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
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Department of Pharmacology, Physiology, and Cancer Biology, Thomas Jefferson University, Philadelphia, Pennsylvania.
JAMA Oncol. 2025 Mar 1;11(3):300-309. doi: 10.1001/jamaoncol.2024.6556.
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.
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.
Randomization to GCC or AM.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT02926911.
对于低风险导管原位癌（DCIS），主动监测（AM）被视为与指南一致的治疗（GCC；包括有或无放疗的手术）的一种潜在替代方案。目前缺乏比较GCC和AM治疗DCIS患者报告结局（PROs）的报道数据。
比较随机接受AM或GCC的低风险DCIS患者在基线和随访期间的PROs。
设计、设置和参与者：这项预先设定的次要结局分析使用了从2017年6月至2023年1月参与低风险DCIS的手术与监测对比（含或不含内分泌治疗）（COMET）研究的参与者在基线、6个月、1年和2年时前瞻性收集的经过验证的问卷。该研究将参与者随机分为接受GCC或AM。
随机分为GCC或AM组。
与背景相关的PROs，包括健康相关生活质量、焦虑、抑郁以及通过经过验证的调查工具测量的症状。采用混合模型，包括敏感性分析，以及组效应、时间点效应和组×时间点效应，比较两组之间的PROs。
在COMET研究的957名参与者中，225名（24%）入组时年龄小于55岁，325名（34%）年龄在55至65岁之间，403名（42%）年龄大于65岁，953名（99.5%）在最初2年内的某个时间点完成了问卷，所有时间点的完成率均超过83%。两组之间的生活质量、焦虑、抑郁、对DCIS的担忧以及症状轨迹相当，随时间有适度波动，但临床意义有限。身体功能是唯一在得分轨迹变化上随时间存在组间差异的特定医学结局研究36项简短健康调查（SF - 36）领域，GCC组的平均得分从50（基线）降至48（6、12和24个月），AM组从50（基线）降至47（12个月）和48（6和24个月）（合并标准差，9.9；P = 0.01），尽管这些差异的临床意义也有限。
在对COMET前瞻性随机试验的这项预先设定的次要分析中，随机接受低风险DCIS的AM治疗的女性在诊断后的2年里的总体生活体验与随机接受GCC治疗的女性相似。
ClinicalTrials.gov标识符：NCT02926911。
