Active Monitoring With or Without Endocrine Therapy for Low-Risk Ductal Carcinoma In Situ
Authors: E. Shelley Hwang, Terry Hyslop, Thomas Lynch, Marc D. Ryser, Anna Weiss, Anna Wolf, Kelsey Norris, Meredith Witten, Lars Grimm, Stuart Schnitt, Sunil Badve, Rachel Factor, Elizabeth Frank, Deborah Collyar, Desiree Basila, Donna Pinto, Mark A. Watson, Robert West, Louise Davies, Jenny L. Donovan, Ayako Shimada, Yutong Li, Yan Li, Antonia V. Bennett, Shoshana Rosenberg, Jeffrey Marks, Eric Winer, Marc Boisvert, Armando Giuliano, Kelsey E. Larson, Kathleen Yost, Priscilla F. McAuliffe, Amy Krie, Nina Tamirisa, Lisa A. Carey, Alastair M. Thompson, Ann H. Partridge, Vinay Gudena, Akiko Chiba, Jessica Bensenhaver, Eleni Andreopoulou, Elizabeth Mittendorf, Cindy Matsen, Rubie Jackson, Deba Sarma, Elie Dib, Heather Neuman, Tina Yen, Doreen Agnese, Rachelle Leong, Patricia Cronin, Ingrid Lizarraga, Joseph Guenther, Kristalyn Gallagher, Reema Batra, Ann Leitch, Timothy Moore, Kimberly Strickland, Moira Christoudias, Marissa Howard-McNatt, Anna Higham, Anasuya Gunturi, John Schallenkamp, Karng Log, Samantha Seaward, Heather Wright, Amy Rivere, Eric Feliberti, Lisa Lai, Jessica Cintolo-Gonzalez, Kandace McGuire, Ki Chung, Anjali Thawani, Emily Marcinkowski, Jennifer Marti, Nathalie Johnson, Sandhya Pruthi, April Phantana-Angkool, Jessica Maxwell, Sangeetha Prabhakaran, Douglas Weckstein, Mahvish Muzaffar, Sarah Sinclair, Christopher McGreevy, Steven Madden, Laura Peterson, Dan Sotirescu, Hannah Hazard, Thomas Lad, Sarah McLaughlin, Sheldon Feldman, Matthias Weiss, Suliat Nurudeen, M. Firdos Ziauddin, Anthony Jaslowski, Ivy Abraham, Faith Goldman, Nicholas DiBella, Mehra Golshan, Tuoc Dao, Howard Gross, Yolanda Tammaro, Mindy Bowie, Katharine Yao, Theodore Kim, Rebecca Aft, Alyssa Throckmorton, Jose Eugenio Najera, Lisa Yee, Jennifer Christman, Shylendra Sreenivasappa, Huong Le-Petross, Rachel Factor, Elissa Ozanne, Rinaa Punglia, Jennifer Gierisch, Lola Fayanju, Celia Kaplan, Laura Colletti, Wendy Stewart, Mary Lou Smith, Joanne Elmore, Lynn Bowlby, Constance Lehman, Stuart Schnitt, Henry Keurer, Deanna Attai, Patricia Ganz, Craig Earle, Karla Kerlikowske, Ruth Etzioni, Rosemarie Hakim, Jennifer Malin, Carol Palackdharry, David Webster, Richard L Schilsky, Robert Smith, Coralia Calomeni, Jessica Wernberg, Ellis Levine, Gary Unzeitig, Kenneth Manning, Chiara Battelli, William Dooley, Trupti Hattiangadi, Ann Mauer, Angela Mislowsky, Jean Bao, Anne Blaes, Theresa Graves, Robert Behrens, Kerry Pulver, Walid El Ayass, Seth Miller
Journal: JAMA (2024)

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 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. Trial Registration ClinicalTrials.gov Identifier: NCT02926911