BASEL, Switzerland--21 Jul--PRNewswire-AsiaNet/InfoQuest Oral Cancer Drug Offers Patients With Stomach Cancer a Highly Effective and Safe Treatment Option Compared to Current Standard Therapy The European Medicines Agency informed Roche today that the filing for a new indication in Europe for the oral cancer drug Xeloda in combination with another chemotherapy (cisplatin) for the treatment of patients with advanced gastric (stomach) cancer has been accepted. Stomach cancer is the fourth most commonly diagnosed cancer and the second leading cause of cancer-related deaths worldwide.(1) The filing is based on results from the first-ever phase III study investigating the efficacy and safety of Xeloda/cisplatin compared to the current standard therapy of infusional 5-fluorouracil (5-FU) plus cisplatin as first-line treatment of the disease. The study results confirmed that patients receiving the Xeloda/cisplatin combination therapy lived at least as long without the cancer progressing as those treated with the current standard therapy. Furthermore, for the first time in any cancer, Xeloda/cisplatinresponse rate (percentage of patients whose cancer shrinks after treatment) was superior, when compared to infusional 5-FU. Xeloda greatly simplifies the treatment regimen due to its oral form, reducing the need for hospital visits and allowing patients more precious time to spend with family and friends. "Today marks a significant milestone for Roche. We are setting in motion the necessary steps to make this new and effective treatment available for European patients fighting advanced stomach cancer -- a particularly painful and debilitating form of cancer," said Ed Holdener, Head of Roche Pharmaceuticals Development. "These new robust data are very encouraging -- for the first time a viablealternative to the current standard intravenous treatment will becomeavailable for stomach cancer patients in Europe," stated lead investigatorProf. Y. K. Kang of the Asan Medical Center, Seoul, South Korea. In Europe alone, nearly 140,000 people die from stomach cancer eachyear.(2) Stomach cancer affects twice as many men as women and occurs morefrequently in people aged over 55 years.(3) Amongst tumours of the uppergastrointestinal tract, oesophagogastric cancer is more common in the West,whilst stomach cancer is predominant in the East.(4) About the ML17032 study The study, conducted by Prof. Kang and his team, is a large international phase III study in advanced stomach cancer. Some key highlights from this remarkable study, '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' include: - This phase III study was conducted in 316 advanced gastric cancer patients who were enrolled in 46 centres across 13 countries in Asia, South America, and Eastern Europe. - The study compared the efficacy and safety of the Xeloda plus cisplatin combination (XP) with the intravenous 5-FU plus cisplatin combination (FP); FP is a standard treatment for 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=