Rycan 2021210036
Rycan 2021210036
Rycan 2021210036
Purpose: To determine the upgrade rate for biopsy-proven radial scars and radial sclerosing lesions (RS).
Materials and Methods: In this retrospective study, radiology and pathology databases from two tertiary breast centers were searched to
identify patients with biopsy-confirmed RS between March 1, 2012, and December 31, 2017, during which all mammography was
performed with digital breast tomosynthesis (DBT). Adjunct modalities such as MRI or US are performed at our centers to better
characterize lesions identified at DBT. Patient demographics, imaging, needle and excisional biopsies, and follow-up data were collect-
ed at the patient level. Clopper-Pearson interval estimate for upgrade was calculated for 95% confidence using PropCIs package with R
version 4.1.0 (R Foundation for Statistical Computing) (1).
Results: During the study period, a total of 155 885 DBT examinations were performed. From these examinations, 146 biopsy-proven
RS were identified in 142 women (median age, 58 years; age range, 26–87 years). A total of 80.1% (117 of 146) of all RS did not have
associated atypia or malignancy, and 19.9% (29 of 146) had associated atypia at initial biopsy. A total of 66.7% (78 of 117) of RS
without atypia or malignancy were surgically excised, 25.6% (30 of 117) were followed (median, 3 years; range, 1–7 years) with benign
findings on imaging, and 7.7% (nine of 117) were lost to follow-up. The rate of malignancy upgrade was 0.9% (one of 117 [95% CI:
0.02, 4.7]); one RS without concurrent atypia or malignancy demonstrated invasive carcinoma at surgical excision.
© RSNA, 2021
Figure 1: Flow diagram of cases of radial sclerosing lesions (RS) and radial scars with and without atypia at core
biopsy and results of excision or imaging follow-up. AD = architectural distortions, ADH = atypical ductal hyperplasia, CA =
carcinoma, DBT = digital breast tomosynthesis, DCIS = ductal carcinoma in situ.
Table 2: Biopsy and Histopathologic Findings in Patients with RS with Atypia at Initial Biopsy and Upgraded to Malig-
nancy at Surgical Excision
of 3 years (range, 1–7 years). One hundred percent (30 of 30) of at US (Fig 2D, 2E). Mammogram obtained after biopsy clip
RS lesions without atypia that were followed with imaging alone placement shows the clip in the abnormality (Fig 2F, 2G), but
were benign. the US biopsy image (Fig 2E) shows the needle slightly superficial
One RS without atypia at biopsy was upgraded to invasive to the mass. This patient had a history of contralateral breast can-
carcinoma (0.9%, one of 117 [95% CI: 0.02, 4.7]). This lesion cer treated with segmental excision and radiation therapy 7 years
presented as AD at DBT (Fig 2A–2C) with a corresponding mass prior. At excisional biopsy, a 7-mm estrogen receptor–positive,
Figure 2: Im-
ages in a 66-year-
old woman with
previous history of
left breast cancer
treated with seg-
mental excision and
radiation therapy 7
years prior. Digital
breast tomosynthesis
(DBT) helped detect
radial sclerosing
lesion (RS) without
atypia in the con-
tralateral (right)
breast, which was
upgraded to inva-
sive carcinoma after
surgical excision. (A) Craniocaudal (CC) digital mammogram and (B) mediolateral oblique (MLO) digital mammogram as well as (C) MLO DBT views. Architectural dis-
tortion with possible associated mass in the upper right breast posteriorly was optimally observed on DBT MLO view (circle). (D, E) Sagittal and biopsy US images show a
subtle 7-mm hypoechoic mass (arrows) corresponding to the DBT finding. (F, G) Postbiopsy mediolateral and laterally exaggerated CC digital mammograms demonstrate
clip placement within the area of architectural distortion. Core biopsy returned radial scar, which was assessed as concordant. Surgical excision was recommended. Final
surgical excisional pathologic analysis demonstrated a 7-mm estrogen receptor–positive, progesterone receptor–positive, human epidermal growth factor receptor 2–neg-
ative, invasive tubular carcinoma Nottingham grade I of III with no lymphovascular invasion, which was identified adjacent to, but distinct from, the biopsy needle track.
progesterone receptor–positive, human epidermal growth fac- the majority of RS were detected with DBT, and the majority of
tor receptor 2–negative, invasive tubular carcinoma Nottingham biopsies were obtained with DBT guidance. This is not surpris-
grade I of III with no lymphovascular invasion was identified adja- ing, as DBT has been shown to help detect more AD and RS
cent to, but distinct from, the biopsy needle track. Sampling error (4,6,11–13).
likely contributed to this upgrade. As Cohen et al postulated, biopsy sampling error may con-
tribute to radiologic-histopathologic discordance and to false-
Discussion negative findings (31,32,36). Our single upgraded RS without
Conventional two-dimensional mammography has been a stal- atypia was 7 mm in size and had three samples taken with a
wart of breast radiology practice. With the advent of DBT, this 12-gauge needle. Excisional histopathologic analysis demon-
new technology is now the predominant form of screening in strated the biopsy needle tracked adjacent to, but not involving,
41.8% of hospital referral regions in the United States and has the invasive carcinoma. In addition, US images from the bi-
improved the sensitivity of screening mammography and our opsy show the needle was likely superficial to the targeted mass,
ability to characterize lesions (5–9,28). As widespread clinical thus sampling error likely contributed to this upgrade. While
use of DBT has identified more RS (4,6,11–13), appropriate some studies have shown that taking more than 12 samples at
management of newly detected RS remains unclear. The pur- biopsy (19,37) reduces the likelihood of missed associated car-
pose of this study was to determine the rate of upgrade to ma- cinoma, AD poses a challenge with regard to sampling error, as
lignancy in RS without atypia and with atypia during a study the spiculations and distortion can extend over a fairly substan-
period when all mammography was performed with DBT. tial distance. Another study demonstrated that a majority of RS
We found that the majority (80.1%, 117 of 146) of RS were upgrades had a needle track that missed the nearby malignancy
without concurrent atypia or malignancy and that the rate of by 6 mm or less (37). The single upgraded lesion in this study
malignancy upgrade among those lesions was minimal (0.9%, likely falls into this category. Precise needle targeting is critical to
one of 117). In contrast, the rate of upgrade was 14% (four decreasing false-negative biopsy results.
of 29) for RS with associated atypia. The proportion of RS In our study, 30 RS lesions without atypia did not undergo
without atypia or malignancy that we found (80.1%) is com- surgical excision; all had stable, benign imaging findings for a
parable to other studies (reported at 75% [91 of 157], 81% median duration of 3 years following biopsy, strongly supporting
[77 of 95], and 87% [76 of 88]) (or 80.1% [95% CI: 62.3, benignity. Another study demonstrating similar results is Kraft et
90.8] vs pooled: 71.8% [95% CI: 60.2, 81.0]; P = .19) (29–31, al, where 50 of 50 patients undergoing active surveillance instead
respectively). The proportion of RS with associated atypia we of excision did not progress on follow-up imaging (35). This is
found (19.9%, 29 of 146) was also comparable to other studies a larger cohort than in previous studies followed with imaging
reporting 25% (66 of 157), 19% (18 of 95), and 13% (12 of alone rather than surgical excision (23,33, 34, 38). For example,
88) (or 19.9% [95% CI: 9.2, 37.7] vs pooled: 28.2% [95% in Martaindale et al, 13 lesions were followed successfully for a
CI: 19.0, 39.8]; P = .19) (29–31, respectively). median of 18 months with benign findings (33). The major-
The upgrade rate for RS associated with atypia in this study ity (66.7%, 78 of 117) of RS without atypia in our study were
was 14%, which is within the range of upgrade rates reported surgically excised. Replacing surgical excisions with follow-up
previously (upgrade rate of 35% [38 of 108] for RS with atypical imaging could have positive mental, emotional, and cosmetic
ductal hyperplasia [32] and upgrade rates of 17% [one of six] outcomes for patients, with minimal risk of a missed cancer. No-
and 10% for RS with atypia [five of 49] [33,34]). These upgrade tably, we had nine patients who were lost to follow-up. This em-
rates support surgical excision as an optimal management deci- phasizes the need to recommend follow-up with imaging care-
sion for patients with RS with atypia at biopsy. fully; establishing benignity in vulnerable populations who may
Our very low upgrade rate of 0.9% (one of 117) for RS with- have sporadic health care access necessitates a shared discussion
out atypia at biopsy strongly supports imaging follow-up over of the feasibility of imaging follow-up. Increasing data regarding
surgical excision as the best treatment for these patients. Similar the minimal upgrade rates of RS without atypia in the DBT era
upgrade rates have been reported in other studies (0% [zero of may help inform management recommendations, potentially al-
92], 0.9% [one of 107], 1.9% [two of 105] 1% [one of 97]) for lowing more lesions to safely be followed with imaging rather
RS without atypia or malignancy at biopsy (26,32,33,35, respec- than undergoing surgical excision.
tively). In one study of DBT-biopsied RS by Martaindale et al, a This study was limited in its ability to recommend manage-
similar upgrade rate of 2.8% (one of 36) was reported for cases ment practice given the small sample size. These are inherent
without atypia at biopsy (33). Interestingly, Rakha et al demon- limitations when studying an uncommon pathologic state at a
strated that the upgrade rate for RS and concurrent atypical duc- small number of centers, though it does examine a larger cohort
tal hyperplasia was similar to the upgrade rate of atypical ductal than some previous studies (33,35,39). In addition, nine patients
hyperplasia alone (32), supporting the hypothesis that atypical were lost to follow-up; the upgrade rate could thus potentially be
ductal hyperplasia is likely the main contributor to malignant higher than the one reported. The radiologists interpreting imag-
potential. ing and performing needle biopsies were all fellowship-trained
An earlier study from our center (23) identified 100 RS with- breast radiologists; thus, the results may not generalize to a gen-
out atypia before the widespread use of DBT; 0% (zero of 100) eral radiology practice. Additionally, we did not consider how
of these were upgraded to malignancy, though only 41 under- other factors, such as the presence of multiple radial scars, dis-
went surgical excisional biopsy. In contrast, in this current study, tantly located concurrent cancer, or the unique breast cancer risk
of the individual, may affect outcomes. With the small numbers 16. American College of Radiology. ACR BI-RADS Atlas: Breast Imaging
Reporting and Data System. Reston, Va: American College of Radiology,
of cases, it would be difficult to discern significance for any of 2014.
these metrics. The one case of upgrade did have previously diag- 17. Freer PE, Wang JL, Rafferty EA. Digital breast tomosynthesis in the analysis
nosed contralateral breast cancer 7 years prior. of fat-containing lesions. RadioGraphics 2014;34(2):343–358.
18. Alshafeiy TI, Nguyen JV, Rochman CM, Nicholson BT, Patrie JT, Harvey
RS without atypia diagnosed at core-needle biopsy after JA. Outcome of Architectural Distortion Detected Only at Breast Tomo-
DBT screening had a very low (0.9%) rate of upgrade to ma- synthesis versus 2D Mammography. Radiology 2018;288(1):38–46.
lignancy. Excision of RS without atypia may not be warranted; 19. Brenner RJ, Jackman RJ, Parker SH, et al. Percutaneous core needle biopsy
of radial scars of the breast: when is excision necessary? AJR Am J Roentgenol
imaging follow-up of these lesions may be a reasonable man- 2002;179(5):1179–1184.
agement plan instead. 20. Jacobs TW, Byrne C, Colditz G, Connolly JL, Schnitt SJ. Radial scars in
benign breast-biopsy specimens and the risk of breast cancer. N Engl J Med
Author contributions: Guarantors of integrity of entire study, P.Y., A.P.L.; study 1999;340(6):430–436.
concepts/study design or data acquisition or data analysis/interpretation, all authors; 21. Li Z, Ranade A, Zhao C. Pathologic findings of follow-up surgical excision
manuscript drafting or manuscript revision for important intellectual content, all for radial scar on breast core needle biopsy. Hum Pathol 2016;48:76–80.
authors; approval of final version of submitted manuscript, all authors; agrees to 22. Sohn VY, Causey MW, Steele SR, Keylock JB, Brown TA. The treatment
ensure any questions related to the work are appropriately resolved, all authors; of radial scars in the modern era--surgical excision is not required. Am Surg
literature research, P.Y., L.D., A.P.L.; clinical studies, P.Y., L.D., A.P.L.; statistical 2010;76(5):522–525.
analysis, P.Y., G.L.B.; and manuscript editing, all authors 23. Kalife ET, Lourenco AP, Baird GL, Wang Y. Clinical and radiologic follow-
up study for biopsy diagnosis of radial scar/radial sclerosing lesion without
Disclosures of conflicts of interest: P.Y. No relevant relationships. L.D. RSNA other atypia. Breast J 2016;22(6):637–644.
News editorial board member. G.L.B. No relevant relationships. A.P.L. No relevant 24. Leong RY, Kohli MK, Zeizafoun N, Liang A, Tartter PI. Radial scar at
relationships. percutaneous breast biopsy that does not require surgery. J Am Coll Surg
2016;223(5):712–716.
25. Resetkova E, Edelweiss M, Albarracin CT, Yang WT. Management of radial
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