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Active Monitoring With or Without Endocrine Therapy for Low-Risk Ductal Carcinoma In Situ
TAKE-HOME MESSAGE
- The COMET randomized clinical trial compared active monitoring with guideline-concordant care, including surgery, in patients with low-risk ductal carcinoma in situ. The study found that the 2-year rate of invasive cancer was 4.2% with active monitoring and 5.9% with guideline-concordant care, establishing active monitoring as noninferior to guideline-concordant care.
- These findings suggest that active monitoring could be a safe alternative for selected patients, potentially reducing overtreatment and preserving quality of life in patients with low-risk ductal carcinoma in situ.
abstract
This abstract is available on the publisher's site.
Access this abstract nowIMPORTANCE
Active monitoring for low-risk ductal carcinoma in situ (DCIS) of the breast has been proposed as an alternative to guideline-concordant care, but the safety of this approach is unknown.
OBJECTIVE
To compare rates of invasive cancer in patients with low-risk DCIS receiving active monitoring vs guideline-concordant care.
DESIGN, SETTING, AND PARTICIPANTS
Prospective, randomized noninferiority trial enrolling 995 women aged 40 years or older with a new diagnosis of hormone receptor-positive grade 1 or grade 2 DCIS without invasive cancer at 100 US Alliance Cancer Cooperative Group clinical trial sites from 2017 to 2023.
INTERVENTIONS
Participants were randomized to receive active monitoring (follow-up every 6 months with breast imaging and physical examination; n = 484) or guideline-concordant care (surgery with or without radiation therapy; n = 473).
MAIN OUTCOMES AND MEASURES
The primary outcome was 2-year cumulative risk of ipsilateral invasive cancer diagnosis, according to planned intention-to-treat and per-protocol analyses, with a noninferiority bound of 0.05%.
RESULTS
The median age of the 957 participants analyzed was 63.6 (95% CI, 55.5-70.5) years in the guideline-concordant care group and 63.7 (95% CI, 60.0-71.6) years in the active monitoring group. Overall, 15.7% of participants were Black and 75.0% were White. In this prespecified primary analysis, median follow-up was 36.9 months; 346 patients had surgery for DCIS, 264 in the guideline-concordant care group and 82 in the active monitoring group. Forty-six women were diagnosed with invasive cancer, 19 in the active monitoring group and 27 in the guideline-concordant care group. The 2-year Kaplan-Meier cumulative rate of ipsilateral invasive cancer was 4.2% in the active monitoring group vs 5.9% in the guideline-concordant care group, a difference of -1.7% (upper limit of the 95% CI, 0.95%), indicating that active monitoring is not inferior to guideline-concordant care. Invasive tumor characteristics did not differ significantly between groups.
CONCLUSIONS AND RELEVANCE
Women with low-risk DCIS randomized to active monitoring did not have a higher rate of invasive cancer in the same breast at 2 years compared with those randomized to guideline-concordant care.
Additional Info
Disclosure statements are available on the authors' profiles:
Active Monitoring With or Without Endocrine Therapy for Low-Risk Ductal Carcinoma In Situ: The COMET Randomized Clinical Trial
JAMA 2024 Dec 12;[EPub Ahead of Print], ES Hwang, T Hyslop, T Lynch, MD Ryser, A Weiss, A Wolf, K Norris, M Witten, L Grimm, S Schnitt, S Badve, R Factor, E Frank, D Collyar, D Basila, D Pinto, MA Watson, R West, L Davies, JL Donovan, A Shimada, Y Li, Y Li, AV Bennett, S Rosenberg, J Marks, E Winer, M Boisvert, A Giuliano, KE Larson, K Yost, PF McAuliffe, A Krie, N Tamirisa, LA Carey, AM Thompson, AH PartridgeFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.