In 2010, Donna Pinto was found to have abnormal cells within the milk ducts of her breast. She was diagnosed with ductal carcinoma in situ (DCIS), a condition affecting more than 50,000 American women every year. DCIS isn’t dangerous in itself, but it can increase the risk of later invasive breast cancer.
Against her first doctor’s opinion, Pinto opted for active surveillance for two years after her diagnosis. Then, when there were signs of growth, fear led Pinto to agree to one surgery and then two more. She still thinks all of it—and particularly the fear—was unnecessary to treat what was always low-risk DCIS.
“This diagnosis is devastating women’s lives, destroying people’s sanity,” said Pinto, who said she lost two years of her life to worry, at a time when she had two young children.
That’s because doctors aren’t quite sure what to do about DCIS, which is usually detected by mammogram. The mixed messages begin right after diagnosis: Women are told DCIS isn’t full-blown cancer—but that they need surgery within the next two weeks. It really isn’t anything to worry about—but it might turn aggressive and kill them. It probably will go nowhere—but they should undergo five to seven weeks of radiation and five to 10 years of hormone therapy to be sure.
DCIS will never lead to life-threatening cancer for many or maybe even the vast majority of those women. But no one knows for sure what those odds are, or how to tell the women who don’t need to worry from those who do—and so virtually everyone with the diagnosis worries.
Now, a trial underway at dozens of cancer centers across the country is hoping to figure out how dangerous DCIS truly is and for whom. This trial and two others in Europe are exploring whether patients diagnosed with DCIS who seem to be at low risk for invasive cancer can afford to skip immediate treatment, opting instead for “active surveillance.”
“We have better imaging. We have better pathology. We have these biomarkers. We know so much more about immunotherapy,” said Dr. Shelley Hwang, the lead investigator of the American trial, called COMET for Comparison of Operative to Monitoring and Endocrine Therapy. But DCIS is still treated the same way it was 40 years ago. “Is this really what we want to do for a non-invasive condition? I personally feel we can do better.”
But that doesn’t mean patients who were aggressively treated for DCIS in the past should second-guess their treatment, said Hwang, also chief of breast surgery at the Duke Cancer Institute. “That was the best we had at the time.”
In the COMET trial, paid for by the federally-funded Patient-Centered Outcomes Research Institute, some women will be randomly assigned to get surgery, and some to get active surveillance, where they will have semi-annual mammograms to make sure there are no worrisome changes in their breasts.
The same kind of “active surveillance” approach is taken in prostate, thyroid, and other slow-growing, non-invasive cancer types, said Ann Partridge, an investigator on the trial and an oncologist at the Dana-Farber Cancer Institute in Boston.
Cassandra Xanthos wanted the least invasive option when she was diagnosed with DCIS this past summer. She joined the trial in part because she was overwhelmed by the conflicting treatment information.
Xanthos, a 49-year-old Boston social worker, was randomly selected to undergo a lumpectomy. She and her radiation oncologist decided against radiation, but her doctor recently convinced her to try hormone therapy, to reduce the chances of a recurrence.
“To take a pill every day for five years seems a little drastic,” said Xanthos, who is still conflicted about how much treatment she should get for a condition that is likely to remain harmless.
To some degree, DCIS is a diagnosis of detection. Before mammograms, there were just few thousand DCIS diagnoses a year, Partridge said. Now, there are 50,000-60,000 a year. “That’s probably a good thing for those patients for whom DCIS was going to turn into invasive cancer,” she said, but “not all those patients would have necessarily developed anything that ever would have been harmful to them.”
Hwang said that people need to understand that cancer is not as black and white as they’ve always believed.
“There’s not that bright dividing line between cancer and non-cancer,” she said. There’s a broad spectrum of “cancers”—some of which are definitely harmless, some of which will lethal, and others in between that may need to be treated but are unlikely to kill.
“We should make patients question what the benefit of intervention would be for their particular condition,” she said.
Going forward, the aim is to give women more choices, Hwang said. Some can’t handle any uncertainty at all. They may still choose to have a mastectomy after a DCIS diagnosis, even after being told it won’t increase their chance of survival. Others, like Xanthos and Pinto, will prefer minimal treatment. And others will want something in between.
To help a woman make the best choice for her, Rinaa Punglia, a radiation oncologist at Dana-Farber, is developing a digital decision aid that will be used in the COMET trial. Women will enter details about their diagnosis and information about their age, preferences, and risk tolerance, and the computer will give them the odds for recurrence with each different treatment approach: lumpectomy, lumpectomy with radiation and/or hormone therapy, and mastectomy.
It can be a challenging choice for women, Punglia said, because the survival odds are pretty similar among all the approaches. “They still have very, very good outcomes no matter what they choose.”
Although it may take another five years to get results, the COMET and other trials are designed to reveal the risks and benefits for active surveillance, as well. Then, women should be able to make an even better-informed choice, Punglia said.
For Donna Pinto, a patient advocate on COMET and founder of a website, DCIS411.com, to support women with DCIS who want a less aggressive treatment approach, that choice can’t come soon enough. “This trial has been in my opinion long overdue.”