Zeneca Pharmaceuticals has launched a nationwide educational campaign about breast cancer risk assessment and the use of tamoxifen(Drug information on tamoxifen) citrate (Nolvadex). The drug recently received FDA approval for use as a preventive measure in women at high risk for developing the disease.
“A woman’s ability to decide about possible methods of reducing her risk of breast cancer must first be based on knowledge of the risk factors and then on an assessment by her doctor of her own personal risk for developing the disease,” said Gerard Kennealey, MD, vice president of medical affairs at Zeneca Pharmaceuticals. “Our educational campaign’s aim is to encourage women to understand the risk factors for breast cancer, seek information about them, and obtain a personal risk evaluation by a qualified physician. Women who are determined to be at high risk for breast cancer may then discuss the appropriateness of Nolvadex therapy with their physician. Regardless of a woman’s risk score, she should continue to practice good breast health including regular mammograms, monthly breast self exams, and annual clinical breast exams.”
Multimedia Approach
The campaign began less than 4 months after tamoxifen was authorized by the FDA for this new indication. The FDA’s approval followed the National Cancer Institute’s announcement of the results of its Breast Cancer Prevention Trial (BCPT), which showed that tamoxifen reduces the incidence of breast cancer by 44% in women who are at high risk of developing the disease.
The campaign includes a 60-second television spot called, “Myths,” consumer information (educational video and brochure), pharmacy education programs, and physician risk assessment tools, including a computer disk, risk assessment slide rule, risk calculator, and a toll-free hot-line for physician risk assessment called “TeleRisk.”
Overcoming the “That’s Not Me” Syndrome
Dr. Marisa Weiss, a practicing oncologist, who is president and founder of Living Beyond Breast Cancer and author of a book by the same name, served as narrator for the educational video.
Dr. Weiss said, “Dealing with the ‘that’s not me’ syndrome is perhaps one of the biggest obstacles to motivating women to take control of their health. Women need to understand that knowledge is power and that knowing their true risk of breast cancer will enable them to make wise choices. This campaign attacks the myths and misperceptions head-on in a very responsible and eloquent way. The educational materials explain the nuances of risk assessment, as well as the benefits and risks of taking Nolvadex for reducing the incidence of breast cancer.”
Tamoxifen reduces but does not eliminate the risk of breast cancer and has not demonstrated an impact on survival. The risk of endometrial cancer and blood clots in the arms, legs, and lungs increases two to three times with tamoxifen use compared to placebo, although each event occurs in less than 1% of women. Stroke, cataracts, and cataract surgery also develop more frequently with tamoxifen, and many treated women experience vaginal discharge and some level of hot flashes.
Tamoxifen therapy may not be appropriate for all women at high risk. For example, women who are pregnant, have a history of blood clots, or who use warfarin(Drug information on warfarin) or coumarin should not take tamoxifen.
Ignorance About Breast Cancer Risk Is Widespread
Recent national surveys report that women are not as informed about their risks for breast cancer as they should be. Most women either underestimate or overestimate their own personal risks and tend not to understand the importance of age as a risk factor. Even the most commonly quoted statistic about breast cancer—that it will affect one woman in nine—is often misunderstood.
The Gail Model Risk Assessment Tool, used in the BCPT trial and developed by Dr. Mitchell Gail, a scientist and researcher at the National Cancer Institute, can accurately forecast a woman’s 5-year and lifetime risk of developing breast cancer. It incorporates a sequential series of questions covering risk factors such as current age, age at first period, number of breast biopsies, age at first birth, and family history of breast cancer in first-degree relatives.
Zeneca has created a slide rule and calculator version of the Gail Model Risk Assessment Tool to facilitate the risk evaluation process for physicians. The company has also set-up a toll-free hot-line for physicians so that they can call in risk assessments and receive a patient’s score. Physicians should contact their Zeneca or Roche representatives for information on risk assessment tools or call 1-800-898-9702.
For full prescribing information for tamoxifen, call 1-800-456-3669 ext. 2231or access the World Wide Web at www.nolvadex.com. For consumer education material about breast cancer risk reduction or physician risk assessment tools, call 1-800-898-9702.
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