Patient-Reported Outcomes for Low-Risk Ductal Carcinoma In Situ: A Secondary Analysis of the COMET Randomized Clinical Trial.

Reported data comparing patient-reported outcomes (PROs) between GCC and AM for DCIS are lacking.

目前缺乏比较GCC和AM对于DCIS患者报告的结果（PROs）的报告数据。

Background

To compare PROs at baseline and over time in patients with low-risk DCIS randomized to receive either AM or GCC.

在被随机分配接受AM或GCC治疗的低危DCIS患者中，比较基线时及随时间变化的患者报告结果(PROs)。

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.

设计、设置和参与者：这项预先指定的次要结果分析使用了从2017年6月至2023年1月期间参加COMET研究的低危DCIS患者中收集的前瞻性验证问卷，该研究将参与者随机分配接受GCC或AM治疗。问卷在基线、6个月、1年和2年时进行收集。

intervention

Randomization to GCC or AM.

随机分配至GCC或AM。

main_outcomes_and_measures

Context-relevant PROs, including health-related quality of life, anxiety, depression, and symptoms measured by validated survey instruments.

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在内的与上下文相关的患者报告结果（PROs）。

Mixed models, including sensitivity analyses, with group, point, and group-by-point effects were used to compare PROs between groups.

混合模型，包括敏感性分析，考虑了组别、时间点以及组别与时间点的交互效应，用于比较不同组别间的患者报告结果（PROs）。

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.

在COMET研究的957名参与者中，225名（24%）在入组时年龄小于55岁，325名（34%）年龄在55至65岁之间，403名（42%）年龄超过65岁。在研究的前两年内，有953名（99.5%）参与者完成了问卷，所有时间点的完成率均超过83%。

Quality of life, anxiety, depression, worries about DCIS, and symptom trajectories were comparable between groups, with modest fluctuations over time of limited clinical significance.

生活质量、焦虑、抑郁、对DCIS的担忧以及症状轨迹在各组之间是可比的，随着时间的推移有适度的波动，但临床意义有限。

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.

在特定的医学结果研究36项简短健康调查（SF-36）领域中，只有身体功能方面随时间变化的得分轨迹在各组之间存在差异，基线时的平均得分范围在GCC组为50（基线）至48（6、12和24个月），在AM组为50（基线）至47（12个月）和48（6和24个月）（合并标准差，9.9；P = .01），尽管这些差异的临床意义也有限。

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.

在这项COMET前瞻性随机试验的预定次要分析中，随机接受AM治疗的低危DCIS女性的整体生活体验与随机接受GCC治疗的女性在诊断后2年内的体验相似。

trial_registration

ClinicalTrials.gov Identifier: NCT02926911.

ClinicalTrials.gov注册号：NCT02926911。