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Title: Study Shows Taxol Improves Survival In Metastatic Breast Cancer Patients
URL: http://www.pslgroup.com/dg/11D5BE.htm
Doctor's Guide
August 4, 1999


SYDNEY, AUSTRALIA -- Aug. 4, 1999 -- Results from a landmark study have demonstrated a significantly increased survival with good quality of life for metastatic breast cancer patients treated with Taxol(R) (paclitaxel).

The study, published in this month's Journal of Clinical Oncology, compared single-agent Taxol to a standard combination of cyclophosphamide, methotrexate, 5-fluorouracil and prednisone (CMFP).

The phase III randomised multicentre trial enrolled 209 patients with previously untreated metastatic breast cancer and was designed to compare single-agent Taxol and CMFP combination chemotherapy as first-line treatments. The study reported a 39 percent two-year survival rate for the Taxol regimen compared to a 20 percent two-year survival rate for the CMFP chemotherapy regimen. Therefore, patients on the Taxol arm had almost double the chance of being alive after two years. Taxol improved survival by an estimated 30 percent when adjusting for factors such as visceral disease, performance status and years since initial diagnosis. The median survival rate for the Taxol arm was 17.3 months compared to 13.9 months for the CMFP arm.

"The single-agent Taxol regimen significantly increased survival for breast cancer patients with metastatic breast cancer without compromising quality of life," said James Bishop, M.D., director, Sydney Cancer Centre, professor of cancer medicine, The University of Sydney, Australia, and lead investigator of the study. "As the more favourable regimen, Taxol should be considered a standard of care for first-line treatment of metastatic breast cancer."

One of the primary treatment objectives for metastatic breast cancer patients is palliation and maintaining the highest possible quality of life. The Bishop study included an intensive quality of life assessment by both patients and physicians in addition to monitoring side effects. Patients on the Taxol arm experienced significantly less toxicity across several parameters, including nausea and vomiting, mucositis, leucopenia and thrombocytopenia. Additionally, patients on the Taxol regimen experienced fewer infections and were hospitalised less frequently for subsequent infections than patients on CMFP. General side effects associated with the Taxol regimen included alopecia, peripheral neuropathy and arthralgia/myalgia.

Taxol patients reported an improvement in overall quality of life while patients on the CMFP arm actually experienced a decline in quality of life.

"This study shows improved survival with Taxol with less chemotherapy related side-effects such as mouth ulcers and nausea,"
Dr. Bishop said.


The National Comprehensive Cancer Network, an organisation comprised of 17 prestigious United States institutions representing the best in cancer care and research, considers taxanes, such as Taxol, as a preferred first-line treatment for metastatic breast cancer.

"This study is part of a growing body of scientific research demonstrating the value of Taxol across all stages of breast cancer,"
Dr. Bishop said. "Taxol has clearly shown a survival benefit for early stage as well as metastatic breast cancer patients."


Approximately 180,000 new cases of breast cancer are diagnosed each year in the United States, according to the American Cancer Society. Breast cancer is the second leading cause of cancer deaths in women. In 1999 approximately 43,300 women and 400 men will die in the United States. Today, there are approximately 164,000 American women living with metastatic breast cancer.

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