Predicting delayed diagnosis rate of intraoperative rapid frozen section pathological examination for early-stage breast cancer: a real-world retrospective study

doi:10.19401/j.cnki.1007-3639.2025.04.008

Abstract

Abstract:

Background and purpose: For few of early-stage breast cancers who are undiagnosed by core needle biopsy, the delayed diagnosis rate of intraoperative rapid frozen section pathological examination is unclear. The purpose of this retrospective cohort study was to investigate the clinical application value of frozen sections in this situation. Methods: This study reviewed data of 876 breast cancer patients that were undiagnosed by core needle biopsy in Fudan University Shanghai Cancer Center from May 1, 2006 to December 31, 2019. Clinical characteristics and image data and pathological data of patients were collected. The correlation between clinical features and delayed diagnosis rate (DDR) of frozen section was explored using logistic regression analysis, then a nomogram was constructed to predict the probability of delayed diagnosis. This study was approved by Ethics Committee of Fudan University Shanghai Cancer Center (No.: 050432-4-2108*). Results: A total of 876 patients met the inclusion standards. The intraoperative diagnosis rate of frozen section for breast cancers that were undiagnosed by core needle biopsy was 67.7%, and the DDR was 32.3%. In multivariate analysis, papillary lesion [odds ratio (OR)=4.251, 95% CI: 2.804-6.492; P<0.001) and sclerosing adenosis (OR=3.727; 95% CI: 1.897-7.376; P<0.001) accompanied by atypical epithelial hyperplasia on core needle biopsy (CNB) were positive correlation factors of delayed diagnosis, while clustered microcalcifications on mammography (OR=0.345; 95% CI: 0.216-0.543; P<0.001) and ultrasonic category 4C-5 according to Breast Imaging Reporting and Data System (BI-RADS) (OR=0.250; 95% CI: 0.081-0.777; P=0.016) were positive correlation factors of intraoperative diagnosis. The nomogram constructed by these factors could better predict the delayed diagnosis rate of frozen section and screen out low delayed diagnosis population. Conclusion: Frozen section has a certain delayed diagnosis rate for breast cancer that is not clearly diagnosed by core needle biopsy. The method of model prediction can effectively eliminate the delayed diagnosis cases and avoid some unnecessary frozen sections.

Key words: Frozen section, Breast cancer, Delayed diagnosis, Prediction model, Core needle biopsy

XUE Jialei, LI Jianwei, GONG Yue, LIU Guangyu, LIU Zhebin. Predicting delayed diagnosis rate of intraoperative rapid frozen section pathological examination for early-stage breast cancer: a real-world retrospective study[J]. China Oncology, 2025, 35(4): 404-411.

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References 31

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Item	Total (n=876)	Training set (n=613)	Testing set (n=263)
Age/year
Median age	53 (28-86)	54 (30-86)	51 (28-83)
<45	183 (20.9)	127 (20.7)	56 (21.3)
45-59	410 (46.8)	286 (46.6)	124 (47.1)
≥60	283 (32.3)	200 (32.6)	83 (31.6)
Ultrasonographic features
Echo type
Mixed echo	82 (9.4)	55 (9.0)	27 (10.3)
Low echo	764 (87.2)	538 (87.8)	226 (85.9)
Medium echo	30 (3.4)	20 (2.2)	10 (3.8)
Maximum diameter D/mm
≤10	111 (12.7)	75 (12.2)	36 (13.7)
>10	765 (87.3)	538 (87.8)	227 (86.3)
Dense punctate strong echo
Yes	298 (34.0)	201 (32.8)	97 (36.9)
No	578 (66.0)	412 (67.2)	166 (63.1)
BI-RADS
1-3	29 (3.3)	18 (2.9)	11 (4.2)
4A or 0	192 (21.9)	136 (22.2)	56 (21.3)
4B	344 (39.3)	240 (39.2)	104 (39.5)
4C or 5	311 (35.5)	219 (35.7)	92 (35.0)
Mammographic features
Microcalcifications
Yes	420 (47.9)	297 (48.5)	123 (46.8)
No	456 (52.1)	316 (51.5)	140 (53.2)
BI-RADS
1-3	71 (8.1)	45 (7.3)	26 (9.9)
4A or 0	269 (30.7)	182 (29.7)	87 (33.1)
4B	247 (28.2)	171 (27.9)	76 (28.9)
4C or 5	289 (33.0)	215 (35.1)	74 (28.1)
Physical examination symptoms
Palpable mass
Yes	812 (92.7)	571 (93.1)	241 (91.6)
No	64 (7.3)	42 (6.9)	22 (8.4)
Nipple discharge
Yes	96 (11.0)	69 (11.3)	27 (10.3)
No	780 (89.0)	544 (88.7)	236 (89.7)
Pathological features
Papillary lesions
Yes	252 (28.8)	174 (28.4)	78 (29.7)
No	624 (71.2)	439 (71.6)	185 (70.3)
Sclerosing adenosis
Yes	61 (7.0)	45 (7.3)	16 (6.1)
No	815 (93.0)	568 (92.7)	247 (93.9)
Frozen section
False negative	283 (32.3)	203 (33.1)	80 (30.4)
Ture positive	593 (67.7)	410 (66.9)	183 (69.6)

Variables	No. of patients (delayed diagnosis/total)	DDR/%	OR	95% CI	P value
Dense punctate strong echo
No	176/412	42.7	1.000	-	-
Yes	27/201	13.4	0.595	0.335-1.044	0.073
US-BI-RADS
1-3	9/18	50.0	1.000	-	-
0 or 4A	61/136	44.9	0.601	0.195-1.861	0.372
4B	88/240	36.7	0.434	0.143-1.321	0.137
4C-5	45/219	20.5	0.250	0.081-0.777	0.016
Microcalcifications on MG
No	155/316	49.1	1.000	-	-
Yes	48/297	16.2	0.345	0.216-0.543	<0.001
Papillary lesions
No	98/439	22.3	1.000	-	-
Yes	105/174	60.3	4.251	2.804-6.492	<0.001
Sclerosing adenosis
No	180/568	31.7	1.000	-	-
Yes	23/45	51.1	3.727	1.897-7.376	<0.001

Cut-off value		No. of patients n		Real DDR/%
Total score	Predicted DDR/%	Total	Delayed diagnosis	Real DDR/%
≤40	≤10	220	22	10.0
≤76	≤15	246	25	10.2
≥190	≥50	235	152	64.7
≥220	≥60	159	114	71.7
≥251	≥70	60	44	73.3
≥288	≥80	8	7	87.5