Active Monitoring With or Without Endocrine Therapy for Low-Risk Ductal Carcinoma In Situ

作者：E. Shelley Hwang, Terry Hyslop, Thomas Lynch, Marc D. Ryser, Anna Weiss, Anna Wolf, Kelsey Norris, Meredith Witten, Lars J. Grimm, Stuart J. Schnitt, Sunil Badve, Rachel E. Factor, Elizabeth S. Frank, Deborah Collyar, Desiree Basila, Donna Pinto, Mark A. Watson, Robert B. West, Louise Davies, Jenny L. Donovan, Ayako Shimada, Yutong Li, Li Yan, Antonia V. Bennett, Shoshana M. Rosenberg, Jeffrey R. Marks, Eric Winer, Marc Boisvert, Armando E. Giuliano, Kelsey E. Larson, Kathleen J. Yost, Priscilla F. McAuliffe, Amy Krie, Nina P. Tamirisa, Lisa A. Carey, Alastair M. Thompson, Ann H. Partridge, COMET Study Investigators, Vinay Gudena, Akiko Chiba, Jessica Bensenhaver, Eleni Andreopoulou, Elizabeth A. Mittendorf, Cindy Matsen, Rubie Jackson, Deba P. Sarma, Elie G. Dib, Heather B. Neuman, Tina Yen, Doreen M. Agnese, Rachelle Leong, Patricia Cronin, Ingrid M. Lizarraga, Joseph M. Guenther, Kristalyn K. Gallagher, Reema Batra, A. Marilyn Leitch, Timothy D. Moore, Kimberly Strickland, Moira Christoudias, Marissa Howard-McNatt, Anna M. Higham, Anasuya Gunturi, John M. Schallenkamp, Karng Log, Samantha A. Seaward, Heather Harris Wright, Amy Rivere, Eric Feliberti, Lisa A. Lai, Jessica Cintolo-Gonzalez, Kandace P. McGuire, Ki Wook Chung, Anjali R. Thawani, Emily Marcinkowski, Jennifer L. Marti, Nathalie Johnson, Sandhya Pruthi, April Phantana-angkool, Jessica E. Maxwell, Sangeetha Prabhakaran, Douglas Weckstein, Mahvish Muzaffar, Sarah Sinclair, Christopher M. McGreevy, Steve Madden, Laura Peterson, Dan Sotirescu, Hannah Hazard‐Jenkins, Thomas E. Lad, Sarah A. McLaughlin, Sheldon Feldman, Matthias Weiss, Suliat Nurudeen, M. Firdos Ziauddin, Anthony J. Jaslowski, Ivy Abraham, Faith Goldman, Nicholas J. DiBella, Mehra Golshan, Tuoc Dao, Howard M. Gross, Yolanda Tammaro, Mindy Bowie, Katharine Yao, Theodore Kim, Rebecca Aft, Alyssa Throckmorton, Jose Eugenio Najera, Lisa Yee, Jennifer Christman, Shylendra B Sreenivasappa, Huong T. Le‐Petross, Rachel E. Factor, Elissa M. Ozanne, Rinaa S. Punglia, Jennifer M. Gierisch, Lola Fayanju, Celia P. Kaplan, Laura Colletti, Wendy Stewart, Mary Lou Smith, Joanne Elmore, Lynn Bowlby, Constance D. Lehman, Stuart J. Schnitt, Henry Keurer, Deanna J. Attai, Peter Ganz, Craig C. Earle, Karla Kerlikowske, Ruth Etzioni, Rosemarie B. Hakim, Jennifer L. Malin, Carol S. Palackdharry, David Webster, Richard L. Schilsky, Robert V. Smith, Coralia Calomeni, Jessica A. Wernberg, Ellis Levine, Gary Unzeitig, Kenneth C. Manning, Chiara Battelli, William C. Dooley, Trupti Hattiangadi, Ann M. Mauer, Angela Mislowsky, Jean Bao, Anne Blaes, Theresa A. Graves, Robert J. Behrens, Kerry Pulver, Walid El Ayass, Seth Miller · 发表于：JAMA · 年份：2024 · DOI：10.1001/jama.2024.26698 · 被引用次数：75 · 研究领域：Breast Cancer Treatment Studies、Breast Lesions and Carcinomas、Medical Imaging Techniques and Applications

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 ca...