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符合临床试验设定的观察标准的导管原位癌患者比例。

Proportion of Patients With Ductal Carcinoma In Situ That Qualify for Observation Criteria Set Forth by Clinical Trials.

作者信息

McAdams Callie D, Clevenger Nicholas, Nicholson Kyra, Pesce Catherine, Kopkash Katherine, Poli Elizabeth, Smith Thomas W, Yao Katherine

机构信息

Department of Surgery, NorthShore University Healthsystem, Evanston, Illinois, USA.

出版信息

J Surg Oncol. 2025 Feb;131(2):115-123. doi: 10.1002/jso.27858. Epub 2024 Sep 19.

DOI:10.1002/jso.27858
PMID:39295556
Abstract

BACKGROUND

The COMET, LORD, and LORIS clinical trials are investigating the role of active surveillance in low-risk ductal carcinoma in situ (DCIS). The objective of this study was to identify the proportion of patients eligible for these trials amongst a cohort of patients treated at our institution.

METHODS

Retrospective chart review was performed of patients diagnosed with DCIS who were treated from 2013 to 2022. Clinical, tumor, and imaging inclusion and exclusion criteria of the aforementioned observation trials were applied to determine the proportion of patients eligible for each trial. Upgrade rate to invasive cancer were examined across all three groups.

RESULTS

Of 1223 patients diagnosed with DCIS, applying the criteria of each trial, 245 (20%), 238 (19.4%), and 264 (21.6%) patients were eligible for the COMET, LORD, and LORIS trials, respectively. High-grade DCIS and mass on imaging had the largest impact on exclusion. Nineteen (7.8%) of women who qualified for COMET were upgraded to invasive disease at excision, compared to 18 (7.6%) for LORD, and 19 (7.2%) for LORIS.

CONCLUSIONS

One in five patients diagnosed with DCIS at our institution would qualify for observation with current trial eligibility. Observation of DCIS may have limited impact on all DCIS patients.

摘要

背景

COMET、LORD和LORIS临床试验正在研究主动监测在低风险导管原位癌(DCIS)中的作用。本研究的目的是确定在我们机构接受治疗的一组患者中符合这些试验条件的患者比例。

方法

对2013年至2022年期间诊断为DCIS并接受治疗的患者进行回顾性病历审查。应用上述观察性试验的临床、肿瘤和影像学纳入及排除标准,以确定符合每项试验条件的患者比例。对所有三组患者的浸润性癌升级率进行了检查。

结果

在1223例诊断为DCIS的患者中,根据每项试验的标准,分别有245例(20%)、238例(19.4%)和264例(21.6%)患者符合COMET、LORD和LORIS试验条件。高级别DCIS和影像学上的肿块对排除的影响最大。符合COMET试验条件的女性中有19例(7.8%)在切除时升级为浸润性疾病,LORIS试验为18例(7.6%),LORIS试验为19例(7.2%)。

结论

在我们机构诊断为DCIS的患者中,五分之一符合当前试验条件可进行观察。对DCIS的观察可能对所有DCIS患者的影响有限。

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J Surg Oncol. 2025 Feb;131(2):115-123. doi: 10.1002/jso.27858. Epub 2024 Sep 19.
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