Taxotere Plus Doxorubicin Active in Metastatic Breast Cancer

EMBARGOED: Not for publication before 11:00 a.m EST, December 15, 1998
Contact: Trish Bates/215-893-6436

Taxotere Plus Doxorubicin Shows Significant Activity in Metastatic Breast Cancer

San Antonio, Texas, December 15, 1998 -- Researchers from the Eastern Cooperative Oncology Group (ECOG) reported today that the combination of two chemotherapeutic agents, Taxotere (docetaxel) plus doxorubicin, is highly active for the treatment of patients with metastatic breast cancer. The physicians were so encouraged by the results with this combination that they have launched a national clinical trial comparing it with a standard chemotherapy regimen in patients with early stage breast cancer. The researchers hope that this new regimen will increase the likelihood of curing early stage disease.

ìThis trial demonstrated that Taxotere and doxorubicin is an active combination for patients suffering from advanced stage breast cancerî, said Dr. Joseph A. Sparano, Director of Breast Medical Oncology at Montefiore Medical Center and the principle investigator of the trial. ìThe use of Taxotere with doxorubicin did not increase the risk of congestive heart failure, a potentially serious complication of doxorubicin therapy. An increase in the risk of heart failure has been seen when other effective drugs are combinedî.

The research involved 54 patients with metastatic breast cancer that had spread beyond the breast to other organs of the body. Fifty-seven percent of patients responded to the therapy, and the response has lasted an average of at least 9 months. Only 4% of patients developed congestive heart failure, a rate of heart failure that is expected for the amount of doxorubicin that patients received.

ìThis regimen was the most effective one in this type of breast cancer that we have tested over the past five years in ECOGî, said Dr. Sparano. ìWe hope that this regimen will more effectively kill microscopic cancer cells after surgery, and therefore increase the likelihood of being cured.î

The ECOG trial that Dr. Sparano referred to, entitled E2197: Phase III Study of Adriamycin/Taxotere vs Adriamycin/Cytoxan in the Adjuvant Treatment of Node Positive and High Risk Node Negative Breast Cancer,î is a newly opened national clinical trial that will involve nearly 3000 women with early stage breast cancer. The trial is supported by the National Cancer Institute. Other groups currently participating in this trial include the North Central Cancer Treatment Group and the Southwest Oncology Group.

Each year, about 180,000 women are diagnosed with breast cancer. It is the leading cause of death in women ages 40-50, accounting for 20% of all deaths in this age group. About 70,000 women each year develop early stage breast cancer, the type of breast cancer that is being included in the E2197 trial.

ECOG, supported by funding from the NCI, is dedicated to the study, prevention, and cure of all forms of adult cancer. Established in 1955, ECOG includes approximately 365 university and community based hospital/practices and over 4,500 researchers and health care professionals, including physicians, statisticians, nurses, clinical research associates, and pharmacists. The Groupís primary function is to evaluate leading treatment alternatives in multicenter cancer clinical trials.

ECOG also conducts smaller trials that assess dosing, toxicity, and response rates. The organization also coordinates and participates in studies in cancer control, cancer prevention, and correlative laboratory science.

For more information about the study, contact the NCIís information line at 1-800-4 CANCER. For a list of ECOG institutions and telephone numbers by state, visit ECOGís website at http://ecog.dfci.harvard.edu.

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