INTRODUCTION:Genomic tests informing systemic therapy recommendations for breast cancer (BC) were developed and validated on primary tumor (PT) tissue. Agreement of genomic tests between the PT and matched lymph node metastases (LNm) in patients with BC is currently unclear, which limits their use in nodal tissue. METHODS:Prespecified study within the international phase III TAXIS trial (NCT03513614). Tissue from PT and matched LNm were assessed with the primary objective of comparing genomic recurrence risk and subtypes. Clinical risk was assessed using the Adjuvant!Online tool and clinical subtypes were determined based on hormone receptor and Her2 testing. Agreement was assessed using Cohen's Kappa (Κ). RESULTS:Eighty-nine patients with stage II/III BC from 26 European centers were included. Median age was 63 years (range 50-72). Agreement in genomic risk between the PT and LNm was found in 84.3 % (Κ=0.64). However, 15.6 % exhibited genomic high risk in the LNm and low risk in the PT, while 16.0 % demonstrated low risk in the LNm and high risk in the PT. Genomic subtypes of PT and LNm showed disagreement in 17.1 % of patients with luminal BC (Κ=0.70). 96.5 % of patients were clinically categorized as high risk, whereas genomically, 25.6 % of them were classified as low risk in the LNm (Κ=0.17) and 31.7 % in the PT (Κ=0.13). Genomic subtyping reclassified 35.5 % of the clinically luminal tumor subtypes. CONCLUSION:Disagreement in genomically estimated risk exists in over 15 % of patients, potentially leading to over- or undertreatment. Consequently, the applicability of genomic tests in LNm remains controversial.

The surgical treatment is still the most effective method in curing of early breast cancer. Breast preservation and the application of oncoplastic principles became generally accepted, the sentinel lymph node biopsy in the surgical treatment of the axilla is primary, and the indication for axillary block dissection (ABD) is narrowing further. The neoadjuvant oncological treatment that is applied more and more widely presented surgery with new challenges. The expansion of quality assurance measures, the enhancement of breast surgery training, and the acceleration of centralisation through the establishment of dedicated breast cancer diagnostic and treatment centres are all anticipated to contribute significantly to the reduction of breast cancer mortality. Hereunder we summarise our recommendations on the surgical treatment of breast cancer based on the content of the 5th Breast Cancer Consensus Conference and considering the latest international studies and professional recommendations.

Recently some serologic parameters emerged as potential prognostic factors of triple-negative breast cancer (TNBC). We aimed to establish the most relevant factors and select optimal cutoff points for prospective investigations. Data from 137 TNBC patients treated with neoadjuvant chemotherapy were analyzed. Beyond pathological factors, white blood cell, neutrophil (NE), lymphocyte (LY) and platelet counts, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII) were investigated at baseline and before the third cycle. In univariate analysis, most parameters at baseline (NE1, LY1, NLR1, PLR1, SII1), in multivariate analysis NLR1 and pathological stage showed significant association with survival.

Background: The use of the Oncotype DX test reduces the rate of adjuvant chemotherapy recommendations. Few in-depth analyses have been performed on this decision-making process. Methods: We retrospectively analyzed patient data based on available Oncotype DX test results (RS) irrespective of nodal status at a single center. We collected recommendations from six oncologists, first without RS (pre-RS) and then with RS results (post-RS). We investigated changes in recommendations, agreement between oncologist decisions, and the effect of different National Comprehensive Cancer Network (NCCN) recommendation categories (for, against, and considering chemotherapy). Results: Data from 201 patients were included in the analysis. Recommendation of chemotherapy decreased by an average of 39.5%. Agreement improved substantially with RS, with a kappa value pre-RS of 0.37 (fair agreement) and post-RS of 0.75 (substantial agreement). Discordance remained substantial in cases where the NCCN recommendations considered chemotherapy only (32%). Pre-RS consensus against chemotherapy predicted low RS results (50 out of 51 patients). Post-RS consensus was highest in the NCCN chemotherapy recommendation group. Conclusions: The Oncotype DX test substantially improves decision accuracy in recommending adjuvant chemotherapy. It may be further improved with a consensus decision. In the case of pre-RS consensus against chemotherapy, the test can be spared.

TPS611 Background: Axillary lymph node dissection (ALND) is standard of care for most patients with clinically node-positive breast cancer (cN+BC), either in the adjuvant setting or in case of residual nodal disease after neoadjuvant chemotherapy (NACT). At least one quarter of patients with breast cancer experience long term morbidity after ALND. The TAXIS trial was designed to investigate if axillary radiotherapy (ART) can replace ALND in patients with cN+ BC who underwent tailored axillary surgery (TAS), which is recognized as one of the most important uncertainties and controversies in axillary management of patients with breast cancer. Methods: To test the remaining indications for ALND in clinical practice, we designed the international, multicenter, phase-III, non-inferiority, randomized controlled TAXIS trial to be pragmatic (average PRECIS-2 score of 4.44). Accordingly, most study domains follow usual care conditions, including eligibility (following routine indications for ALND in clinical practice), surgical skills and techniques, and follow up. The radiation oncology protocol included detailed recommendations and an extensive quality assurance program, which was developed to address the limitations of prior landmark trials and increase acceptability among recruiters. The main objective of the trial is to demonstrate that treatment with TAS and ART is non-inferior to TAS and ALND in terms of disease-free survival (DFS) of patients with cN+ BC detected by imaging or palpation in the upfront surgery setting or in case of residual disease after NACT. Randomization at a 1:1 ratio is mainly performed intraoperatively to either use TAS followed by ALND and regional nodal irradiation excluding the dissected axilla as a target volume (arm A) or to use TAS followed by regional nodal irradiation including the full axilla (arm B). The sample size is based on the primary endpoint DFS. With a type I error of 5% and a power of 80%, 385 events will be needed to show non-inferiority of TAS and axillary RT in comparison to ALND with a non-inferiority hazard ratio of 1.289 (corresponding to a DFS at 5 years of 80% in the ALND arm and 75% in the TAS and axillary RT arm). The sample size was calculated to be 1500 patients (750 per arm). Enrolment started in July 2018 and will stop after reaching 1500 patients, which is expected to be completed by Q4/2025. With currently 51 active sites from Europe, Canada and Korea within the network of the Oncoplastic Breast Consortium (OPBC), >950 patients were randomized by January 2024. Another 14 sites in Europe, USA, and South America will join the trial in 2024. The interim analysis (after 20% of the required events) is expected for Q4/2024 and will be reviewed by the IDMC. The primary endpoint analysis is planned in Q4/2030. Clinical trial information: NCT03513614 .

Metaplastic breast tumour is a rare, aggressive, mostly triple- negative, dedifferentiated malignancy, which poorly responds to chemotherapy compared to other invasive breast tumours. Since 2000, the WHO has considered it as a separate entity among breast tumours. Given the extremely poor prognosis of the tumour, more studies are needed to establish the most effective treatment strategy supported by data to increase overall survival. The objective of our research was a retrospective analysis of 77 patients with metaplastic breast cancer treated between 01.01.2012 and 28.02.2023 at our institute. Following the descriptive statistics of the patients, the pathological or clinical response was examined in cases of 15 patients treated with neoadjuvant and 14 patients with palliative chemotherapy. Finally, we compared the overall and progression-free survival of metaplastic breast cancer patients treated at our institute with those described in the international literature. The research results, both at our institute and in the literature, are limited by the small number of cases. In our research, with similar numbers of cases as many other investigations, we obtained results close to international data, thereby supporting the collection of data and further research necessary for the most effective treatment strategy for this rare tumour.

TPS611 Background: Axillary lymph node dissection (ALND) is standard of care for most patients with clinically node-positive breast cancer (cN+BC), either in the adjuvant setting or in case of residual nodal disease after neoadjuvant chemotherapy (NACT). At least one quarter of patients with breast cancer experience long term morbidity after ALND. The TAXIS trial was designed to investigate if axillary radiotherapy (ART) can replace ALND in patients with cN+ BC who underwent tailored axillary surgery (TAS), which is recognized as one of the most important uncertainties and controversies in axillary management of patients with breast cancer. Methods: To test the remaining indications for ALND in clinical practice, we designed the international, multicenter, phase-III, non-inferiority, randomized controlled TAXIS trial to be pragmatic (average PRECIS-2 score of 4.44). Accordingly, most study domains follow usual care conditions, including eligibility (following routine indications for ALND in clinical practice), surgical skills and techniques, and follow up. The radiation oncology protocol included detailed recommendations and an extensive quality assurance program, which was developed to address the limitations of prior landmark trials and increase acceptability among recruiters. The main objective of the trial is to demonstrate that treatment with TAS and ART is non-inferior to TAS and ALND in terms of disease-free survival (DFS) of patients with cN+ BC detected by imaging or palpation in the upfront surgery setting or in case of residual disease after NACT. Randomization at a 1:1 ratio is mainly performed intraoperatively to either use TAS followed by ALND and regional nodal irradiation excluding the dissected axilla as a target volume (arm A) or to use TAS followed by regional nodal irradiation including the full axilla (arm B). The sample size is based on the primary endpoint DFS. With a type I error of 5% and a power of 80%, 385 events will be needed to show non-inferiority of TAS and axillary RT in comparison to ALND with a non-inferiority hazard ratio of 1.289 (corresponding to a DFS at 5 years of 80% in the ALND arm and 75% in the TAS and axillary RT arm). The sample size was calculated to be 1500 patients (750 per arm). Enrolment started in July 2018 and will stop after reaching 1500 patients, which is expected to be completed by Q4/2025. With currently 51 active sites from Europe, Canada and Korea within the network of the Oncoplastic Breast Consortium (OPBC), >950 patients were randomized by January 2024. Another 14 sites in Europe, USA, and South America will join the trial in 2024. The interim analysis (after 20% of the required events) is expected for Q4/2024 and will be reviewed by the IDMC. The primary endpoint analysis is planned in Q4/2030. Clinical trial information: NCT03513614 .

A korai és lokálisan előrehaladott colontumorok esetében a megfelelő onkológiai minőségű sebészi resectio a kezelés központi eleme. Jobb oldali vastagbél tumorok sebészi ellátásában – a kedvezőbb hosszú távú onkológiai eredmények elérése céljából – egyre szélesebb körben elfogadott a Hohenberger által 2009-ben elsőként publikált „complett mesocolicus-excisio” (CME) és centrális érlekötés (CVL).Esetünkben egy 78 éves nőbeteg jobb alhasi faeculens váladékozása miatt indult kivizsgálása során a hasfalat szélesen infiltráló coecum tumor igazolódott. Az Onkoterápiás Bizottság – tekintettel az egyértelmű távoli áttét hiányára, a beteg jó általános állapotára, a fennálló colo-cutan sipolyra és egyértelmű irresecabilitási jelek hiányára – műtétet javasolt. A kuratív intenció és kellő radikalitás érdekében, komplett mesocolicus excisio és kiterjesztett hasfali resectio mellett döntöttünk. A műtét során a kialakult hasfali defektus rekonstrukciójához a jobb comb lateralis felszínéről tensor fasciae lateae musculocutan (TFL) lebenyt preparáltunk. A hasfali defektust, mind a fascia, mind a subcutis-cutis rétegében helyreállítottuk, a donor területet primeren zártuk. A posztoperatívumban a lebeny distalis végén vénás pangás jelei majd felületes necrosis mutatkozott. Sorozatos necrectomia és negatívnyomás-terápia (NPWT) mellett a hasfal végig intakt maradt és per secundam gyógyult.Megfelelő betegszelekció esetén, centrumokban elvégezve – onkosebész és helyreállító plasztikai sebész szoros együttműködésével – a radikális műtét kiterjesztett hasfali resectiót igénylő jobb colonfél tumoroknál is biztonsággal elvégezhető.

Background Tailored axillary surgery (TAS) is a novel surgical concept for clinical node-positive breast cancer. It consists of the removal of the sentinel lymph nodes (LNs), as well as palpably suspicious nodes. The TAS technique can be utilized in both the upfront and neoadjuvant chemotherapy (NACT) setting. This study assessed whether/how imaging-guided localization (IGL) influenced TAS. Patients and Methods This was a prospective observational cohort study preplanned in the randomized phase-III OPBC-03/TAXIS trial. IGL was performed at the surgeon’s discretion for targeted removal of LNs during TAS. Immediate back-up axillary lymph node dissection (ALND) followed TAS according to TAXIS randomization. Results Five-hundred patients were included from 44 breast centers in six countries, 151 (30.2%) of whom underwent NACT. IGL was performed in 84.4% of all patients, with significant variation by country (77.6–100%, p < 0.001). No difference in the median number of removed (5 vs. 4, p = 0.3) and positive (2 vs. 2, p = 0.6) LNs by use of IGL was noted. The number of LNs removed during TAS with IGL remained stable over time ( p = 0.8), but decreased significantly without IGL, from six (IQR 4–6) in 2019 to four (IQR 3–4) in 2022 ( p = 0.015). An ALND was performed in 249 patients, removing another 12 (IQR 9–17) LNs, in which a median number of 1 (IQR 0–4) was positive. There was no significant difference in residual nodal disease after TAS with or without IGL (68.0% vs. 57.6%, p = 0.2). Conclusions IGL did not significantly change either the performance of TAS or the volume of residual nodal tumor burden. Trial registration : ClinicalTrials.gov Identifier: NCT03513614.

Introduction: Chemotherapy is recommended for patients with luminal breast cancer and more than three positive nodes. In addition, recent landmark trials raised the question if the exact number of positive nodes is required to indicate genomic testing. In the neoadjuvant setting, response-driven therapy is increasingly used and may be influenced by surgical staging of the axilla. The present study addressed the role of axillary lymph node dissection (ALND) as decision aid for systemic therapy in a contemporary cohort of patients with clinically node-positive breast cancer in the adjuvant and neoadjuvant setting. Methods: The study was preplanned in the international multicenter phase-III OPBC-03/TAXIS trial (ClinicalTrials.gov Identifier: NCT03513614). The first 500 patients with clinically node-positive breast cancer who were randomized after tailored axillary surgery (TAS) to undergo ALND or axillary radiotherapy (ART) without ALND in the context of extended regional irradiation were included from August 2018 to June 2022. Clinically node-positive breast cancer was defined by confirmed nodal disease at the time of initial diagnosis; in case of neoadjuvant therapy, the finding of residual nodal disease was mandatory for randomization. TAS consisted of removal of palpably suspicious findings and the sentinel nodes with the option of image guidance. In the ART arm, the total number of positive nodes was not known. We analyzed the impact of ALND on rate and type of systemic therapy. Results: A total of 500 patients with a median age of 57 years (IQR: 48-69 years) were included at 44 breast centers from six European countries. Subtype was hormone receptor (HR) positive (+) and human epidermal growth factor receptor 2 (HER2) negative (-) in 393 (80.0%), HR+/HER2+ in 52 (10.6%), HR-/HER2+ in 5 (1.0%) and HR-/HER2- in 34 (6.9%) patients. Of 343 patients (68.6%) who were treated in the adjuvant setting, 297 had HR+/HER2- disease. Of these 297 patients, 145 (48.8%) underwent ART without ALND and 152 (51.2%) underwent ALND after TAS. In the ART arm, the median number of lymph nodes removed was five (IQR 4-8), three (IQR 1-4) of which were positive and in the ALND arm, the number was 19 (IQR 14-26), four (IQR 2-9) of which were positive (p < 0.001). The use of ALND had no significant impact on the rate of patients with HR+/HER2- disease undergoing adjuvant chemotherapy (51.0% in the ART and 57.9% in the ALND arm, p=0.2), and there were no significant differences in type of systemic therapy with the exception of tamoxifen, which was 18.4% with ALND versus 9.0% without (p=0.018). A total of 143 patients (28.6%) underwent neoadjuvant chemotherapy, 13 had neoadjuvant antihormonal treatment and one had neoadjuvant double HER2-blockade without chemotherapy. Of the 143 patients who received neoadjuvant chemotherapy, 71 (49.7%) underwent ART without ALND and 72 (50.3%) underwent ALND. In the ART arm, the median number of lymph nodes removed was four (IQR 3-6), one (IQR 1-3) of which was positive and in the ALND arm, the number was 16 (IQR 12-19), two (IQR 1-5) of which were positive (p < 0.001). The use of ALND in patients after neoadjuvant treatment had no significant impact on the rate of adjuvant systemic therapy (71.8% in the ART and 65.3% in the ALND arm, p=0.4), with no significant differences in type of chemotherapy (e.g., capecitabine: 11.3% vs 12.5%, p=0.8; T-DM1: 11.3% vs. 11.1%, p>0.9) or antihormonal therapy (e.g., aromatase inhibitors: 49.3% vs. 41.7%, p=0.4; tamoxifen: 11.3% vs. 5.6%, p=0.2). Discussion: This study showed that although ALND significantly increased the number of positive nodes removed in the adjuvant and neoadjuvant setting, it had no relevant impact on rate and type of adjuvant systemic therapy. Citation Format: Walter P. Weber, Zoltan Matrai, Stefanie Hayoz, Christoph Tausch, Guido Henke, Daniel R. Zwahlen, Günther Gruber, Frank Zimmermann, Thomas Ruhstaller, Simone Muenst, Markus Ackerknecht, Sherko Küemmel, Vesna Bjelic-Radisic, Viktor Smanykó, Conny Vrieling, Rok Satler, Inna Meyer, Charles Becciolini, Susanne Bucher, Colin Simonson, Peter M. Fehr, Natalie Gabriel, Robert Maráz, Dimitri Sarlos, Konstantin J. Dedes, Cornelia Leo, Gilles Berclaz, Hisham Fansa, Christopher Hager, Klaus Reisenberger, Ákos Sávolt, Christian F. Singer, Roland Reitsamer, Jelena Winkler, Giang Thanh Lam Lam, Mathias K. Fehr, Tatiana Naydina, Magdalena Kohlik, Karine Clerc, Valerijus Ostapenko, Florian Fitzal, Martin Heidinger, Nadia Maggi, Alexandra Schulz, Pagona Markellou, Loïc Lelièvre, Daniel Egle, Jörg Heil, Michael Knauer, Christian Kurzeder. PD15-11 Axillary dissection to determine nodal burden to inform systemic therapy recommendations in patients with clinically node-positive breast cancer: Pre-planned substudy of TAXIS (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101) [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD15-11.

Importance:The role of axillary lymph node dissection (ALND) to determine nodal burden to inform systemic therapy recommendations in patients with clinically node (cN)-positive breast cancer (BC) is currently unknown.Objective:To address the association of ALND with systemic therapy in cN-positive BC in the upfront surgery setting and after neoadjuvant chemotherapy (NACT).Design, Setting, and Participants:This was a prospective, observational, cohort study conducted from August 2018 to June 2022. This was a preplanned study within the phase 3 randomized clinical OPBC-03/TAXIS trial. Included were patients with confirmed cN-positive BC from 44 private, public, and academic breast centers in 6 European countries. After NACT, residual nodal disease was mandatory, and a minimum follow-up of 2 months was required.Exposures:All patients underwent tailored axillary surgery (TAS) followed by ALND or axillary radiotherapy (ART) according to TAXIS randomization. TAS removed suspicious palpable and sentinel nodes, whereas imaging-guidance was optional. Systemic therapy recommendations were at the discretion of the local investigators.Results:A total of 500 patients (median [IQR] age, 57 [48-69] years; 487 female [97.4%]) were included in the study. In the upfront surgery setting, 296 of 335 patients (88.4%) had hormone receptor (HR)-positive and Erb-B2 receptor tyrosine kinase 2 (ERBB2; formerly HER2 or HER2/neu)-negative disease: 145 (49.0%) underwent ART, and 151 (51.0%) underwent ALND. The median (IQR) number of removed positive lymph nodes without ALND was 3 (1-4) nodes compared with 4 (2-9) nodes with ALND. There was no association of ALND with the proportion of patients undergoing adjuvant chemotherapy (81 of 145 [55.9%] vs 91 of 151 [60.3%]; adjusted odds ratio [aOR], 0.72; 95% CI, 0.19-2.67) and type of systemic therapy. Of 151 patients with NACT, 74 (51.0%) underwent ART, and 77 (49.0%) underwent ALND. The ratio of removed to positive nodes was a median (IQR) of 4 (3-7) nodes to 2 (1-3) nodes and 15 (12-19) nodes to 2 (1-5) nodes in the ART and ALND groups, respectively. There was no observed association of ALND with the proportion of patients undergoing postneoadjuvant systemic therapy (57 of 74 [77.0%] vs 55 of 77 [71.4%]; aOR, 0.86; 95% CI, 0.43-1.70), type of postneoadjuvant chemotherapy (eg, capecitabine: 10 of 74 [13.5%] vs 10 of 77 [13.0%]; trastuzumab emtansine-DM1: 9 of 74 [12.2%] vs 11 of 77 [14.3%]), or endocrine therapy (eg, aromatase inhibitors: 41 of 74 [55.4%] vs 36 of 77 [46.8%]; tamoxifen: 8 of 74 [10.8%] vs 6 of 77 [7.8%]).Conclusion:Results of this cohort study suggest that patients without ALND were significantly understaged. However, ALND did not inform systemic therapy recommendations.

The aim of this study was to evaluate clinical practice heterogeneity in use of neoadjuvant systemic therapy (NST) for patients with clinically node-positive breast cancer in Europe. The study was preplanned in the international multicenter phase-III OPBC-03/TAXIS trial (ClinicalTrials.gov Identifier: NCT03513614) to include the first 500 randomized patients with confirmed nodal disease at the time of surgery. The TAXIS study’s pragmatic design allowed both the neoadjuvant and adjuvant setting according to the preferences of the local investigators who were encouraged to register eligible patients consecutively. A total of 500 patients were included at 44 breast centers in six European countries from August 2018 to June 2022, 165 (33

Introduction: Even though randomized controlled trials could not show a significant survival benefit for the use of neoadjuvant systemic therapy (NST), it is increasingly recommended for patients with clinically node-positive breast cancer due to its implications on prognosis, locoregional downstaging and response-driven adjuvant systemic therapy. The aim of this study was to assess the need for international standardization of treatment recommendations by evaluating clinical practice heterogeneity in use of NST for patients with clinically node-positive breast cancer in Europe. Methods: The study was preplanned in the international multicenter phase-III OPBC-03/TAXIS trial (ClinicalTrials.gov Identifier: NCT03513614) after randomization of the first 500 patients with clinically node-positive breast cancer who underwent axillary lymph node dissection (ALND) or axillary radiation (ART) without ALND after tailored axillary surgery (TAS) in the context of extended regional nodal irradiation. Clinically node-positive breast cancer was defined by confirmed nodal disease at the time of initial diagnosis; in case of neoadjuvant therapy, residual nodal disease was mandatory. Investigators were encouraged to enroll all eligible patients consecutively. However, TAXIS is unique inasmuch as its pragmatic design allows both the neoadjuvant and adjuvant setting according to the preferences of the treating physicians and institutions and thus provides an excellent opportunity to study patterns and trends in use of NST in patients with clinically positive nodes in Europe. Results: A total of 500 patients with a median age of 57 years (IQR: 48-69 years) were included at 44 breast centers in 6 European countries from August 2018 to June 2022. Subtype was hormone receptor (HR) positive (+) and human epidermal growth factor receptor 2 (HER2) negative (-) in 393 (80.0%), HR+/HER2+ in 52 (10.6%), HR-/HER2+ in 5 (1.0%) and HR-/HER2- in 34 (6.9%) patients. The rate of patients undergoing NST was 31.4% with a significant upward trend over time during the study period (from 20.0% in 2018 to 38.1% in 2022; p=0.044). The use of NST varied significantly by country (p=< 0.001) and by site (p=0.015). For patients with clinical AJCC tumor stage II and III, the rates of patients undergoing NST in Switzerland were 26.5% (18 of 68) and 35.9% (92 of 256), in Germany 22.2% (2 of 9) and 30.4% (7 of 23), in Austria 50% (7 of 14) and 60% (9 of 15) and in Hungary 0% (0 of 15) and 20.7% (18 of 87), respectively (p=0.019 and 0.004). Large differences by country were found for ER+/HER2- breast cancer, ranging from 13.1% (11 of 84) in Hungary to 47.8% (11 of 23) in Austria (p=0.007). Within Switzerland, which was the country with most included patients (328 of 500) and participating sites (n=25), the rate of patients undergoing NST for ER+/HER2- breast cancer varied considerably by site, ranging from 10% (2 of 20) to 50% (11 of 22). Discussion: This study revealed substantial heterogeneity in clinical practice in Europe, indicating the need for development of and adherence to consistent guidelines to standardize the international use of NST. Citation Format: Walter P. Weber, Zoltan Matrai, Stefanie Hayoz, Guido Henke, Daniel R. Zwahlen, Günther Gruber, Frank Zimmermann, Thomas Ruhstaller, Simone Muenst, Markus Ackerknecht, Christian Kurzeder, Sherko Küemmel, Vesna Bjelic-Radisic, Viktor Smanykó, Conny Vrieling, Rok Satler, Inna Meyer, Charles Becciolini, Susanne Bucher, Colin Simonson, Peter M. Fehr, Natalie Gabriel, Robert Maráz, Dimitri Sarlos, Konstantin J. Dedes, Cornelia Leo, Gilles Berclaz, Hisham Fansa, Christopher Hager, Klaus Reisenberger, Ákos Sávolt, Christian F. Singer, Roland Reitsamer, Jelena Winkler, Giang Thanh Lam Lam, Mathias K. Fehr, Tatiana Naydina, Magdalena Kohlik, Karine Clerc, Valerijus Ostapenko, Florian Fitzal, Martin Heidinger, Nadia Maggi, Alexandra Schulz, Pagona Markellou, Loïc Lelièvre, Daniel Egle, Jörg Heil, Michael Knauer, Christoph Tausch. Trends in neoadjuvant systemic therapy rates in Europe: Pre-planned substudy of TAXIS (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101) [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-14-08.

This text is based on the recommendations accepted by the 4th Hungarian Consensus Conference on Breast Cancer, modified on the basis of the international consultation and conference within the frames of the Central-Eastern European Academy of Oncology. The recommendations cover non-operative, intraoperative and postoperative diagnostics, determination of prognostic and predictive markers and the content of cytology and histology reports. Furthermore, they address some specific issues such as the current status of multigene molecular markers, the role of pathologists in clinical trials and prerequisites for their involvement, and some remarks about the future.

Round block Oncoplastic Breast-Conserving Surgery (OBCS) can cause dilatation of the areola and a sharp periareolar scar that leads to significant asymmetry of the breasts. Here, we modified the round block OBCS by using the tendency of areolar expansion and placing the incision line and de-epithelization of the epidermal layer in the Perimamillar (PM) area rather than in the periareolar area. PM OBCS was indicated for the radical resection of solitary or multifocal malignant tumors (<30 mm) located in any quadrant of the breast. The Breast Q questionnaire, BCCT.core, and Likert scale were used to evaluate the subjective and objective aesthetic results. A prospectively led database of 60 patients was used in this retrospective study. Re-excisions were performed due to involved margins in 5 (8.3%) cases. The median follow-up time was 11 months. In total, 8 (13.3%) grade-I complications and 2 (3.3%) grade-II complications were recorded. The PM OBCS technique did not significantly influence the subjective and objective aesthetic results. High patient satisfaction was observed. The PM OBCS technique is effective Level-I oncoplastic for cT1 breast tumors. Thus, “invisible” surgery could be a realistic expectation. Compared to periareolar de-epithelization, this technique allows better preservation of breast projection.

Abstract IntroductionThe immediate (I-BR) or delayed-immediate (DI-BR) implant-based breast reconstruction (BR) of the affected breast following nipple, areola, skin-sparing mastectomy (NSM, ASM, SSM) techniques requires almost in all cases symmetrization of the contralateral breast. The long term results of implant-based BR (subpectoral or prepectoral) and symmetrization following advanced postmastectomy BR techniques significantly decrease over time and later result in a limited patient satisfaction rate. Beyond the satisfactory early results BRs, there are only limited long term data on cosmetics and patient satisfaction. In fact with time patient dissatisfaction necessitates repeated surgeries, with an extra load for both to the patient and the health system. The aim of the study is to gain high quality data about the deteriorating cosmetic outcomes of bilateral BRs on the long term. Trial design In this response-adaptive prospective randomized study patients are sub-grouped into 6 study groups after BR surgery with silicone implant (following uni- or bilateral NSM, ASM, SSM) with symmetrization in case of unilateral mastectomy (mastopexy and/or silicone implant and/or mesh sling technique to suspend the breast with or without reduction) or simple mastectomy without symmetrization. The planned number of patients is a minimum of 528 cases. The measurements of the breast, the ptosis, photo documentation using valid BCCT.core software, BREAST-Q questionnaire and Likert scale are performed preoperatively, 4 weeks after delayed BR with symmetrization, 3 months after, every 6 months for 5 years. Primary endpoint Using correlation analysis to measure objective changes over time in the quality of life (QoL) and patient satisfaction associated with the symmetry achieved by different surgical techniques up to five years of follow-up. To compare the QoL and the satisfaction rate in the control group with a simple mastectomy, bilateral SSM, ASM, NSM and BR. Secondary endpoint To determine the prognostic factors, patient subgroups, and surgical techniques associated with patients, surgery, and oncological therapies in an optimal way. Furthermore, the study should give relevant data about the oncoplastic concept of prophylactic SSM, ASM, or NSM on the contralateral side and BR, without the presence of hereditary breast and ovarian cancer syndrome, using the same surgical technique than on the affected side. The long term PRO results of postmastectomy BR should be necessarily part of the initial patient information in the future. Inclusion criteria- Under the age of 65 with uni- or bilateral primary breast cancer, needing advanced mastectomy independently of the axillary surgery, having I-BR os DI-BR on the ipsilateral side and symmetrization on the contralateral side - Control group: patients under 65 years with unilateral simplex mastectomy without BR. Exclusion criteria-Pregnancy-associated breast cancer-Prior breast surgery and/or radiotherapy -Severe non-surgical complication-Long-term steroid usage Present accrual and target accrual The trial was activated on 22 April 2020. As of 5 July, 23 patients have been randomized. Accrual is currently running according to protocol and is planned until 2025. Interim analysis performed after 2 years’ median follow-up period. The final analysis is performed 5 years after closing the patient inclusion period. Citation Format: Mihály Újhelyi, Ákos Sávolt, Orsolya Huszár, Orsolya Ping, Norbert Mészáros, Nóra Jani, Mátyás Újlaki, István Kenessey, Zsófia József, Zoltán Mátrai. Examining and comparing the temporal changes and results of cosmetic, quality of life and patient satisfaction achieved with immediate and delayed-immediate implant-based breast reconstruction procedures and contralateral symmetrisation techniques after skin-sparing mastectomies with unilateral simple mastectomy and with bilateral skin-sparing mastectomies and immediate implant-based breast reconstructive surgeries. (ClinicalTrials.gov Identifier: NCT04356235) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-23-01.