Tomosynthesis-Guided Vacuum-Assisted Excision of B3 Breast Lesions: Reducing Overtreatment Without Compromising Safety

Role of vacuum assisted excision in minimising overtreatment of ductal atypias

Traditionally B3 breast lesions are treated surgically, but overtreatment is a concern, as the majority have a final benign diagnosis. A national screening program introduced vacuum-assisted excision (VAE) for managing B3 lesions in late 2016. This retrospective study aimed to assess the outcomes associated with this approach. All B3 lesions diagnosed between 01/2017 and 12/2019 were identified at two centres. Information was obtained on the initial biopsy and final histology, and method of VAE image guidance, needle size and number of cores. Lesions were excluded if there was cancer elsewhere in the breast at the time of diagnosis; the lesion was not suitable for VAE due to position in the breast or had B3 pathology for which open biopsy was still required. The final decision to offer VAE was always made at a multidisciplinary meeting (MDM). Risk difference was used to test the significance at p ≤ .05. In total, 258 B3 lesions were diagnosed, 105 (40.7%) met the inclusion criteria and underwent VAE. VAE was performed under X-ray (89/105) or ultrasound guidance (16/105), taking an average of 18.5 cores with the 10-G needle or 10.8 cores with the 7-G needle. Nine cases (8.6%) were upgraded to a malignant diagnosis following VAE. Malignancy was found in 15.5% (9/58) of B3 lesions with epithelial atypia, but in none without atypia (0/47) (p = .004). No new lesions or malignancy has occurred at the site of the VAE with an average mammographic follow-up of 2.2 years. Upgrade to malignancy following VAE was uncommon (8.6%) and associated with atypia in the initial biopsy. VAE is an alternative approach to the management of B3 lesions, reducing open surgical procedures. • Upgrade to malignancy after a vacuum-assisted excision of a B3 breast lesion is uncommon with an 8.6% upgrade rate. • The risk of a malignant diagnosis after a vacuum-assisted excision was significantly higher for B3 lesions with atypia compared to those without (+15.5% difference, p = .004).

Traditionally B3 breast lesions are treated surgically, but overtreatment is a concern, as the majority have a final benign diagnosis. A national screening program introduced vacuum-assisted excision (VAE) for managing B3 lesions in late 2016. This retrospective study aimed to assess the outcomes associated with this approach. All B3 lesions diagnosed between 01/2017 and 12/2019 were identified at two centres. Information was obtained on the initial biopsy and final histology, and method of VAE image guidance, needle size and number of cores. Lesions were excluded if there was cancer elsewhere in the breast at the time of diagnosis; the lesion was not suitable for VAE due to position in the breast or had B3 pathology for which open biopsy was still required. The final decision to offer VAE was always made at a multidisciplinary meeting (MDM). Risk difference was used to test the significance at p ≤ .05. In total, 258 B3 lesions were diagnosed, 105 (40.7%) met the inclusion criteria and underwent VAE. VAE was performed under X-ray (89/105) or ultrasound guidance (16/105), taking an average of 18.5 cores with the 10-G needle or 10.8 cores with the 7-G needle. Nine cases (8.6%) were upgraded to a malignant diagnosis following VAE. Malignancy was found in 15.5% (9/58) of B3 lesions with epithelial atypia, but in none without atypia (0/47) (p = .004). No new lesions or malignancy has occurred at the site of the VAE with an average mammographic follow-up of 2.2 years. Upgrade to malignancy following VAE was uncommon (8.6%) and associated with atypia in the initial biopsy. VAE is an alternative approach to the management of B3 lesions, reducing open surgical procedures. • Upgrade to malignancy after a vacuum-assisted excision of a B3 breast lesion is uncommon with an 8.6% upgrade rate. • The risk of a malignant diagnosis after a vacuum-assisted excision was significantly higher for B3 lesions with atypia compared to those without (+15.5% difference, p = .004).

Management of lesions of uncertain malignant potential on breast core needle histology: Vacuum-assisted excision as an alternative to surgical excision

In recent years vacuum-assisted excision (VAE) has been described as an alternative treatment for some B3 lesions. This study aims to assess the effectiveness of using VAE to manage selected B3 lesions by quantifying the number of B3 lesions undergoing VAE, the malignant upgrade rate, and the complications encountered. Our department evaluated all B3 lesions diagnosed between January 2019 and October 2021 and treated them with VAE. The data were collected during the initial biopsy and final histology based on VAE image guidance, also considering initial lesions and complications. The exclusion criteria were: B3 lesion of size > 20mm, presence of a concomitant malignant lesion, lesion < 5.0mm distant from the skin, nipple or pectoral muscle, phyllodes tumours or indeterminate B3 lesions. Lesions that upgraded to malignancy underwent surgical excision, while benign lesions performed radiological follow-ups. From 416 B3 lesions diagnosed, 67 (16.1%) underwent VAE. VAE was performed under X-ray (50/67) or ultrasound guidance (17/67). Five cases (7.5%) upgraded to a malignant lesion, 2 ADH, 2 LIN and one papillary lesion that underwent surgery. No malignancy or new lesions has occurred at the site of the VAE, with an average radiological follow-up of 14.9months. VAE could be a safe and effective pathway for managing selected B3 lesions. Lesions initially subjected to CNB with ADH and LN outcome, before undergoing VAE, should perform a VAB for better tissue characterization and management.

Simple SummaryThe widespread use of screening mammography and breast ultrasound has enhanced early diagnosis and reduced breast cancer mortality. At the same time, this practice has led to an increase in breast biopsies for suspicious lesions, some of them ultimately resulting in breast lesions of uncertain malignant potential (B3 lesions). The correct management of B3 lesions is controversial, but surgical excision is generally recommended because of the considerable risk of an upgrade to cancer diagnosis upon final histology. Very little data exist concerning the role of B3 diagnosis as a risk factor for future development of breast cancer. The current study analyzes the largest series of B3 lesions from a single institution, providing new insights on both the risk of immediate upgrade to cancer and the subsequent risk of cancer development during the follow-up. An upgrade to carcinoma was found in 4.8% to 39.8% of B3 lesions depending on histologic subtype and in 22.7% on average. In the subsequent years, a diagnosis of breast carcinoma occurred in 9.2% of the patients. This information has considerable implications for future management of patients with B3 lesions.Breast lesions of uncertain malignant potential (B3) are frequently diagnosed in the era of breast cancer (BC) screening and their management is controversial. They are generally removed surgically, but some international organizations and guidelines for breast research suggest follow-up care alone or, more recently, propose vacuum-assisted excision (VAE). The risk of upgrade to BC is known, but very little data exist on its role as risk factor for future BC development. We analyzed 966 B3 lesions diagnosed at our institution, 731 of which had long-term follow-up available. Surgical removal was performed in 91%, VAE in 3.8%, and follow-up in 5.2% of cases. The B3 lesions included flat epithelial atypia (FEA), atypical ductal hyperplasia (ADH), lobular intraepithelial neoplasia (LIN), atypical papillary lesions (PLs), radial scars (RSs), and others. Overall, immediate upgrade to BC (invasive or in situ) was 22.7%. After long-term follow-up, 9.2% of the patients were diagnosed with BC in the same or contralateral breast. The highest risk was associated with ADH diagnosis, with 39.8% of patients upgraded and 13.6% with a future BC diagnosis (p < 0.0001). These data support the idea that B3 lesions should be removed and provide evidence to suggest annual screening mammography for women after a B3 diagnosis because their BC risk is considerably increased.

Introduction: Breast lesions of uncertain malignant potential (B3) represent a group with heterogeneous malignancy risk. Overtreatment is a concern, as most of these lesions are ultimately benign. However, non-negligible underestimation rates for malignancy underscore the importance of identifying features that can guide individualized treatment strategies. Our study aimed to evaluate the positive predictive value for malignancy in excised B3 lesions, identify potential upgrading risk factors, and compare different management methods. Methods: This retrospective study reviewed a single-center series of patients being followed in the context of a histological diagnosis of a B3 lesion. Only patients without a synchronous diagnosis of a higher-grade lesion were included. Results: 51 patients were included (median age, 51 [IQR=12.0] years), 54.9% of whom presented with breast symptoms. The most prevalent diagnosis was papillary lesions (PL) at 66.7%. Chosen management included a follow-up-only strategy in 31.4%, open excision in 43.1%, and vacuum-assisted excision (VAE) in 23.5%. The upstage rate was 8.6% in excised lesions. There was a 5.4% follow-up upgrade risk over 2 years. We found statistical significance between the chosen management modality and family risk for breast cancer (p=0.033), used diagnostic tool (p&lt;0.001), and histological diagnosis (p=0.029). As for total malignancy, we found classical lobular neoplasia (LN) (p=0.017), multifocality (p=0.023), and BIRADS≥4b at diagnosis (p=0.019) as associated risk factors. Conclusion: VAE offers a safe and effective treatment for B3 lesions, reducing the number of open surgical procedures, as confirmed by the low upgrade rate to malignancy after a VAE in this study. Our findings are consistent with the current literature by confirming varying malignancy risks among B3 subtypes and in the identified risk factors. We propose a more conservative approach to treating PL, whereas surgical excision seems justified for LN.

Introduction: Vacuum-assisted excision (VAE) of breast lesions is a technique used for diagnostic and therapeutic purposes and is performed on an outpatient basis, with local anesthesia and image guidance. Currently, VAE is used in the management of benign lesions and lesions of uncertain malignant potential (B3 lesions). More recently, there has been interest in the application of VAE for the percutaneous treatment of small breast cancers with the aim of reducing morbidity and aggressive surgical treatment of breast cancers detected by screening programs. The way conventional VAE is performed, histopathological assessment of resection margins is not possible. Obtaining free margins after a breast cancer resection is a primary objective in the surgical treatment of this disease. If VAE could ensure free margins and absence of residual tumor in the resection cavity, this would also be a method safely used for minimally invasive treatment, providing an effective percutaneous treatment of early breast cancers. Objectives: evaluate the effectiveness of vacuum-assisted excision associated with percutaneous sampling of cavity margins for the complete resection of breast cancers ensuring the absence of residual disease in surgical pathology. Methods: Inclusion criteria are women with unifocal lesions smaller than 1.5 cm, Category 4 or 5 ACR BI-RADS™, identified by screening or clinical alteration. Non-inclusion criteria are multifocal and multicentric breast cancers, breast cancers associated with diffuse and extensive microcalcifications. Sensitivity, specificity, accuracy, positive predictive value, negative predictive value, false negative and false positive rate of vacuum-assisted excision associated with percutaneous sampling of cavity margins for the complete resection of breast cancers will be calculated. The data collected will also encompass demographics, characteristics of the lesion, and information regarding the biopsy, surgical pathology, and surgical procedures, as well as data on side effects, patient acceptance, cosmetic results and patients’ experience during VAE (BreastQ questionnaire). Ethics and dissemination: Ethics approval has been obtained by the Brazilian National Research Ethics Commission (CONEP) 61781922.5.0000.5109 and is registered in Brazilian Registry of Clinical Trials (https://ensaiosclinicos.gov.br/), identifier U1111-1301-4235. Participants will provide written informed consent, and researchers will follow institutional guidelines for data collection and management. Citation Format: H. L. Couto, B. A. Coelho, T. C. Oliveira, B. F. Ricardo, P. H. Toppa, D. d. Pires, S. d. Ferreira, L. B. Oliveira, A. C. Mendonça, R. G. Saliba, T. P. Moraes, P. C. Soares, C. A. Padua, G. F. Cunha Júnior, M. S. Castilho, L. L. Dominguez, J. S. Oliveira, A. C. Oliveira, D. R. Siqueira, B. A. Pires, A. Mattar, G. d. Silva Junior, M. Antonini, E. C. Pessoa, F. M. Reis, BreastMit Collaborative Research Group. Vacuum Assisted Excision (VAE): A single-step approach to the diagnosis and percutaneous treatment of Early Breast Cancer (THE VAE BReast 01 TRIAL) [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-08-02.

Vacuum-assisted excision of breast lesions of uncertain malignant potential (B3) – an alternative to surgery in selected cases

Veiled in Gynecomastia: A B3 breast lesion in a male patient with subsequent “upgrade” to invasive malignancy

Breast needle core biopsy (NCB) is now a commonplace diagnostic procedure in breast cancer screening, providing accurate diagnoses of both benign and malignant lesions. However, NCB may result in the borderline diagnoses of lesion of uncertain malignant potential (B3) or suspicious of malignancy (B4). The aim was to study a large series of B3 cases from population-based screening subjects in order to evaluate positive predictive values (PPVs) for malignancy. The results of 523 NCBs of women screened over a 7-year period (1999-2006) in the East Midlands region, UK, with a B3 diagnosis who underwent surgical excision, were reviewed and compared with the final excision histology. Five percent of NCBs were reported as B3. The most frequent histological subtypes were atypical intraductal epithelial proliferation (AIDEP) and radial scar/complex sclerosing lesion (RS/CSL). Final excision histology was benign in 417 (80%) and malignant in 106 (20%) subjects (60 ductal carcinoma in situ and 46 invasive carcinoma). Lesion-specific PPVs were as follows: AIDEP 32%; lobular neoplasia (LN) 30%; RS/CSL with AIDEP or LN 24%; RS/CSL without atypia 9%; papillary lesion with AIDEP or LN 36%; and papillary lesion without atypia 4%. Five of the 32 fibroepithelial lesions with cellular stroma were phyllodes tumours (four benign and one borderline). None of the five mucinous lesions on NCB was malignant. Our results show that approximately one-fifth of NCB of screen-detected breast lesions classified as B3 are malignant on excision, and the likelihood of malignancy varies substantially between different histological subtypes.

&lt;p dir="ltr"&gt;Following advances in diagnostic imaging modalities over the last decade, lesions of uncertain malignant potential have been increasingly diagnosed, primarily through mammography and sonography. These diagnoses, however, increase patient anxiety and result in an abundance of work-ups, including biopsies for radiologists, and often lead to unnecessary surgery.&lt;/p&gt;&lt;p dir="ltr"&gt;One modern field of research is the integration of artificial intelligence (AI) based computer-aided detection (CAD) systems into various types of equipment to improve their accuracy. Our first study (Study 1) investigated the grading of previous benign biopsies using an AI-CAD system that has been integrated into mammography.&lt;/p&gt;&lt;p dir="ltr"&gt;Another modern field of research has been the use of larger bore needles in breast biopsies, such as vacuum-assisted biopsy needles with an outer diameter of up to 7G (4.6 mm). These needles can provide a sufficient tissue sample with which to obtain a more accurate diagnosis, while at the same time allowing the operator to completely excise the specimen under local anesthesia. Our second study (Study 2) investigated how needle size affected the time and results of the excision procedure. Our third study (Study 3) evaluated the procedure from the patients' perspective, documenting their experiences and any eventual adverse effects after the procedure. Our fourth study (Study 4) compared the first diagnostic pathology report to the reports obtained post-excision to identify lesion characteristics that would help determine which lesions are more susceptible to excision with a larger needle.&lt;/p&gt;&lt;p dir="ltr"&gt;In Study 1 we retrospectively applied a commercial AI-CAD system (Insight MMG, version 1.1.4.3; Lunit Inc.) to a dataset of screening mammograms from 10,889 women. We divided the study population into three groups: women who did not undergo a biopsy, those who underwent a biopsy before or after screening mammography (with benign results), and those who were diagnosed with breast cancer. The AI system flagged all women above the cutoff threshold, which was defined as 0.4 on a scale of 0.0 to 1.0. The percentages of women flagged were as follows: 3.5% for healthy women without a biopsy, 11% for those with benign biopsy findings, and 84% for those with breast cancer (P &lt; 0.001). The AI-CAD system flagged a much larger proportion of women who underwent a biopsy than those who did not; however, the flagging rate was not any higher than that of the radiologists.&lt;/p&gt;&lt;p dir="ltr"&gt;In Study 2 we performed a randomized controlled trial to compare the excision completeness and efficacy of the vacuum-assisted excision (VAE) procedure using 7G and 10G vacuum needles. We enrolled 208 patients, and after withdrawal of consent, the trial population included 194 patients. There were no differences in procedure time (P = 0.126) or excision completeness (P = 0.109) between procedures performed using 7G and 10G needles. Of the 127 patients who attended the 24-month follow-up, 88% (112/127) had lesions completely excised, with no statistically significant difference between the 7G and 10G needles.&lt;/p&gt;&lt;p dir="ltr"&gt;In Study 3 we administered a questionnaire to all of the patients included in Study 2. Patient acceptance of the procedure and short- and long-term complications were also documented. We calculated the total hospital costs of the VAE procedures and compared them with those of open surgical excision (OSE), the previous standard of care for surgical excision. There were no significant differences in pain levels (P = 0.713), complications (P = 0.724), or patient acceptance of the procedure between the 7G and 10G needle groups (P = 0.401). Approximately 97% (173/178) of the patients would recommend the procedure to others, and the total hospital procedural cost of VAE was estimated to be 60% lower than that of OSE.&lt;/p&gt;&lt;p dir="ltr"&gt;In Study 4 we retrospectively examined the results of the pathology reports of all patients included in Study 2; however, we excluded patients who did not have a cytological or histopathological diagnosis prior to the VAE, during which tissue samples were placed in one, two, or three successive containers, starting at the core of the lesion and moving outwards to the normal tissue. The results of the diagnostic reports from the initial biopsy (cytology and/or histology) were compared with those from the tissues obtained during the VAE. The discrepancy between the diagnoses of fine needle aspiration (FNA) specimens and those from VAE was 38%, while that for core needle biopsy (CNB) was 29%. The upgrade rate to cancer was most common after a diagnosis of atypical ductal hyperplasia (ADH) on CNB.&lt;/p&gt;&lt;p dir="ltr"&gt;In conclusion, this thesis provides new knowledge on how to improve the performance of AI-CAD systems and broadens our understanding of we can improve the performance of AI. This confirms the necessity for alternative solutions to surgery for the diagnosis and treatment of undetermined lesions and provides data to support a separate personalized approach for different lesion types.&lt;/p&gt;&lt;h3&gt;List of scientific papers&lt;/h3&gt;&lt;p dir="ltr"&gt;I. &lt;b&gt;Athanasios Zouzos&lt;/b&gt;, Aleksandra Milovanovic, Karin Dembrower, Fredrik Strand&lt;/p&gt;&lt;p dir="ltr"&gt;Effect of Benign Biopsy Findings on an Artificial Intelligence-Based Cancer Detector in Screening Mammography: Retrospective Case-Control Study&lt;/p&gt;&lt;p dir="ltr"&gt;JMIR AI 2023 | vol. 2 | e48123 | p. 7&lt;br&gt;&lt;a href="https://doi.org/10.2196/48123" rel="noreferrer" target="_blank"&gt;https://doi.org/10.2196/48123&lt;/a&gt;&lt;/p&gt;&lt;p dir="ltr"&gt;&lt;br&gt;II. &lt;b&gt;Athanasios Zouzos&lt;/b&gt;, Irma Fredriksson, Andreas Karakatsanis, Iliana Aristokleous, Theodoros Foukakis, Fredrik Strand&lt;/p&gt;&lt;p dir="ltr"&gt;&lt;br&gt;Effect of needle size on outcomes of vacuum-assisted excision of breast lesions. A randomized controlled trial&lt;/p&gt;&lt;p dir="ltr"&gt;&lt;br&gt;European Journal of Radiology 183 (2025) 111895&lt;br&gt;&lt;a href="https://doi.org/10.1016/j.ejrad.2024.111895" rel="noreferrer" target="_blank"&gt;https://doi.org/10.1016/j.ejrad.2024.111895&lt;/a&gt;&lt;/p&gt;&lt;p dir="ltr"&gt;&lt;br&gt;&lt;/p&gt;&lt;p dir="ltr"&gt;III. &lt;b&gt;Athanasios Zouzos&lt;/b&gt;, Irma Fredriksson, Andreas Karakatsanis, Fredrik Strand&lt;/p&gt;&lt;p dir="ltr"&gt;Patient experience and healthcare cost aspects of vacuum-assisted excision of breast lesions. A report from the Swedish VAE randomized clinical trial&lt;/p&gt;&lt;p dir="ltr"&gt;[Manuscript]&lt;/p&gt;&lt;p dir="ltr"&gt;IV. &lt;b&gt;Athanasios Zouzos&lt;/b&gt;, Irma Fredriksson, Andreas Karakatsanis, Johan Hartman, Fredrik Strand&lt;/p&gt;&lt;p dir="ltr"&gt;Variation in pathological appearance across repeated sampling from probably benign breast lesions&lt;/p&gt;&lt;p dir="ltr"&gt;[Manuscript]&lt;/p&gt;

&lt;p dir="ltr"&gt;Following advances in diagnostic imaging modalities over the last decade, lesions of uncertain malignant potential have been increasingly diagnosed, primarily through mammography and sonography. These diagnoses, however, increase patient anxiety and result in an abundance of work-ups, including biopsies for radiologists, and often lead to unnecessary surgery.&lt;/p&gt;&lt;p dir="ltr"&gt;One modern field of research is the integration of artificial intelligence (AI) based computer-aided detection (CAD) systems into various types of equipment to improve their accuracy. Our first study (Study 1) investigated the grading of previous benign biopsies using an AI-CAD system that has been integrated into mammography.&lt;/p&gt;&lt;p dir="ltr"&gt;Another modern field of research has been the use of larger bore needles in breast biopsies, such as vacuum-assisted biopsy needles with an outer diameter of up to 7G (4.6 mm). These needles can provide a sufficient tissue sample with which to obtain a more accurate diagnosis, while at the same time allowing the operator to completely excise the specimen under local anesthesia. Our second study (Study 2) investigated how needle size affected the time and results of the excision procedure. Our third study (Study 3) evaluated the procedure from the patients' perspective, documenting their experiences and any eventual adverse effects after the procedure. Our fourth study (Study 4) compared the first diagnostic pathology report to the reports obtained post-excision to identify lesion characteristics that would help determine which lesions are more susceptible to excision with a larger needle.&lt;/p&gt;&lt;p dir="ltr"&gt;In Study 1 we retrospectively applied a commercial AI-CAD system (Insight MMG, version 1.1.4.3; Lunit Inc.) to a dataset of screening mammograms from 10,889 women. We divided the study population into three groups: women who did not undergo a biopsy, those who underwent a biopsy before or after screening mammography (with benign results), and those who were diagnosed with breast cancer. The AI system flagged all women above the cutoff threshold, which was defined as 0.4 on a scale of 0.0 to 1.0. The percentages of women flagged were as follows: 3.5% for healthy women without a biopsy, 11% for those with benign biopsy findings, and 84% for those with breast cancer (P &lt; 0.001). The AI-CAD system flagged a much larger proportion of women who underwent a biopsy than those who did not; however, the flagging rate was not any higher than that of the radiologists.&lt;/p&gt;&lt;p dir="ltr"&gt;In Study 2 we performed a randomized controlled trial to compare the excision completeness and efficacy of the vacuum-assisted excision (VAE) procedure using 7G and 10G vacuum needles. We enrolled 208 patients, and after withdrawal of consent, the trial population included 194 patients. There were no differences in procedure time (P = 0.126) or excision completeness (P = 0.109) between procedures performed using 7G and 10G needles. Of the 127 patients who attended the 24-month follow-up, 88% (112/127) had lesions completely excised, with no statistically significant difference between the 7G and 10G needles.&lt;/p&gt;&lt;p dir="ltr"&gt;In Study 3 we administered a questionnaire to all of the patients included in Study 2. Patient acceptance of the procedure and short- and long-term complications were also documented. We calculated the total hospital costs of the VAE procedures and compared them with those of open surgical excision (OSE), the previous standard of care for surgical excision. There were no significant differences in pain levels (P = 0.713), complications (P = 0.724), or patient acceptance of the procedure between the 7G and 10G needle groups (P = 0.401). Approximately 97% (173/178) of the patients would recommend the procedure to others, and the total hospital procedural cost of VAE was estimated to be 60% lower than that of OSE.&lt;/p&gt;&lt;p dir="ltr"&gt;In Study 4 we retrospectively examined the results of the pathology reports of all patients included in Study 2; however, we excluded patients who did not have a cytological or histopathological diagnosis prior to the VAE, during which tissue samples were placed in one, two, or three successive containers, starting at the core of the lesion and moving outwards to the normal tissue. The results of the diagnostic reports from the initial biopsy (cytology and/or histology) were compared with those from the tissues obtained during the VAE. The discrepancy between the diagnoses of fine needle aspiration (FNA) specimens and those from VAE was 38%, while that for core needle biopsy (CNB) was 29%. The upgrade rate to cancer was most common after a diagnosis of atypical ductal hyperplasia (ADH) on CNB.&lt;/p&gt;&lt;p dir="ltr"&gt;In conclusion, this thesis provides new knowledge on how to improve the performance of AI-CAD systems and broadens our understanding of we can improve the performance of AI. This confirms the necessity for alternative solutions to surgery for the diagnosis and treatment of undetermined lesions and provides data to support a separate personalized approach for different lesion types.&lt;/p&gt;&lt;h3&gt;List of scientific papers&lt;/h3&gt;&lt;p dir="ltr"&gt;I. &lt;b&gt;Athanasios Zouzos&lt;/b&gt;, Aleksandra Milovanovic, Karin Dembrower, Fredrik Strand&lt;/p&gt;&lt;p dir="ltr"&gt;Effect of Benign Biopsy Findings on an Artificial Intelligence-Based Cancer Detector in Screening Mammography: Retrospective Case-Control Study&lt;/p&gt;&lt;p dir="ltr"&gt;JMIR AI 2023 | vol. 2 | e48123 | p. 7&lt;br&gt;&lt;a href="https://doi.org/10.2196/48123" rel="noreferrer" target="_blank"&gt;https://doi.org/10.2196/48123&lt;/a&gt;&lt;/p&gt;&lt;p dir="ltr"&gt;&lt;br&gt;II. &lt;b&gt;Athanasios Zouzos&lt;/b&gt;, Irma Fredriksson, Andreas Karakatsanis, Iliana Aristokleous, Theodoros Foukakis, Fredrik Strand&lt;/p&gt;&lt;p dir="ltr"&gt;&lt;br&gt;Effect of needle size on outcomes of vacuum-assisted excision of breast lesions. A randomized controlled trial&lt;/p&gt;&lt;p dir="ltr"&gt;&lt;br&gt;European Journal of Radiology 183 (2025) 111895&lt;br&gt;&lt;a href="https://doi.org/10.1016/j.ejrad.2024.111895" rel="noreferrer" target="_blank"&gt;https://doi.org/10.1016/j.ejrad.2024.111895&lt;/a&gt;&lt;/p&gt;&lt;p dir="ltr"&gt;&lt;br&gt;&lt;/p&gt;&lt;p dir="ltr"&gt;III. &lt;b&gt;Athanasios Zouzos&lt;/b&gt;, Irma Fredriksson, Andreas Karakatsanis, Fredrik Strand&lt;/p&gt;&lt;p dir="ltr"&gt;Patient experience and healthcare cost aspects of vacuum-assisted excision of breast lesions. A report from the Swedish VAE randomized clinical trial&lt;/p&gt;&lt;p dir="ltr"&gt;[Manuscript]&lt;/p&gt;&lt;p dir="ltr"&gt;IV. &lt;b&gt;Athanasios Zouzos&lt;/b&gt;, Irma Fredriksson, Andreas Karakatsanis, Johan Hartman, Fredrik Strand&lt;/p&gt;&lt;p dir="ltr"&gt;Variation in pathological appearance across repeated sampling from probably benign breast lesions&lt;/p&gt;&lt;p dir="ltr"&gt;[Manuscript]&lt;/p&gt;

The UK National Health Service Breast Screening Programme has proposed five categories for reporting breast needle core biopsies. The majority of cores are reported as benign (B1), normal (B2) or malignant (B5). The predictive value of the two borderline categories suspicious of malignancy (B4) and lesion of uncertain malignant potential (B3) was studied. Over a 2-year period a total of 3822 breast needle core biopsies were performed, with 2997 from symptomatic patients and 825 from women undergoing mammographic screening, including 43 B4 reports (40 patients) and 120 B3 reports (116 lesions in 115 patients). The frequencies of B4 (2.5% versus 0.7%) and B3 cores (7.3% versus 2.0%) were both higher in screening than in symptomatic patients. B4 was most commonly used for small fragments of atypical cells separate from the main core or focal atypical intraductal proliferations. The criteria for calling a core B3 were: atypical intraductal epithelial proliferations (including foci that in excision specimens would be classified as atypical ductal hyperplasia), lobular neoplasia, radial scar, papillary lesion, fibroepithelial lesion with cellular stroma and spindle cell proliferations. Excision biopsies were performed in 39 patients with B4 core and 96 with B3 core. Invasive carcinoma or ductal carcinoma in situ was seen in 33 of the patients with B4 (85%) and in 29 of those with B3 cores (25%). Some categories of B3 core were associated with a higher rate of malignancy (40% for atypical intraductal epithelial proliferations and 46% for lobular neoplasia). The positive predictive value for carcinoma is high following a B4 core (86%). The lesion should be excised, but definitive cancer treatment is not appropriate. In some cases a definite diagnosis of malignancy can be made on repeat core. The B3 group is more heterogeneous and has a lower rate of malignancy on further biopsy (25%). The majority of B3 lesions require excision. All these patients should be discussed at multidisciplinary meetings.

An audit of mammographic screen detected lesions of uncertain malignant potential (B3) diagnosed on initial image guided needle biopsy: how has our practice changed over 10 years?