Active Monitoring With or Without Endocrine Therapy for Low-Risk Ductal Carcinoma In Situ: The COMET Randomized Clinical Trial.

• Tác giả: Sunil Badve, Desiree Basila, Antonia V Bennett, Marc Boisvert, Lisa A Carey, Deborah Collyar, Louise Davies, Jenny L Donovan, Rachel Factor, Elizabeth Frank, Armando Giuliano, Lars Grimm, E Shelley Hwang, Terry Hyslop, Amy Krie, Kelsey E Larson, Yan Li, Yutong Li, Thomas Lynch, Jeffrey Marks, Priscilla F McAuliffe, Kelsey Norris, Ann H Partridge, Donna Pinto, Shoshana Rosenberg, Marc D Ryser, Stuart Schnitt, Ayako Shimada, Nina Tamirisa, Alastair M Thompson, Mark A Watson, Anna Weiss, Robert West, Eric Winer, Meredith Witten, Anna Wolf, Kathleen Yost
• Ngôn ngữ: eng
• Ký hiệu phân loại: 133.446 Therapeutic spells and charms
• Thông tin xuất bản: United States : JAMA , 2025
• Bộ sưu tập: NCBI
• ID: 720539

Tóm tắt

 IMPORTANCE: 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 5%. 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02926911.