Major Clinical Study Improves the Treatment of Breast

Cancer / Cancer and Leukemia Group B Acknowledge Significance of TAXOL Clinical Trial Chicago (PROTEXT)

A landmark breast cancer trial, headed by the Cancer and Leukemia Group B (CALGB), has significantly improved treatment outcomes for women with early stage breast cancer. This trial represents one of the most notable accomplishments in breast cancer research in 30 years. The results of this study are central to a supplemental new drug application filed today by Bristol-Myers Squibb Company for a European registration for this indication. This is one of the most significant advances in adjuvant (chemotherapy after surgery) breast cancer therapy in the past 30 years, when researchers discovered that combination chemotherapy, after surgery, substantially improved breast cancer survival compared to surgery alone. The recent study was the largest adjuvant breast cancer study ever conducted, and included the participation of all the major cancer cooperative groups, with more than 1,000 investigators at several hundred sites around the U.S. The results of this study (CALGB 9344), which continue to be analyzed, showed that the addition of the anti-cancer drug TAXOL(R) (paclitaxel) to standard chemotherapy dramatically increases the chances of a woman with breast cancer being alive and free of disease. According to the preliminary analysis, the study demonstrated that administering TAXOL in addition to a standard chemotherapy regimen reduced mortality rate by 26 percent and reduced the risk of cancer recurrence by 22 percent compared to the previous standard treatment regimen. These important results have been updated to include the 30-month survival data included in the U.S. and European filings. "This represents one of the most significant advances in the treatment of early-stage breast cancer since the introduction of doxorubicin," said Richard L. Schilsky, M.D., director, University of Chicago Cancer Research Center; professor of medicine, University of Chicago; and chairman, CALGB. "This new combination therapy has the potential to save tens of thousands of lives worldwide each year. We anticipate that this regimen will now become the standard against which new therapies will be compared." "The results of this study are very important. These data clearly demonstrate that we are substantially improving a woman's chances for remaining alive and free of her breast cancer by adding TAXOL sequentially to the standard regimen of doxorubicin and cyclophosphamide," said Larry Norton, M.D., head, Division of Solid Tumor Oncology, Memorial Sloan-Kettering Cancer Center. Dr. Norton is also chair of the Breast Committee of CALGB. "Because it significantly improves survival, this regimen represents a new standard for patients with breast cancer." Of the 183,000 women newly diagnosed with breast cancer each year in the United States, approximately 75,500 are candidates for adjuvant therapy. "If we can decrease the risk of death among this large patient population by about 20 percent, it could have important and significant implications for the treatment of breast cancer," said I. Craig Henderson, M.D., adjunct professor of medicine, University of California at San Francisco. Dr. Henderson was the principal investigator of the trial, which involved over 3,000 women. "In a challenging disease like cancer, where ground-breaking advances are often made in minor increments, this study represents a major step forward for patients. Simply stated, this regimen offers more women a chance to live free of their disease," said Dr. Norton. This trial was a phase III adjuvant study coordinated by the CALGB and was designed to compare doxorubicin plus cyclophosphamide to these two drugs followed by TAXOL in women with breast cancer involving the lymph nodes under the arm. Sequential use supports a mathematical analysis of breast cancer growth developed by Larry Norton, MD. Involvement of the lymph nodes indicates the cancer has begun to metastasize or spread. The trial involved more than 3,000 women and is the largest study ever completed with TAXOL. Other cancer cooperative study groups involved in this study were the Eastern Cooperative Oncology Group, the Southwest Oncology Group and the North Central Cancer Treatment Group, which are all sponsored and supported by the National Cancer Institute. In all, several hundred institutions participated in this study. The CALGB is a national cooperative research group, headquartered in Chicago and sponsored by the National Cancer Institute. The CALGB was founded in 1955 with a goal of bringing together clinical oncologists and laboratory investigators to develop better treatments for cancer. Since then the CALGB has grown into a national network of 31 university medical centers, more than 200 community hospitals and more than 3,000 physicians who collaborate in clinical studies aimed at reducing the morbidity and mortality from cancer and developing new strategies for early detection and prevention of cancer. CALGB research is focused on seven major disease areas: leukemia, lymphoma, breast cancer, lung cancer, gastrointestinal malignancies, prostate cancer, and melanoma. The most current study with TAXOL in adjuvant breast cancer is but the latest in the many advances in cancer care made by the CALGB. ots Original Text Service: Cancer and Leukemia Group B Internet: http://www.newsaktuell.de Contact: John V. A. Easton Director of Media Affairs of University of Chicago Hospitals (USA) 773-702-6241; or Richard Schilsky, M.D. Chairman of Cancer and Leukemia Group B (USA) 888- 295-7900 Company News On-Call: http://www.prnewswire.com or Fax, (USA) 201-432-0504, ext. 269329 Web site: http://www.bms.com

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