Marc E. Boisvert, MD, Breast Surgery

MedStar Health Research Institute investigators and patients are participating in an exciting national study to determine whether low-risk DCIS breast cancer is  better treated with standard cancer therapies or active monitoring. Ninety-seven percent of patients in the U.S. undergo surgery to remove ductal carcinoma in situ (DCIS)—precancerous lesions in the breast’s milk ducts. About one-third of these surgeries are mastectomies, and almost half of the patients also have radiation therapy. Yet studies suggest that more than half of patients with low-risk DCIS may never develop invasive breast cancer.   This has led to a growing number of researchers—including MedStar Health Research Institute— asking whether patients can avoid potentially unnecessary treatments and side effects that can significantly reduce the quality of life, including pain, scarring, and medical costs. Our researchers are participating in a first-of-its-kind clinical study, Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET), to determine whether patients who do not have aggressive DCIS can avoid surgery and participate in active monitoring instead. Doctors assess DCIS as grade I-III, from lowest to highest risk of developing invasive breast cancer. Previous research considered data from all grades, resulting in sweeping recommendations for surgery.   COMET is the first clinical research trial of its kind to directly compare surgery and active monitoring for patients with low-risk DCIS. This Phase III study funded by the Patient-Centered Outcomes Research Institute (PCORI) is now enrolling 1,200 patients at medical centers across the country—including at MedStar Health. In the COMET study, patients are randomly assigned to receive either surgery to remove the DCIS or treatment with active monitoring.   Patients who have surgery will receive the standard procedure for their DCIS, either a lumpectomy (removal of a portion of the breast) or mastectomy (removal of the whole breast), depending on the size of the DCIS and the surgeon’s recommendation. Patients who participate in active monitoring will get mammograms every six months to check for changes in the breast tissue. If no changes are detected, patients will remain in the monitoring program. If changes develop , the patient and doctor will discuss whether surgery is needed.   With either option, patients and their doctors can decide whether to take medicines to block hormones associated with cancer growth (endocrine therapy).   Not all patients with DCIS will qualify for the COMET trial, but we’re already seeing great enthusiasm among eligible patients. To qualify for COMET, a woman must: Be at least 40 years old Have a recent diagnosis of low-risk DCIS Have no history of breast cancer or DCIS five years before her current DCIS diagnosis Have no mass on physical exam or imaging MedStar Health has built a dynamic team of breast cancer experts who care for the holistic health of our patients throughout their cancer diagnosis and treatment. Moreover, our cancer support services team helps patients access rehabilitation, genetic counseling, support groups, survivorship programming, and other critical services.   We hope the COMET trial will demonstrate that many patients with low-risk DCIS can get the most effective, least invasive breast cancer care, sparing more women from unnecessary lumpectomy, mastectomy, and radiation. In the process, we hope to significantly improve the quality of life for the many people for whom cancer surgery is unnecessary.  

Radiation therapy plays a critical role in preventing cancer recurrence and is often recommended for women with breast cancer undergoing a lumpectomy. However, traditional radiation therapy requires a daily commitment to drive to radiation sessions five days a week for up to six weeks. For women who play the role of wife, mother, sister, friend, daughter, business owner, employee, or a combination of any of those, life doesn't just stop after a breast cancer diagnosis. There are still refrigerators that need to be stocked, children who need to be picked up from soccer practice, and looming work deadlines that don't change. There's another option that's faster, more convenient, and just as effective for women with early-stage breast cancer. Intraoperative radiation therapy (IORT), can help eradicate the disease for good with a single, high dose of radiation immediately following a lumpectomy. This revolutionary advance in radiation oncology offers many benefits to women with breast cancer over 50 who have an estrogen- and progesterone-receptor-positive tumor in the breast three centimeters or less. (IORT is not appropriate for all women with breast cancer, such as those with ductal carcinoma in situ or invasive lobular carcinoma.) Click to Tweet Intraoperative radiation therapy uses innovative equipment to deliver electron beams, x-rays, or high-dose-rate brachytherapy directly to the cavity that remains after a lumpectomy. This eliminates cancer cells immediately after surgery, as opposed to external beam radiation therapy (EBRT) which may not begin until a few weeks after surgery. Studies conducted over the past decade show that intraoperative radiation therapy is as effective as external beam radiation. While standard radiation therapy is a critical tool used to treat breast cancer in combination with surgery and chemotherapy, it is not always convenient. A conventional radiation therapy schedule involves radiation treatment sessions five days a week for up to six weeks. This regimen typically doesn't begin right after surgery to allow recovery time before undergoing whole-breast radiation that can result in undesirable side effects.   In comparison, intraoperative radiation therapy allows radiation oncologists to deliver a single dose of radiation in the minutes following surgery to remove a breast cancer tumor. The short procedure takes 20 to 45 minutes while the patient is still asleep from anesthesia, which minimizes the repeated discomfort commonplace with traditional radiation. And, women can leave the hospital on the same day of their lumpectomy without needing to return for multiple visits after surgery. With intraoperative radiation therapy, breast cancer survivors can immediately begin their journey to physical and emotional healing upon their departure from the operating room. After the breast cancer cells are removed during a lumpectomy, the radiation oncology team positions the IORT machine at the appropriate location and determines the necessary dosage of radiation based on evidence-based guidelines. This one-time dosage is less than the amount of radiation used in EBRT. During the procedure, a radiation oncologist places a spherical applicator in the breast where the tumor was removed. Radiation is aimed precisely where the risk of cancer recurrence is highest. As a result, nearby healthy tissue is spared, and local organs, like the lungs and heart, receive less radiation than during traditional radiation therapy. For women with early-stage breast cancer, targeted intraoperative radiotherapy is just as effective as external radiation to the whole breast. Uncomfortable side effects like swelling, redness, and skin irritation are common after conventional radiation therapy. In comparison, women undergoing IORT report better cosmetic outcomes with fewer side effects and less rigidity in the breast. Because radiation oncologists can dispense a high dose of radiation in one session rather than 30 sessions, the affected breast(s) remain softer with less swelling than after EBRT. In addition, the procedure doesn't require any additional recovery time after surgery or result in any added side effects aside from the typical discomfort to the incision site. At MedStar Health, we were pioneers involved in clinical trials of IORT, and we remain one of few health systems in the region to use INTRABEAM® radiotherapy for women with early-stage breast cancer. If you have a patient who may benefit from intraoperative radiation, you can count on our multidisciplinary team of experts to deliver the latest advances in cancer treatment with compassionate care. Together, we can eliminate their cancer while protecting their quality of life.

Estimated reading time: 4 minutes Over the past decade, advances in breast cancer have been changing women’s lives for the better. Take breast conservation surgery. Lumpectomy followed by radiation therapy removes only diseased tissue, leaving healthy tissue intact. Yet it delivers a high success rate previously achieved only via mastectomy, total removal of the breast. Radiation delivered to the site of a tumor has long been acknowledged as one of the most critical defenses against a return of the cancer. And, for many women, Intraoperative Radiation Therapy (IORT)—administered immediately after lumpectomy—is now the fastest, most convenient way to dispense that radiation. IORT is delivered in a single treatment, in the operating room, right after surgery. While conventional whole-breast radiation requires treatment five days each week for up to seven weeks, IORT takes an average of just 30 minutes, saving the patient multiple post-surgery hospital visits. Proven in trials worldwide, IORT recently achieved a landmark 18 years of research data—the gold standard for demonstrating a cancer treatment’s safety and effectiveness. Surgery alone does not deliver the best possible odds of preventing cancer’s return. But a focused dose of X-ray energy can destroy the DNA of cancer cells and stop their replication. Following lumpectomy, IORT lets us direct the radiation precisely where it needs to be—into the tumor bed, the empty space left behind after the tumor is removed. This is the space in which tumors would be most likely to recur. The treatment is so accurately focused on the tumor site, it gets the job done in just one treatment, at a fraction of the dose typically applied in whole-breast radiation. Since 2012, MedStar Washington Hospital Center and MedStar Georgetown University Hospital have been the only medical centers in the Washington, D.C. area equipped to offer this valuable therapeutic approach to breast cancer patients. Between the two hospitals, we have completed close to 200 procedures, most of them now included in the U.S. research trial registry. While our full analysis of the procedure’s performance will take some time, we know anecdotally that it has been very effective and has saved hundreds of hours of post-surgical maintenance for women and their families. For women undergoing lumpectomy, the simplicity, speed and convenience of IORT is a real game-changer. An ideal candidate for IORT is typically a woman 50 and over, whose tumor is three centimeters in size (just over an inch) or smaller, non-lobular and both estrogen- and progesterone-positive. Although whole-breast radiation after surgery can save lives—and is still a recommended approach for some women—it requires a higher dosage and carries a greater risk of side effects, including increased wound contracture, swelling and skin irritation. And treatment cannot be started until three to four weeks after surgery, when the surgery site is relatively healed. IORT, on the other hand, is performed minutes after surgery, eliminating repeat visits after recovery. Research shows it to be as effective in the appropriate patient population as whole-breast radiation, at less cost. And as mentioned, it can spare the patient the inconvenience of follow-up visits to the hospital several days a week for radiation care. In the operating room, our lumpectomy patient is put to sleep, and the breast surgery team removes the tumor. Then, the radiation oncology team takes over. They position the IORT machine and calculate the dosage of radiation based on evidence-based guidelines. It is delivered via a smooth, round applicator, placed directly into the tumor bed via the surgeon’s incision. We protect the skin where radiation can cause irritation and redness, taking careful measurements to ensure the applicator is not too close. Once activated, the machine is left in place for 20–35 minutes, as the patient sleeps. The radiation field is very shallow, so the heart and lungs are never at risk. Following radiation, we remove the applicator and close the incision in the normal fashion, and the patient is taken to the recovery area. IORT adds no extra recovery time, and unpleasant side effects are rare. Typically, patients consult me after their screening mammogram shows an abnormality. The patient then meets with the breast surgeon, and together we begin our approach to treatment. We take an extensive medical history and evaluate risk factors, family history, mammography and follow-up imaging, and biopsy findings. If cancer is confirmed, the patient’s information is presented to our multi-disciplinary tumor board, a team of experts working together to determine a unique course of action for each patient. The board includes eminently qualified surgery, medical oncology, radiation oncology, plastic surgery, rehabilitation, pathology, nutrition and genetic counseling staff, as well as breast surgery and oncology fellows. Many of our board members have been colleagues for decades. We assign a nurse navigator to communicate the treatment plan to the patient and coordinate consultations and procedures. Depending on the tumor board’s recommendation, the navigator helps the patient get scheduled with the relevant specialists on our team. By the time surgery is scheduled, the patient has seen everyone she needs to see, and our entire team knows the plan for that patient. We work together to make surgery and continuity of care as efficient and effective as possible, a truly comprehensive, multi-disciplinary effort. Here at MedStar Washington Hospital Center, our leading-edge medical research gives breast cancer patients access to newly developed treatments. Like any cancer diagnosis, time is of the essence when it comes to breast cancer. The later the cancer, the more challenging the diagnosis and treatment, with more procedures and potential side effects. So of course, it’s always preferable to treat early whenever possible. That’s why your screening mammogram is so important! And don’t let the pandemic keep you from getting the care you need. We continue to adhere to strict safety and screening protocols regarding COVID-19 to protect patients and staff. Your safety is our top priority.