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| |  FDA Advisory Panel Backs Taxol For Adjuvant Breast Cancer Treatment PRINCETON, N.J. -- September 17, 1999 -- The Oncologic Drugs Advisory Committee (ODAC) today unanimously recommended that the U.S. Food and Drug Administration approve Taxol® (paclitaxel) Injection for sequential administration to doxorubicin-containing therapy for the adjuvant treatment of node-positive breast cancer. This recommendation was based on data from a nationwide study led by the Cancer and Leukemia Group B (CALGB) involving more than 3,000 women, the largest adjuvant breast cancer study ever conducted. Of the more than 180,000 women diagnosed with breast cancer each year in the U.S., approximately 40 percent are candidates for adjuvant therapy. "In a challenging disease like cancer, where ground-breaking advances are often made in only minor increments, this recommendation represents a major step forward for patients," said Richard L. Schilsky, M.D., professor of medicine, associate dean for clinical research, University of Chicago, and chairman, CALGB. "It is even more critical now that women with breast cancer are diagnosed and treated early to increase their chances of living disease free." The CALGB-9344 study results demonstrate 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. The study was a randomized, phase III clinical trial comparing doxorubicin plus cyclophosphamide alone versus these drugs followed by Taxol in women with breast cancer that spread to the lymph nodes under the arm. "Today’s recommendation further supports the clinical benefit of Taxol (paclitaxel) Injection," said Renzo Canetta, M.D., vice president, clinical oncology, Bristol-Myers Squibb. "This study which demonstrates Taxol improving survival in patients with early stage breast cancer illustrates why we remain committed to researching new applications and developing Taxol to its fullest potential." In the U.S., breast cancer is the second leading cause of cancer death in women, after lung cancer. It comprises approximately 30 percent of all female cancer cases and 16 percent of all female cancer deaths. One in eight women will develop breast cancer in her lifetime. In 1960, the risk was one in 14. Improvements in chemotherapy treatments, such as adding Taxol to doxorubicin-containing adjuvant chemotherapy, have reduced a woman’s risk of developing recurrent breast cancer. "When approved by the FDA, this latest advance will provide breast cancer patients an additional early-stage treatment option," said Susan Nathanson, executive director, Y-ME. Ongoing research continues to demonstrate that early detection and treatment may significantly increase a breast cancer patient’s chance of being disease-free. "We want women diagnosed with breast cancer to educate themselves and make informed decisions about all the powerful new therapies available to them." "Taxol continues to demonstrate versatility in treating a variety of cancers, particularly in the early stages of breast cancer when there is a real hope for cure," said Rick Winningham, president, Bristol-Myers Squibb, Oncology/Immunology. "This advance will help enable physicians to extend the lives of the brave women battling breast cancer." In breast cancer, adjuvant chemotherapy is used soon after surgery, primarily in early stage disease, with the objective of curing 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. Since it was first cleared for marketing in the U.S. in 1992, Taxol has been used to treat cancer in hundreds of thousands of patients around the world. Currently Taxol is approved as first-line (in combination with cisplatin) and subsequent therapy for the treatment of advanced cancer of the ovary and for the treatment of breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline, unless clinically contraindicated. Taxol (paclitaxel) Injection is also indicated for use in combination with cisplatin for first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy, and for second-line treatment of AIDS-related Kaposi’s sarcoma. In general, Taxol is 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 in breath, low blood pressure and rash. All patients who receive Taxol should be premedicated as specified in the product insert prior to receiving Taxol to help prevent this reaction.
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