Patients with low-risk ductal carcinoma in situ (DCIS) who underwent active monitoring and those who received upfront treatment reported comparable physical, emotional, and psychological outcomes, according to results from the COMET trial presented at the 2024 San Antonio Breast Cancer Symposium (Abstract GS2-06).
A steady increase in mammography and other breast cancer screening methods has led to the identification of more cases of DCIS. An estimated 25% to 60% of cases progress to invasive cancer, which makes the determination of how best to treat DCIS controversial. In the primary analysis of the COMET trial, also presented at the San Antonio meeting, researchers found that active monitoring of patients with low-risk DCIS and upfront standard-of-care treatment resulted in comparable rates of invasive ipsilateral breast cancer diagnosis.
Ann Partridge, MD, MPH
But a common concern with treatment de-escalation is that patients may feel more anxious about their cancer worsening or returning, explained Ann Partridge, MD, MPH, Interim Chair of the Department of Medical Oncology at Dana-Farber Cancer Institute and Professor at Harvard Medical School, Boston, who presented a secondary analysis of the COMET trial evaluating how active monitoring compares with upfront treatment with regard to quality of life.
“It is critical that we understand how women feel when they are living with an active-monitoring approach and how it impacts their overall quality of life, psychosocial health, worries about DCIS, anxiety and depression, and other related symptoms,” Dr. Partridge said.
Study Methodology
The investigators evaluated patient-reported outcomes from the COMET study, which enrolled 995 patients with grade 1 or 2, hormone receptor–positive, HER2-negative DCIS with no evidence of microinvasive or invasive disease. They randomly assigned 473 patients to undergo active monitoring and 484 patients to receive guideline-concordant care consisting of surgery with or without adjuvant radiation.
Patients in the active monitoring arm could elect to have surgery at any time, and surgery was recommended if the tumor showed signs of invasive disease progression. Patients in both treatment arms were allowed to receive endocrine therapy, if desired.
Patients were asked to complete several clinically validated questionnaires at baseline, 6 months, 1 year, and every subsequent year after treatment assignment. Questionnaires were designed to assess health-related quality of life (including both physical and mental components), anxiety, depression, worry about DCIS, and breast cancer treatment–related symptoms including pain. Patients who responded to at least one survey were included in the study.
Key Findings
Overall health-related quality of life remained stable from baseline to 2 years and did not differ significantly between the two treatment arms. There were also no significant differences in anxiety scores and worry about DCIS over time. Although depression scores were not significantly different between the two treatment arms, there was a trend toward higher depression scores and a higher probability of depression over time in the guideline-concordant care arm compared to the active monitoring arm.
The physical functioning scores for health-related quality of life differed significantly over time between arms, with lower average scores among patients in the active monitoring arm than patients in the guideline-concordant care arm. However, because 46% of patients assigned to the guideline-concordant care arm declined to undergo surgery, the investigators conducted a separate analysis of patients who adhered to their assigned treatment. In this analysis, average physical scores were transiently and significantly lower over time among patients who received guideline-concordant care than among those who received active monitoring; those in the guideline-concordant care arm reported a significantly greater burden from arm problems, breast pain, and sensory disturbances (ie, numbness) on average, though mean differences resolved within 2 years.
When the researchers normalized scores based on race, age, tumor grade, and use of endocrine therapy, no significant differences in physical functioning over time were observed between the two treatment arms.
Study Implications
Dr. Partridge viewed the similarities in experience between the two treatment arms as encouraging, demonstrating that neither approach had a markedly negative impact on patients’ quality of life.
“The data suggest that, in the short term, active monitoring is a reasonable approach in terms of patient experience,” she said. “If longer-term data hold up, this approach could be considered as a management option for women with low-risk DCIS.”
Limitations of this study include underrepresentation of women from racial and ethnic minority groups, the exclusion of patients under age 40, and the relatively short follow-up period of 2 years.
Disclosure: Funding for this study was provided by the Patient-Centered Outcomes Research Institute, the Breast Cancer Research Foundation, the Rising Tide Foundation, the National Cancer Institute of the National Institutes of Health, the University Cancer Research Fund of North Carolina, and Alliance Foundation Trials. Dr. Partridge reported no conflicts of interest.
