[MOL] Canada Approves Taxol (Paclitaxel) Adjuvant Therapy For Early Brea [01885] Medicine On Line


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[MOL] Canada Approves Taxol (Paclitaxel) Adjuvant Therapy For Early Breast Cancer



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Title: Canada Approves Taxol (Paclitaxel) Adjuvant Therapy For Early Breast Cancer
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Canada Approves Taxol (Paclitaxel) Adjuvant Therapy For Early Breast Cancer

MONTREAL, QC -- April 18, 2000 -- Thousands of Canadian women diagnosed with breast cancer now have a new treatment option. Health Canada has just approved Taxol(R) (paclitaxel) Injection as an adjuvant therapy for early stage breast cancer, giving thousands of women renewed hope of a cure.

"This represents a significant step forward and a platform on which to build," said Dr. Clifford Hudis, a leading American cancer doctor in a presentation to a satellite symposium at the National Cancer Institute of Canada's clinical group meeting over the weekend. "The addition of this non- cross resistant agent to standard regimens appears to improve outcomes," Dr. Hudis told the doctors at the Toronto meeting.

Approval of Taxol was based in part on the results of a U.S. nationwide study (Cancer and Leukemia Group B-CALGB) involving more than 3,000 women - the largest adjuvant breast cancer study ever conducted. The CALGB study compared doxorubicin plus cyclophosphamide (AC) alone versus AC followed by Taxol in women with breast cancer that spread to the lymph nodes under the arm. The results were first reported at the ASCO 1998 meeting (American Society of Clinical Oncology) in Los Angeles and became the catalyst for AC followed by Taxol becoming the standard treatment for treating adjuvant breast cancer in the U.S.

"In the United States, AC followed by T was felt to represent the single most significant advance in the treatment of breast cancer in the past 20 years," said Dr. Brian Leyland-Jones, professor of Medicine and Oncology at the McGill University and Physician at the Montreal General Hospital, the Royal Victoria Hospital and the St-Mary's Hospital in Montreal.

"The fact that most clinical trials in node positive adjuvant breast cancer now incorporate taxanes as an integral part of the treatment regimen confirms the importance of this observation. I am delighted that AC followed by Taxol is now available in Canada as a treatment option for women with early breast cancer," said Dr. Leyland-Jones, who moderated the satellite symposium. "It is critical that women with breast cancer are diagnosed and treated early to increase their chances of living disease free," he said.

"The approval by Health Canada further supports the clinical benefit of Taxol Injection," said Nacia Faure, M.D., and medical director at Bristol- Myers Squibb, manufacturer of Taxol. "CALGB clearly demonstrated that Taxol improves survival in patients with early stage breast cancer, which is why we remain committed to researching new applications and developing Taxol to its fullest potential," she said.

Breast cancer is the second leading cause of cancer death in Canada after lung cancer, according to recently released statistics from the Canadian Cancer Society. It is estimated that 19,200 women will be diagnosed with breast cancer this year. Approximately 40 per cent are candidates for adjuvant therapy. Research shows that one in eight women will develop breast cancer in her lifetime. Forty years ago, the risk was one in 14.

Advances in chemotherapy treatments such as adding Taxol to doxorubicin- containing adjuvant chemotherapy have reduced a woman's risk of developing recurrent breast cancer. In treating early stage breast cancer, adjuvant chemotherapy is used soon after surgery to help cure the patient. Adjuvant therapies, including chemotherapy, hormone and radiation therapy, are used either alone or in combination to combat the spread of disease throughout the body.

Taxol was first approved in Canada in 1992. It has been used to treat cancer in hundreds of thousands of patients around the world and is currently indicated, alone or in combination, as first-line treatment for ovarian carcinoma, second-line treatment of metastatic carcinoma of the ovary, second- line treatment of metastatic carcinoma of the breast and first-line of treatment of advanced non-small cell lung cancer.

Taxol is generally well tolerated. The most common side effects are reduction in white blood cell count, known as myelosuppression, hair loss and numbness. Numbness in the extremities (peripheral neuropathy), muscle or joint pain (myalgia/arthralgia), diarrhea and nausea also may occur. A less frequent but serious side effect is severe hypersensitivity reaction, which is demonstrated by symptoms of shortness of breath, low blood pressure and rash.

Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. Its Canadian operations are headquartered in Montreal, Quebec.

Related Links: Taxol (paclitaxel) and Bristol-Myers Squibb.

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