Zeneca Pharmaceuticals has launched a
nationwide educational campaign about breast cancer risk assessment
and the use of 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 womans 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 campaigns 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 womans risk
score, she should continue to practice good breast health including
regular mammograms, monthly breast self exams, and annual clinical
The campaign began less than 4 months after tamoxifen was authorized
by the FDA for this new indication. The FDAs approval followed
the National Cancer Institutes 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
Overcoming the Thats 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 thats 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 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 cancerthat it will
affect one woman in nineis 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 womans
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
patients 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.