Dataset Information

Digital breast tomosynthesis versus X-ray of the breast specimen for intraoperative margin assessment: A randomized trial.

ABSTRACT:

Background

Involved resection margins after breast conserving surgery (BCS) often require a re-operation with increased patient anxiety and risk of impaired cosmesis. We investigated the number of re-operations due to involved resection margins after BCS comparing digital breast tomosynthesis(DBT) with X-ray for intraoperative margin evaluation. Furthermore, we assessed the diagnostic accuracy of these methods to predict histopathological margin status. Finally, we evaluated risk factors for re-operation.

Methods

In this randomized, non-blinded study, 250 invasive breast cancer patients were randomized (1:1), whereof 241 were analyzed intraoperatively with either DBT (intervention, n = 119) or X-ray (standard, n = 122). Pearson's chi-squared test, Fisher's exact test, t-test, logistic and ordinal regression analysis was used as appropriate.

Results

No difference was found in the number of re-operations between the DBT and X-ray group (16.8 % vs 19.7 %, p = 0.57), or in diagnostic accuracy to predict histopathological margin status (77.5 %, CI: 68.6-84.9 %) and (67.3 %, CI: 57.7-75.9 %), respectively. We evaluated 5 potential risk factors for re-operation: Ductal carcinoma in situ (DCIS) outside tumor, OR = 9.4 (CI: 4.3-20.6, p < 0.001); high mammographic breast density, OR = 6.1 (CI: 1.0-38.1, p = 0.047); non-evaluable margins on imaging, OR = 3.8 (CI: 1.3-10.8, p = 0.016); neoadjuvant chemotherapy, OR = 3.0 (CI: 1.0-8.8, p = 0.048); and T2 tumor-size, OR = 2.6 (CI: 1.0-6.4, p = 0.045).

Conclusions

No difference was found in the number of re-operations or in diagnostic accuracy to predict histopathological margin status between DBT and X-ray groups. DCIS outside the tumor showed the highest risk of re-operation. Intraoperative methods with improved visualization of DCIS are needed to obtain tumor free margins in BCS.

SUBMITTER: Palimaru Manhoobi I

PROVIDER: S-EPMC10749898 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature

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Publications

Digital breast tomosynthesis versus X-ray of the breast specimen for intraoperative margin assessment: A randomized trial.

Palimaru Manhoobi Irina I Tramm Trine T Redsted Søren S Bodilsen Anne A Foldager Leslie L Christiansen Peer P

Breast (Edinburgh, Scotland) 20231201

<h4>Background</h4>Involved resection margins after breast conserving surgery (BCS) often require a re-operation with increased patient anxiety and risk of impaired cosmesis. We investigated the number of re-operations due to involved resection margins after BCS comparing digital breast tomosynthesis(DBT) with X-ray for intraoperative margin evaluation. Furthermore, we assessed the diagnostic accuracy of these methods to predict histopathological margin status. Finally, we evaluated risk factors ...[more]

PMID: 38064928

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Project description:Background Breast Imaging Reporting and Data System (BI-RADS) breast density categories assigned by interpreting radiologists often influence decisions surrounding supplemental breast cancer screening and risk assessment. The landscape of mammographic screening continuously evolves, and different mammographic screening modalities may result in different perception of density, reflected in different assignment of BI-RADS density categories. Purpose To investigate the effect of screening mammography modality on BI-RADS breast density assessments. Materials and Methods Data were retrospectively analyzed from 24 736 individual women (42.3% [10 455 of 24 736] white women, 57.7% [14 281 of 24 736] black women; mean age, 56.3 years; age range, 40.0-74.9 years) who underwent from one to seven mammographic screening examinations from September 2010 through February 2017 (60 766 examinations). Three screening modalities were used: digital mammography alone (8935 examinations); digital mammography with digital breast tomosynthesis (DBT; 30 779 examinations); and synthetic mammography with DBT (21 052 examinations). Random-effects logistic regression analysis was performed to estimate the likelihood of assignment to high versus low BI-RADS density category according to each modality, adjusted for ethnicity, age, body mass index (BMI), and radiologist. The interactions of modality with ethnicity and BMI on density categorization were also tested with the model. Results Women screened with DBT versus digital mammography alone had lower likelihood regarding categorization of high density breasts (digital mammography and DBT vs digital mammography: odds ratio, 0.69 [95% confidence interval: 0.61, 0.80], P < .001; synthetic mammography and DBT vs digital mammography: odds ratio, 0.43 [95% confidence interval: 0.37, 0.50], P < .001). Lower likelihood of high density was also observed at synthetic mammography and DBT compared with digital mammography and DBT (odds ratio, 0.62; 95% confidence interval: 0.56, 0.69; P < .001). There were interactions of modality with ethnicity (P = .007) and BMI (P = .003) on breast density assessment, with greater differences in density categorization according to modality observed for black women than for white women and groups with higher BMI. Conclusion Breast density categorization may vary by screening mammographic modality, and this effect appears to vary by ethnicity and body mass index. © RSNA, 2019 Online supplemental material is available for this article. See also the editorial by Philpotts in this issue.

Project description:ObjectiveEvaluate the oncologic outcomes and cost analysis of transitioning to a specimen oriented intraoperative margin assessment protocol from a tumour bed sampling protocol in oral cavity (OCSCC) and oropharyngeal squamous cell carcinoma (OPSCC).Study designRetrospective case series and subsequent prospective cohort study SETTING: Tertiary care academic teaching hospital SUBJECTS AND METHODS: Retrospective case series of all institutional T1-T2 OCSCC or OPSCC treated with primary surgery between January 1st 2009 - December 31st 2014. Kaplan-Meier survival estimates with log rank tests were used to compare patients based on final margin status. Cost analysis was performed for escalation of therapy due to positive final margins. Following introduction of a specimen derived margin protocol, successive prospective cohort study of T1-T4 OCSCC or OPSCC treated with primary surgery from January 1st 2017 - December 31st 2018. Analysis and comparison of both protocols included review of intraoperative margins, final pathology and treatment cost.ResultsAnalysis of our intra-operative tumour bed frozen section protocol revealed 15 of 116 (12.9%) patients had positive final pathology margins, resulting in post-operative escalation of therapy for 14/15 patients in the form of re-resection (7/14), radiation therapy (6/14) and chemoradiotherapy (1/14). One other patient with positive final margins received escalated therapy for additional negative prognostic factors. Recurrence free survival at 3 years was 88.4 and 50.7% for negative and positive final margins respectively (p = 0.048). Implementation of a specimen oriented frozen section protocol resulted in 1 of 111 patients (0.9%) having positive final pathology margins, a statistically significant decrease (p < 0.001). Utilizing our specimen oriented protocol, there was an absolute risk reduction for having a final positive margin of 12.0% and relative risk reduction of 93.0%. Estimated cost avoidance applying the specimen oriented protocol to our previous cohort was $412,052.812017 CAD.ConclusionImplementation of a specimen oriented intraoperative margin protocol provides a statistically significant decrease in final positive margins. This change in protocol leads to decreased patient morbidity by avoiding therapy escalation attributable only to positive margins, and avoids the economic costs of these treatments.

Project description:ImportanceMany US radiologists have screening mammography recall rates above the expert-recommended threshold of 12%. The influence of digital breast tomosynthesis (DBT) on the distribution of radiologist recall rates is uncertain.ObjectiveTo evaluate radiologists' recall and cancer detection rates before and after beginning interpretation of DBT examinations.Design, setting, and participantsThis cohort study included 198 radiologists from 104 radiology facilities in the Breast Cancer Surveillance Consortium who interpreted 251 384 DBT and 2 000 681 digital mammography (DM) screening examinations from 2009 to 2017, including 126 radiologists (63.6%) who interpreted DBT examinations during the study period and 72 (36.4%) who exclusively interpreted DM examinations (to adjust for secular trends). Data were analyzed from April 2018 to July 2019.ExposuresDigital breast tomosynthesis and DM screening examinations.Main outcomes and measuresRecall rate and cancer detection rate.ResultsA total of 198 radiologists interpreted 2 252 065 DM and DBT examinations (2 000 681 [88.8%] DM examinations; 251 384 [11.2%] DBT examinations; 710 934 patients [31.6%] aged 50-59 years; 1 448 981 [64.3%] non-Hispanic white). Among the 126 radiologists (63.6%) who interpreted DBT examinations, 83 (65.9%) had unadjusted DM recall rates of no more than 12% before using DBT, with a median (interquartile range) recall rate of 10.0% (7.5%-13.0%). On DBT examinations, 96 (76.2%) had an unadjusted recall rate of no more than 12%, with a median (interquartile range) recall rate of 8.8% (6.3%-11.3%). A secular trend in recall rate was observed, with the multivariable-adjusted risk of recall on screening examinations declining by 1.2% (95% CI, 0.9%-1.5%) per year. After adjusting for examination characteristics and secular trends, recall rates were 15% lower on DBT examinations compared with DM examinations interpreted before DBT use (relative risk, 0.85; 95% CI, 0.83-0.87). Adjusted recall rates were significantly lower on DBT examinations compared with DM examinations interpreted before DBT use for 45 radiologists (35.7%) and significantly higher for 18 (14.3%); 63 (50.0%) had no statistically significant change. The unadjusted cancer detection rate on DBT was 5.3 per 1000 examinations (95% CI, 5.0-5.7 per 1000 examinations) compared with 4.7 per 1000 examinations (95% CI, 4.6-4.8 per 1000 examinations) on DM examinations interpreted before DM use (multivariable-adjusted risk ratio, 1.21; 95% CI, 1.11-1.33).Conclusions and relevanceIn this study, DBT was associated with an overall decrease in recall rate and an increase in cancer detection rate. However, our results indicated that there is wide variability among radiologists, including a subset of radiologists who experienced increased recall rates on DBT examinations. Radiology practices should audit radiologist DBT screening performance and consider additional DBT training for radiologists whose performance does not improve as expected.

Project description:BackgroundDigital breast tomosynthesis (DBT) combined with digital mammography (DM) is increasingly used in the United States instead of DM alone for breast cancer screening. Early screening outcomes incorporating synthetic mammography (SM) with DBT have suggested that SM is an acceptable non-radiation dose alternative to DM.PurposeTo compare multicenter outcomes from breast cancer screening with SM/DBT versus DM/DBT.Materials and MethodsThis was a retrospective study of consecutive screening mammograms obtained at two institutions. Eligible studies consisted of 34 106 DM/DBT examinations between October 3, 2011, and October 31, 2014, and 34 180 SM/DBT examinations between January 7, 2015, and February 2, 2018, at the University of Pennsylvania and 51 148 DM/DBT examinations between January 1, 2012, and May 31, 2016, and 31 929 SM/DBT examinations between June 1, 2016, and March 30, 2018, at the University of Vermont. Demographics of women who attended screening and results from screening were recorded. Recall rate, biopsy rate, false-negative rate, cancer detection rate, positive predictive value, sensitivity, and specificity were calculated according to modality and institution. Descriptive statistics, χ2 tests, and logistic regression were used in analysis.ResultsThe study included 151 363 screening examinations among 151 363 women (mean age, 58.1 years ± 10.9 [standard deviation]). The unadjusted recall rate was lower with SM/DBT than with DM/DBT (7.0% [4630 of 66 109 examinations] for SM/DBT vs 7.9% [6742 of 85 254 examinations] for DM/DBT; P < .01). However, after multivariable adjustment, SM/DBT was associated with a slightly higher recall rate compared with DM/DBT (adjusted odds ratio [OR], 1.06; adjusted 95% CI: 1.01, 1.11; P = .02). Similarly, after multivariable adjustment, SM/DBT was associated with slightly lower specificity compared with DM/DBT (adjusted OR, 0.95; adjusted 95% CI: 0.90, 0.99; P = .02). There was no statistically significant difference in biopsy rate (P = .54), false-negative rate (P = .38), cancer detection rate (P = .55), invasive or in situ cancer detection rate (P = .52 and P = .98, respectively), positive predictive value (P = .78), or sensitivity (P = .33) for SM/DBT versus DM/DBT overall or within either institution (P > .05 for all).ConclusionBreast cancer screening performance is maintained within benchmarks when synthetic mammography replaces digital mammography in digital breast tomosynthesis imaging.© RSNA, 2020Online supplemental material is available for this article.See also the editorial by Lång in this issue.

Dataset Information

Digital breast tomosynthesis versus X-ray of the breast specimen for intraoperative margin assessment: A randomized trial.

Background

Methods

Results

Conclusions

Publications

Digital breast tomosynthesis versus X-ray of the breast specimen for intraoperative margin assessment: A randomized trial.

Similar Datasets

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