Violet Merle McIntosh, MD, is chief of breast surgery at Englewood Health and a member of the leadership team at The Lefcourt Family Cancer Treatment and Wellness Center at Englewood Hospital.
Englewood Health is a clinical trial site for the Comparison of Operative to Monitoring and Endocrine Therapy (COMET) study for low-risk ductal carcinoma in situ (DCIS). This is the first large Phase III randomized clinical trial in the United States to look at different clinical management strategies for low-risk DCIS.
Chief of breast surgery Violet Merle McIntosh, MD, a site principal investigator for the COMET trial, shares insights about this important study.
What is DCIS?
Dr. McIntosh: Ductal carcinoma in situ (DCIS) is noninvasive breast cancer, accounting for approximately 20 percent of new breast cancer cases each year. It is a condition in which some of the cells lining the milk ducts undergo a cancerous change, dividing and filling up the ducts. DCIS does not spread beyond the ducts to other parts of the breast or to other parts of the body.
What is low-risk DCIS?
Dr. McIntosh: There are three grades of DCIS: low, intermediate, and high. Generally, low and intermediate grades (Grades I and II) are considered to be “low risk,” with the lowest chance of becoming an invasive cancer or of recurrence. There is increasing scientific evidence that low-risk DCIS grows slowly and, left untreated, would not cause health problems during a woman’s lifetime.
What is the COMET study?
Dr. McIntosh: Currently, women with any grade of DCIS are treated with surgery, with or without radiation. The COMET study is comparing that standard treatment with monitoring, for low-risk DCIS.
How does the study work?
Dr. McIntosh: Study participants, who have been diagnosed with low-risk DCIS, are randomly assigned to one of two groups:
- Active surveillance: ongoing monitoring with mammograms and physical exam every six months or
- Surgery, with or without radiation therapy, and an annual mammogram
Participants in both groups may choose to have adjuvant hormone therapy. Patients in active surveillance are closely monitored during the five years of the study, and if they advance to an invasive cancer, receive appropriate treatment.
Who is eligible to participate?
Dr. McIntosh: Women who are newly diagnosed with low-risk (Grade I or II) DCIS are eligible for the COMET trial. Currently, if a woman is diagnosed with DCIS, her treating physician cannot say, “Let’s try active surveillance,” as it is not the standard of care. Therefore, the only way to receive active surveillance at this point is to participate in the trial.
Why is this clinical trial so important for women?
Dr. McIntosh: According to a study published in JAMA Surgery, about 80 percent of women diagnosed with DCIS will not have a future DCIS or invasive breast cancer. The big question is, “Are we overtreating women?” Right now, we don’t know how to identify who is at high risk and who can safely avoid surgery and possibly radiation treatment, with or without hormone treatment. We are hoping to answer these questions with this important study.
What holds patients back from participating in a clinical trial?
Dr. McIntosh: Patients often say, “I don’t want to be a guinea pig.” The reality is that most of the time in these studies, we are comparing reasonable treatments. It is usually a question of whether one treatment is better than the other.
In the COMET trial, researchers want to confirm that active surveillance is effective for most patients.
Englewood Health is currently the only site in Bergen County enrolling patients in the COMET clinical trial.
Posted October 2019
Violet Merle McIntosh, MD, is chief of breast surgery at Englewood Health and a member of the leadership team at The Lefcourt Family Cancer Treatment and Wellness Center at Englewood Hospital.