Quantitative Health Sciences, Mayo Clinic, Jacksonville, Florida.
Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota.
JAMA Surg. 2024 Feb 1;159(2):193-201. doi: 10.1001/jamasurg.2023.6382.
Benign breast disease (BBD) comprises approximately 75% of breast biopsy diagnoses. Surgical biopsy specimens diagnosed as nonproliferative (NP), proliferative disease without atypia (PDWA), or atypical hyperplasia (AH) are associated with increasing breast cancer (BC) risk; however, knowledge is limited on risk associated with percutaneously diagnosed BBD.
To estimate BC risk associated with BBD in the percutaneous biopsy era irrespective of surgical biopsy.
DESIGN, SETTING, AND PARTICIPANTS: In this retrospective cohort study, BBD biopsy specimens collected from January 1, 2002, to December 31, 2013, from patients with BBD at Mayo Clinic in Rochester, Minnesota, were reviewed by 2 pathologists masked to outcomes. Women were followed up from 6 months after biopsy until censoring, BC diagnosis, or December 31, 2021.
Benign breast disease classification and multiplicity by pathology panel review.
The main outcome was diagnosis of BC overall and stratified as ductal carcinoma in situ (DCIS) or invasive BC. Risk for presence vs absence of BBD lesions was assessed by Cox proportional hazards regression. Risk in patients with BBD compared with female breast cancer incidence rates from the Iowa Surveillance, Epidemiology, and End Results (SEER) program were estimated.
Among 4819 female participants, median age was 51 years (IQR, 43-62 years). Median follow-up was 10.9 years (IQR, 7.7-14.2 years) for control individuals without BC vs 6.6 years (IQR, 3.7-10.1 years) for patients with BC. Risk was higher in the cohort with BBD than in SEER data: BC overall (standard incidence ratio [SIR], 1.95; 95% CI, 1.76-2.17), invasive BC (SIR, 1.56; 95% CI, 1.37-1.78), and DCIS (SIR, 3.10; 95% CI, 2.54-3.77). The SIRs increased with increasing BBD severity (1.42 [95% CI, 1.19-1.71] for NP, 2.19 [95% CI, 1.88-2.54] for PDWA, and 3.91 [95% CI, 2.97-5.14] for AH), comparable to surgical cohorts with BBD. Risk also increased with increasing lesion multiplicity (SIR: 2.40 [95% CI, 2.06-2.79] for ≥3 foci of NP, 3.72 [95% CI, 2.31-5.99] for ≥3 foci of PDWA, and 5.29 [95% CI, 3.37-8.29] for ≥3 foci of AH). Ten-year BC cumulative incidence was 4.3% for NP, 6.6% for PDWA, and 14.6% for AH vs an expected population cumulative incidence of 2.9%.
In this contemporary cohort study of women diagnosed with BBD in the percutaneous biopsy era, overall risk of BC was increased vs the general population (DCIS and invasive cancer combined), similar to that in historical BBD cohorts. Development and validation of pathologic classifications including both BBD severity and multiplicity may enable improved BC risk stratification.
重要性：良性乳腺疾病（BBD）约占乳腺活检诊断的 75%。非增殖性（NP）、非典型性增生（PDWA）或非典型性增生（AH）的手术活检标本与乳腺癌（BC）风险增加相关；然而，关于经皮诊断的 BBD 相关风险的知识有限。
目的：在不考虑手术活检的情况下，估计经皮活检时代 BBD 的 BC 风险。
设计、设置和参与者：在这项回顾性队列研究中，对 2002 年 1 月 1 日至 2013 年 12 月 31 日期间在明尼苏达州罗切斯特市 Mayo 诊所因 BBD 接受活检的患者的 BBD 活检标本进行了回顾性分析。两位病理学家对结果进行了盲法评估。女性从活检后 6 个月开始随访，直至出现 BBD 病变或发生 BC 诊断或 2021 年 12 月 31 日。
暴露因素：良性乳腺疾病分类和病理面板评估的多发性。
主要结果：主要结果是总体诊断为 BC，并分为导管原位癌（DCIS）或浸润性 BC。通过 Cox 比例风险回归评估存在与不存在 BBD 病变的风险。与爱荷华州监测、流行病学和结果（SEER）计划中的女性乳腺癌发病率相比，比较了 BBD 患者的风险。
结果：在 4819 名女性参与者中，中位年龄为 51 岁（IQR，43-62 岁）。中位随访时间为对照组无 BC 患者的 10.9 年（IQR，7.7-14.2 年）与 BC 患者的 6.6 年（IQR，3.7-10.1 年）。与 SEER 数据相比，BBD 队列的风险更高：BC 总发病率（标准发病率比[SIR]，1.95；95%CI，1.76-2.17）、浸润性 BC（SIR，1.56；95%CI，1.37-1.78）和 DCIS（SIR，3.10；95%CI，2.54-3.77）。BBD 严重程度越高，SIR 越高（NP 为 1.42[95%CI，1.19-1.71]、PDWA 为 2.19[95%CI，1.88-2.54]、AH 为 3.91[95%CI，2.97-5.14]），与具有 BBD 的手术队列相当。随着病变多发性的增加，风险也会增加（SIR：NP 为≥3 个病灶的 2.40[95%CI，2.06-2.79]、PDWA 为≥3 个病灶的 3.72[95%CI，2.31-5.99]和 AH 为≥3 个病灶的 5.29[95%CI，3.37-8.29]）。NP 的 10 年 BC 累积发病率为 4.3%、PDWA 为 6.6%、AH 为 14.6%，而预期人群的累积发病率为 2.9%。
结论和相关性：在这项当代经皮活检时代女性 BBD 的队列研究中，与一般人群（DCIS 和浸润性癌症合并）相比，BC 的总体风险增加，与历史 BBD 队列相似。包括 BBD 严重程度和多发性在内的病理分类的制定和验证可能会提高 BC 风险分层。
