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数字乳腺断层合成筛查 10 年后的假阳性结果累积概率与数字乳腺钼靶摄影比较。

Cumulative Probability of False-Positive Results After 10 Years of Screening With Digital Breast Tomosynthesis vs Digital Mammography.

机构信息

Division of Biostatistics, Department of Public Health Sciences, University of California Davis School of Medicine, Davis.

Department of Training and Scientific Research, University Medical Center, Ho Chi Minh City, Vietnam.

出版信息

JAMA Netw Open. 2022 Mar 1;5(3):e222440. doi: 10.1001/jamanetworkopen.2022.2440.

Abstract

IMPORTANCE

Breast cancer screening with digital breast tomosynthesis may decrease false-positive results compared with digital mammography.

OBJECTIVE

To estimate the probability of receiving at least 1 false-positive result after 10 years of screening with digital breast tomosynthesis vs digital mammography in the US.

DESIGN, SETTING, AND PARTICIPANTS: An observational comparative effectiveness study with data collected prospectively for screening examinations was performed between January 1, 2005, and December 31, 2018, at 126 radiology facilities in the Breast Cancer Surveillance Consortium. Analysis included 903 495 individuals aged 40 to 79 years. Data analysis was conducted from February 9 to September 7, 2021.

EXPOSURES

Screening modality, screening interval, age, and Breast Imaging Reporting and Data System breast density.

MAIN OUTCOMES AND MEASURES

Cumulative risk of at least 1 false-positive recall for further imaging, short-interval follow-up recommendation, and biopsy recommendation after 10 years of annual or biennial screening with digital breast tomosynthesis vs digital mammography, accounting for competing risks of breast cancer diagnosis and death.

RESULTS

In this study of 903 495 women, 2 969 055 nonbaseline screening examinations were performed with interpretation by 699 radiologists. Mean (SD) age of the women at the time of the screening examinations was 57.6 (9.9) years, and 58% of the examinations were in individuals younger than 60 years and 46% were performed in women with dense breasts. A total of 15% of examinations used tomosynthesis. For annual screening, the 10-year cumulative probability of at least 1 false-positive result was significantly lower with tomosynthesis vs digital mammography for all outcomes: 49.6% vs 56.3% (difference, -6.7; 95% CI, -7.4 to -6.1) for recall, 16.6% vs 17.8% (difference, -1.1; 95% CI, -1.7 to -0.6) for short-interval follow-up recommendation, and 11.2% vs 11.7% (difference, -0.5; 95% CI, -1.0 to -0.1) for biopsy recommendation. For biennial screening, the cumulative probability of a false-positive recall was significantly lower for tomosynthesis vs digital mammography (35.7% vs 38.1%; difference, -2.4; 95% CI, -3.4 to -1.5), but cumulative probabilities did not differ significantly by modality for short-interval follow-up recommendation (10.3% vs 10.5%; difference, -0.1; 95% CI, -0.7 to 0.5) or biopsy recommendation (6.6% vs 6.7%; difference, -0.1; 95% CI, -0.5 to 0.4). Decreases in cumulative probabilities of false-positive results with tomosynthesis vs digital mammography were largest for annual screening in women with nondense breasts (differences for recall, -6.5 to -12.8; short-interval follow-up, 0.1 to -5.2; and biopsy recommendation, -0.5 to -3.1). Regardless of modality, cumulative probabilities of false-positive results were substantially lower for biennial vs annual screening (overall recall, 35.7 to 38.1 vs 49.6 to 56.3; short-interval follow-up, 10.3 to 10.5 vs 16.6 to 17.8; and biopsy recommendation, 6.6 to 6.7 vs 11.2 to 11.7); older vs younger age groups (eg, among annual screening in women ages 70-79 vs 40-49, recall, 39.8 to 47.0 vs 60.8 to 68.0; short-interval follow-up, 13.3 to 14.2 vs 20.7 to 20.9; and biopsy recommendation, 9.1 to 9.3 vs 13.2 to 13.4); and women with entirely fatty vs extremely dense breasts (eg, among annual screening in women aged 50-59 years, recall, 29.1 to 36.3 vs 58.8 to 60.4; short-interval follow-up, 8.9 to 11.6 vs 19.5 to 19.8; and biopsy recommendation, 4.9 to 8.0 vs 15.1 to 15.3).

CONCLUSIONS AND RELEVANCE

In this comparative effectiveness study, 10-year cumulative probabilities of false-positive results were lower on digital breast tomosynthesis vs digital mammography. Biennial screening interval, older age, and nondense breasts were associated with larger reductions in false-positive probabilities than screening modality.

摘要

重要提示

与数字乳房 X 线摄影相比,数字乳腺断层合成术可能会降低假阳性结果。

目的

估计在 US 中进行 10 年数字乳腺断层合成术与数字乳房 X 线摄影筛查后,每 10 年至少收到 1 次假阳性结果的概率。

设计、设置和参与者:这是一项具有前瞻性的观察性比较有效性研究,数据是在 2005 年 1 月 1 日至 2018 年 12 月 31 日期间从 126 个放射科设施收集的,纳入了 903495 名年龄在 40 至 79 岁之间的个体。数据分析于 2021 年 2 月 9 日至 9 月 7 日进行。

暴露情况

筛查方式、筛查间隔、年龄和乳房成像报告和数据系统(BI-RADS)乳房密度。

主要结果和测量

每年或每两年进行一次数字乳腺断层合成术与数字乳房 X 线摄影筛查 10 年后,进一步成像的至少 1 次假阳性召回、短间隔随访推荐和活检推荐的累积风险,同时考虑乳腺癌诊断和死亡的竞争风险。

结果

在这项对 903495 名女性的研究中,699 名放射科医生对 2969055 次非基线筛查检查进行了解读。女性筛查检查时的平均(SD)年龄为 57.6(9.9)岁,58%的检查在 60 岁以下的人群中进行,46%在乳房致密的女性中进行。共有 15%的检查使用断层合成术。对于年度筛查,与数字乳房 X 线摄影相比,数字乳腺断层合成术的 10 年累积假阳性结果概率在所有结果中均显著降低:召回的概率分别为 49.6%和 56.3%(差值,-6.7;95%CI,-7.4 至-6.1),短间隔随访推荐的概率分别为 16.6%和 17.8%(差值,-1.1;95%CI,-1.7 至-0.6),活检推荐的概率分别为 11.2%和 11.7%(差值,-0.5;95%CI,-1.0 至-0.1)。对于两年筛查,与数字乳房 X 线摄影相比,数字乳腺断层合成术的假阳性召回概率显著降低(分别为 35.7%和 38.1%;差值,-2.4;95%CI,-3.4 至-1.5),但在短间隔随访推荐和活检推荐方面,不同模式的累积概率无显著差异(分别为 10.3%和 10.5%;差值,-0.1;95%CI,-0.7 至 0.5)或活检推荐(分别为 6.6%和 6.7%;差值,-0.1;95%CI,-0.5 至 0.4)。与数字乳房 X 线摄影相比,数字乳腺断层合成术的假阳性结果累积概率降低幅度最大的是乳房不致密的女性的年度筛查(召回的差异分别为-6.5 至-12.8;短间隔随访的差异分别为 0.1 至-5.2;活检推荐的差异分别为-0.5 至-3.1)。无论模式如何,与年度筛查相比,两年筛查的假阳性结果累积概率都显著降低(总召回率分别为 35.7%和 38.1%与 49.6%和 56.3%;短间隔随访的差异分别为 10.3%和 10.5%与 16.6%和 17.8%;活检推荐的差异分别为 6.6%和 6.7%与 11.2%和 11.7%);年龄较大与年龄较小的年龄组(例如,在年龄 70-79 岁的女性中与年龄 40-49 岁的女性相比,召回率分别为 39.8%和 47.0%与 60.8%和 68.0%;短间隔随访的差异分别为 13.3%和 14.2%与 20.7%和 20.9%;活检推荐的差异分别为 9.1%和 9.3%与 13.2%和 13.4%);乳房脂肪组织和致密组织(例如,在年龄 50-59 岁的女性中,召回率分别为 29.1%和 36.3%与 58.8%和 60.4%;短间隔随访的差异分别为 8.9%和 11.6%与 19.5%和 19.8%;活检推荐的差异分别为 4.9%和 8.0%与 15.1%和 15.3%)。

结论和相关性

在这项比较有效性研究中,与数字乳房 X 线摄影相比,数字乳腺断层合成术的 10 年累积假阳性结果概率更低。与筛查间隔、年龄较大和乳房不致密相比,筛查模式与假阳性概率降低的相关性较小。

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