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At its core, screening for breast cancer aims to save lives. The idea is intuitively attractive: Find a tumor early, before the disease becomes more serious, and some combination of surgery, radiation, chemotherapy, and hormone therapy can reduce a woman’s chance of dying from breast cancer.
But it’s not so simple. The pluses and minuses of mammograms, used to detect breast cancer, have created disagreement about when and how often women should be screened.
|No Two Patients Should Be Treated the Same—PCORI-funded researchers want to know whether tailoring treatments to a patient's specific needs and desires will provide better outcomes.|
Breast cancer surgeon and researcher Laura Esserman, MD, MBA, says, “Breast cancer turns out to be a mix of several different types of cancer that range from slow growing and not likely to be harmful to very aggressive, with a high chance of causing death. Early detection does not improve treatment success for all kinds of breast cancer. That complicates approaches to early detection.”
To help women make better-informed decisions, Esserman is leading a PCORI-funded project that compares the outcomes of women who have annual mammograms with those of women who receive mammograms on a schedule determined by their personal risk. The project, called the Wisdom Study, will begin recruiting participants this summer.
For National Women’s Health Week, May 8 to 14, PCORI spoke with Esserman and one of her patient partners, Diane Heditsian, a communications professional who has been diagnosed with two different breast cancers.
Why do we need a study of mammography?
Diane Heditsian: It’s been extremely confusing to women over the last years. Women don’t know when and how often to get mammograms. Reports appear in the media regularly stating that the US Preventive Services Task Force, the American Cancer Society, and other organizations all have different guidelines for breast cancer screening. Women are afraid of breast cancer, and they don’t know what to do.
Laura Esserman: Mammography screening is one of the most controversial areas of medicine today. Mammograms sometimes suggest that a woman has cancer, but later, more-accurate tests show that she doesn’t. The initial result creates anxiety, and the woman gets procedures that have their own risks and side effects that can cause suffering. The experience may undermine women’s willingness to undergo future screening.
We also now know that there are some early or precancerous breast lesions that you actually could leave alone. Some tumors spotted on mammograms may grow extremely slowly and never spread, and so women with such tumors undergo unnecessary treatment. The more intensively you screen, the more you will find these kinds of precancerous lesions. More screening is not necessarily better. It is just more. And sometimes more is worse. That is what we are going to study.
Who will participate in this study, and who will benefit from it?
Laura Esserman: We’re recruiting 100,000 women. We’ve designed the trial so that any woman at the designated centers between age 40 and 74 can participate, unless she’s had a diagnosis of breast cancer. A woman normally undergoes screening for 30 to 40 years. Why not participate in the study for five years of that and help answer the question for yourself, your mother, daughters, sisters, and friends?
In the main part of the study, women will be randomly assigned to annual or personalized screening. We’re going to test everyone for errors or variations in genes that are associated with breast cancer, and we’ll combine that with family history, breast density, and other individual factors to figure out a woman’s risk. On the basis of that risk, we will assign an age to start, an age to stop, and how often to screen.
Randomization will give us the best answer. But if women feel strongly, they can choose which arm they want—the personalized arm or the annual arm.
Diane Heditsian: Patient partners were involved in the early study design and suggested that a part of the study should be for women with strong opinions about screening, who don’t want to be randomly assigned but want to participate in the study.
Laura Esserman: We believe we can learn from everyone. For women who don’t want to be randomized, we will compare the outcomes of those who choose annual screening versus those who choose the individualized approach. This information will supplement what we get from the randomized part of the trial. Women, doctors, insurers all want this information. If everyone participates, then everyone’s going to benefit.
Ms. Heditsian, what perspective do you bring to the study as a patient?
Diane Heditsian: I’m a two-time survivor of breast cancer. Both tumors were early-stage cancers, and both were caught with mammograms. But in the first case, I had to go through chemo because there was no personalized test yet to tell whether my tumor was at high or low risk of recurring and whether chemo would help. It was almost a year of my life. But I got a wig, I went back to work, and I weathered the chemo. Still, there are long-term effects from those very toxic drugs that will be with me for the rest of my life.
Exactly 10 years later, at the time of my cancer diagnosis in the other breast, I was a patient of Dr. Esserman. By then, personalized medicine had emerged, so she was able to offer me a genomic test of the biology of this specific tumor. The results came back that I had an ultralow risk of recurrence and low likelihood that chemo would be of benefit. With Dr. Esserman’s help, I chose to forgo chemo.
So I am a big fan of personalized medicine that can tell us what is the appropriate amount of care—not overtreatment or undertreatment. As a patient partner on the Wisdom Study, I’m committed to seeing if this personalized approach can successfully determine the appropriate screening schedule for each woman.
What study results would you like to see?
Laura Esserman: I don’t have a stake in saying the women receiving personalized screening will do better than the others. But I think they will. I think there will be less testing and less anxiety, and the women will be just as safe. By that I mean, we won’t see more cases of advanced breast cancer. We also want to find out, do women feel comfortable with the individualized approach?
Everyone benefits if we come up with more-targeted approaches where fewer people receive unnecessary tests and treatments, and more of the people whose lives are at risk are getting optimal screening and treatment. We need to develop and test an entirely new approach to optimize how we screen, taking into account every woman’s risk and potential benefits.
Diane Heditsian: I think a personalized approach is the way to go with breast cancer screening. But mostly I hope the study results will end the confusion over how often and at what ages women should be screened. That is my hope, to settle it one way or the other.
The views expressed here are those of the author(s) and not necessarily those of PCORI.
December 19, 2018, 6:05 PM
Comment by Diane Heditsian,
Although the WISDOM Study began in California additional states in which women can enroll are being added all the time. Women in Illinois and New Jersey can now enroll and in January 2019 women we're adding 8 additional states. Visit WISDOMStudy.org for the latest updates and to enroll.
December 19, 2018, 6:01 PM
Comment by Diane Heditsian,
The WISDOM Study is adding new states in which women can participate. We have just added Illinois and New Jersey and at the beginning of the year 8 additional states will be added. Please check www.wisdomstudy.org for updates and to participate.
May 11, 2016, 2:19 PM
Comment by Lila Guterman, PCORI,
Thank you for your interest! The Wisdom Study will be taking place at the Athena Breast Health Network (University of California medical schools) and the Sanford Health system.
May 10, 2016, 7:45 PM
Comment by Wendy Nickel,
I would be very interested in learning which centers are participating.
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