Evaluating the Efficacy of 6-Month Follow-Up for BI-RADS 3 Lesions Identified by Screening Ultrasound: A Retrospective Study

Jirapa Chansangrat (1), Nattawut Keeratibharat (2)
(1) School of Radiology, Institute of Medicine, Suranaree University of Technology, Nakhon Ratchasima 30000 Thailand, Thailand,
(2) School of Surgery, Institute of Medicine, Suranaree University of Technology, Nakhon Ratchasima 30000 Thailand, Thailand


Background: The Breast Imaging-Reporting and Data System (BI-RADS), developed to standardize mammographic findings, categorizes 'probably benign' lesions as BI-RADS 3, aiming to reduce unnecessary biopsies from false positives, with a cancer likelihood of less than 2%. In some countries, screening programs have been expanded to include ultrasound alongside mammography, particularly in populations with predominantly dense breast tissue, leading to an increased detection of BI-RADS 3 lesions through this additional modality. This study examines the effectiveness of 6-month follow-ups for these ultrasound-identified BI-RADS 3 lesions. The purpose is to evaluate cancer detection rates and diagnostic performance of ultrasound findings leading to decision for biopsy.

Materials and Methods: We retrospectively analyzed 7,577 women who underwent mammography and ultrasound screening from January 2016 to December 2021. Of these, 2,907 were classified as BI-RADS 3 based on ultrasound findings. The study focused on 1,163 patients with normal mammography and assessed BI-RADS 3 from ultrasound findings, who completed a 24-month follow-up. Data analysis included assessing demographic data, breast cancer risk, imaging features, and pathological findings.

Results: Among the 1,163 patients, the cancer detection of the entire cohort was 0.7%, with no cancers detected during the first six months. The cancer found at 6 months and 12-24 months were 0 and 0.17%, respectively (p<0.001). The median time to be reassesed from BI-RADS 3 to BI-RADS 4 was 18.4 months. Upon the change of BI-RADS, spiculation and angular margins were the most predictive ultrasound features for malignancy (AUROC=0.75 and 0.69, respectively). Lesion size growth alone was found insufficient as a biopsy criterion. A 28% growth cutoff distinguished between benign and malignant lesions better than 20% cutoff (AUROC=0.68 vs 0.64, p=0.038).

Conclusion: A 12-month follow-up interval may be more appropriate than the traditional 6-month interval for average-risk patients with BI-RADS 3 lesions detected by screening ultrasound. Combining suspicious imaging features with size increases enhances diagnostic accuracy, proposing a tailored follow-up approach based on individual risk profiles and imaging characteristics.

Full text article

Generated from XML file


Cyrlak D. Induced costs of low-cost screening mammography. Radiology 1998;168(3):661-663 DOI: 10.1148/radiology.168.3.3406395

Leung JW, Sickles EA. The probably benign assessment. Radiol Clin North Am 2007;45(5):773-789 DOI: 10.1016/j.rcl.2007.06.008

Helvie MA, Pennes DR, Rebner M, Adler DD. Mammographic follow-up of low-suspicion lesions: compliance rate and diagnostic yield. Radiology 1991;178(1):155-8 DOI: 10.1148/radiology.178.1.1984295

Berg WA, Berg JM, Sickles EA, Burnside ES, Zuley ML, Rosenberg RD, et al. Cancer yield and patterns of follow-up for BIRADS category 3 after screening mammography recall in the national mammography database. Radiology 2020;296:32-41 https://doi.org/10.1148/radiol.2020192641

Dunleavy G, Verma N, Tiemann E, Ho J, Srivastava Y. Enhancing patient-centered approaches to optimize early-breast cancer care: a review of current practice and opportunities for improvement in Thailand. The Economist Group 2023. https://impact.economist.com/perspectives/sites/default/files/msd_thailand_early_breast_cancer_report_final.pdf

Moon HJ, Kim MJ, Yoon JH, Kim EK. Follow-up interval for probably benign breast lesions on screening ultrasound in women at average risk for breast cancer with dense breasts. Acta Radiologica 2018;59(9):1045-1050 DOI: 10.1177/0284185117745906

Chae EY, Cha JH, Shin HJ, Choi WJ, Kim HH. Reassessment and follow-up results of BI-RADS category 3 lesions detected on screening breast ultrasound. AJR 2016;206:666-672 DOI: 10.2214/AJR.15.14785

Barr RG, Zhang Z, Mendelson EB, Berg WA. Probably benign lesions at screening breast US in a population with elevated risk: prevalence and rate of malignancy in the ACRIN 6666 trial. Radiology 2013;269:701-712 DOI: 10.1148/radiol.13122829

Liu X. Classification accuracy and cut point selection. Stat Med 2012; 31(23): 2676-86.

Huh S, Suh HJ, Kim EK, Kim MJ, Yoon JH, Park VY, et al. Follow-up intervals for breast imaging reporting and data system category 3 lesions on screening ultrasound in screening and tertiary referral centers. Korean J Radiol 2020; 21(9):1027-1035 DOI: 10.3348/kjr.2019.0747

Ha SM, Chae EY, Cha JH, Shin HJ, Choi WJ, Kim HH. Growing BI-RADS category 3 lesions on follow-up breast ultrasound: malignancy rates and worrisome features. Br J Radiol 2018;91:20170787 DOI: 10.1259/bjr.20170787

Nam SY, Ko EY, Han BK, Shin JH, Ko ES, Hahn SY. Breast imaging reporting and data system category 3 lesions detected on whole-breast screening ultrasound. J Breast Cancer 2016;19(3):301-307 DOI: 10.4048/jbc.2016.19.3.301

Starvos AT, Thickman D, Rapp CL, Dennis MA, Parker SH, Sisney GA. Solid breast nodules: use of sonography to distinguish between benign and malignant lesions. Radiology 1995;196:123-134 DOI: 10.1148/radiology.196.1.7784555

Hong AS, Rosen EL, Soo MS, Baker JA. BI-RADS for sonography: positive and negative predictive values of sonographic features. AJR 2005;184:1260-1265 DOI: 10.2214/ajr.184.4.01841260

Baker JA, Kornguth PJ, Soo MS, Walsh R, Mengoni P. Sonography of solid breast lesions: observer variability of lesion description and assessment. AJR 1999;172:1621-1625 DOI: 10.2214/ajr.172.6.10350302

Gordon PB, Gagnon FA, Lanzlowsky L. Solid breast masses diagnosed as fibroadenoma at fine-needle aspiration biopsy: acceptable rates of growth at long-term follow-up. Radiology 2003;229:233-238 DOI: 10.1148/radiol.2291010282

Moon HJ, Eun KK, Kwak JY, Yoon JH, Kim MJ. Interval growth of probably benign breast lesions on follow-up ultrasound: how can these be managed? Eur Radiol 2011;21:908-918 DOI: 10.1007/s00330-010-2012-3

Kerlikowske K, Zhu W, Tosteson AN, Sprague BL, Tice JA, Lehman CD, et al. Identifying women with dense breasts at high risk for interval cancer. Ann Intern Med 2015;162:673-681 DOI: 10.7326/M14-1465


Jirapa Chansangrat
jirapacha1986@gmail.com (Primary Contact)
Nattawut Keeratibharat
Chansangrat J, Keeratibharat N. Evaluating the Efficacy of 6-Month Follow-Up for BI-RADS 3 Lesions Identified by Screening Ultrasound: A Retrospective Study. Arch Breast Cancer [Internet]. [cited 2024 Apr. 22];11(2). Available from: https://archbreastcancer.com/index.php/abc/article/view/894

Article Details