Major Clinical Study Improves the Treatment of Breast

Cancer / Cancer and Leukemia Group B Acknowledge Significance ofTAXOL Clinical Trial Chicago (PROTEXT) - A landmark breast cancer trial, headed bythe Cancer and Leukemia Group B (CALGB), has significantlyimproved treatment outcomes for women with early stage breastcancer. This trial represents one of the most notableaccomplishments in breast cancer research in 30 years. Theresults of this study are central to a supplemental new drugapplication filed today by Bristol-Myers Squibb Company for aEuropean registration for this indication. This is one of the most significant advances in adjuvant(chemotherapy after surgery) breast cancer therapy in the past 30years, when researchers discovered that combination chemotherapy,after surgery, substantially improved breast cancer survivalcompared to surgery alone. The recent study was the largestadjuvant breast cancer study ever conducted, and included theparticipation of all the major cancer cooperative groups, withmore than 1,000 investigators at several hundred sites around theU.S. The results of this study (CALGB 9344), which continue to beanalyzed, showed that the addition of the anti-cancer drugTAXOL(R) (paclitaxel) to standard chemotherapy dramaticallyincreases the chances of a woman with breast cancer being aliveand free of disease. According to the preliminary analysis, thestudy demonstrated that administering TAXOL in addition to astandard chemotherapy regimen reduced mortality rate by 26percent and reduced the risk of cancer recurrence by 22 percentcompared to the previous standard treatment regimen. Theseimportant results have been updated to include the 30-monthsurvival data included in the U.S. and European filings. "This represents one of the most significant advances in thetreatment of early-stage breast cancer since the introduction ofdoxorubicin," said Richard L. Schilsky, M.D., director,University of Chicago Cancer Research Center; professor ofmedicine, University of Chicago; and chairman, CALGB. "This newcombination therapy has the potential to save tens of thousandsof lives worldwide each year. We anticipate that this regimenwill now become the standard against which new therapies will becompared." "The results of this study are very important. These dataclearly demonstrate that we are substantially improving a woman'schances for remaining alive and free of her breast cancer byadding TAXOL sequentially to the standard regimen of doxorubicinand cyclophosphamide," said Larry Norton, M.D., head, Division ofSolid Tumor Oncology, Memorial Sloan-Kettering Cancer Center. Dr.Norton is also chair of the Breast Committee of CALGB. "Becauseit significantly improves survival, this regimen represents a newstandard for patients with breast cancer." Of the 183,000 women newly diagnosed with breast cancer eachyear in the United States, approximately 75,500 are candidatesfor adjuvant therapy. "If we can decrease the risk of death amongthis large patient population by about 20 percent, it could haveimportant and significant implications for the treatment ofbreast cancer," said I. Craig Henderson, M.D., adjunct professorof medicine, University of California at San Francisco. Dr.Henderson was the principal investigator of the trial, whichinvolved over 3,000 women. "In a challenging disease like cancer, where ground-breakingadvances are often made in minor increments, this studyrepresents a major step forward for patients. Simply stated, thisregimen offers more women a chance to live free of theirdisease," said Dr. Norton. This trial was a phase III adjuvant study coordinated by theCALGB and was designed to compare doxorubicin pluscyclophosphamide to these two drugs followed by TAXOL in womenwith breast cancer involving the lymph nodes under the arm.Sequential use supports a mathematical analysis of breast cancergrowth developed by Larry Norton, MD. Involvement of the lymphnodes indicates the cancer has begun to metastasize or spread.The trial involved more than 3,000 women and is the largest studyever completed with TAXOL. Other cancer cooperative study groupsinvolved in this study were the Eastern Cooperative OncologyGroup, the Southwest Oncology Group and the North Central CancerTreatment Group, which are all sponsored and supported by theNational Cancer Institute. In all, several hundred institutionsparticipated in this study. The CALGB is a national cooperative research group,headquartered in Chicago and sponsored by the National CancerInstitute. The CALGB was founded in 1955 with a goal of bringingtogether clinical oncologists and laboratory investigators todevelop better treatments for cancer. Since then the CALGB hasgrown into a national network of 31 university medical centers,more than 200 community hospitals and more than 3,000 physicianswho collaborate in clinical studies aimed at reducing themorbidity and mortality from cancer and developing new strategiesfor early detection and prevention of cancer. CALGB research isfocused on seven major disease areas: leukemia, lymphoma, breastcancer, lung cancer, gastrointestinal malignancies, prostatecancer, and melanoma. The most current study with TAXOL inadjuvant breast cancer is but the latest in the many advances incancer care made by the CALGB. ots Original Text Service: Cancerand Leukemia Group B Internet: http://www.newsaktuell.deContact: John V. A. Easton Director of Media Affairs ofUniversity of Chicago Hospitals (USA) 773-702-6241; or RichardSchilsky, M.D. Chairman of Cancer and Leukemia Group B (USA) 888-295-7900 Company News On-Call: http://www.prnewswire.com orFax, (USA) 201-432-0504, ext. 269329 Web site:http://www.bms.com

Subscribers please note that material bearing the slug"PROTEXT" is not part of CTK's news service and is not to bepublished under the "CTK" slug. Protext is a commercial serviceproviding distribution of press releases from clients, who areidentified in the text of Protext reports and who bear fullresponsibility for their contents.

PROTEXT