Patient-Reported Outcomes for Low-Risk Ductal Carcinoma In Situ
Authors: Ann H. Partridge, Terry Hyslop, Shoshana M. Rosenberg, Antonia V. Bennett, Sarah Drier, Mattias Jonsson, Ayako Shimada, Yutong Li, Yan Li, Thomas Lynch, Elizabeth Frank, Deborah Collyar, Desiree Basila, Donna Pinto, Anna Weiss, Anna Wolf, Kelsey Norris, Meredith Witten, Marc Boisvert, Armando Giuliano, Kelsey E. Larson, Kathleen Yost, Priscilla F. McAuliffe, Amy Krie, Nina Tamirisa, Sonja Darai, Lisa Carey, Alastair Thompson, E. Shelley Hwang, 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, Jeffrey Marks, 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 Oncology (2024)

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