel. www.oncologychannel.com/gastriccancer/. Visited on 15th March 2006

4. Crew, K & Neugut, A. Epidemiology of gastric cancer. World J Gastroenterol. 2006 Jan 21; 12(3):354-62

/Web Site: http://www.roche.com http://www.thenewsmarket.com /


Source: Roche

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