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FDA approves Taxol  for early breast cancer treatment (dateline November 10, 1999)

The U.S. Food and Drug Administration recently approved the anti-cancer drug Taxol (generic name paclitaxel) to treat early stage breast cancer that has spread to the lymph nodes under the arm. The approval comes after a unanimous recommendation from the FDA’s Oncologic Drugs Advisory Committee (ODAC). In the largest adjuvant breast cancer study ever conducted, the Cancer and Leukemia Group B (CALGB) ( observed a 20% decrease in recurrent node-positive breast cancer and a reduced mortality rate of 26% in 3000 patients who were given Taxol. Taxol has been approved to treat early breast cancer in patients who have received doxorubicin-based chemotherapy.

First marketed in 1992, Taxol has also been used to treat metastatic breast cancer (cancer that has spread beyond the breast and lymph nodes under the arm), ovarian cancer, certain types of lung cancer, and in some cases, Karposi’s sarcoma (Karposi’s sarcoma is a cancer that begins as soft, brownish, or purple pimples on the feet and spreads through the skin to the lymph nodes and abdominal organs). Since it is now estimated that more than 180,000 women will be diagnosed with breast cancer each year in the United States, researchers are focusing more and more on preventive and early-stage treatment options. According to the ODAC, 40% of breast cancer patients are candidates for adjuvant chemotherapy (drug therapy in addition to other treatment).

Adjuvant chemotherapy is commonly used in early breast cancer patients soon after breast surgery (lumpectomy or mastectomy) in hopes of completely eliminating the cancer. Adjuvant therapies (chemotherapy, hormone treatment, radiation, etc.) are often used alone or in conjunction with other breast cancer treatments to prevent cancer from spreading to other parts of the body. In clinical trials, women who received Taxol after chemotherapy consisting of doxorubicin plus cyclophosphamide had significantly higher breast cancer survival rates compared to women who underwent the doxorubin/cyclophosphamide chemotherapy alone.

Richard L. Schilsky, M.D. and professor of medicine at the University of Chicago believes using Taxol to treat early breast cancer will greatly improve a patient’s chances of living disease-free. In its 3000 patient study, the CALGB reported that Taxol was well-tolerated by most women.

Common side effects to Taxol include:

  • a reduced white blood cell count (myelosuppression)
  • hair loss (alopecia)
  • numbness in the extremities (peripheral neuropathy)

Other side effects of Taxol include:

  • muscle or joint pain (myalgia/arthralgia)
  • diarrhea
  • nausea

In addition to treating early breast cancer, Taxol is used to effectively treat advanced stages of the disease. A recent study published in the Journal of Clinical Oncology revealed that women with metastatic breast cancer who were given Taxol with CMFP (cyclophosphamide, methotrexate, 5-fluorouracil and prednisone) combination chemotherapy have a 39% two year survival rate compared to a 20% survival rate among women who received CMFP chemotherapy alone.

Women with breast cancer are encouraged to discuss Taxol with their cancer treatment team.

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