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Randomized Controlled Trial
. 2025 Mar 1;11(3):300-309.
doi: 10.1001/jamaoncol.2024.6556.

Patient-Reported Outcomes for Low-Risk Ductal Carcinoma In Situ: A Secondary Analysis of the COMET Randomized Clinical Trial

Ann H Partridge  1 , Terry Hyslop  2 , Shoshana M Rosenberg  3 , Antonia V Bennett  4 , Sarah Drier  5 , Mattias Jonsson  6 , Ayako Shimada  7 , Yutong Li  7 , Yan Li  8 , Thomas Lynch  9 , Elizabeth Frank  10 , Deborah Collyar  10 , Desiree Basila  10 , Donna Pinto  10 , Anna Weiss  11 , Anna Wolf  12 , Kelsey Norris  12 , Meredith Witten  13 , Marc Boisvert  14 , Armando Giuliano  15 , Kelsey E Larson  16 , Kathleen Yost  17 , Priscilla F McAuliffe  18 , Amy Krie  19 , Nina Tamirisa  20 , Sonja Darai  1 , Lisa Carey  5 , Alastair Thompson  21 , E Shelley Hwang  9 ; COMET Study Consortium
Collaborators, Affiliations
Randomized Controlled Trial

Patient-Reported Outcomes for Low-Risk Ductal Carcinoma In Situ: A Secondary Analysis of the COMET Randomized Clinical Trial

Ann H Partridge et al. JAMA Oncol. .

Abstract

Importance: Active monitoring (AM) for low-risk ductal carcinoma in situ (DCIS) has been considered as a potential alternative to guideline-concordant care (GCC; inclusive of surgery with or without radiation). Reported data comparing patient-reported outcomes (PROs) between GCC and AM for DCIS are lacking.

Objective: To compare PROs at baseline and over time in patients with low-risk DCIS randomized to receive either AM or GCC.

Design, setting, and participants: This prespecified secondary outcome analysis used prospectively collected validated questionnaires at baseline, 6 months, 1 year, and 2 years from participants enrolled from June 2017 to January 2023 in the Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) study for low-risk DCIS, which randomized participants to receive GCC or AM.

Intervention: Randomization to GCC or AM.

Main outcomes and measures: Context-relevant PROs, including health-related quality of life, anxiety, depression, and symptoms measured by validated survey instruments. Mixed models, including sensitivity analyses, with group, point, and group-by-point effects were used to compare PROs between groups.

Results: Of the 957 participants in COMET, 225 (24%) were younger than 55 years at enrollment, 325 (34%) were aged 55 to 65 years, and 403 (42%) were older than 65 years, and 953 (99.5%) completed questionnaires at some point within the first 2 years, with a completion rate of more than 83% at all points. Quality of life, anxiety, depression, worries about DCIS, and symptom trajectories were comparable between groups, with modest fluctuations over time of limited clinical significance. Physical functioning was the only specific Medical Outcomes Study 36-item short-form health survey (SF-36) domain for which changes in the score trajectory differed by group over time, with mean scores ranging from 50 (baseline) to 48 (6, 12, and 24 months) in the GCC group and 50 (baseline) to 47 (12 months) and 48 (6 and 24 months) in the AM group (pooled SD, 9.9; P = .01), although these were also of limited clinical significance.

Conclusions and relevance: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT02926911.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Hyslop reported grants from Thomas Jefferson University during the conduct of the study as well as grants from the National Cancer Institute and Breast Cancer Research Foundation (BCRF) outside the submitted work. Dr Rosenberg reported grants from Pfizer and Conquer Cancer outside the submitted work. Dr Bennett reported grants from the Patient-Centered Outcomes Research Institute (PCORI) and Rising Tide Foundation during the conduct of the study. Dr Yan Li reported grants from PCORI and BCRF during the conduct of the study. Dr Lynch reported grants from PCORI, BCRF, and the US Department of Defense during the conduct of the study. Dr Collyar reported personal fees from the Alliance for Clinical Trials in Oncology during the conduct of the study as well as personal fees from SimBioSys, AstraZeneca, Parexel, Evidera, MaxisHealth, Aster Insights, CRUK, Incyte, Apellis, Kinnate, and Gilead outside the submitted work. Dr Basila reported personal fees from PCORI during the conduct of the study. Dr Weiss reported advisory board payments from Merck. Dr Thompson reported grants from PCORI during the conduct of the study and a spouse’s employment with Eli Lilly outside the submitted work. Dr Hwang reported grants from PCORI during the conduct of the study. No other disclosures were reported.

References

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    1. Maxwell AJ, Hilton B, Clements K, et al. Unresected screen-detected ductal carcinoma in situ: outcomes of 311 women in the Forget-Me-Not 2 study. Breast. 2022;61:145-155. doi: 10.1016/j.breast.2022.01.001 - DOI - PMC - PubMed
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    1. Hwang ES, Hyslop T, Lynch T, et al. The COMET (Comparison of Operative versus Monitoring and Endocrine Therapy) trial: a phase III randomised controlled clinical trial for low-risk ductal carcinoma in situ (DCIS). BMJ Open. 2019;9(3):e026797. doi: 10.1136/bmjopen-2018-026797 - DOI - PMC - PubMed
    1. Hwang ES, Hyslop T, Lynch T, et al. Early oncologic outcomes following active monitoring or surgery (+/− radiation) for low risk DCIS: the comparing an operation to monitoring, with or without endocrine therapy (COMET) study (AFT-25) [abstract]. Proceedings of the 2024 San Antonio Breast Cancer Symposium. December 10-13, 2024; San Antonio, TX.

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