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| |  Early Results Show Taxol/Adriamycin Effective In Breast Cancer DENVER -- May 22, 1997 -- Results of a study reported by the Eastern Cooperative Oncology Group (ECOG) at the plenary session of the 33rd Annual Meeting of the American Society of Clinical Oncology in Denver, show promising evidence that combination chemotherapy is a better treatment for first-line metastatic breast cancer than single-agent therapy. The study, a Phase III multi-centered randomized clinical trial, was conducted by ECOG, in conjunction with other National Cancer Institute (NCI) sponsored cooperative groups, including the North Central Cancer Treatment Group and the Southwest Oncology Group. Taxol(R) (paclitaxel) and Adriamycin(R) (doxorubicin) are currently considered two of the most active agents against breast cancer. This study was designed to compare the response rate, time to progression of disease and overall survival of patients with metastatic breast cancer. There were three treatment arms compared: Taxol vs. Adriamycin vs. a combination of Taxol and Adriamycin. As part of the study, there was a "cross-over'' design for the wo single-agent arms. Some patients who initially received Adriamycin and experienced progression of disease were then placed on Taxol therapy. Similarly, some patients who initially received Taxol therapy and had disease progression were placed on Adriamycin. Seven hundred thirty nine patients with recurrent or metastatic breast cancer were randomized to receive Adriamycin (60 mg/m2), Taxol (175 mg/m2/24hr.), or the combination of Adriamycin/Taxol (50 mg/m2/150 mg/G-CSF) in the first line setting. "In this trial, the combination of Taxol (paclitaxel) plus Adriamycin (doxorubicin) has shown better response than either of the single agent therapies,'' said George W. Sledge, Jr., M.D., ECOG study chairman, Indiana University School of Medicine, Indianapolis, IN. "The combination therapy data shows superior overall response rates and time to treatment failure over single agent therapy.'' For example, the average length of time until disease progression (or time to treatment failure) in a patient on the combination therapy arm was greater than the time to treatment failure on either of the single agent arms. Additionally, no greater cardiac toxicity was seen in the combination therapy compared with the single agent therapy, Adriamycin. The study also showed no differences between Taxol and Adriamycin used as single agents. There appears to be no differences seen in quality of life. Further review of this data is necessary to fully assess the responses of the crossover therapy. The results of this study were based on analysis of data collected over a two and a half year period. Some further analysis of the data may be conducted. ECOG, supported by the NCI, is devoted to the study and cure of cancer. Established in 1955, ECOG is an international organization of over 365 university and community based hospitals/practices. The membership includes over 4,000 participating scientists and health care professionals, including physicians, statisticians, nurses, clinical research associates, and pharmacists.
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