Canada Approves Taxol (Paclitaxel) For Adjuvant Treatment
Of Breast Cancer
MONTREAL, QC -- April 14, 2000 -- Health Canada today approved Taxol(R)
(paclitaxel) for the adjuvant treatment of node positive breast cancer
administered sequentially to standard combination therapy, doxorubicin
and cyclophosphamide (AC). In early stage breast cancer this new treatment
option increases the chance for cure and will renew hope for thousands
of Canadian women.
"There is no doubt that AC followed by Taxol is an option that should
be offered to Canadian women fighting early breast cancer. This is a major
step forward in the treatment of node-positive breast cancer, especially
with a challenging disease like cancer, where ground-breaking advances
are often made in minor increments," 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. "It is critical that women with breast cancer are
diagnosed and treated early to increase their chances of living disease
free."
Approval of Taxol was based in part on the results of an 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-9344 study
was a randomized, phase III clinical trial comparing doxorubicin plus cyclophosphamide
(AC) alone versus AC followed by Taxol in women with breast cancer that
spread to the lymph nodes under the arm. This study, first reported at
the ASCO 1998 meeting (American Society of Clinical Oncology) in Los Angeles,
was the catalyst for AC followed by Taxol becoming the standard of care
for treating adjuvant breast cancer in the U.S.
The study results demonstrate a significant survival advantage in the
Taxol arm with a reduction in the risk of relapse of 22 percent (P equals
0.0022) and a reduction of 26 percent in the relative risk of death (P
equals 0.0065). This is a major advance similar to that which was seen
nearly 30 years ago when it was discovered that combination chemotherapy
after surgery improved breast cancer survival compared to surgery alone.
"Today's approval by Health Canada further supports the clinical benefit
of Taxol," said Dr. Nacia Faure, 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. Of the more than 18,700 women diagnosed with breast
cancer each 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.
The AC followed by Taxol adjuvant chemotherapy regimen is considered
to be a major advance in reducing 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 continues to demonstrate versatility in treating a variety of
cancers," said Dr. Nacia Faure. "This advance will help enable physicians
to extend the lives of women battling breast 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, and is one of Canada's largest pharmaceutical companies with
more than 1200 employees. Its principal businesses are pharmaceuticals,
consumer products, nutritionals and medical devices. It is a leading maker
of innovative therapies for cancer, cardiovascular, metabolic and infectious
diseases, central nervous system and dermatological disorders. Its Canadian
head office is located in Montreal, Quebec.
Related Links: Taxol
(paclitaxel) and Bristol-Myers
Squibb.
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