Mammography screening, the accepted "gold standard" for early detection of breast cancer has dramatically reduced the mortality rate for the number two cancer killer of women. When found at Stage 0 or 1, women have a 100 percent five-year survival rate, according to the American Cancer Society.
Now, breast tomosynthesis, dubbed "3-D mammography," a newly available technology in Hampton Roads, has shown it can detect tumors even earlier and more consistently than traditional digital screenings.
"It's revolutionary. This is the biggest change in 30 years," said Dr. Kelley Allison, a fellowship-trained radiologist, who pioneered the screenings locally at the Dorothy G. Hoefer Comprehensive Breast Center at Sentara Port Warwick in Newport News, in January. "This is going to be it for a long time."
Introduction of 3-D
The 3-D screening results in a 35 percent increased detection of early-stage breast cancer and up to a 40 percent reduction in "call-backs" — when unclear images result in patients being asked to return for more tests, which serve to heighten anxiety as well as increase costs — according to studies cited by Hologic. The company is the exclusive U.S. commercial manufacturer of the "Selenia Dimensions" machine.
The stacked 2-D images are commonly called "3-D" because it's easier to explain than "breast tomsynthesis," said Jim Culley, Hologic's senior director of marketing. Similar to a CT scan, it produces multiple images of the breast tissue in 1 mm "slices." Instead of seeing one flat image, the radiologist can scroll through the slices to find the slightest tissue change. "When I go layer by layer I can see these sharp edges — that's a tip-off," said Allison, as she examined a slightly-changing image crawling across the computer screen. "It gives you more confidence." It is also more time-consuming, taking twice as much time to read.
The technology received Food and Drug Administration approval two years ago, since when it has been used in more than 2.5 million screenings in 49 states (Maine's the exception). There are now 700 systems installed nationwide, with several in Northern Virginia, one in Richmond and eight in Sentara locations in Hampton Roads.
Pilot efforts at Sentara's two busiest breast centers, Port Warwick and Virginia Beach General, resulted in unofficial findings that paralleled the claims made by Hologic on early detection and call-backs, according to Allison. That propelled the installation of six more machines at Sentara medical outlets throughout Hampton Roads in October.
"We really vetted it out and scrutinized the technology," said Cindy Allen, vice president of oncology services. "We diagnose 1,600 new breast cancer patients annually in the Sentara Cancer Network. That's a pretty staggering volume. Our best defense is finding cancers early," she added.
Tomosynthesis technology dates back decades, but radiation levels delayed its use for mammography. Just a couple of years ago, it delivered four times the dose, said fellowship-trained radiologist Dr. Ben Pettus of Peninsula Radiology, addressing a group at Riverside's Cancer Care Center in Newport News on its risks and benefits.
It now delivers the rough equivalent of a 2-D digital mammogram, but used together the result is more than twice the exposure for patients. That's a concern for him, though it still falls well within the safety standard set by the American College of Radiologists.
The ACR itself has not yet taken an official position. "Tomosynthesis is a promising technology. The ACR continues to monitor clinical trials and gather information before making any endorsements or recommendations," Shawn Farley, director of public affairs, wrote in an e-mail.
"We never want to give more, but it's still well below the MQSA (the federal guideline) and well below the background radiation from a year living in the United States," said radiologist Dr. Saba Hasan with Medical Center Radiologists, who has been using the 3-D for a month.
For patients, the tomosynthesis test doesn't feel any different than a traditional mammogram. "It's still compression, unfortunately," said Donna Wood, a radiologic tech at Sentara's breast center. "The only difference — but patients don't notice it — is that the tube head makes a beeping sound." The time it takes to make an arc gathering multiple images at different angles is just a few seconds.
Insurance doesn't yet cover the 3-D element, so patients must be willing to pay the additional cost, typically $50. "It's new technology. I think that's going to change," said Allison.
Scheduler Celia Gary tells patients about the option when they call for appointments. "We do have to tell them about the out-of-pocket fee, but 60 percent of patients say 'yes.' The ones with dense breasts and the call-backs want to do it; a few have already read about it," she said.
In June, when Windsor resident Gayle Sawyer, 64, was scheduled for her annual screening, she didn't suspect any problem, but she opted for the 3-D. "I had knee surgery last year. I knew how much better the 3-D showed," she said. The mammogram duly picked up an early stage tumor and within a couple of weeks she had a lumpectomy and radiation right in the wound with no need for chemotherapy.
"I felt like it made a difference. That early detection did help," she said. Sawyer's younger sister died of breast cancer a few years ago. A month after her annual 2-D mammogram had shown nothing, she felt a lump. It was already at Stage 3.
The 3-D mammogram has particular benefits for women with dense breast tissue — or half of all women. They are not only at increased risk for breast cancer, but also for the cancer going undetected until it reaches a later stage. Last year, the Virginia General Assembly passed a law, effective July 2012, which required doctors to notify patients if a mammogram shows they have dense breast tissue. (See info box).
Denser tissue does not correlate to feel, but shows white on mammograms and blocks the X-ray, explained Riverside radiologist Pettus. "There's a need for something for women with denser tissue in a complex pattern," he said, but questioned 3-D use for all women.
Riverside currently does not have a Hologic machine, but is evaluating a purchase, according to spokesman Peter Glagola.
Similarly, the Bon Secours Maryview Foundation is half-way to its fund-raising goal to add breast tomosynthesis to its Harbour View location in Suffolk. Hasan, who practices at various locations in Hampton Roads, including the Millie Lancaster Women's Center at Bon Secours Health Center, has used the 3-D screening at Sentara locations. "It definitely does help. In the couple of weeks we've done it, I've picked up a couple of things," she said. "All of us have found things we didn't see in other screenings."
She put the decrease in call-backs at almost 40 percent. Typically, with a 2-D mammogram, the rate of call-back is one in every 10 women, of whom a tiny fraction will actually have cancer. "Usually it's just overlapping breast tissues. With the 3-D, we're able to scroll through the slices and see it's just a shadow, not a mass," said Hasan.
Allison, who has the most experience with the new technology, put the improvement in detection at 35 percent, with detection for invasive, aggressive cancers even higher, at 40 to 50 percent.
The American Cancer Society and other cancer advocacy groups recommend all women over 40 receive an annual mammogram. Allison emphasized its importance, whether 2-D or 3-D, to ensure early detection. "The goal is to find it before you can feel it," she said.
Salasky can be reached by phone at 757-247-4784
This breast cancer screening method, sometimes called "3-D" imaging, received approval from the Food and Drug Administration in 2011. As in a traditional 2-D mammogram, the breast is compressed while the X-ray arm of the machine makes an arc above, taking a series of images at different angles. A computer then reconstructs the breast tissue, showing it in one-millimeter layers instead of a flat image.
Currently, it is used in conjunction with a 2-D mammogram, which means that patients receive more than double the exposure to radiation, but still well within the American College of Radiology safety guidelines. To find a machine near you, go to http://www.Hologic3D.com or http://www.BreastTomo.com.
There are four measurements for breast density; they cannot be determined by feel. By law (since July 2012), doctors in Virginia must notify women by mail if their tissue falls into the two highest categories. Those in the highest category are at six times the risk of having breast cancer than the general population.
• scattered fibroglandular
• heterogeneously dense, 10 percent
• extremely dense, 40 percent