Best Practice Guidelines - DEGUM Recommendations on Breast Ultrasound.

Breast ultrasound has been established for many years as an important method in addition to mammography for clarifying breast findings. The goal of the Best Practice Guidelines Part III of the DEGUM breast ultrasound working group is to provide colleagues working in senology with information regarding the specific medical indications for breast ultrasound in addition to the current ultrasound criteria and assessment categories published in part I and the additional and optional sonographic diagnostic methods described in part II. The value of breast ultrasound for specific indications including follow-up, evaluation of breast implants, diagnostic workup of dense breast tissue, diagnostic workup during pregnancy and lactation, and the diagnostic workup of breast findings in men is discussed.

Best Practice Guidelines - DEGUM Recommendations on Breast Ultrasound.

Breast ultrasound has been established for many years as an important method in addition to mammography for clarifying breast findings. The goal of the Best Practice Guidelines Part III of the DEGUM breast ultrasound working group is to provide colleagues working in senology with information regarding the specific medical indications for breast ultrasound in addition to the current ultrasound criteria and assessment categories published in part I and the additional and optional sonographic diagnostic methods described in part II. The value of breast ultrasound for specific indications including follow-up, evaluation of breast implants, diagnostic workup of dense breast tissue, diagnostic workup during pregnancy and lactation, and the diagnostic workup of breast findings in men is discussed.

Evaluation of Ex Vivo Shear Wave Elastography of Axillary Sentinel Lymph Nodes in Patients with Early Breast Cancer.

The pretherapeutic assessment of axillary lymph node status is crucial in staging early breast cancer patients, significantly influencing their further treatment and prognosis. According to current guidelines, patients with clinically unsuspicious axillary status regularly undergo a biopsy of sentinel lymph nodes (SLNs), whereby metastasis is detected in up to 20% of cases. In recent years, the use of shear wave elastography (SWE) has been studied as an additional ultrasound tool for the non-invasive assessment of tumors in the breast parenchyma and axillary lymph nodes.

Axillary Surgery in Breast Cancer - Primary Results of the INSEMA Trial.

Background: Whether surgical axillary staging as part of breast-conserving therapy can be omitted without compromising survival has remained unclear.

Methods: In this prospective, randomized, noninferiority trial, we investigated the omission of axillary surgery as compared with sentinel-lymph-node biopsy in patients with clinically node-negative invasive breast cancer staged as T1 or T2 (tumor size, ≤5 cm) who were scheduled to undergo breast-conserving surgery. We report here the per-protocol analysis of invasive disease-free survival (the primary efficacy outcome).

Breast-conserving surgery is not associated with increased local recurrence in patients with early-stage node-negative triple-negative breast cancer treated with neoadjuvant chemotherapy.

Background: Neoadjuvant chemotherapy (NACT) is routinely used for patients with triple-negative breast cancer (TNBC). Upfront breast-conserving therapy (BCT) consisting of breast-conserving surgery (BCS) and adjuvant radiotherapy (RT) has been shown to be associated with improved outcome in patients with early TNBC as compared to mastectomy.

Methods: We identified 2632 patients with early TNBC from the German Breast Group meta-database.

Ultrasound Radiomics Features to Identify Patients With Triple-Negative Breast Cancer: A Retrospective, Single-Center Study.

Objectives: Patients with triple-negative breast cancer (TNBC) exhibit a fast tumor growth rate and poor survival outcomes. In this study, we aimed to develop and compare intelligent algorithms using ultrasound radiomics features in addition to clinical variables to identify patients with TNBC prior to histopathologic diagnosis.

Methods: We used single-center, retrospective data of patients who underwent ultrasound before histopathologic verification and subsequent neoadjuvant systemic treatment (NAST).

Deep learning to predict breast cancer sentinel lymph node status on INSEMA histological images.

Background: Sentinel lymph node (SLN) status is a clinically important prognostic biomarker in breast cancer and is used to guide therapy, especially for hormone receptor-positive, HER2-negative cases. However, invasive lymph node staging is increasingly omitted before therapy, and studies such as the randomised Intergroup Sentinel Mamma (INSEMA) trial address the potential for further de-escalation of axillary surgery. Therefore, it would be helpful to accurately predict the pretherapeutic sentinel status using medical images.

Intra- and Interobserver Reliability of Shear Wave Elastography in Breast Cancer Diagnosis.

Objectives: Shear wave elastography (SWE) is increasingly used in breast cancer diagnostics. However, large, prospective, multicenter data evaluating the reliability of SWE is missing. We evaluated the intra- and interobserver reliability of SWE in patients with breast lesions categorized as BIRADS 3 or 4.

Can multi-modal radiomics using pretreatment ultrasound and tomosynthesis predict response to neoadjuvant systemic treatment in breast cancer?

Objectives: Response assessment to neoadjuvant systemic treatment (NAST) to guide individualized treatment in breast cancer is a clinical research priority. We aimed to develop an intelligent algorithm using multi-modal pretreatment ultrasound and tomosynthesis radiomics features in addition to clinical variables to predict pathologic complete response (pCR) prior to the initiation of therapy.

Methods: We used retrospective data on patients who underwent ultrasound and tomosynthesis before starting NAST.

Conventional specimen radiography in breast-conserving therapy: a useful tool for intraoperative margin assessment after neoadjuvant therapy?

Purpose: A previous study in our breast unit showed that the diagnostic accuracy of intraoperative specimen radiography and its potential to reduce second surgeries in a cohort of patients treated with neoadjuvant chemotherapy were low, which questions the routine use of Conventional specimen radiography (CSR) in this patient group. This is a follow-up study in a larger cohort to further evaluate these findings.

Methods: This retrospective study included 376 cases receiving breast-conserving surgery (BCS) after neoadjuvant chemotherapy (NACT) of primary breast cancer.

Prevalence of Pathogenic Germline Variants in Women with Non-Familial Unilateral Triple-Negative Breast Cancer.

Introduction: International guidelines recommend genetic testing for women with familial breast cancer at an expected prevalence of pathogenic germline variants (PVs) of at least 10%. In a study sample of the German Consortium for Hereditary Breast and Ovarian Cancer (GC-HBOC), we have previously shown that women with TNBC diagnosed before the age of 50 years but without a family history of breast or ovarian cancer (sTNBC) meet this criterion. The present study investigates the PV prevalence in and nine additional cancer predisposition genes in an extended sTNBC study sample including a cohort of women with a later age at sTNBC diagnosis.

Noninferiority of Local Control and Comparable Toxicity of Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost in Breast Cancer: 5-Year Results of the IMRT-MC2 Phase III Trial.

Purpose: The IMRT-MC2 trial was conducted to demonstrate the noninferiority of conventionally fractionated intensity modulated radiation therapy with a simultaneous integrated boost to 3-dimensional conformal radiation therapy with a sequential boost for adjuvant breast radiation therapy.

Methods And Materials: A total of 502 patients were randomized between 2011 and 2015 for the prospective, multicenter, phase III trial (NCT01322854). Five-year results of late toxicity (late effects normal tissue task force-subjective, objective, management, and analytical), overall survival, disease-free survival, distant disease-free survival, cosmesis (Harvard scale), and local control (noninferiority margin at hazard ratio [HR] of 3.

Best Practice Guideline - DEGUM Recommendations on Breast Ultrasound.

Alongside mammography, breast ultrasound is an important and well-established method in assessment of breast lesions. With the "Best Practice Guideline", the DEGUM Breast Ultrasound (in German, "Mammasonografie") working group, intends to describe the additional and optional application modalities for the diagnostic confirmation of breast findings and to express DEGUM recommendations in this Part II, in addition to the current dignity criteria and assessment categories published in Part I, in order to facilitate the differential diagnosis of ambiguous lesions.The present "Best Practice Guideline" has set itself the goal of meeting the requirements for quality assurance and ensuring quality-controlled performance of breast ultrasound.

Imaging of lumpectomy surface with large field-of-view confocal laser scanning microscopy 'Histolog® scanner' for breast margin assessment in comparison with conventional specimen radiography.

Purpose: The Histolog® Scanner (SamanTree Medical SA, Lausanne, Switzerland) is a large field-of-view confocal laser scanning microscope designed to allow intraoperative margin assessment by the production of histological images ready for assessment in the operating room. We evaluated the feasibility and the performance of the Histolog® Scanner (HS) to correctly identify infiltrated margins in clinical practice of lumpectomy specimens. It was extrapolated if the utilization of the HS has the potential to reduce infiltrated margins and therefore reduce re-operation rates in patients undergoing breast conserving surgery (BCS) due to a primarily diagnosed breast cancer including ductal carcinoma in situ.

Potential of Lesion-to-Fat Elasticity Ratio Measured by Shear Wave Elastography to Reduce Benign Biopsies in BI-RADS 4 Breast Lesions.

Objectives: We evaluated whether lesion-to-fat ratio measured by shear wave elastography in patients with Breast Imaging Reporting and Data System (BI-RADS) 3 or 4 lesions has the potential to further refine the assessment of B-mode ultrasound alone in breast cancer diagnostics.

Methods: This was a secondary analysis of an international diagnostic multicenter trial (NCT02638935). Data from 1288 women with breast lesions categorized as BI-RADS 3 and 4a-c by conventional B-mode ultrasound were analyzed, whereby the focus was placed on differentiating lesions categorized as BI-RADS 3 and BI-RADS 4a.

Clinical prototype implementation enabling an improved day-to-day mammography compression.

Purpose: In mammography, breast compression is achieved by lowering a compression paddle on the breast. Despite the directive that compression is needed, there is no concrete guideline on its execution. To estimate the degree of compression, current mammography units only provide compression force and breast thickness as parameters.

Impact of age on indication for chemotherapy in early breast cancer patients: results from 104 German institutions from 2008 to 2017.

Purpose: Today, the decision to treat patients with chemotherapy for early breast cancer (EBC) is made based on the patient's individual risk stratification and tumor biology. In cases with chemotherapy indication, the neoadjuvant application (NACT) is the preferred option in comparison with primary surgery and adjuvant chemotherapy (ACT). Age remains a relevant factor in the decision-making process.

Patient-reported outcomes for the Intergroup Sentinel Mamma study (INSEMA): A randomised trial with persistent impact of axillary surgery on arm and breast symptoms in patients with early breast cancer.

Background: In clinically node-negative breast cancer patients, the INSEMA trial (NCT02466737) assessed the non-inferiority of avoiding sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Here we present patient-reported outcomes (PROs) as a secondary endpoint.

Methods: PROs were assessed for patients with no axillary surgery, SLNB alone, and ALND.

COGNITION: a prospective precision oncology trial for patients with early breast cancer at high risk following neoadjuvant chemotherapy.

Background: COGNITION (Comprehensive assessment of clinical features, genomics and further molecular markers to identify patients with early breast cancer for enrolment on marker driven trials) is a diagnostic registry trial that employs genomic and transcriptomic profiling to identify biomarkers in patients with early breast cancer with a high risk for relapse after standard neoadjuvant chemotherapy (NACT) to guide genomics-driven targeted post-neoadjuvant therapy.

Patients And Methods: At National Center for Tumor Diseases Heidelberg patients were biopsied before starting NACT, and for patients with residual tumors after NACT additional biopsy material was collected. Whole-genome/exome and transcriptome sequencing were applied on tumor and corresponding blood samples.