Patient-Reported Outcomes for Low-Risk Ductal Carcinoma In Situ
Authors: Partridge Ann H. , Hyslop Terry , Rosenberg Shoshana M. , Bennett Antonia V. , Drier Sarah , Jonsson Mattias , Shimada Ayako , Li Yutong , Li Yan , Lynch Thomas , Frank Elizabeth , Collyar Deborah , Basila Desiree , Pinto Donna , Weiss Anna , Wolf Anna , Norris Kelsey , Witten Meredith , Boisvert Marc , Giuliano Armando , Larson Kelsey E. , Yost Kathleen , McAuliffe Priscilla F. , Krie Amy , Tamirisa Nina , Darai Sonja , Carey Lisa , Thompson Alastair , Hwang E. Shelley ,   COMET Study Consortium, Gudena Vinay , Chiba Akiko , Bensenhaver Jessica , Andreopoulou Eleni , Mittendorf Elizabeth , Matsen Cindy , Jackson Rubie , Sarma Deba , Dib Elie , Neuman Heather , Yen Tina , Agnese Doreen , Leong Rachelle , Cronin Patricia , Lizarraga Ingrid , Guenther Joseph , Gallagher Kristalyn , Batra Reema , Leitch Ann , Moore Timothy , Strickland Kimberly , Christoudias Moira , Howard-McNatt Marissa , Higham Anna , Gunturi Anasuya , Schallenkamp John , Log Karng , Seaward Samantha , Wright Heather , Rivere Amy , Feliberti Eric , Lai Lisa , Cintolo-Gonzalez Jessica , McGuire Kandace , Chung Ki , Thawani Anjali , Marcinkowski Emily , Marti Jennifer , Johnson Nathalie , Pruthi Sandhya , Phantana-Angkool April , Maxwell Jessica , Prabhakaran Sangeetha , Weckstein Douglas , Muzaffar Mahvish , Sinclair Sarah , McGreevy Christopher , Madden Steven , Peterson Laura , Sotirescu Dan , Hazard Hannah , Lad Thomas , McLaughlin Sarah , Feldman Sheldon , Weiss Matthias , Nurudeen Suliat , Ziauddin M. Firdos , Jaslowski Anthony , Abraham Ivy , Goldman Faith , DiBella Nicholas , Golshan Mehra , Dao Tuoc , Gross Howard , Tammaro Yolanda , Bowie Mindy , Yao Katharine , Kim Theodore , Aft Rebecca , Throckmorton Alyssa , Najera Jose Eugenio , Yee Lisa , Christman Jennifer , Sreenivasappa Shylendra , Le-Petross Huong , Factor Rachel , Marks Jeffrey , Ozanne Elissa , Punglia Rinaa , Gierisch Jennifer , Fayanju Lola , Kaplan Celia , Colletti Laura , Stewart Wendy , Smith Mary Lou , Elmore Joanne , Bowlby Lynn , Lehman Constance , Schnitt Stuart , Keurer Henry , Attai Deanna , Ganz Patricia , Earle Craig , Kerlikowske Karla , Etzioni Ruth , Hakim Rosemarie , Malin Jennifer , Palackdharry Carol , Webster David , Schilsky Richard L , Smith Robert , Calomeni Coralia , Wernberg Jessica , Levine Ellis , Unzeitig Gary , Manning Kenneth , Battelli Chiara , Dooley William , Hattiangadi Trupti , Mauer Ann , Mislowsky Angela , Bao Jean , Blaes Anne , Graves Theresa , Behrens Robert , Pulver Kerry , El Ayass Walid , Miller Seth 
Published: December 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