COMET Trial: Active Monitoring Shows Similar Quality of Life to Surgery for Low-Risk DCIS
Key Insights
The COMET trial reveals that active monitoring in low-risk DCIS (search) patients results in similar overall quality of life compared to upfront surgery with or without radiation.
No significant differences were observed in anxiety or worry about DCIS (search) between the active monitoring and guideline-concordant care groups over a two-year follow-up period.
The rate of invasive cancer was comparable between the active monitoring group (4.2%) and the surgery group (5.9%) after two years.
Patients with low-risk ductal carcinoma in situ (search) (DCIS (search)) who underwent active monitoring reported comparable physical, emotional, and psychological outcomes to patients who received upfront treatment, according to results from the COMET clinical trial presented at the San Antonio Breast Cancer (search) Symposium (SABCS). The study, simultaneously published in JAMA Oncology, addresses concerns about the impact of active monitoring on patient well-being.
Active Monitoring vs. Standard Care
The COMET trial enrolled 995 patients with grade 1 or 2, hormone receptor-positive, HER2 (search)-negative DCIS (search), without microinvasive or invasive disease. Participants were randomized to either active monitoring (484 patients) or guideline-concordant care, which included surgery with or without adjuvant radiation (473 patients). Active monitoring involved close observation, with surgery reserved for those showing signs of invasive progression. Both groups could receive endocrine therapy (search).
Quality of Life Outcomes
Patient-reported outcomes were evaluated using clinically validated questionnaires at baseline, six months, one year, and annually thereafter. These questionnaires assessed health-related quality of life, anxiety, depression, worry about DCIS (search), and breast cancer (search) treatment-related symptoms.
Overall health-related quality of life remained stable from baseline to two years, with no significant differences between the two treatment arms. Anxiety scores and worry about DCIS (search) also showed no significant differences over time. While depression scores were similar, there was a trend toward higher depression scores in the guideline-concordant care arm.
Physical Functioning
Physical functioning scores initially differed, with lower average scores in the active monitoring arm. However, after adjusting for factors like race, age, tumor grade, and endocrine therapy (search) use, no significant differences in physical functioning were observed between the groups. Patients in the guideline-concordant care arm reported a greater burden from arm problems, breast pain, and sensory disturbances early on, but these differences resolved by two years.
Expert Commentary
"The data suggest that, in the short term, active monitoring is a reasonable approach in terms of patient experience," said Ann Partridge, MD, MPH, interim chair of the Department of Medical Oncology at Dana-Farber Cancer Institute. "If longer-term data hold up, this approach could be considered as a management option for women with low-risk DCIS (search)."
Limitations and Future Directions
Limitations of the study include underrepresentation of women from racial and ethnic minority groups, exclusion of patients under age 40, and a relatively short follow-up period of two years. Longer-term data will be crucial to confirm the safety and efficacy of active monitoring as a management option for low-risk DCIS (search).
After two years of follow up, the rate of invasive cancer in women in the surgery group was 5.9%, compared to 4.2% in women who did active monitoring.