Byng Danalyn, Retèl Valesca P, Schaapveld Michael, Wesseling Jelle, van Harten Wim H
Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Health Technology and Services Research Department, Technical Medical Centre, University of Twente, P.O. Box 217, 7500 AE, Enschede, The Netherlands.
Breast Cancer Res Treat. 2021 May;187(1):187-196. doi: 10.1007/s10549-020-06042-1. Epub 2021 Jan 3.
Results from active surveillance trials for ductal carcinoma in situ (DCIS) will not be available for > 10 years. A model based on real-world data (RWD) can demonstrate the comparative impact of non-intervention for women with low-risk features.
Multi-state models were developed using Surveillance, Epidemiology, and End Results Program (SEER) data for three treatment strategies (no local treatment, breast conserving surgery [BCS], BCS + radiotherapy [RT]), and for women with DCIS low-risk features. Eligible cases included women aged ≥ 40 years, diagnosed with primary DCIS between 1992 and 2016. Five mutually exclusive health states were modelled: DCIS, ipsilateral invasive breast cancer (iIBC) ≤ 5 years and > 5 years post-DCIS diagnosis, contralateral IBC, death preceded by and death not preceded by IBC. Propensity score-weighted Cox models assessed effects of treatment, age, diagnosis year, grade, ER status, and race.
Data on n = 85,982 women were used. Increased risk of iIBC ≤ 5 years post-DCIS was demonstrated for ages 40-49 (Hazard ratio (HR) 1.86, 95% Confidence Interval (CI) 1.34-2.57 compared to age 50-69), grade 3 lesions (HR 1.42, 95%CI 1.05-1.91) compared to grade 2, lesion size ≥ 2 cm (HR 1.66, 95%CI 1.23-2.25), and Black race (HR 2.52, 95%CI 1.83-3.48 compared to White). According to the multi-state model, propensity score-matched women with low-risk features who had not died or experienced any subsequent breast event by 10 years, had a predicted probability of iIBC as first event of 3.02% for no local treatment, 1.66% for BCS, and 0.42% for BCS+RT.
RWD from the SEER registry showed that women with primary DCIS and low-risk features demonstrate minimal differences by treatment strategy in experiencing subsequent breast events. There may be opportunity to de-escalate treatment for certain women with low-risk features: Hispanic and non-Hispanic white women aged 50-69 at diagnosis, with ER+, grade 1 + 2, < 2 cm DCIS lesions.
导管原位癌（DCIS）主动监测试验的结果在10多年内都无法获得。基于真实世界数据（RWD）的模型可以证明对具有低风险特征的女性不进行干预的相对影响。
使用监测、流行病学和最终结果计划（SEER）数据，针对三种治疗策略（不进行局部治疗、保乳手术[BCS]、BCS+放疗[RT]）以及具有DCIS低风险特征的女性开发多状态模型。符合条件的病例包括年龄≥40岁、在1992年至2016年期间被诊断为原发性DCIS的女性。对五个相互排斥的健康状态进行建模：DCIS、DCIS诊断后同侧浸润性乳腺癌（iIBC）≤5年和>5年、对侧IBC、IBC之前的死亡和IBC之后的死亡。倾向评分加权Cox模型评估治疗、年龄、诊断年份、分级、雌激素受体（ER）状态和种族的影响。
使用了n = 85,982名女性的数据。结果显示，与50-69岁相比，40-49岁的女性在DCIS诊断后≤5年发生iIBC的风险增加（风险比[HR] 1.86，95%置信区间[CI] 1.34-2.57）；与2级病变相比，3级病变发生iIBC的风险增加（HR 1.42，95%CI 1.05-1.91）；病变大小≥2 cm的女性发生iIBC的风险增加（HR 1.66，95%CI 1.23-2.25）；黑人女性发生iIBC的风险增加（与白人相比，HR 2.52，95%CI 1.83-3.48）。根据多状态模型，对于具有低风险特征、10年内未死亡或未经历任何后续乳腺事件的倾向评分匹配女性，以iIBC作为首个事件的预测概率，不进行局部治疗为3.02%，BCS为1.66%，BCS+RT为0.42%。
SEER登记处的RWD显示，原发性DCIS且具有低风险特征的女性在经历后续乳腺事件方面，不同治疗策略之间的差异极小。对于某些具有低风险特征的女性，可能有机会降低治疗强度：诊断时年龄为50-69岁的西班牙裔和非西班牙裔白人女性，ER阳性，1+2级，DCIS病变<2 cm。
