DCIS QOL Outcomes Similar With Active Monitoring Vs Surgery

TOPLINE:

Women with low-risk ductal carcinoma in situ (DCIS) who underwent active monitoring showed similar quality of life (QOL), anxiety levels, and symptom trajectories compared with those receiving surgery during 2 years of follow-up. The study included 957 participants with a completion rate exceeding 83% at all assessment points.

METHODOLOGY:

• Prior research demonstrated relatively favorable QOL overall for women treated for DCIS, though some studies found declines in vitality and mental health, along with heightened anxiety and fear of recurrence similar to women with invasive breast cancer.
• Recognizing that not all DCIS progresses to invasive breast cancer with potential for metastasis, healthcare providers and patients have shown interest in active monitoring as an alternative management strategy.
• In the new study, 957 participants were randomized 1:1 to receive either guideline-concordant care (GCC) or active monitoring (AM) between June 2017 and January 2023, with stratification by age at diagnosis ( 65 years), maximum diameter of microcalcifications, and DCIS nuclear grade.
• Participants completed validated questionnaires at baseline, 6 months, 1 year, and 2 years, measuring health-related QOL, anxiety, depression, and symptoms, with response rates exceeding 83% at all assessment points.
• Analysis included mixed models with group, point, and group-by-point effects to compare patient-reported outcomes between groups, controlling for participant age with a first-order autoregressive variance structure.

TAKEAWAY:

• Physical functioning was the only specific Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain showing fluctuations differing significantly by group over time, with mean scores ranging from 50 (baseline) to 48 (6, 12, and 24 months) in the GCC group and from 50 (baseline) to 47 (12 months) and 48 (6 and 24 months) in the AM group (pooled standard deviation, 9.9; P = .01). These differences were of limited clinical significance.
• Mean State Trait Anxiety Inventory scores remained low in both groups, ranging from 31 to 33 in the GCC group and from 30 to 31 in the AM group, indicating no significant differences in anxiety levels over time.
• QOL measures remained stable, with SF-36 general health scores showing minimal changes from 52 to 50 in the GCC group and 52 to 51 in the AM group over 24 months (pooled standard deviation, 9.2).
• Breast Cancer Prevention Trial symptom assessments and measures of overall pain showed no significant differences between groups over time, with participants reporting relatively low mean levels of menopausal and body image symptoms.

IN PRACTICE:

“In this prespecified secondary analysis of the COMET prospective randomized trial, the overall lived experience of women randomized to undergo AM for low-risk DCIS was similar to that of women randomized to GCC during the 2 years following diagnosis... For women considering AM or GCC for managing low-risk DCIS, the COMET study provides critical data suggesting that in short-term follow-up, both strategies have only limited effects on average health-related QOL, psychosocial outcomes, and breast cancer treatment-related symptoms,” wrote the authors of the new research.

SOURCE:

The study was led by Ann Partridge, MD, MPH, Dana-Farber Cancer Institute in Boston. It was published online on December 12 in JAMA Oncology.

LIMITATIONS:

According to the authors, while the study included 100 Alliance for Clinical Trials in Oncology Foundation Trials member sites, women of racial and ethnic minority groups were underrepresented and women aged less than 40 years were not eligible for participation, limiting the generalizability of findings to these populations. The researchers noted that longer-term follow-up is needed to fully capture the experience of individuals treated with active monitoring for low-risk DCIS, particularly those who may experience disease progression over time. Additionally, contamination bias may have affected the results, as the proportion of participants undergoing surgery during 2-year follow-up in the AM group was lower than the proportion not undergoing surgery in the GCC arm.

DISCLOSURES:

The COMET study received funding through Patient-Centered Outcomes Research Institute award (PCS-1505-30497), Breast Cancer Research Foundation awards (BCRF-23-074, SPEC-24-020, and SPEC-22-021), and a Rising Tide Foundation Award (CCR-22-900). The study was sponsored by Alliance Foundation Trials.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.