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COMET试验对非典型导管增生管理的意义

Implications of the COMET Trial for the Management of Atypical Ductal Hyperplasia.

作者信息

Zaveri Shruti, Sun Susie X, Bevers Therese B, Albarracin Constance T, Bedrosian Isabelle

机构信息

Division of Surgical Oncology, Department of Surgery, The University of Texas Southwestern Medical Center, Dallas, TX, USA.

Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

出版信息

Ann Surg Oncol. 2025 Sep 4. doi: 10.1245/s10434-025-18236-2.

DOI:10.1245/s10434-025-18236-2
PMID:40908450
Abstract

BACKGROUND

The recently reported results from the COMET trial investigating the nonoperative management of low-risk ductal carcinoma in situ (DCIS) question the need for routine excision of atypical ductal hyperplasia (ADH). This study aimed to examine the upgrade rates of patients with ADH who met applicable COMET trial criteria.

METHODS

Cases of ADH managed with surgery at our institution between 2004 and 2022 were identified, and clinical variables were extracted from the medical record. Rates of ADH upgrade to in situ and invasive disease were compared between patients who met the selected COMET criteria for age, imaging findings, and personal history of breast cancer and those who did not.

RESULTS

Of the 362 ADH cases that met the inclusion criteria for this study; 233 (64.4 %) met the selective COMET criteria (cohort 1) and 129 (35.6 %) did not (cohort 2). The two cohorts did not differ significantly in terms of age, race, breast density, or size of lesion on imaging. The cohort 1 patients were more likely to have their diagnosis determined by mammography (94 % vs 72 %; p < 0.01) and more likely to present with calcifications (82 % vs 30.2 %; p < 0.01). The rate of upgrade to DCIS did not differ significantly between the cohorts, but the rate of invasive disease was significantly lower in cohort 1 (3.43 % vs 10.85 %; p < 0.01).

CONCLUSION

The study data showed a very low rate of ADH upgrade to invasive disease for the patients who met the COMET criteria for age, imaging findings, and breast cancer history, suggesting that such patients also could be considered a low-risk cohort for whom observation might be appropriate.

摘要

背景

最近公布的COMET试验结果对低风险导管原位癌(DCIS)的非手术治疗进行了研究,对非典型导管增生(ADH)进行常规切除的必要性提出了质疑。本研究旨在检查符合适用的COMET试验标准的ADH患者的升级率。

方法

确定2004年至2022年期间在本机构接受手术治疗的ADH病例,并从病历中提取临床变量。比较符合所选COMET年龄、影像学表现和乳腺癌个人史标准的患者与不符合这些标准的患者中ADH升级为原位癌和浸润性疾病的发生率。

结果

在符合本研究纳入标准的362例ADH病例中,233例(64.4%)符合选择性COMET标准(队列1),129例(35.6%)不符合(队列2)。两组在年龄、种族、乳腺密度或影像学上的病变大小方面无显著差异。队列1中的患者更有可能通过乳腺X线摄影确定诊断(94%对72%;p<0.01),更有可能出现钙化(82%对30.2%;p<0.01)。两组之间升级为DCIS的发生率无显著差异,但队列1中浸润性疾病的发生率显著较低(3.43%对10.85%;p<0.01)。

结论

研究数据显示,对于符合年龄、影像学表现和乳腺癌病史COMET标准的患者,ADH升级为浸润性疾病的发生率非常低,这表明此类患者也可被视为观察可能合适的低风险队列。

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引用本文的文献

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Ann Surg. 2022 Dec 1;276(6):e932-e936. doi: 10.1097/SLA.0000000000004849. Epub 2021 Mar 4.
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Preneoplasia of the Breast and Molecular Landscape.乳腺肿瘤前病变与分子特征
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Upgrade Rate of Percutaneously Diagnosed Pure Atypical Ductal Hyperplasia: Systematic Review and Meta-Analysis of 6458 Lesions.
经皮诊断的单纯非典型性导管增生升级率:6458 例病灶的系统评价和荟萃分析。
Radiology. 2020 Jan;294(1):76-86. doi: 10.1148/radiol.2019190748. Epub 2019 Oct 29.
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The COMET (Comparison of Operative versus Monitoring and Endocrine Therapy) trial: a phase III randomised controlled clinical trial for low-risk ductal carcinoma in situ (DCIS).COMET(手术与监测和内分泌治疗比较)试验:一项针对低危导管原位癌(DCIS)的 III 期随机对照临床试验。
BMJ Open. 2019 Mar 12;9(3):e026797. doi: 10.1136/bmjopen-2018-026797.
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Multivariate model to identify women at low risk of cancer upgrade after a core needle biopsy diagnosis of atypical ductal hyperplasia.多变量模型识别在核心针活检诊断为非典型导管增生后癌症升级风险低的女性。
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Subsequent Breast Cancer Risk Following Diagnosis of Atypical Ductal Hyperplasia on Needle Biopsy.针吸活检诊断为非典型导管增生后发生乳腺癌的后续风险。
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Long-Term Safety of Observation in Selected Women Following Core Biopsy Diagnosis of Atypical Ductal Hyperplasia.非典型导管增生核心活检诊断后部分女性观察的长期安全性
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