To print: Select File and then Print from your browser's menu

Title: New Clinical Trial Data On The Role Of Xeloda (Capecitabine) As A Combination Agent In The Treatment Of Colorectal Cancer: Presented at CFS

"New Clinical Trial Data On The Role Of Xeloda (Capecitabine) As A Combination Agent In The Treatment Of Colorectal Cancer: Presented at CFS"

- Additional Study Results Show Promise in the Use of Xeloda in Gastroesophageal Cancer - NEW YORK, NY -- November 14, 2002 -- Important new data presented yesterday at the 20th annual Chemotherapy Foundation Symposium highlights Roche's Xeloda® (capecitabine), an oral tumor-activated chemotherapy, in combination with Eloxatin® (oxaliplatin) for first-line treatment of patients with metastatic colorectal cancer. Data from another study also show promise in the use of Xeloda monotherapy as an option for first-line therapy in esophago-gastric cancer and in combination with other chemotherapy agents. Xeloda + Eloxatin (oxaliplatin) James Cassidy, M.D., Professor of Medical Oncology, Glasgow University, Glasgow, Scotland, presented updated data from ASCO 2002 on an international Phase II study of Xeloda in combination with oxaliplatin (XELOX) as first-line therapy for metastatic colorectal cancer. The data from this 96-patient study show an objective response rate of 55 percent with an additional 32 percent of patients having stable disease for greater than three months. In addition, median survival is 19.5 months and median time to progression is currently 7.6 months. Patients enrolled in this study received 130 mg/m2 of oxaliplatin intravenously day 1 of each 21-day treatment cycle and 1,000 mg/m2 of oral Xeloda twice daily days 1-14 with one week rest. Oxaliplatin, in combination with 5-FU/LV, was approved by the U.S. FDA as second-line therapy for metastatic colorectal cancer on August 9, 2002. Xeloda was approved by the U.S. FDA on April 30, 2001 as first-line treatment for metastatic colorectal cancer when treatment with fluoropyrimidine therapy alone is preferred. "These results are encouraging and demonstrate the potential of Xeloda as a combination agent with oxaliplatin in colorectal cancer," said Peter Kozuch, M.D., St. Luke's-Roosevelt Hospital, New York, N.Y. "These results may be good news for physicians as they point to potential new options in the management of colorectal cancer." Xeloda in Esophago-gastric Cancer Niall Tebbutt, M.D. of Royal Marsden Hospital, Sutton, United Kingdom, presented interim analysis from a randomized, multicenter Phase III study comparing Xeloda with 5-FU and oxaliplatin with cisplatin in patients with advanced esophago-gastric cancer. This study is a four-arm study comparing the following regimens: ECF (epirubicin, cisplatin, continuous infusional (CI) 5-FU) versus ECX (epirubicin, cisplatin, Xeloda twice daily without rest for the duration of therapy) and EOF (epirubicin, oxaliplatin, CI 5-FU) versus EOX (epirubicin, oxaliplatin, Xeloda twice daily without rest for the duration of therapy). The interim results of this study has demonstrated an overall response rate of 54 percent for the Xeloda treatment arms versus 28 percent for the CI 5-FU treatment arms and 34 percent for the cisplatin treatment arms versus 47.5 percent for the oxaliplatin treatment arms. Additionally, rates of time to disease progression were 13 percent in the Xeloda treatment arms versus 33 percent in the 5-FU treatment arms and 20 percent in the cisplatin treatment arms versus 25 percent in the oxaliplatin treatment arms. The safety profile included the incidences of diarrhea, stomatitis and hand-and- foot syndrome at 14 percent, 3 percent and 3 percent for the 5-FU treatment arms and 3 percent, 0 percent and 3 percent respectively for the Xeloda treatment arms. The incidence of grade 3/4 neutropenia ranged from 32 to 42 percent; however, it was generally brief in duration and the incidence of febrile neutropenia ranged from 2 to 6 percent. This interim analysis is based on 80 patients, however the study plans to recruit a total of 600 patients. This is the first study comparing Xeloda to continuous infusional 5-FU regimen. Xeloda + Camptosar® (irinotecan) An additional Phase I study led by Dan Budman, M.D., North Shore Medical Center evaluated the safety of an every other week dosing regimen of Xeloda in combination with Camptosar for patients with metastatic colorectal cancer. The data show that the combination of Xeloda and Camptosar on the every other week schedule is generally well tolerated in the patient population studied. Patients treated with the combination of Xeloda and Camptosar experienced mostly mild to moderate side effects (Grade 1 to 2) including anorexia, nausea, vomiting, diarrhea, and fatigue. One patient experienced Grade 3 diarrhea. About Xeloda Xeloda is indicated as first-line treatment of patients with metastatic colorectal cancer when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with Xeloda monotherapy in colorectal cancer. Use of Xeloda instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage. Xeloda in combination with Taxotere® (docetaxel) is indicated for the treatment of metastatic breast cancer after failure of prior anthracyline-containing chemotherapy. Xeloda monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within six months of completing treatment with an anthracycline-containing adjuvant regimen. Xeloda is covered by Medicare. To further improve patient safety, Roche submitted data from a clinical pharmacology trial that confirmed an interaction between Xeloda and warfarin. To heighten physicians' awareness, Roche agreed with FDA to make the Xeloda and warfarin interaction information more prominent in a black box warning and to support an ongoing program for physician and patient awareness of the potential interaction between Xeloda and coumarin derivative anticoagulants, such as warfarin. Xeloda Safety Information Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. A clinically important Xeloda-warfarin drug interaction was demonstrated in a clinical pharmacology trial. Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking Xeloda concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon. Post-marketing reports have shown clinically significant increases in prothrombin time (PT) and INR in patients who were stabilized on anticoagulants at the time Xeloda was introduced. These events occurred within several days and up to several months after initiating Xeloda therapy and, in a few cases, within one month after stopping Xeloda. These events occurred in patients with and without liver metastases. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy. The most common adverse events > or = 20% of Xeloda monotherapy were anemia, diarrhea, hand-and-foot syndrome, nausea, fatigue, vomiting, hyperbilirubinemia, dermatitis, stomatitis, anorexia, paresthesia, abdominal pain, lymphopenia, neutropenia and thrombocytopenia. When Xeloda was combined with docetaxel, additional common adverse events > or = 20% included leukopenia, alopecia, edema, pyrexia, asthenia and constipation. Adverse events were more common in patients > or = 80 years of age receiving monotherapy; and in patients > or = 60 years of age receiving combination therapy. Patients with severe diarrhea should be carefully monitored. Xeloda is contraindicated in patients who have a known hypersensitivity to 5-fluorouracil, and in patients with severe renal impairment. For patients with moderate renal impairment, dose reduction is required. As with any cancer therapy, there is a risk of side effects, and these are usually manageable and reversible with dose modification or interruption. Visit http://www.xeloda.com or call Roche at 800-526-6367 for full prescribing information. Xeloda is a registered trademark of Hoffmann-La Roche Inc. About Roche Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals, diagnostics and vitamins. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C. For more information on the Roche pharmaceuticals business in the United States, visit the company's web site at: http://www.rocheusa.com Eloxatin® (oxaliplatin) is manufactured by Sanofi. Camptosar® (irinotecan) is manufactured by Pharmacia Corporation. Platinol® (cisplatin) is manufactured by Bristol-Myers Squibb. SOURCE: Hoffmann-La Roche Inc.

Copyright © 2009 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content.