Division of Molecular Pathology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Division of Molecular Pathology, Netherlands Cancer Institute, Amsterdam, the Netherlands; Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Eur J Cancer. 2023 Oct;192:113276. doi: 10.1016/j.ejca.2023.113276. Epub 2023 Aug 4.
Ductal carcinoma in situ (DCIS) can progress to invasive breast cancer (IBC), but most DCIS lesions remain indolent. However, guidelines recommend surgery, often supplemented by radiotherapy. This implies overtreatment of indolent DCIS. The non-randomised patient preference LORD-trial tests whether active surveillance (AS) for low-risk DCIS is safe, by giving women with low-risk DCIS a choice between AS and conventional treatment (CT). Here, we aim to describe how participants are distributed among both trial arms, identify their motives for their preference, and assess factors associated with their choice.
Data were extracted from baseline questionnaires. Descriptive statistics were used to assess the distribution and characteristics of participants; thematic analyses to extract self-reported reasons for the choice of trial arm, and multivariable logistic regression analyses to investigate associations between patient characteristics and chosen trial arm.
Of 377 women included, 76% chose AS and 24% CT. Most frequently cited reasons for AS were "treatment is not (yet) necessary" (59%) and trust in the AS-plan (39%). Reasons for CT were cancer worry (51%) and perceived certainty (29%). Women opting for AS more often had lower educational levels (OR 0.45; 95% confidence interval [CI], 0.22-0.93) and more often reported experiencing shared decision making (OR 2.71; 95% CI, 1.37-5.37) than women choosing CT.
The LORD-trial is the first to offer women with low-risk DCIS a choice between CT and AS. Most women opted for AS and reported high levels of trust in the safety of AS. Their preferences highlight the necessity to establish the safety of AS for low-risk DCIS.
导管原位癌(DCIS)可能进展为浸润性乳腺癌(IBC),但大多数 DCIS 病变仍处于惰性状态。然而,指南建议进行手术,通常辅以放疗。这意味着对惰性 DCIS 的过度治疗。非随机患者偏好 LORD 试验通过给予低危 DCIS 患者在主动监测 (AS) 和常规治疗 (CT) 之间进行选择,来测试低危 DCIS 的 AS 是否安全。在这里,我们旨在描述参与者在试验臂之间的分布情况,确定他们选择试验臂的动机,并评估与他们的选择相关的因素。
数据从基线问卷中提取。使用描述性统计来评估参与者的分布和特征;使用主题分析提取选择试验臂的自我报告原因,并使用多变量逻辑回归分析调查患者特征与所选试验臂之间的关联。
在 377 名女性中,76%选择 AS,24%选择 CT。选择 AS 的最常见原因是“目前不需要治疗”(59%)和对 AS 计划的信任(39%)。选择 CT 的原因是癌症担忧(51%)和感知确定性(29%)。选择 AS 的女性受教育程度较低的比例更高(OR 0.45;95%置信区间 [CI],0.22-0.93),并且更经常报告经历过共同决策(OR 2.71;95% CI,1.37-5.37)比选择 CT 的女性。
LORD 试验是第一个为低危 DCIS 患者提供 CT 和 AS 之间选择的试验。大多数女性选择 AS,并对 AS 的安全性高度信任。他们的偏好强调了为低危 DCIS 建立 AS 安全性的必要性。