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Benefits of Oral Capecitabine (Xeloda) Over Continuous Intravenous Chemotherapy Confirmed for Advanced Stomach Cancer BASEL, SWITZERLAND -- January 7, 2008 -- Data recently published in the New England Journal of Medicine confirm oral chemotherapy tablet capecitabine (Xeloda) as a first-line treatment for advanced stomach cancer. Stomach cancer is the fourth most commonly diagnosed cancer and the second leading cause of cancer-related deaths worldwide.(1) Annually, there are an estimated 911,000 deaths worldwide,(2) with nearly 140,000 deaths in Europe alone.(3) "As an oral chemotherapy, capecitabine gives patients a valuable option over the current standard of intravenous treatment," said Professor David Cunningham, Head of the Gastrointestinal and Lymphoma Units of the Royal Marsden NHS Foundation Trust, London. "Capecitabine is at least as effective as intravenous treatment and reduces the time patients need to spend in the hospital allowing patients to lead more routine lives and have more personal time. It may also avoid the need for a central intravenous line with its associated inconvenience and complications." There is growing consensus that oral therapies should replace IV alternatives as long as they can demonstrate at least equivalent efficacy and that tolerability is not compromised. 82% of US oncologists interviewed in a survey stated that their key consideration in selecting an oral chemotherapy agent was efficacy at least equivalent to iv alternatives.(4) The approval of Xeloda in combination with platinum-based chemotherapy (with or without epirubicin), was based on two trials called ML17032 (5) and REAL-2;(6) the latter was published this week in the New England Journal of Medicine. Both these trials showed that patients on the Xeloda-containing arms lived as long overall as those on the 5-fluorouracil (5-FU) arms. Furthermore, the REAL-2 study showed patients on one of the Xeloda-containing arms (EOX; epirubicin, oxaliplatin and Xeloda) lived longer than the reference 5-FU arm (ECF; epirubicin, cisplatin and 5-FU).(6) For patients with advanced gastric cancer, oral Xeloda in combination with a platinum-based regimen is a well tolerated alternative to combination regimens using continuous infusion 5-FU, as shown in both the REAL-2 and ML17032 studies.(5,6) Stomach Cancer: · is the fourth most commonly diagnosed cancer(1) · is the second leading cause of cancer-related deaths worldwide(1) · annually accounts for an estimated 911,000 deaths worldwide(2) · annually accounts for approximately 140,000 deaths in Europe alone(3) · is nearly twice as common in men as in women(3) About the REAL-2 Study · The largest-ever phase 3 study in advanced gastro-oesophageal cancer. · It was conducted in 1002 advanced gastro-oesophageal cancer patients from 61 centres mainly in the UK · The study aimed to establish the potential use of Xeloda (X) and oxaliplatin (O) in previously untreated patients · Patients were randomised to one of four regimens: epirubicin, cisplatin and 5-FU (ECF), epirubicin, oxaliplatin and 5-FU (EOF), epirubicin, cisplatin and Xeloda (ECX) or epirubicin, oxaliplatin and Xeloda (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). The study objective was to show Xeloda to be as effective as 5-FU, and oxaliplatin to be as effective as cisplatin · The study showed that Xeloda was at least as effective as 5-FU and could replace 5-FU · The study showed that patients treated with the combination of Xeloda plus oxaliplatin and epirubicin (EOX) live longer overall, compared to patients treated with standard epirubicin, cisplatin and 5-FU (ECF) About Study ML17032 · The study, led by Professor Y K Kang and his team of the Asan Medical Centre, Seoul, South Korea, is a large randomised, open-label, international phase III study in advanced stomach cancer. · It was conducted in 316 patients enrolled in 46 centres across 13 countries in Asia, South America and Europe · The study compared the efficacy and safety of Xeloda and cisplatin (XP) with intravenous (IV) 5-FU and cisplatin (FP): FP is a standard treatment for advanced stomach cancer in many countries including Asia and the USA · The primary end point was non-inferiority in progression-free survival comparing XP to the standard FP · Patients receiving the XP combination therapy lived as long without the cancer progressing as those treated with FP · Patients on XP also lived as long overall as those on FP, showing XP to be at least as effective as FP · The study confirms that Xeloda can effectively replace the old standard IV 5-FU, in combination with cisplatin, as first-line therapy for advanced stomach cancer Xeloda (Capecitabine) Known as a 'smart pill', Xeloda is designed to be activated by an enzyme present at higher levels in cancer cells, preserving more normal, healthy cells. This results in favourable tolerability and more convenient treatment, as compared with current standard IV chemotherapy. Xeloda is an oral chemotherapy pill that is licensed for advanced gastric cancer, advanced breast cancer and colorectal (bowel) cancer including colorectal cancer that has spread (metastatic), and following potentially curative surgery for colon cancer. The most commonly reported adverse events with Xeloda include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (palmar-plantar erythrodysesthaesia). All trademarks used or mentioned in this release are legally protected. REFERENCES: Ajani, J. Evolving Chemotherapy for Advanced Gastric Cancer. The Oncologist, Oct. 2005; Vol. 10, Sup. 3, 49-582 World Health Organisation, 2005. Boyle, P & Ferlay, J. Cancer incidence and mortality in Europe 2004. Annals of Oncology 2005; 16(3):481-4883. Decision Resources Survey. Oral chemotherapeutic agents: key success factors and reimbursement issues. A survey of US Oncologists and HMO pharmacy directors. June 2005 Kang Y.K. Abstract LBA4018 presented at ASCO 2006 Cunningham et al, NEJM 2008, Vol 358:36-46. SOURCE: Roche E-mail this page to a friend or colleague! To print, use this version