From the Departments of Radiology (W.A.B., A.V., D.M.C., A.H.L., M.A.G., A.E.K., B.E.N., J.Y.H., U.W., C.M.H., K.S.H., R.F.R., D.D.S., B.A.C., C.S.C., L.P.W., J.H.S., M.L.Z.) and Computational and Systems Biology (J.M.B.), University of Pittsburgh School of Medicine, 300 Halket St, Pittsburgh, PA 15213; Department of Radiology, UPMC Magee-Womens Hospital, Pittsburgh, Pa (W.A.B., A.V., D.M.C., A.H.L., M.A.G., C.M.H., D.D.S., C.S.C., J.H.S., M.L.Z.); and Department of Biostatistics, University of Pittsburgh School of Public Health, Pittsburgh, Pa (A.I.B.).
Radiology. 2024 Apr;311(1):e231991. doi: 10.1148/radiol.231991.
Background Digital breast tomosynthesis (DBT) is often inadequate for screening women with a personal history of breast cancer (PHBC). The ongoing prospective Tomosynthesis or Contrast-Enhanced Mammography, or TOCEM, trial includes three annual screenings with both DBT and contrast-enhanced mammography (CEM). Purpose To perform interim assessment of cancer yield, stage, and recall rate when CEM is added to DBT in women with PHBC. Materials and Methods From October 2019 to December 2022, two radiologists interpreted both examinations: Observer 1 reviewed DBT first and then CEM, and observer 2 reviewed CEM first and then DBT. Effects of adding CEM to DBT on incremental cancer detection rate (ICDR), cancer type and node status, recall rate, and other performance characteristics of the primary radiologist decisions were assessed. Results Among the participants (mean age at entry, 63.6 years ± 9.6 [SD]), 1273, 819, and 227 women with PHBC completed year 1, 2, and 3 screening, respectively. For observer 1, year 1 cancer yield was 20 of 1273 (15.7 per 1000 screenings) for DBT and 29 of 1273 (22.8 per 1000 screenings; ICDR, 7.1 per 1000 screenings [95% CI: 3.2, 13.4]) for DBT plus CEM ( < .001). Year 2 plus 3 cancer yield was four of 1046 (3.8 per 1000 screenings) for DBT and eight of 1046 (7.6 per 1000 screenings; ICDR, 3.8 per 1000 screenings [95% CI: 1.0, 7.6]) for DBT plus CEM ( = .001). Year 1 recall rate for observer 1 was 103 of 1273 (8.1%) for (incidence) DBT alone and 187 of 1273 (14.7%) for DBT plus CEM (difference = 84 of 1273, 6.6% [95% CI: 5.3, 8.1]; < .001). Year 2 plus 3 recall rate was 40 of 1046 (3.8%) for DBT and 92 of 1046 (8.8%) for DBT plus CEM (difference = 52 of 1046, 5.0% [95% CI: 3.7, 6.3]; < .001). In 18 breasts with cancer detected only at CEM after integration of both observers, 13 (72%) cancers were invasive (median tumor size, 0.6 cm) and eight of nine (88%) with staging were N0. Among 1883 screenings with adequate reference standard, there were three interval cancers (one at the scar, two in axillae). Conclusion CEM added to DBT increased early breast cancer detection each year in women with PHBC, with an accompanying approximately 5.0%-6.6% recall rate increase. Clinical trial registration no. NCT04085510 © RSNA, 2024
背景 数字乳腺断层合成术（DBT）通常不适合有乳腺癌病史（PHBC）的女性筛查。正在进行的前瞻性断层合成术或对比增强乳腺摄影或 TOCEM 试验包括每年进行三次筛查，包括 DBT 和对比增强乳腺摄影（CEM）。目的 当 CEM 添加到 PHBC 女性的 DBT 中时，评估癌症检出率、分期和召回率的中期评估。材料和方法 2019 年 10 月至 2022 年 12 月，两名放射科医生对两种检查均进行了解读：观察者 1 先查看 DBT，然后查看 CEM，观察者 2 先查看 CEM，然后查看 DBT。评估了在添加 CEM 后对增量癌症检出率（ICDR）、癌症类型和淋巴结状态、召回率以及主要放射科医生决策的其他性能特征的影响。结果 在参与者中（进入时的平均年龄为 63.6 岁±9.6[SD]），1273、819 和 227 名 PHBC 女性分别完成了第 1、2 和 3 年的筛查。对于观察者 1，第 1 年的癌症检出率为 1273 例中的 20 例（每 1000 例筛查 15.7 例），1273 例中的 29 例（每 1000 例筛查 22.8 例；ICDR，每 1000 例筛查 7.1 例[95%CI：3.2，13.4]）为 DBT 加 CEM（<.001）。第 2 年和第 3 年的癌症检出率为 1046 例中的 4 例（每 1000 例筛查 3.8 例），1046 例中的 8 例（每 1000 例筛查 7.6 例；ICDR，每 1000 例筛查 3.8 例[95%CI：1.0，7.6]）为 DBT 加 CEM（=.001）。第 1 年观察者 1 的召回率为 1273 例中的 103 例（8.1%）为（发生率）DBT 单独，1273 例中的 187 例（14.7%）为 DBT 加 CEM（差异为 1273 例中的 84 例，6.6%[95%CI：5.3，8.1]；<.001）。第 2 年和第 3 年的召回率为 1046 例中的 40 例（3.8%）为 DBT，1046 例中的 92 例（8.8%）为 DBT 加 CEM（差异为 1046 例中的 52 例，5.0%[95%CI：3.7，6.3]；<.001）。在整合两位观察者后仅在 CEM 中检测到的 18 例乳腺癌中，13 例（72%）为浸润性癌（中位肿瘤大小 0.6cm），9 例中有 8 例（88%）为 N0 期。在 1883 次有充分参考标准的筛查中，有 3 例为间期癌（1 例位于瘢痕处，2 例位于腋窝）。结论 CEM 添加到 DBT 中，每年增加 PHBC 女性早期乳腺癌的检出率，同时召回率增加约 5.0%-6.6%。临床试验注册号 NCT04085510 © RSNA，2024
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