To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Fludarabine Results Positive in Treating Chronic Lymphocytic Leukemia URL: http://www.pslgroup.com/dg/EEFA.htm Doctor's Guide December 18, 1996
MONTREAL, Dec. 18, 1996 -- People suffering from the most common form of leukemia in the western world can look forward to higher complete response rates and longer progression-free periods through the use of the advanced cancer drug fludarabine, according to the recently-released results of a major North American clinical trial. The study involved 395 patients with chronic lymphocytic leukemia and consisted of a randomized comparison of fludarabine with chlorambucil, currently considered the standard therapy. The results of the study were presented by chief investigator Dr. Kanti Rai of the Albert Einstein College of Medicine, Long Island Jewish Medical Center, New York, at the 38th annual meeting of the American Society of Hematology, held in Orlando, Florida last week. HIGHER RESPONSE RATES, LONGER DURATIONS OF RESPONSE AND IMPROVED PROGRESSION-FREE SURVIVAL The study concludes that fludarabine produces higher rates of response, especially complete response, longer durations of response, and improved progression-free survival. The overall response rate for complete and partial responses with fludarabine was 70% as compared to 43% with chlorambucil. Moreover, 27% of the patients treated with fludarabine achieved a complete response whereas only 3% of the chlorambucil patients did so. The duration of response following treatment with fludarabine was also significantly longer. Fludarabine patients had a median response duration of 33 months as compared to 17 months for those taking chlorambucil. Similarly, the median progression-free survival was 27 months for patients receiving fludarabine versus 17 months for those receiving the other agent. According to Dr. Bruce Cheson, Head of the Medicine Section of the National Cancer Institute, Bethesda, Maryland, and clinical investigator, "If you have a therapy that gives you a 70% response rate in first line, gives you very long progression-free survival and compare that to an agent that you have to keep getting off and on, there is clear benefit to giving your better therapy first. "Moreover, we now have two large studies showing that this agent is no more toxic and considerably more effective than alkylating agent-based therapy", added Cheson. CHRONIC LYMPHOCYTIC LEUKEMIA IN CANADA Chronic lymphocytic leukemia, which is the most common form of leukemia in the western world, typically occurs in individuals over 60 years of age. It is estimated that about 5000 Canadians are currently suffering from this form of leukemia. Annually, some 900 people are diagnosed with the disease in this country. CANADIAN INVOLVEMENT IN LARGEST NORTH AMERICAL CLL STUDY With 395 previously untreated patients, including 107 in Canada, this is the largest randomized trial in chronic lymphocytic leukemia ever conducted in North America. It was undertaken by a number of leading cancer research centres, in cooperation with the National Cancer Institute of Canada. Between October 1990 and December 1994, the 395 patients were treated with either fludarabine or chlorambucil. Those who did not respond positively to their treatment were then given the other medication. An estimated 62% of patients in both groups survived at least four years. Eighty-one patients initially treated with chlorambucil have now received fludarabine, with only 37 crossovers from fludarabine to chlorambucil. Both drugs were well tolerated with similar toxicity profiles and additional follow-up will be conducted to assess the duration of overall survival. Dr. Jean-Francois Grenier, Vice-president, Scientific Affairs, Berlex Canada said: "The importance of these very encouraging results for fludarabine is that they point towards a new approach in the treatment of chronic lymphocytic leukemia, a disease for which life expectancy and quality of life have changed little over the past 40 years. This study showed a 27% complete response rate with fludarabine. Prior to fludarabine, there was no treatment to induce such a high rate of complete response. This is possibly the key to improved long-term survival and a better quality of life for these patients.'' Fludara(R) (fludarabine phosphate) was developed by Berlex in cooperation with the U.S. National Cancer Institute. In Canada, Fludara has been available since 1993. It is indicated for patients with chronic lymphocytic leukemia (CLL) who have failed first-line therapy. Berlex Canada Inc. is a research-based pharmaceutical company producing a range of healthcare products in the fertility control, oncology, diagnostic imaging, and neurology (multiple sclerosis). --------------------------------------------------------------------------------------------- Copyright © 1999 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. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.