When it comes to breast cancer screening, what works for one woman might not work for another. Mammography has been the gold-standard for many years, but experts are starting to realize that in some cases, additional screening with other technology is needed.

“Mammograms aren’t perfect and they certainly do have a decreased ability to pick up cancers in certain women, but there are ways that we’re improving,” says Dr. Jennifer Drukteinis, radiologist and director of breast imaging research at Moffitt Cancer Center.

It’s becoming more apparent that a personalized approach to breast cancer screening is needed that takes into consideration a woman’s age, risk and breast density.

Newer modalities, including contrast-enhanced spectral mammography, tomosynthesis, automated whole breast ultrasound, molecular imaging and MR, are broadening the options but the unanswered question is — how do providers determine which is the best screening option for the individual? Some hospitals are implementing personalized breast screening programs and making strides in that direction, but it’s still unclear what exactly the future of breast cancer screening will look like.

Getting more personal
NorthShore University HealthSystem in Illinois is one of the pioneers in taking a more personalized breast cancer screening approach.

In May, they launched their High Risk Breast Program after receiving a donation from the North Suburban Healthcare Foundation.

“We wanted to develop a program where any women could really come in and have her risk for breast cancer assessed because obviously it’s on the minds of a lot of women in the United States,” says Barb Guido, the program’s nurse practitioner.

Three of their hospitals currently have the program and they are working on bringing it to their fourth hospital in the near future.

Women enrolled in the program receive a health and family history evaluation and undergo a clinical breast exam and statistical risk models to identify their risk of breast cancer.

Once they collect all of that information, they stratify risk and place the women into certain categories. “We may see a woman that has an increased risk and depending on the level of risk then we make some recommendations about what things would be appropriate and develop a very personalized breast health care plan dependant on that,” says Guido.

The health care plan can range from recommending additional screening with a breast ultrasound or genetic testing, to helping women make lifestyle changes such as decreasing the amount of alcohol they drink and increasing their physical activity.

Guido says that she has been in the nursing practice for 30 years and has noticed a variety of cycles regarding the standard of care for breast cancer screening. About 10 to 15 years ago, there was a push to standardize care plans and it was important to ensure that everyone was following one set of standards, but that’s not the case anymore.

“I think we’re going away from that again and we’re now doing a more personalized approach based on what a patient’s risk factors are so that we can talk about the ones that are modifiable,” she says.

Measuring density
The reason mammography is the go-to screening tool is because it has been proven effective in catching breast cancers, based on various clinical trial results. But experts are encountering scenarios where mammography isn’t as effective. “I do think [mammography] is a viable option and I think it’s still a very good one, I just think that we’re finding alternative ways to become better,” says Moffitt’s Drukteinis.

One of the scenarios when mammography isn’t as effective at detecting breast cancer is when a woman has dense breasts. Women with dense breasts have a greater amount of connective tissue than fatty tissue and the connective tissue shows up white on mammograms, but tumors do as well.

Breast imagers are offered multiple tools to detect breast cancer; however, they are challenged with how these devices should be used and implemented,” says Jennifer Okken, product manager for the MAMMOMAT Inspiration Prime Edition at Siemens Healthcare. “We need to define — we have five or six technologies for breast imaging — what’s the best for each patient? Although we’ve done a great job so far, more studies need to be done to define clinical use,” she says.

Some doctors urge women to undergo additional screening with another method, but there is still some uncertainty around that. “It’s unclear the best way to screen,” said Dr. Carol Lee, chair of the American College of Radiology’s Communications Committee of the Breast Imaging Commission. “For women whose only additional risk factor is breast density — we really don’t know whether they need to have additional screening or if so, which modality would be best.”

The reason why it’s unclear is because there have not been any prospective, randomized trials conducted for these alternative modalities. But Lee doesn’t think that those types of trials will ever be conducted because of the time and expense involved.

However, she does think that as doctors gain more experience with the supplemental screening and by collecting that information going forward, they will be able to determine what modality is most useful for certain women.

Breast ultrasound has proven to be very helpful as a supplement to mammography when a woman has dense breasts. Recently, there have been a couple developments in the field that are making the exams faster and more comfortable for the patient.

In January, Delphinus Medical Technologies, Inc. got FDA approval for its SoftVue whole breast ultrasound tomography system. During the exam, the breast is suspended in warm water for one or two minutes and the system created a full map of the whole breast. The company says it’s the first to manufacture a breast ultrasound system that uses ring transducer technology to transmit and receive ultrasound signals.

The conventional hand-held ultrasound and automated breast ultrasound systems only receive the reflected echoes in the direction of the linear transducer but SoftVue receives reflections from all directions around the breast and also obtains transmitted signals that go through the breast.

GE Healthcare received FDA approval on its Invenia Automated Breast Ultrasound System in early June. It uses 3-D ultrasound technology to image women with dense breast faster and more comfortably.

The acquisition time is about 20 seconds faster than the first generation and the transducer is shaped to the patient’s breast. “It’s slightly concaved in nature and that makes it a lot more comfortable for the patient,” says Bob Thompson, general manager of automated breast ultrasound at GE.

One of the reasons that GE manufactured this technology is because of the heightened attention and legislative activity revolving around breast density the past few years. Connecticut became the first state in 2009 to pass a law that required radiologists to inform women that they have dense breasts and to give them advice about supplemental screening. Since then, 15 other states have enacted breast density laws, with Rhode Island being the most recent after signing the law in late May.

According to the organization, Are You Dense?, 40 percent of women have dense breast tissue. Furthermore, many studies have shown that women with dense breasts have a four-to six-fold increase in risk for breast cancer.

Siemens is also in the mix. The company designed the ACUSON S2000 Automated Breast Volume Scanner — a unit that attaches to a regular ultrasound system, to provide a full acquisition that’s reconstructed into 3-D images.

Many are supporting the notification laws, but others have their doubts. “Unfortunately, I think the intention of the breast density notification laws was good but to tell you the truth, I’m skeptical about what the outcome is going to be,” says Lee.

Right now, there is no set guidance for what a woman should do once she is notified that she has dense breasts. “What exactly does it mean to get the letter that you have dense breast — does that mean a woman should go out and seek supplemental screening?,” says Lee. “I don’t know that that has been determined.”

The traditional way to measure breast density is with the American College of Radiology’s Breast Imaging Reporting and Data System (BI-RADS). It classifies breast density in four groups from entirely fatty to extremely dense.

Entirely fatty is when the glandular tissue is less than 25 percent of the breast, scattered fibroglandular densities is when fibrous and glandular tissue is 25 to 50 percent of the breast, heterogeneously dense means there is 51 to 75 percent of fibrous and glandular tissue found throughout the breast and extremely dense is when the breast is made up of 75 percent fibrous and glandular tissue.

The radiologist is the one who interprets how dense the woman’s breast is and interpretations may vary. In light of that, several companies have manufactured automated breast density measurement tools.

Philips Healthcare received FDA clearance on their Spectral Breast Density Measurement Application for their MicroDose SI full-field digital mammography system in December 2013. The company claims that it’s the first tool that can differentiate fat and glandular tissue to accurately measure volumetric breast density.

It independently measures the glandularity and thickness in each pixel of the mammogram image to calculate the total volume and volumetric percentage of glandular tissue. After the calculations are complete, the examination is automatically allocated a MicroDose density score that correlates to the BI-RADS.

It does all of that with photon counting technology, which sorts photons into low or high energy categories, and eliminates the need for two exposures.

iCAD Inc. and VuCOMP Inc. also have products on the market. iCAD’s Volpara uses a 3-D volumetric measurement of the dense fibroglandular tissue and the volume of the breast and produces a breast density in the range of zero to 35 percent. What they call the Volpara Density Grade maps directly to the BI-RAD categories.

Instead of using a volumetric approach, VuCOMP’s M-Vu Breast Density analyzes the structure and texture of the tissue and calculates a percentage of the breast areas that are dense and converts it to one of the four BI-RAD categories.

Lee has reservations about these automated programs though. “All of the data on density and risk have not been based on these automated programs,” she says. “I think that the research has to be done about how they operate and what the significance is.”

She says it’s not that simple to prove significance because it’s not only important to know the percentage of density, but also the pattern of it. “Density is not like your cholesterol level — it’s not one number, it’s a whole spectrum of different tissue patterns,” she says.

Determining the best treatment
The way that women are screened for breast cancer is starting to change and the way they are treated is also changing. Genomic tests are one of the recent developments that have shown promise in helping to determine the course of action to help treat the disease.

At the American Society of Breast Surgeons conference this year, evidence was revealed that showed that Agendia’s MammaPrint and BluePrint are genetic tests that provide insight into how to treat breast cancer. Tests like these examine the activity of genes inside of a cancer tumor in order to give a more comprehensive view of the cancer and treatment choices.

MammaPrint predicts how likely a woman’s breast cancer will recur and may help discern between patients who would have an advantage with comprehensive radiation treatment and those who can safely be treated with more targeted radiation. The BluePrint test determines the molecular subtype of the woman’s cancer and predicts how her tumor will respond to targeted therapies both before and after surgery.

In the Neoadjuvant Breast Registry Symphony Trial study that was presented at the conference, the researchers looked at how the conventional immunohistochemistry-fluorescence in situ hybridization pathology test and MammaPrint-BluePrint classified each patient’s subtype.

They analyzed how the patients responded to neoadjuvant chemotherapy or endocrine treatment in order to see which method was better at predicting response to neoadjuvant therapy. They found that BluePrint reclassified 22 percent of the tumors in the study.

IBM Watson — the supercomputer that won Jeopardy! in 2011 — is also helping to treat breast cancer. IBM and Memorial Sloan Kettering Cancer Center collaborated in early 2012 to develop a tool built on IBM Watson to give doctors improved access to current, comprehensive cancer data and practices in order to help them develop personalized cancer treatment recommendations.

Doctors at the cancer center have been working hard to “teach” Watson. It ingests the key attributes regarding the patient and the disease from the patient’s medical record.

“Watson is able to synthesize the relevant clinical information with the large body of medical science and literature to direct a patient and physician to the optimal treatment plan for their cancer,” says Dr. Andrew Siedman, medical oncologist at the cancer center.

Right now, it’s in beta-testing stage and doctors are starting to broaden their horizons and focus on over a dozen malignancies, not just breast but also lung and colon cancers. Siedman says that the commercial availability of it depends on the outcome of the beta testing.

He adds that he thinks it’s going to be a “paradigm shifter.” “Leveraging Watson’s supercomputing abilities to integrate patient derived data, including genomic information, with the scientific medical literature to direct increasingly overburdened oncologists toward best treatment options can only lead to better care and outcomes,” he says. “This is revolutionary.”

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