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Aim We developed tailored axillary surgery (TAS) to reduce the axillary tumor volume in patients with clinically node-positive breast cancer to the point where radiotherapy can control it. The aim of this study was to quantify the extent of tumor load reduction achieved by TAS. Methods International multicenter prospective study embedded in a randomized trial. TAS is a novel pragmatic concept for axillary surgery de-escalation that combines palpation-guided removal of suspicious nodes with the sentinel procedure and, optionally, imaging-guided localization. Pre-specified study endpoints quantified surgical extent and reduction of tumor load. Results A total of 296 patients were included at 28 sites in four European countries, 125 (42.2%) of whom underwent neoadjuvant chemotherapy (NACT) and 71 (24.0%) achieved nodal pathologic complete response. Axillary metastases were detectable only by imaging in 145 (49.0%) patients. They were palpable in 151 (51.0%) patients, of whom 63 underwent NACT and 21 had residual palpable disease after NACT. TAS removed the biopsied and clipped node in 279 (94.3%) patients. In 225 patients with nodal disease at the time of surgery, TAS removed a median of five (IQR 3–7) nodes, two (IQR 1–4) of which were positive. Of these 225 patients, 100 underwent ALND after TAS, which removed a median of 14 (IQR 10–17) additional nodes and revealed additional positive nodes in 70/100 (70%) of patients. False-negative rate of TAS in patients who underwent subsequent ALND was 2.6%. Conclusions TAS selectively reduced the tumor load in the axilla and remained much less radical than ALND., Highlights • Tailored axillary surgery is a novel concept for clinically node-positive breast cancer • Tailored axillary surgery selectively removes positive lymph nodes • Tailored axillary surgery is much less radical than axillary dissection • Tailored axillary surgery removes the clipped node in the vast majority of patients

Absztrakt: Bevezetés: A korszerű onkoplasztikus emlősebészet következményeként megjelenő jelentős emlőrekonstrukciós igény számos rendszerszintű kérdést vet fel. Vizsgálatra és szabályozásra várnak az onkoterápiák hatására és az idő múlásával bekövetkező esztétikai változások, illetve hosszú távú szövődmények miatti korrekciós műtétek indikációi; meghatározandó a helyreállító beavatkozások optimális és maximális száma, az elérni kívánt esztétikai végcél és az ezekhez szükséges emlősebészeti kapacitások, valamint finanszírozás. Célkitűzés: A jelen vizsgálat célja, hogy kérdőíves vizsgálattal felmérje a magyar emlőrákos populáció korszerű emlőrekonstrukciós igényeit és véleményét. Anyag és módszer: A vizsgálatba 500, mastectomián és azonnali vagy halasztott-azonnali emlőrekonstrukción átesett nőbeteg került bevonásra. Tizenegy kérdésből álló kérdőív segítségével történt az emlő rekonstrukciójához való ismereteknek és személyes viszonyulásnak, az esztétikai végeredménnyel és az ellátás szakmai színvonalával kapcsolatos elvárásoknak, továbbá az ellátórendszerrel és a finanszírozással kapcsolatos igényeknek a felmérése, majd elvégeztük az eredmények biostatisztikai elemzését. Eredmények: A betegek medián életkora 47 év (min.–max.: 26–73) volt, döntő részük (59%; n = 294) házas volt, és 52% (n = 260) rendelkezett egyetemi végzettséggel. A betegek 70%-a (n = 348) az emlő-helyreállítás eredményeként mezítelenül is nagyjából egyforma emlőket szeretett volna. Ehhez 43%-uk (n = 217) maximum kettő, 37%-uk (n = 184) maximum három-négy műtétet vállalna. A felmérésben részt vettek 44%-a (n = 220) szerint az egészségbiztosítónak három-négy rekonstrukciós beavatkozást kellene támogatnia. A betegek 86%-a (n = 430) a daganatos emlő korszerű sebészi kezelését speciálisan képzett emlősebészre bízná. Következtetés: Az emlőrák modern onkoplasztikus sebészi ellátása összetett, rendszerszintű kérdéseket vet fel. Az emlőrákos betegek jól képzett emlősebészeket szeretnének, akik az emlőrák korszerű sebészi kezelésén túl mastectomia esetén az egészségbiztosító által támogatott formában, maximum két műtéttel képesek magas esztétikai eredménnyel az emlők helyreállítására. Orv Hetil. 2020; 161(29): 1221–1228.

Absztrakt: Bevezetés és célkitűzés: A szerzők a Regnault „B” típusú emlőfelvarrás sebészi technikájának módosításával végzett onkoplasztikus műtéti technikát és az új emlősebészeti módszer alkalmazásához kapcsolódó retrospektív klinikopatológiai vizsgálat eredményeit mutatják be. Módszer: 2012. április és 2018. október között, emlőrák miatt, módosított Regnault „B” technikával operált 215 nőbeteg klinikopatológiai adatait prospektíven vezetett adatbázis alapján retrospektív módon vizsgáltuk. A betegek életminőségét validált kérdőív segítségével mértük fel, míg a műtétek esztétikai eredményét a szintén validált Breast Cancer Conservative Treatment (BCCT.core) számítógépes program és az 5 pontos Likert-skála alapján értékeltük. Eredmények: A betegek átlagéletkora 53 év (szórás: 29–81 év) volt. A medián utánkövetési idő 47 hónap (szórás: 7–85 hónap) volt. Az átlag műtéti idő 47 perc (szórás: 35–85 perc) volt, míg a patológiai tumorméret átlagosan 33 mm-nek (szórás: 18–58 mm) bizonyult. Pozitív sebészi szél miatt 13 (6%) esetben irányított reexcisióra, míg 3 (1,4%) esetben mastectomiára kényszerültünk. Az összesített szövődményarány 7,4% (n = 16) volt. Az esztétikai eredmények Likert-skála szerinti átlagértéke 4,2 (szórás: 2–5), míg a BCCT.core program alapján 1,3 pont (szórás: 1–4 pont) volt. Az életminőséggel kapcsolatos kérdőívek eredményei magas betegelégedettséget igazoltak. Következtetés: A módosított Regnault „B” emlőmegtartó technika biztonságos és hatékony standard ’level II.’ onkoplasztikus emlősebészeti technika. A műtét magas betegelégedettséggel, illetve kozmetikai eredménnyel képes a közepes vagy nagyobb térfogatú emlők külső, illetve külső-felső negyedeinek T1–T3-as tumorai miatt az emlők akár 20–50%-ának eltávolítására, majd egyidejű parenchymaáthelyezéssel történő rekonstrukciójára. A módszer előnye, hogy nem igényel ellenoldali szimmetrizációs műtétet, míg hátránya, hogy az emlő bőrpalástján vezetett metszések komplettáló mastectomia esetén az azonnali rekonstrukciót nehezítik. Orv Hetil. 2020; 161(24): 1002–1011.

Involving 207 breast cancer patients a retrospective study was performed to facilitate the acceptance of the central pedicled, modified Wise-pattern therapeutic mammoplasty technique as a standard volume-displacement level II oncoplastic breast-conserving surgery (OBCS). The overall local recurrence rate was 5.8% with an average follow-up of 43.9 months. The median time to the initiation of the adjuvant treatment was 4.9 weeks. Due to positive surgical margins, 13 (6.84%) completional surgeries were performed. In total, 45 complications (12.9%) were recorded. The median values of the esthetic outcomes represented improved cosmetic results. The modified Wise-pattern technique could be a standard, safe and repeatable level II volume-displacement OBCS.

Background This study presents a novel Level I oncoplastic breast-conserving surgery technique for performing tumorectomy by retroglandular exploration through a skin incision made in the inferior mammary fold. Patients and Methods A retrospective single-center cohort study involving patients with early-stage breast cancer (n = 102) was performed. The patient characteristics were recorded, as well as the quality of life rated by BREAST-Q. Postoperative complications were assessed using the Clavien-Dindo classification system. Esthetic outcomes were evaluated with Breast Cancer Conservative Treatment-cosmetic results (BCCT.core) software and a 5-point Likert scale. Results The median follow-up time was 11 months (range, 7-25 months). The median specimen weight and operative time were 49.8 g (range, 13.4-117.9 g) and 40 minutes (range, 20-80 minutes), respectively. The mean pathologic tumor size was 15 mm (SD, ±7). Owing to positive surgical margins, re-excisions and mastectomies were performed in 13.7% and 2.9% of patients, respectively. The overall complication rate was 24.5% (n = 25), with the most common being seroma formation (13.7%; n = 14). The median Likert scale score was 4.3 (range, 2.1-5), and the median overall esthetic outcome assessed by BCCT.core was 2.1 points (range, 1-4 points). In BREAST-Q domains, the median scores of the “adverse effects of radiation,” “physical well-being,” the “satisfaction with breasts,” and the “psychosocial well-being” were 27, 35, 90, and 93, respectively. Conclusion Retroglandular oncoplastic breast-conserving surgery is a novel, effective Level I oncoplastic technique for radical resection of breast tumors ≤ 3 cm in size. Additional advantages include the preservation of natural breast shape, the safety of the technique, and the lack of a need for contralateral symmetrization.

In recent years some serologic parameters emerged as potential prognostic factors. The neutrophil-to-lymphocyte ratio (NLR) has the most evidence; however, other serologic factors were also reported. The only established systemic treatment in triple-negative breast cancer (TNBC) is chemotherapy which is preoperatively applied more widely. For these patients few data are available on which serologic markers would be the best predictor for disease-free (DFS) and overall survival (OS). Data of 137 TNBC patients treated (2005-2016) with neoadjuvant chemotherapy at our center were analyzed. Beyond pathological factors, white blood cell (WBC), neutrophil (NE), lymphocyte (LY) and platelet (PL) counts, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII) were investigated. In univariate analysis, most parameters (NE1, LY1, NLR1, PLR1, SII1) measured at baseline and before the third cycle (NE3, LY3, etc.) of chemotherapy showed significant association with survival. After the exclusion of correlated variables, in multivariate analysis NLR1, Ki67 and pathological stage were independent predictors of DFS and OS. In an exploratory analysis new markers were found: dichotomization by NLR1xNLR3 and PL1/(PL3)2 resulted in significantly different DFS of patients with low and high NLR1, respectively. A high PL3xLY3 level was an exclusive marker of relapse after pathological complete remission.

The significant need for breast reconstruction resulting from the spread of oncoplastic breast surgery raises a number of systemic issues. Clarification and regulation of the indications are needed for aesthetic changes of the reconstructed breast due to oncotherapy treatments, ageing and technical problems of implants; a number of operations, targeted aesthetic goals as well as surgical capacities and financial background should also be determined.Our aim was to conduct a survey on the opinions and needs of the Hungarian breast cancer population about a modern breast reconstruction system.A study was conducted enrolling 500 patients who underwent mastectomy with immediate or delayed reconstruction. A structured questionnaire containing eleven questions was used to measure the attitude for loss and reconstruction of breast, the expectation of cosmetic outcome and qualification of the operating surgeon and the needs relating to the health system and funding.The median age was 47 years (min.-max.: 26-73), 59% (n = 294) was married and 52% (n = 260) had graduated in university. The majority of women (70%; n = 348) would like to have nakedly also similar breasts after the reconstruction process. To achieve this, 43% (n = 217) and 37% (n = 184) would undergo maximum two or four procedures, respectively, supported by the national health insurance company. 86% (n = 430) would like to choose qualified breast surgeon for her treatment.The modern oncoplastic treatment raises complex, systemic issues. Women with breast cancer would like to have qualified breast surgeons restoring their breasts by two operations, all funded by the national health insurance company. Orv Hetil. 2020; 161(29): 1221-1228.

This study aimed to describe the modified Regnault "B" oncoplastic technique as a standard volume-displacement level II oncoplastic breast-conserving surgery and the related clinicopathological study.A retrospective, single-centre study was performed between April 2012 and October 2018 involving 215 breast-cancer patients. Patient characteristics and postoperative complications were recorded, and the quality of life was rated by questionnaires. Aesthetic outcomes were evaluated with BCCT.core software and a five-point Likert scale.The mean patient age was 53 years (range: 29-81 years), with a median follow-up of 47 months (range: 7-85 months). The average surgery time was 47 min (range: 35-85 min) and the pathological average size of the tumours was 33 mm (range: 18-58 mm). Due to positive surgical margins, 13 (6%) completion re-excisions and 3 (1.4%) mastectomies were performed. In total, 16 complications (7.4%) were recorded. The median Likert scale score was 4.2, and the median overall aesthetic outcome assessed by BCCT.core was 1.3 points. According to the quality of life questionnaire, average points of the results demonstrated a high level of patient satisfaction.In medium- to large-breasted patients, the modified Regnault "B" technique is a safe and repeatable level II volume-displacement oncoplastic breast-conservation technique. This technique allows extended removal (20-50% of breast tissue) of T1-T3 tumours from the upper outer quadrant and the border of outer quadrants of the breast with improved aesthetic results. The advantage of this technique is that contralateral symmetrisation is not required, while disadvantage of this technique is the skin incision on the breast skin envelope that can make some difficulties when completion mastectomy is required with immediate reconstruction. Orv Hetil. 2020; 161(24): 1002-1011.

Abstract: Introduction and aim: To report the clinical outcomes of second breast-conserving therapy with perioperative interstitial radiotherapy for the treatment of ipsilateral breast tumor recurrences. Method: Between 1999 and 2015, 33 patients, presenting with an ipsilateral breast tumor recurrence after previous breast conserving therapy, were salvaged by re-excision and perioperative high-dose-rate interstitial brachytherapy. A median of 8 (range: 4–24) catheters were implanted into the tumor bed intraoperatively. A total dose of 22 Gy in 5 fractions of 4.4 Gy was delivered to the tumor bed with a margin of 1–2 cm, on 3 consecutive days. The adjuvant systemic treatments consisted of hormonal therapy for 24 patients (73%) and chemotherapy for 6 patients (18%). The survival results were estimated by the Kaplan–Meier method. Late side effects and cosmetic results were also registered. Results: The median follow-up time following the second breast conserving therapy was 61 months (range: 26–189 months). During the follow-up, 4 patients (12.1%) developed second local recurrence. The five-year actuarial rates of the second local, regional and distant recurrence were 6.3%, 6.1%, and 14.9%, respectively. The five-year probabilities of disease-free, cancer-specific and overall survival were 76.2%, 92.4%, and 89.2%, respectively. Four (12%), 19 (58%), 4 (12%) and 6 (18%) patients had excellent, good, fair and poor cosmetic results, respectively. Grade 2 and 3 fibrosis developed in 9 (27%) and 1 (3%) patients. Asymptomatic fat necrosis was detected in 7 (21%) women. Conclusion: Second breast conserving therapy with perioperative high-dose-rate interstitial brachytherapy is a safe and feasible option for the management of ipsilateral breast tumor recurrences. Interstitial brachytherapy may decrease the risk of second local relapse with acceptable cosmetic results and low rate of late side effects. Hence, in selected cases it can provide a feasible alternative to salvage mastectomy. Orv Hetil. 2018; 159(11): 430–438.

Background Acellular dermal matrices have been used for direct-to-implant (DTI) breast reconstruction (BR), eliminating the load of the lower pole skin envelope. However, the available allograft matrices add considerable health care costs. This study examined the long-term follow-up of synthetic ULTRAPRO ® mesh as a low-cost potential alternative to biological matrices. Patients and methods A retrospective cohort study was performed between January 2013 and January 2016, involved 112 early-stage breast cancer and/or BRCA 1/2 patients, and evaluated 189 immediate DTI BRs following skin-, areola- or nipple-sparing mastectomy using ULTRAPRO ® mesh. Patient characteristics and postoperative complications were recorded, and quality of life was rated by the patients using the EORTC-QLQ-C30-BR23 questionnaire. Aesthetic outcomes and palpability of the implants were evaluated by four breast surgeons on a 5-point Likert scale. All recorded parameters were statistically analysed. Results Ten patients were lost-to-follow-up, resulting in 102 patients and 174 breast surgery cases analysed. The mean age was 43 years, with 23.4 months of follow-up on average. Forty-six patients (45.1%) had previous radiotherapy with pre-existing scars. In total, 32 complications (18.3%) were recorded, including 12 minor (6.9%) and 20 major (11.4%) complications requiring revision. All median quality of life scores were above 83 points, representing a high score, with an average 4-point rating for the aesthetic outcome and natural consistency of the breast. Conclusion Partially absorbable ULTRAPRO ® mesh could be used successfully in DTI BR, offering a safe, less expensive alternative to biological matrices. Adequate indications and patient selection are necessary.

Background Breast cancer diagnosed in very young women (VYWBC; ≤35 years) and young women (YWBC; 36–45 years) tends to be heterogeneous. The current study aimed to compare the clinicopathological characteristics and long-term clinical outcomes between YWBC and VYWBC subgroups. Patients and methods The institutional prospectively led database was retrospectively analysed from 2000 to 2014 at the National Institute of Oncology, Hungary. A total of 297 patients were assigned to the VYWBC group, and 301 patients were assigned to the YWBC group. Results The median follow-up period was 69 months for the VYWBC group and 79 months for the YWBC group. Significant differences were observed based on breast cancer subtype. The proportion of Triple-negative and ER-negative patients was higher in the VYWBC group than in the YWBC group (P = 0.00008). The incidence of distant metastasis was significantly higher in the VYWBC group (P = 0.01). Significant differences in the frequency of chemotherapy (P = 0.049) and endocrine therapy (P = 0.037) were observed between the two groups. The YWBC group exhibited significantly better overall survival (OS) and disease-free survival (DFS) rates than did the VYWBC group (P = 0.00005 and P = 0.00004, respectively). Conclusion Breast cancers in VYWBC are biologically different from those in YWBC and tend to be more aggressive. Younger age was associated with worse OS and DFS. Young women with breast cancer should be subgrouped into VYWBC and YWBC populations, and these subgroups should be targeted by specialized clinical trials and further investigations.

Introduction: We developed tailored axillary surgery (TAS) to selectively remove positive nodes and omit axillary lymph node dissection (ALND) in patients with clinically node-positive breast cancer irrespective of the use of neoadjuvant chemotherapy. In this study, we evaluate the performance of this novel surgical concept that tailors the extent of axillary surgery to the extent of axillary disease. Methods: A prospective study was pre-specified to assess the performance of TAS in the international multicenter phase-III TAXIS trial randomizing patients with clinically node-positive breast cancer to undergo ALND or axillary radiation after TAS. TAS consists of selective removal of all palpably suspicious findings and the SLNs followed by specimen radiography to document removal of the clip placed in the sampled node. Imaging-guided localization is encouraged to increase the chances of clip removal. Only patients with confirmed nodal disease at the time of surgery can be randomized in TAXIS; the first 200 randomized patients were analyzed together with the ones achieving nodal pCR in this study. ClinicalTrials.gov Identifier: NCT03513614. Results: A total of 296 patients with a median age of 56.5 years (range: 25-88 years) were included at 28 breast centers from four European countries, 125 (42.3%) of whom underwent NACT and 75 (25.3%) of whom had nodal pCR. Subtype was hormone receptor (HR) positive (+) and human epidermal growth factor receptor 2 (HER2) negative (-) in 194 (65.5%), HR+/HER2+ in 40 (13.5%), HR-/HER2+ in 17 (5.7%) and HR-/HER2- in 39 (13.2%) patients. Breast-conserving surgery was performed in 178 patients (60%) and mastectomy in 117 (40%). Imaging-guided localization was attempted in 258 patients (87.2%) and was successful in 243 (82.1%). TAS removed a median of two (interquartile range [IQR] 0-3) palpably suspicious lesions and two (IQR 1-3) SLNs, thereby successfully removing the clip in 279 (94.3%) patients. There were no significant differences by use of imaging-guided localization (94.6% with vs 92.1% without, p=0.47) or type of clip (p=0.19), but a trend toward lower rate of clip removal after NACT (91.2% with vs 96.5% without NACT, p=0.075). Palpable disease was left behind after TAS in two (2.1%) patients and no SLN was detected in three (3.1%). In the 200 randomized patients with confirmed nodal disease at the time of surgery, lymph node metastases were palpable at the time of initial diagnosis in 102 (51%) patients and detectable only by imaging in 98 (49%). The median number of lymph nodes removed by TAS was four (IQR 2-8), two (IQR 1-4) of which were positive. Completion ALND following TAS removed additional positive nodes in 71 of 100 (71%) patients in the control group (20% with one additional node, 9% with 2, 8% with 3, 6% with 4, and 28% with >4). The median number of additional lymph nodes removed by ALND was 14 (IQR 10-18), two (IQR 0-6) of which were positive. Of the 200 randomized patients, one in the TAS group received a radiotherapy boost and one in the ALND group returned to the operating room for residual suspicious findings on imaging. Discussion: The present results suggest that TAS has the potential to become the new axillary surgery standard in patients with clinically node-positive breast cancer. TAS was successfully performed in the vast majority of patients, with no further improvement by imaging-guided localization, which makes the procedure feasible at most breast centers. TAS selectively removed positive lymph nodes and was much less radical than ALND, but ALND removed additional positive nodes in more than two thirds of patients. Disease-free survival and quality of life will be assessed in the randomized trial. Citation Format: Walter Paul Weber, Guido Henke, Stefanie Hayoz, Karin Ribi, Stefanie Seiler, Charlotte Maddox, Thomas Ruhstaller, Daniel Rudolf Zwahlen, Simone Muenst, Markus Ackerknecht, Florian Fitzal, Mihály Újhelyi, Christian Kurzeder, Loïc Lelièvre, Christoph Tausch, Daniel Egle, Jörg Heil, Zoltan Matrai, Michael Knauer. Tailored axillary surgery to omit axillary lymph node dissection independently from the use of neoadjuvant chemotherapy in patients with clinically node-positive breast cancer: Pre-specified subproject within TAXIS (SAKK 23/16 / IBCSG 57-18 / ABCSG-53 / GBG 101) [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 PD4-04.

Background Main weaknesses of neoadjuvant chemotherapy (NACT) to avoid axillary dissection (ALND) in patients with clinically node-positive breast cancer are frequent failure of achieving nodal pathologic complete response (pCR) and administration of chemotherapy even though not indicated otherwise in many cases. Tailored axillary surgery (TAS) was designed to selectively remove positive nodes and omit ALND in patients with clinically node-positive breast cancer either in the upfront surgery setting or in case of residual nodal disease after neoadjuvant therapy, which distinguishes this trial from all others ongoing and published. Trial design In this international, multi-center, phase-III, non-inferiority randomized controlled trial, including 61 study sites from six countries, we plan to randomize 1500 patients to either receive TAS followed by ALND and regional nodal irradiation excluding the dissected axilla, or receive TAS only followed by regional nodal irradiation including the full axilla. TAS consists of selective removal of the sentinel lymph nodes (SLNs) and all palpably suspicious findings, thereby tailoring the extent of axillary surgery to the extent of axillary disease, followed by specimen radiography to document removal of the clip placed in the sampled node. Imaging-guided localization is encouraged to increase the chances of clip removal. All patients undergo adjuvant whole-breast irradiation after breast conserving surgery and chest wall irradiation after mastectomy. Inclusion of internal mammary nodes is recommended irrespective of treatment arm. ClinicalTrials.gov Identifier: NCT03513614. Inclusion criteria - Clinically node-positive breast cancer (all molecular subtypes allowed) - Node-positivity palpable or detectable only by imaging at time of initial diagnosis - Newly diagnosed or isolated in-breast recurrence or second ipsilateral breast cancer after previous breast conserving surgery and sentinel procedure and at least 3 years disease free and no prior axillary dissection or axillary RT. - In case of prior neoadjuvant treatment: residual disease (including residual ITCs) confirmed by pathology at the time of surgery - Clipping of sampled axillary lymph node Exclusion criteria - Absence of clip in the specimen radiography - Palpable disease left behind in the axilla after TAS - No SLN identified in the axilla Specific aims To test the hypothesis that treatment with TAS and axillary radiotherapy is non-inferior to ALND in terms of disease-free survival (DFS) of clinically node-positive breast cancer patients. Secondary objective is to test if quality of life is significantly better with TAS and axillary radiotherapy compared to ALND. Statistical methods With type I error 5% and power 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 (HR) 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), including one interim analysis for efficacy/futility after 20% of the required events have occurred. The sample size needed is 1500 patients (750 per arm). The HR and one-sided 95% confidence interval will be calculated using a Cox regression model based on the per-protocol set. Present accrual and target accrual The trial was activated on 31 July 2018 and the first patient was randomized on 07 August 2018. As of 03 July 2020, 291 patients have been randomized. Accrual is currently running according to protocol and is planned until end of 2023 with the primary endpoint analysis expected in 2029. Contact information Prof. Dr. Walter Paul Weber, University Hospital Basel; Tel: +41 61 328 61 49; Walter.Weber@usb.ch Citation Format: Walter Paul Weber, Guido Henke, Stefanie Hayoz, Karin Ribi, Stefanie Seiler, Charlotte Maddox, Thomas Ruhstaller, Daniel Rudolf Zwahlen, Simone Muenst, Markus Ackerknecht, Florian Fitzal, Mihály Újhelyi, Christian Kurzeder, Loïc Lelièvre, Christoph Tausch, Daniel Egle, Jörg Heil, Zoltan Matrai, Michael Knauer. Tailored axillary surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node-positive breast cancer (SAKK 23/16 / IBCSG 57-18 / ABCSG-53 / GBG 101 - TAXIS): A multicenter randomized phase III trial [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-04-03.

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.

Introduction: Immediate breast reconstruction provides oncological safety, requires longer operation time. It does not influence the initiation of adjuvant therapy and radiological control, and results in favourable cosmetic outcome. Aim: Assessing the Hungarian data of immediate postmastectomy breast reconstructions, and comparing them to international findings. Method: Between May, 2011 and September, 2014 121 therapeutic and prophylactic, postmastectomy immediate breast reconstructions were performed in 100 patients. The clinico-pathological findings were assessed retrospectively, and surgical, oncological and cosmetic outcomes were evaluated statistically. Results: The mean age of patients was 42.6 years, the follow up time was 29.4 months, and the duration of operation was 132 minutes. Skin-sparing mastectomy was performed most commonly (64%) with submuscular tissue expander placement (70%). Early postoperative complication was identified in 18 patients, and loco-regional recurrence in 1 patient. Most patients (89%) were satisfied with the cosmetic outcome. The average initiation time of adjuvant therapy was 4.8 weeks. Conclusions: Immediate breast reconstruction is a safe and effective option in line with international findings. Orv. Hetil., 2016, 157(46), 1830–1838.

Introduction: The European Society of Breast Cancer Specialists has created quality indicators for breast units to establish minimum standards and to ensure specialist multimodality care with the conscious aim of improving outcomes and decreasing breast cancer mortality. Aim: The aim of this study was to analyse the breast cancer care in the National Institute of Oncology according to the European Society of Breast Cancer Specialists requirements and in a large number of cases in order to present representative clinico-pathological data on the incidence of breast cancer in Hungary. Method: According to the European Society of Breast Cancer Specialists uniformed criteria clinico-pathological data of multimodality treated breast cancer cases were retrospectively analysed between June 1, 2011 and May 31, 2012. Results: During the period of interest 906 patients underwent breast surgery for malignant or benign lesions. According to the European Society of Breast Cancer Specialists quality indicators the breast cancer care of the National Institute of Oncology is eligible. Conclusions: The diagnostic modalities and multimodality care of breast cancer of the National Institute of Oncology breast unit meets the critical mass and minimum standards of the European Society of Breast Cancer Specialists criteria. Orv. Hetil., 2016, 157(42), 1674–1682.

Purpose The purpose of this study was to report the clinical outcomes of a second breast-conserving therapy (2nd BCT) with perioperative interstitial brachytherapy (iBT) vs. those of salvage mastectomy (sMT) in the treatment of ipsilateral breast tumor recurrences (IBTRs). Methods and Materials Between 1999 and 2015, 195 patients with IBTR after a previous breast-conserving treatment were salvaged either with reexcision and perioperative high-dose-rate iBT (n = 39), or with sMT (n = 156). In the 2nd BCT group, a total dose of 22 Gy in five fractions of 4.4 Gy was delivered to the tumor bed with intraoperatively implanted catheters for 3 consecutive days. Results The median followup time was 59 months (1–189) in the 2nd BCT, and 56 months (3–189) in the sMT group. The mean size of IBTR was 16 mm (2–70) vs. 24 mm (2–90), respectively (p = 0.0005), but there were no other significant differences in patient- or IBTR-related parameters between the two groups. During the followup period, 4 of 39 (10.2%) and 28 of 156 (17.9%) second local recurrences (2nd LR) occurred in the 2nd BCT and the sMT group, respectively. The 5-year actuarial rate of 2nd LR was 6% vs. 18% (p = 0.22), the 5-year probability of disease-free, cancer-specific and overall survival was 69% vs. 65% (p = 0.13), 85% vs. 78% (p = 0.32), and 81% vs. 66% (p = 0.15), respectively. In the 2nd BCT group, the rate of good to excellent cosmesis was 70%. Conclusions 2nd BCT with perioperative high-dose-rate iBT is a safe and feasible option for the management of IBTR, resulting in similar 5-year oncological outcomes and better cosmetic results compared with sMT.

Introduction Limited data is available from studies that directly compare oncoplastic breast surgery and conventional breast-conserving surgery (CBCS) procedures. The aim of this study was to compare three volume displacement oncoplastic breast-conserving surgery (OBCS) techniques to CBCS procedures, providing more evidence and facilitating the standardization of OBCS techniques. Patients and methods A retrospective single-centre comparative study was performed between January 2010 and January 2017 involving 758 breast cancer patients. The endpoints for comparison were oncological safety, frequency of complications, initiation time of adjuvant therapy, aesthetic outcome, quality of life and operation time. To compare data, statistical analyses were performed. Results The mean follow-up time was 51 months for the OBCS group and 52 months for the CBCS group. The excised weight of the specimens was significantly larger in the OBCS group than in the CBCS group (90 g vs. 63 g). The overall complication rate (5.7% vs. 6.6%), the initiation time of adjuvant therapy (4.2 weeks vs. 4.1 weeks) and the local recurrence rate (2.0% vs. 3.7%) did not differ significantly. Scores for the aesthetic outcome were significantly higher in the OBCS group; however, required longer operation time. Conclusion The investigated OBCS procedures allowed the removal of large volumes of breast tissue with improved cosmetic outcomes without delay in adjuvant therapies, maintaining the oncological safety. However, OBCS required longer operation time. Furthermore, the extended radicality of the OBCS could reduce the rate of re-excision and completion mastectomy, although it may result in the overtreatment of some breast cancer patients.

Aim of the study The arsenal of questions and answers about the minor cancer initiating cancer stem cell (CSC) population put responsible for cancer invasiveness and metastases, has left with an unsolved puzzle. Specific aims of a complex project were partly focused on revealing new biomarkers of cancer. We designed and set up novel techniques to facilitate the detection of cancerous cells. Materials and methods As a novel approach, we investigated B cells infiltrating breast carcinomas and melanomas (TIL-B) in terms of their tumour antigen binding potential. By developing the TIL-B phage display technology we provide here a new technology for the specific detection of highly tumour-associated antigens. Single chain Fv (scFv) antibody fragment phage ELISA, immunofluorescence (IF) FACS analysis, chamber slide technique with IF confocal laser microscopy and immunohistochemistry (IHC) in paraffin-embedded tissue sections were set up and standardized. Results We showed strong tumour-associated disialylated glycosphingolipid expression levels on various cancer cells using scFv antibody fragments, generated previously by uniquely invasive breast carcinoma TIL-B phage display library technology. Conclusions We report herein a novel strategy to obtain antibody fragments of human origin that recognise tumour-associated ganglioside antigens. Our investigations have the power to detect privileged molecules in cancer progression, invasiveness, and metastases. The technical achievements of this study are being harnessed for early diagnostics and effective cancer therapeutics.

To report the clinical outcomes of second breast-conserving therapy with perioperative interstitial radiotherapy for the treatment of ipsilateral breast tumor recurrences.Between 1999 and 2015, 33 patients, presenting with an ipsilateral breast tumor recurrence after previous breast conserving therapy, were salvaged by re-excision and perioperative high-dose-rate interstitial brachytherapy. A median of 8 (range: 4-24) catheters were implanted into the tumor bed intraoperatively. A total dose of 22 Gy in 5 fractions of 4.4 Gy was delivered to the tumor bed with a margin of 1-2 cm, on 3 consecutive days. The adjuvant systemic treatments consisted of hormonal therapy for 24 patients (73%) and chemotherapy for 6 patients (18%). The survival results were estimated by the Kaplan-Meier method. Late side effects and cosmetic results were also registered.The median follow-up time following the second breast conserving therapy was 61 months (range: 26-189 months). During the follow-up, 4 patients (12.1%) developed second local recurrence. The five-year actuarial rates of the second local, regional and distant recurrence were 6.3%, 6.1%, and 14.9%, respectively. The five-year probabilities of disease-free, cancer-specific and overall survival were 76.2%, 92.4%, and 89.2%, respectively. Four (12%), 19 (58%), 4 (12%) and 6 (18%) patients had excellent, good, fair and poor cosmetic results, respectively. Grade 2 and 3 fibrosis developed in 9 (27%) and 1 (3%) patients. Asymptomatic fat necrosis was detected in 7 (21%) women.Second breast conserving therapy with perioperative high-dose-rate interstitial brachytherapy is a safe and feasible option for the management of ipsilateral breast tumor recurrences. Interstitial brachytherapy may decrease the risk of second local relapse with acceptable cosmetic results and low rate of late side effects. Hence, in selected cases it can provide a feasible alternative to salvage mastectomy. Orv Hetil. 2018; 159(11): 430-438.

BACKGROUND/AIM Despite well-organized Hungarian invitational mammography screening, participation rates have never reached 50%. This is similar to rates in Central Eastern Europe. In order to reduce breast cancer mortality, the participation rate should be at least 70%. This questionnaire-based study assessed the barriers associated with low adherence rates. MATERIALS AND METHODS Women 45-65 years of age were interviewed by questionnaire containing 15 structured questions focused on socioeconomic status and barriers to screening. RESULTS A total of 3,313 women completed the questionnaire. The main reasons for avoiding screening were work absenteeism (18.9%), fear of painful examination (18.39%), and poor understanding of mammography screening (14.94%). CONCLUSION Education is required to increase awareness among women about the utility and availability of breast screening services. This report provides information on the appropriate level of intervention needed to increase screening participation in Hungary and other developing countries in Central Eastern Europe to reduce breast cancer-related mortality.

Background According to European guidelines, breast cancer patients requiring mastectomy should be informed about available options regarding breast reconstruction. There are clear differences in the quality standards of oncoplastic care throughout Europe, with slight improvements in Central European countries like Hungary. The aim of the present investigation was to evaluate patients’ knowledge and demand for postmastectomy breast reconstruction, as well as their psychosocial background regarding decision-making. Material/Methods A questionnaire containing 15 structured questions was given to 500 breast cancer patients on the day before undergoing mastectomy. The questions focused on the emotional impact of the malignant disease and the loss of a breast; the importance of environmental conditions; the desire for breast reconstruction; and patients’ knowledge and sources of information about the procedure. All answers were statistically analyzed in the context of patient age, marital status, educational level, and place of residence. Results Descriptive statistical results of the answers to all questions, as well as associations of the different aspects of the decision-making process, are presented. Conclusions Hungarian breast cancer patients have very limited knowledge regarding breast reconstruction. We confirmed that patients scheduled for mastectomy have a great degree of anxiety due to their disease and breast loss. Almost 50% of the responders declared their desire for postmastectomy breast reconstruction. Patient’s age, residence, educational level, marital status, and profession were confirmed as predictive factors in the decision-making process for breast reconstruction.

Immediate breast reconstruction provides oncological safety, requires longer operation time. It does not influence the initiation of adjuvant therapy and radiological control, and results in favourable cosmetic outcome.Assessing the Hungarian data of immediate postmastectomy breast reconstructions, and comparing them to international findings.Between May, 2011 and September, 2014 121 therapeutic and prophylactic, postmastectomy immediate breast reconstructions were performed in 100 patients. The clinico-pathological findings were assessed retrospectively, and surgical, oncological and cosmetic outcomes were evaluated statistically.The mean age of patients was 42.6 years, the follow up time was 29.4 months, and the duration of operation was 132 minutes. Skin-sparing mastectomy was performed most commonly (64%) with submuscular tissue expander placement (70%). Early postoperative complication was identified in 18 patients, and loco-regional recurrence in 1 patient. Most patients (89%) were satisfied with the cosmetic outcome. The average initiation time of adjuvant therapy was 4.8 weeks.Immediate breast reconstruction is a safe and effective option in line with international findings. Orv. Hetil., 2016, 157(46), 1830-1838.

The European Society of Breast Cancer Specialists has created quality indicators for breast units to establish minimum standards and to ensure specialist multimodality care with the conscious aim of improving outcomes and decreasing breast cancer mortality.The aim of this study was to analyse the breast cancer care in the National Institute of Oncology according to the European Society of Breast Cancer Specialists requirements and in a large number of cases in order to present representative clinico-pathological data on the incidence of breast cancer in Hungary.According to the European Society of Breast Cancer Specialists uniformed criteria clinico-pathological data of multimodality treated breast cancer cases were retrospectively analysed between June 1, 2011 and May 31, 2012.During the period of interest 906 patients underwent breast surgery for malignant or benign lesions. According to the European Society of Breast Cancer Specialists quality indicators the breast cancer care of the National Institute of Oncology is eligible.The diagnostic modalities and multimodality care of breast cancer of the National Institute of Oncology breast unit meets the critical mass and minimum standards of the European Society of Breast Cancer Specialists criteria. Orv. Hetil., 2016, 157(42), 1674-1682.

Breast-conserving surgery (BCS) is considered the standard treatment for early-stage breast cancer. However, fair to poor cosmetic outcomes following conventional BCS have been observed in as many as one-third of cases. The aim of this study was to determine the critical tumor-to-breast volume ratio for each quadrant of the breast beyond which conventional BCS would no longer offer acceptable cosmetic and functional results or satisfactory quality of life for the patient.A prospective cohort study was performed between December 2011 and December 2013 involving 350 patients younger than 70 years with early-stage unifocal (T ≤ 30 mm) breast cancer who underwent wide excision and axillary sentinel lymph node biopsy followed by whole-breast irradiation. Using validated panels and software (the Breast Cancer Treatment Outcome Scale [BCTOS], EORTC Cancer Quality of Life Questionnaire number C30-BR23, and Breast Cancer Conservative Treatment - cosmetic results [BCCT.core] software), quality of life and aesthetic and functional parameters and their changes in correlation to the percentage of breast volume excised were statistically analyzed.The maximum percentages of breast volume that were resectable by conventional BCS without resulting in unacceptable aesthetic and functional outcomes or decreased quality of life were 18-19% in the upper-outer quadrant (p 0.0001), 14-15% in the lower-outer quadrant (p 0.0001), 8-9% in the upper-inner quadrant (p 0.0001), and 9-10% in the lower-inner quadrant (p 0.0001).Aided by the calculated cut-off values for each breast quadrant, breast surgeons might render more objective decisions regarding performing conventional BCS, using oncoplastic techniques or choosing mastectomy with immediate reconstruction.

Background Revealing novel cancer targeting biomarkers is a great challenge, and especially urging in cancer types with a more pronounced metastatic feature. We focus on potential anti-tumor immune reactions of the host. In order to harness the natural humoral immune response a novel immunological and molecular genetic panel assay has been developed for the investigation of patients with melanomas.