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Selection of patients who are most likely to benefit from Herceptin is important because of the possible serious risks from the drug, including weakening of the heart muscle that can lead to congestive heart failure. It is not known whether Herceptin has beneficial effects in women with normal levels of the HER2 protein.

FDA also approved in September 1998 a test called DAKO HercepTest to measure HER2 protein in tumors.

Nolvadex: A drug that has been used as a breast cancer treatment for more than 20 years, Nolvadex (tamoxifen citrate) was approved by FDA in October 1998 for breast cancer risk reduction in high-risk women.

Doctors know that estrogen promotes the growth of breast cancer cells. Tamoxifen interferes with the activity of estrogen by slowing or stopping the growth of cancer cells already present in the body. As adjuvant therapy, tamoxifen has been shown to help prevent both the original breast cancer from returning, and also the development of new cancers in the other breast.

A National Cancer Institute study showed that the drug reduced the short-term chance of getting breast cancer by 44 percent in women who were judged to be at increased risk for the disease. FDA emphasizes, however, that tamoxifen, manufactured by Zeneca Pharmaceutical Inc., Wilmington, Del., will not eliminate breast cancer risk completely, and should be used only following a medical evaluation of individual risk factors.

Due to potentially serious side effects, including endometrial (lining of the uterus) cancer and blood clots in major veins and the lungs, the American Society of Clinical Oncology recommends that patients talk with their regular health-care providers to determine whether individual medical circumstances and histories are appropriate for considering use of tamoxifen.

Xeloda: Xeloda (capecitabine), made by Hoffmann-La Roche, Nutley, N.J., was approved by FDA in April 1998 for the treatment of breast cancer that has spread to other parts of the body (metastasized) and is resistant to both paclitaxel and an anthracycline-containing regimen. Xeloda does not kill the cancer cells directly. Instead, once the drug enters the cancer cells, it is metabolized to 5-fluorouracil (5-FU), a drug routinely used for breast cancer. The advantage of Xeloda, in addition to the convenience of its pill form, is that cancer cells actively convert it to 5-FU, but normal cells convert very little to 5-FU.

Taxotere: In May 1996, FDA gave accelerated approval to Taxotere (docetaxel) to treat patients whose locally advanced or metastasized breast cancer has progressed despite treatment with other drugs. The approval was conditional on the manufacturer, Rhone-Poulenc Rorer Pharmaceuticals, Inc., Collegeville, Pa., conducting additional studies. In June 1998, after additional studies confirmed its safety and effectiveness, the drug was granted full FDA approval.

In addition to these newer drugs, combinations of the anticancer drugs Cytoxan (cyclophosphamide) and Adriamycin (doxorubicin), with or without Adrucil (fluorouracil), may be used to treat breast cancer.

Chemotherapy (drug treatment) is given in cycles, with each period of treatment followed by a recovery period. The total course of chemotherapy can last three to six months, depending on the drugs and how far the cancer has spread.

Kelly Munsell of Tucson, Ariz., took the combination Adriamycin and Cytoxan in six cycles, spaced three weeks apart, after doctors diagnosed her breast cancer in 1996 at age 27.

"Chemo for me was torture," Munsell recalls, describing profuse vomiting and severe weight gain as two of the serious side effects. But despite the discomfort, Munsell, whose mother and grandmother both died of breast cancer, is glad she underwent the grueling treatment two years ago. "My recent battery of tests came back negative for cancer," she says.

In addition to the drugs actually battling the disease, there also is help for patients in severe pain from cancer. FDA approved Actiq (oral transmucosal fentanyl citrate) in November 1998 as a treatment specifically for cancer patients with severe pain that breaks through their regular narcotic therapy. A narcotic more potent than morphine, Actiq is in the form of a flavored sugar lozenge that dissolves slowly in the mouth. Actiq is approved for patients already taking at least 60 milligrams of morphine per day for their underlying persistent cancer pain.

Looking Ahead

It is important for every woman to consider herself at risk for breast cancer, ACS says, simply because she's female. At the same time, however, studies continue to uncover lifestyle factors and habits that can alter that risk, and many new chemotherapy drugs and drug combinations continue to be developed and tested in clinical trials. Drugs and procedures currently under investigation include bisphosphonates (a group of drugs routinely used to treat osteoporosis), monoclonal antibodies (similar to Herceptin), and angiogenesis inhibitors (drugs that block the development of blood vessels that nourish cancer cells).

"While death rates from breast cancer are falling, and while there are a number of exciting new strategies being developed," says Michael A. Friedman, M.D., former FDA deputy commissioner and cancer research specialist, "we recognize that a great deal more needs to be done."

Mammography: A Lifesaving Step

The American Cancer Society says that the best strategy for successfully beating breast cancer is to follow guidelines for early detection. Currently, the most effective technique for early detection is screening mammography, an x-ray procedure that can detect small tumors and breast abnormalities up to two years before they can be felt and when they are most treatable.

Studies show that regular screening mammograms can help decrease the chance of dying from breast cancer. Finding a breast tumor early may mean that a woman can choose breast-saving surgery. Furthermore, she may not have to undergo chemotherapy.

Cancer Liaison Program

FDA's Cancer Liaison Program answers questions from patients, their friends and family members, and patient advocates about therapies for life-threatening diseases. The staff works closely with cancer patients, other federal agencies (including the National Cancer Institute), and cancer patient advocacy programs, listening to their concerns and educating them about the FDA drug approval process, cancer clinical trials, and access to investigational therapies.

Stages of Breast Cancer

Stages of breast cancer, according to the American Cancer Society, indicate the size of a tumor and how far the cancer has spread within the breast, to nearby tissues, and to other organs. Specific treatment is most often determined by the following stages of the disease:

Carcinoma in situ: Cancer is confined to the lobules (milk-producing glands) or ducts (passages connecting milk-producing glands to the nipple) and has not invaded nearby breast tissue.

Stage I: Tumor is smaller than or equal to 2 centimeters in diameter and underarm (axillary) lymph nodes test negative for cancer.

Stage II: Tumor is between 2 and 5 centimeters in diameter with or without positive lymph nodes, or tumor is greater than 5 centimeters without positive lymph nodes.

Stage III: This stage is divided into substages known as IIIA and IIIB:

IIIA: Tumor is larger than 5 centimeters with positive movable lymph nodes, or tumor is any size with lymph nodes that adhere to one another or surrounding tissue.

IIIB: Tumor of any size has spread to the skin, chest wall, or internal mammary lymph nodes (located beneath the breast and inside the chest).

Stage IV: Tumor, regardless of size, has metastasized (spread) to distant sites such as bones, lungs, or lymph nodes not near the breast.

Recurrent breast cancer: The disease has returned in spite of initial treatment.

Tags: Breast Cancer

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