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Introduction Patients’ satisfaction after breast reconstruction can be evaluated with validated questionnaires as the Breast-Q questionnaire. The Breast-Q questionnaire includes different domains; one of them is “satisfaction with the result”. Material and methods: In the multicentre, prospective studies PRO (patient related outcome)-BRA (clinicaltrials.gov: NCT01885572) and PRO-Pocket (clinicaltrials.gov: NCT03868514), patient satisfaction was assessed using the Breast-Q questionnaire. In the PRO-Bra study, 269 patients underwent subpectoral surgery using the TiLOOP® Bra polypropylene mesh (pfm medical ag, Germany). In the "PRO-Pocket" study, 311 patients underwent prepectoral surgery using the TiLOOP® Bra Pocket polypropylene mesh. For the evaluation, those patients from the PRO-Bra and PRO-Pocket studies who completed a Breast-Q questionnaire 6 and/or 12 months after surgery were included. The BreastQ score is measured from 0 to 100, with a score of 100 corresponding to "very satisfied". Satisfaction with the result of the breast reconstruction was evaluated. Results: In the PRO-Bra study, a total of 221 and 203 patients completed a Breast-Q at 6 months and/or 12 months FU, respectively. The mean age and BMI of the patients with completed Breast-Q were comparable between the two studies (PRO-Bra: 49.3 [±11.6] years, 22.9 kg/m2 [±3.5]; PRO-Pocket: 47.7 [±11.7] years, 24.5 kg/m2 [±4.3]). In the PRO-Pocket study, a total of 258 and 266 patients completed a Breast-Q at 6 months and/or 12 months FU, respectively. In the PRO-Bra study the mean score of satisfaction with the result at 6 months follow-up (FU) was 74.5 (±19.9), in the PRO-Pocket 79.1 (±19.1), at 12 months FU the mean scores were 76.3 (±18.9) for PRO-Bra and 78.2 (±20.4) for PRO-Pocket. Furthermore, stratification according to age (cutoff 50 years) or BMI (cutoff 25 kg/m2) did not reveal any differences between the subgroups or the two studies (see Table). PRO-Bra PRO-Pocket mean score (±SD) 6 months 12 months 6 months 12 months BMI ≤ 25 75.1 (±19.7) 76.4 (±17.8) 77.7 (±19.9) 78.9 (±19.8) BMI > 25 72.1 (±20.7) 76.1 (±22.9) 82.1 (±16.9) 76.8 (±21.8) age ≤ 50 76.4 (±18.7) 77.0 (±18.9) 80.1 (±18.7) 78.1 (±19.6) age > 50 71.5 (±21.5) 75.3 (±19.0) 77.5 (±19.5) 78.4 (±21.8) Conclusion: Our data so far show high patient satisfaction with overall outcome of the surgery. In addition, patients’ satisfaction with the result was comparable after subpectoral as well as prepectoral implant placement. This is particularly important in the PRO-Pocket study, as approximately 60% of the operations and the follow-up period took place during the COVID-19 pandemic. Citation Format: Stefan Paepke, Anne Andrulat, Christine Ankel, Lelia Bauer, Kristin Baumann, Jens-Uwe Blohmer, Andree Faridi, Visnja Fink, Claudia Gerber-Schaefer, Daphne Gschwantler-Kaulich, Jörg Heil, Sherko Kuemmel, Anette Kossmann-Meiré, Ralf Ohlinger, Marc Thill. Satisfaction of patients after implant-based subpectoral reconstruction with a titanized polypropylene mesh (TiLOOP® Bra) compared to prepectoral reconstruction with a titanzied polypropylene pocket (TiLOOP® Bra Pocket) [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 P4-07-13.

BackgroundBreast cancer is a common and increasingly treatable disease. However, survivors have a significantly elevated risk of cardiac events afterwards. This study aimed to characterise cardiac changes during cardiotoxic cancer therapy using cardiovascular magnetic resonance (CMR) imaging.MethodsThis study involved 34 patients with histologically proven breast cancer and planned cardiotoxic therapy. All patients underwent CMR before starting therapy, and 6 and 12 months thereafter. The CMR protocol included volumetric and functional analyses, parametric mapping, and deformation analysis using feature tracking. As the control group, 10 healthy female volunteers were scanned using the same protocol.ResultsWith therapy, there was a significant reduction of left ventricular and right ventricular ejection fractions (both p < 0.05). Left ventricular radial (p = 0.008), circumferential (p = 0.010), and longitudinal strain (p = 0.036) were also reduced at follow-up. In the parametric mapping, there was a significant increase in native T1 time (1037 ± 41 ms vs. 1068 ± 51 ms vs. 1017 ± 57 ms, p < .001) and T2 time (55 ± 4 ms vs. 59 ± 3 ms vs. 57 ± 3 ms, p = 0.001), with unchanged extracellular volume and relative late gadolinium enhancement. Twelve months after cancer diagnosis, the breast cancer patients exhibited significant impairments in left ventricular global radial (p = 0.001), circumferential (p = 0.001), and longitudinal strain (p = 0.002) and T2 time (p = 0.008) compared to the healthy controls.DiscussionBreast cancer patients receiving cardiotoxic chemotherapy show persistent deterioration in left ventricular strain values. This is accompanied by inflammatory changes in non-invasive tissue characterisation. Larger studies with longer follow-up periods are needed to identify patients at risk and establish preventive and therapeutic approaches.

As the available information about breast cancer is growing every day, the decision-making process for the therapy is getting more complex. ChatGPT as a transformer-based language model possesses the ability to write scientific articles and pass medical exams. But is it able to support the multidisciplinary tumor board (MDT) in the planning of the therapy of patients with breast cancer? We performed a pilot study on 10 consecutive cases of breast cancer patients discussed in MDT at our department in January 2023. Included were patients with a primary diagnosis of early breast cancer. The recommendation of MDT was compared with the recommendation of the ChatGPT for particular patients and the clinical score of the agreement was calculated. Results showed that ChatGPT provided mostly general answers regarding chemotherapy, breast surgery, radiation therapy, chemotherapy, and antibody therapy. It was able to identify risk factors for hereditary breast cancer and point out the elderly patient indicated for chemotherapy to evaluate the cost/benefit effect. ChatGPT wrongly identified the patient with Her2 1+ and 2+ (FISH negative) as in need of therapy with trastuzumab and called endocrine therapy “hormonal treatment”. Support of artificial intelligence by finding individualized and personalized therapy for our patients is unavoidable in this time of rapidly expanding amount of information. ChatGPT has the potential to find its spot in clinical medicine, but the current version is not able to provide specific recommendations for the therapy of patients with primary breast cancer.

Silicone gel-filled implants exist in a wide range of shapes and textures, and yet there are relatively few long-term large-scale studies, particularly on recently developed "semi-smooth" implants. The present study fills this gap by presenting the 3-year findings from an ongoing 10-year multicenter prospective study on breast implants with four different surface types: smooth, semi-smooth, microtextured, and macrotextured. A total of 908 patients were recruited in 15 investigational sites across Europe and divided into three groups: 653 primary augmentations in Group 1, 144 revision augmentations in Group 2, and 111 reconstructions in Group 3. All 4 types of implant shells were manufactured by the same company using the same silicone material. Surgeons were free to choose their preferred technique and implant surface, but data were collected using a standardized software and included all complications, and satisfaction levels reported by the patients at each visit. The incidence of post-operative complications was estimated based on Kaplan-Meier risk rates, on a per patient basis. At 3 years post implantation, capsular contracture (Baker grade III/IV) was the most common complication, with a per-patient risk rate of 1.5% in Group 1. Interestingly, there was no capsular contracture in this group when semi-smooth implants were used. The risk of implant rupture in Group 1 was 0.2%. The preliminary findings of this 10-year prospective study indicate that, 3 years after the operation, the four types of silicone gel-filled implants investigated were safe, with a low complication rate in comparison with the most favorable results published in other similar studies.

Background: Predict Breast (www.predict.nhs.uk) is an online prognostication and treatment benefit tool for early invasive breast cancer. The aim of this study was to incorporate the prognostic effect of progesterone receptor (PR) status into a new version of PREDICT and to compare its performance to the current version (2.2).Method: The prognostic effect of PR status was based on the analysis of data from 45,088 European patients with breast cancer from 49 studies in the Breast Cancer Association Consortium. Cox proportional hazard models were used to estimate the hazard ratio for PR status. Data from a New Zealand study of 11,365 patients with early invasive breast cancer were used for external validation. Model calibration and discrimination were used to test the model performance.Results: Having a PR-positive tumour was associated with a 23% and 28% lower risk of dying from breast cancer for women with oestrogen receptor (ER)-negative and ER-positive breast cancer, respectively. The area under the ROC curve increased with the addition of PR status from 0.807 to 0.809 for patients with ER-negative tumours (p = 0.023) and from 0.898 to 0. 902 for patients with ER-positive tumours (p = 2.3 x 10(-6)) in the New Zealand cohort. Model calibration was modest with 940 observed deaths compared to 1151 predicted.Conclusion: The inclusion of the prognostic effect of PR status to PREDICT Breast has led to an improvement of model performance and more accurate absolute treatment benefit predic-tions for individual patients. Further studies should determine whether the baseline hazard function requires recalibration. (C) 2022 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

In der Gruppe der Mammakarzinome hat das triple-negative Mammakarzinom (TNBC, „triple-negative breast cancer“) das heterogenste Outcome und die schlechteste Prognose. Durch das Fehlen von Hormonrezeptoren und des HER2/neu(„human epidermal growth factor receptor 2“)-Rezeptor bestehen in der aktuellen klinischen Routine keine Zielstrukturen fur eine spezifische Therapie. Es erfolgte eine Literaturrecherche zur aktuellen Studienlage und vielversprechenden Therapieansatzen. In der kurativen Situation finden sich neue Ansatze in der Hinzunahme von Checkpointinhibitoren zusatzlich zur Standardchemotherapie. Ebenfalls gibt es mit Capecitabin analog der CREATE-X-Studie bei non-PCR eine postneoadjuvante Therapie. In der palliativen Situation findet man neben verschiedenen Chemotherapien einen Ansatz in der Testung von Tumorgewebe und der Keimbahn. Bei PD-L1(„programmed cell death 1 ligand 1“)-Positivitat kann auf den bereits zugelassenen Checkpointinhibitor Atezolizumab zuruckgegriffen werden. Bevacizumab ist auch bei manchen Patientinnen eine Option. Weitere mogliche Antikorpertherapien umfassen in Zukunft Pembrolizumab sowie die Antikorper-drug-Konjugate Sacituzumab-Govitecan und Trastuzumab-Deruxtecan. Bei einer Aktivierung des AKT/PI3K(Phosphoinositid-3-Kinase)-Signalwegs scheinen AKT-Inhibitoren wie Capivasertib oder Ipatasertib eine Option darzustellen. Bei BRCA-Positivitat stehen PARP(Poly[ADP-ribose]-Polymerasen)-Inhibitoren zur Verfugung. Trotz Fehlens der Hormonrezeptoren und des HER2/neu-Rezeptors bestehen mittlerweile mit der PD-L1-Testung, der Keimbahnanalyse und auch der Testung auf eine Aktivierung des AKT/PI3K-Signalwegs weitere zielgerichtete Therapieoptionen fur das TNBC sowohl in der kurativen als auch in der palliativen Situation.

Das metastasierte Mammakarzinom gilt allgemein als nicht kurabel; dennoch hat die Lebenserwartung der betroffenen Patientinnen durch den Einsatz moderner Systemtherapien in den letzten Jahrzehnten zugenommen. Zum aktuellen Zeitpunkt stellt die primare operative Resektion des Brusttumors keine Standardtherapie dar, und ihr Effekt auf ein langeres Uberleben ist bislang nicht eindeutig geklart. In diesem Ubersichtsartikel werden Argumente pro und kontra eine primare Brustoperation beim metastasierten Mammakarzinom herausgearbeitet und validiert. Literaturrecherche retro- und prospektiver Studien in Bezug auf eine Operation bei Patientinnen mit Erstdiagnose eines Stadium-IV-Mammakarzinoms Viele retrospektive Studien legen fur Patientinnen mit metastasiertem Mammakarzinom einen Uberlebensvorteil durch die Operation des Primarius dar. Diese Untersuchungen weisen jedoch methodische Limitationen und Selektionsbias auf. Neuere prospektive Daten konnen den Uberlebensvorteil empirisch nicht bestatigen. Dennoch deuten Subgruppenanalysen auf einen Vorteil fur junge Patientinnen mit hormonrezeptorpositiver Tumorbiologie und Oligometastasierung in den Knochen hin. Ausgehend von der aktuellen Datenlage ist es nicht moglich, eine eindeutige Schlussfolgerung pro oder kontra Brustoperation in der metastasierten Erkrankungssituation zu treffen. Junge hormonrezeptorpositive Patientinnen mit Knochenmetastasen scheinen am meisten von der Resektion des Primartumors zu profitieren. Die Wertigkeit einer solchen Operation sollte allerdings immer interdisziplinar fur den Einzelfall gepruft werden.

This study examined 5-year overall, recurrence and distant metastasis-free survival (OS, RFS, MFS) of high- and intermediate-risk breast cancer (BC) patients who declined guideline-recommended adjuvant chemotherapy (CHT).In the prospective multicenter cohort study BRENDA II, patients with primary BC were sampled over a period of four years (2009-2012). A multi-professional team (tumorboard) discussed recommendation for adjuvant CHT according to the German guideline. Potential differences in 5 year survival were analyzed using Kaplan-Meier curves and Cox regression. The hazard ratios (HR) were adjusted for age, Charlson Comorbidity Score, American Society of Anesthesiologist (ASA) physical status classification, and endocrine therapy.A total of 759 patients were enrolled of which 688 could receive CHT according to the guidelines (n = 219 had a clear indication, in n = 304 it was possible). For 360 patients, the tumorboard advised to perform CHT, for 304 it advised against and in 24 cases, no decision was documented. Of those with a positive suggestion, 83% received CHT. Until 5 years after diagnosis, 57 patients were deceased, 41 had at least one distant metastasis and 29 a recurrence. There was no evidence for differences in OS and MFS in patients who declined CHT despite tumorboard recommendation (HR 3.5, 95% CI 0.8-15.1 for OS, HR 1.9, 95% 0.6-6.6 for MFS). Patients who received CHT had significantly better 5-year RFS compared to those who declined (HR 0.3, 95% CI 0.1-0.9, p = 0.03). There was no evidence for different survival in those who had no CHT because of comorbidity and those who declined actively, neither for OS, MFS nor RFS.The prospective BRENDA II study demonstrates benefit in RFS by guideline adherence in adjuvant breast cancer treatment, indicating prospectively the value of internationally validated guidelines in breast cancer care.

Die Komplexitat und Vielfalt an plastisch-operativen und rekonstruktiven Eingriffsmoglichkeiten an der Mamma erfordert eine operative Spezialisierung des chirurgisch tatigen Gynakologen auf diesem Gebiet. Eine gute und facherubergreifende Zusammenarbeit mit der plastischen Chirurgie ist zwingende Voraussetzung, um den Wunschen und Bedurfnissen der Patientinnen gerecht werden zu konnen. Ein Schwerpunkt der operativen Therapiemoglichkeiten liegt heute in der onkoplastischen Mammachirurgie, die neben der onkologisch sicheren In-sano-Resektion des Karzinoms eine asthetisch fur die Patientin zufriedenstellende Wiederherstellung der Brust zum Ziel hat. Von verschiedenen brusterhaltenden Ansatzen kommen hier u. a. Verfahren mit auto- und heterologen Rekonstruktionsmoglichkeiten nach Mastektomie zum Einsatz. In diesem Zusammenhang ist auch die prophylaktische Mastektomie bei Hochrisikopatientinnen (BRCA-Mutationstragerinnen) zu nennen. Weitere Indikationen fur plastisch-operative Eingriffe sind angeborene oder erworbene Fehlbildungen, z. B. Aplasie/Hypoplasie, eine tubulare Brust oder eine deutliche Makromastie mit entsprechenden korperlichen Beschwerden. Besonders bei rekonstruktiven und plastisch-asthetischen Operationen muss vorher umfassend uber den Eingriff, mogliche Komplikationen und Alternativen aufgeklart werden.

Background: Further progress in the treatment of breast cancer will likely come from contributions of molecular biology and immunologic approaches. The search for druggable molecular aberrations may enable treatment based on the molecular profile. A better identification of patients with a high risk of relapse facilitates the selection of these pts for clinical trials investigating early therapeutic molecular-based interventions. Trial Design: The BRandO BiO Registry is a multi-center regional registry to record clinical, epidemiological, and biological data from patients with newly diagnosed breast and ovarian cancer at the University of Ulm, Dept. of Gynecology and 19 affiliated network hospitals and practices in the Alb-Allgäu Bodensee region (outreach area of the Comprehensive Cancer Center Ulm). Longitudinal biobanking is included with collection of paraffin-embedded samples of the primary tumor as well as blood samples at first diagnosis, after 6 and 12 months and at first relapse to isolate and investigate cell-free and germline DNA. Epidemiological, life style and quality of life (QOL) questionnaires are collected at first diagnosis, after 12, 36 and 60 months. The follow up is planned for 10 years. Eligibility criteria: Patients with primary newly diagnosed untreated breast or ovarian cancer of ≥ 18 years are eligible; primary metastatic untreated disease is allowed. Exclusion criteria comprise severe neurological or psychiatric disorders interfering with the ability to give an informed consent, no consent for registration, storage and processing of the individual disease characteristics and bio samples, and any malignant tumor in the last 3 years (except in situ disease). Specific aims: To register the majority of patients with newly diagnosed breast or ovarian cancer in all BRandO-BiO participating centers of a well-defined geographical area. To assess clinical characteristics and outcome data (event-free survival, overall survival) of these patients. To evaluate the primary tumor of all patients for mutational (druggable) aberrations. Further to assess cell-free DNA in the serial blood samples at baseline, 6 and 12 months and correlate these results with clinical outcome data as well as tumor and patient characteristics to look for early markers predicting relapse. To perform a longitudinal assessment of the patients' sociodemographic factors, comorbidities, lifestyle and QOL factors by analyzing serial questionnaires collected at recruitment and at 12, 36 and 60 months. Present accrual and target accrual: The BRandO BiO Registry started January 2016 in the Dept. of Gynecology, University of Ulm and February 2017 at the network hospitals and practices. Until June 2018, 1180 patients with primary breast or ovarian cancer have been enrolled. The current adherence to serial blood testing and serial questionnaires is good with a return rate of 90%. A sample size of 3000 patients is planned. Contact information: Jens Huober, University of Ulm, Dept of Gynecology, Breast Center, jens.huober@uniklinik-ulm.de Amelie de Gregorio, University of Ulm, Dept of Gynecology, Breast Center, Amelie.de Gregorio@uniklinik-ulm.de Citation Format: Huober J, Nagel G, Rempen A, Schlicht E, Flock F, Fritz S, Thiel F, Wiesmüller L, Felderbaum R, Heilmann V, Bekes I, Fink V, Albrecht S, De Gregorio N, Tzschaschel M, Ernst K, Wolf C, Kuhn P, Friedl T, Janni W, De Gregorio A. The BRandO BiO registry – A multicenter regional registry for patients with primary breast and ovarian cancer with longitudinal biobanking and evaluation of epidemiological, life style and quality of life factors [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT1-11-01.

Objective In this study, we investigated to which extent patients feel well informed about their disease and treatment, which areas they wish more or less information and which variables are associated with a need for information about the disease, medical tests and treatment. Methods In a German multi-centre prospective study, we enrolled 759 female breast cancer patients at the time of cancer diagnosis (baseline). Data on information were captured at 5 years after diagnosis with the European Organisation for Research and Treatment of Cancer (EORTC) Information Module (EORTC QLQ-INFO24). Good information predictors were analysed using linear regression models. Results There were 456 patients who participated at the 5-year follow-up. They reported to feel well informed about medical tests (mean score 78.5) and the disease itself (69.3) but relatively poorly about other services (44.3) and about different places of care (31.3). The survivors expressed a need for more information concerning: side effects and long-term consequences of therapy, more information in general, information about aftercare, prognosis, complementary medicine, disease and therapy. Patients with higher incomes were better informed about medical tests (β 0.26, p 0.04) and worse informed with increasing levels of fear of treatment (β − 0.11, p 0.02). Information about treatment was reported to be worse by survivors > 70 years old (β -0.34, p 0.03) and by immigrants (β -0.11, p 0.02). Survivors who had received additional written information felt better informed about disease, medical tests, treatment and other services (β 0.19/0.19/0.20/0.25; each p Conclusion Health care providers have to reconsider how and what kind of information they provide. Providing written information, in addition to oral information, may improve meeting those information needs.

Hematologic toxicities are one of the greatest challenges in adjuvant chemotherapy for breast cancer. This analysis of the ADEBAR trial aims to evaluate application and effect of granulocyte colony-stimulating factor (G-CSF) and epoetin alfa (EPO) on hematologic parameters and fatigue in patients with breast cancer during chemotherapy.In the ADEBAR trial, 1493 patients with node-positive primary breast cancer were randomized to either 6 × 5-fluorouracil, epirubicin, and cyclophosphamide (FEC120) or 4 × epirubicin and cyclophosphamide followed by 4 × docetaxel (EC-DOC). Co-medication with G-CSF or EPO was applied to treat chemotherapy-induced leukopenia or anemia. Fatigue was assessed at baseline and after one-half of the chemotherapy.In total, 899 patients could be included in the analysis. There was no evidence for an association between leucocyte or hemoglobin levels and application of G-CSF and EPO in the preceding cycle, respectively. Hemoglobin levels (B = -0.41; P .001) were affected by treatment regimen. Fatigue during chemotherapy was mostly affected by the level of fatigue before the start of chemotherapy (B = 0.41; P .001). Patients with G-CSF application in the preceding cycle showed an increased fatigue score (B = 5.43; P = .02).We showed that fatigue during adjuvant chemotherapy was mostly affected by the level of fatigue present before the start of chemotherapy. This result suggests that the level of fatigue before the start of treatment should be included as an important factor when deciding on type and toxicity of chemotherapy in early breast cancer.

Bei Diagnose eines Mammakarzinoms gibt es mehrere klinische Befunde, neben der Stanzbiopsie und der Immunhistochemie, die erhoben werden sollten. Am Anfang der diagnostischen Kette steht die Inspektion und Palpation der Brust.

Background: A recent meta-analysis has reported benefits of adjuvant bisphosphonate treatment in early breast cancer patients with improved breast cancer survival and reduced rate of breast cancer recurrences in the bone, especially in postmenopausal patients. However, a comparison between bisphosphonate treatments duration is lacking. Therefore, we examined 2 and 5 years of zoledronate treatment following adjuvant chemotherapy in the SUCCESS A trial. Methods: The SUCCESS A trial is a randomized, open-label, 2x2 factorial design Phase III study in high-risk early breast cancer patients that were randomized to adjuvant chemotherapy treatment with 3 cycles of FEC followed by either 3 cycles of docetaxel or 3 cycles of gemcitabine-docetaxel. After chemotherapy, patients were subject to a second randomization of 5 years of zoledronate treatment (4 mg i.v. every 3 months for 2 years, followed by 4 mg i.v. every 6 months for 3 years) vs. 2 years of zoledronate treatment (4 mg i.v. every 3 months for 2 years). Outcome was analyzed using adapted disease-free survival (DFS) and adapted overall survival (OS), with survival times measured as of 2 years after the start of zoledronate treatment. Maximal observation time was set to 4 years. Median observation time was 2.95 years for DFS and 3 years for OS. Results: Overall, 3421 of the 3754 patients randomized in the SUCCESS A study received at least one zoledronate dose. 434 patients had a DFS event or were lost to follow up in the first two years after the start of zoledronate treatment; thus, 2987 patients were available for analysis (1540 and 1447 patients in the 5-year and 2-year zoledronate treatment arm, respectively). Both adapted DFS and adapted OS did not differ between the two treatment arms (5 vs. 2 years) as shown by multivariate cox regressions adjusted for patient and tumor characteristics as well as chemotherapy (DFS: hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.75 – 1.25, p = 0.81; OS: HR 0.98, 95% CI 0.67 – 1.42, p = 0.90). In addition, subgroup analyses according to menopausal status revealed no difference in DFS or OS between the two treatment arms in premenopausal women (DFS: HR 1.21, 95% CI 0.81 – 1.81, p = 0.35; OS: HR 0.93, 95% CI 0.57 – 1.53, p = 0.78) or postmenopausal women (DFS: HR 0.85, 95% CI 0.62 – 1.16, p = 0.30; OS: HR 0.96, 95% CI 0.67 – 1.39, p = 0.84). Conclusions: Our study showed no difference in DFS or OS between 5-years and 2-years of adjuvant zoledronate treatment in early breast cancer patients, irrespectively of menopausal status. Thus, our results indicate that extended treatment with zoledronate does not improve DFS or OS in high-risk early breast cancer patients. Citation Format: Janni W, Friedl TWP, Fehm T, Müller V, Lichtenegger W, Blohmer J, Lorenz R, Forstbauer H, Bauer E, Fink V, Bekes I, Jückstock J, Schneeweiss A, Tesch H, Mahner S, Brucker SY, Heinrich G, Beckmann MW, Coleman R, Rack B. Extended adjuvant bisphosphonate treatment over five years in early breast cancer does not improve disease-free and overall survival compared to two years of treatment: Phase III data from the SUCCESS A study [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr GS1-06.

Importance Bisphosphonate treatment in patients with early breast cancer has become part of care, but the optimal treatment duration is still unclear. Objective To compare 2 vs 5 years of zoledronate treatment following adjuvant chemotherapy in patients with early breast cancer. Design, Setting, and Participants The SUCCESS A phase 3 multicenter randomized open-label clinical trial with a 2 × 2 factorial design enrolled 3754 patients from September 21, 2005, to March 12, 2007 (last patient out, May 7, 2014). Final data analysis was conducted from September 2019 to October 2020. In 250 German study centers, patients were eligible for participation in the SUCCESS A trial if they had either node-positive or high-risk node-negative (defined as at least 1 of the following: tumor size ≥ pT2, histologic grade 3, negative hormone receptor status, or age ≤35 years) primary invasive breast cancer. Interventions Patients were first randomized to adjuvant chemotherapy with 3 cycles of fluorouracil, epirubicin, and cyclophosphamide followed by 3 cycles of docetaxel with or without gemcitabine (not presented in this report). After chemotherapy, patients underwent a second randomization of 5 years of zoledronate treatment (4 mg intravenously every 3 months for 2 years, followed by 4 mg intravenously every 6 months for 3 years) vs 2 years of zoledronate treatment (4 mg intravenously every 3 months for 2 years). Main Outcomes and Measures The primary end point of the study was disease-free survival; secondary end points were overall survival, distant disease-free survival, and the incidence of skeletal-related adverse events. Survival times were measured from 2 years after the start of zoledronate treatment (landmark analysis). Results Overall, data on 2987 patients were available for analysis; median age was 53 (range, 21-86) years. Disease-free survival, overall survival, and distant disease-free survival did not differ significantly between the 2 treatment arms (5 vs 2 years) as shown by adjusted multivariable Cox proportional hazards regression models (disease-free survival: hazard ratio [HR], 0.97; 95% CI, 0.75-1.25;P = .81; overall survival: HR, 0.98; 95% CI, 0.67-1.42;P = .90; distant disease-free survival: HR, 0.87; 95% CI, 0.65-1.18;P = .38). Adverse events were observed more often in the 5-year (46.2%) vs 2-year (27.2%) zoledronate treatment arm, which was particularly true for the skeletal-related events bone pain (5 years, 8.3% vs 2 years, 3.7%) and arthralgia (5 years, 5.1% vs 2 years, 3.1%). Conclusions and Relevance The results of this phase 3 randomized clinical trial indicate that extending the zoledronate treatment beyond 2 years does not improve the prognosis of high-risk patients with early breast cancer receiving chemotherapy, suggesting that the currently recommended bisphosphonate treatment duration of 3 to 5 years could be reduced. Trial Registration ClinicalTrials.gov Identifier:NCT02181101

Elderly breast cancer patients are affected by poorer quality of life (QoL) compared to younger patients. Because QoL has a relevant impact on guideline-adherent treatment, elderly breast cancer patients are often undertreated, especially with regard to adjuvant chemotherapy, and overall survival is decreased. Thus, understanding the impact of chemotherapy on QoL in elderly patients is crucial. This study compared QoL in patients aged 65 years and 65 to 70 years receiving adjuvant chemotherapy as a secondary outcome in the prospective randomized multicenter ADEBAR trial.Patients with lymph node-positive breast cancer were prospectively randomized for either sequential anthracycline-taxane or epirubicin/fluorouracil/cyclophosphamid chemotherapy (FEC) therapy. QoL was assessed at baseline (t1), before cycle 4 FEC, and cycle 5 epirubicin/cyclophosphamid-docetaxel (EC-DOC) (t2), 4 weeks after chemotherapy (t3), and 6 weeks after radiation (t4) using the European Organization for Research and Treatment for Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and the Breast Cancer-Specific Module (QLQ-BR23). We compared patients aged 65 years and 65 to 70 years with respect to QoL and discontinuation of chemotherapy.A total of 1363 patients were enrolled onto the ADEBAR trial, with 16.7% of the patients aged 65 to 70 years. In elderly patients, Eastern Cooperative Oncology Group performance status was higher and global health status and physical functioning were lower at baseline. Global health status decreased between t1 and t3 by 7 points in patients 65 years and by 11 points in patients 65 to 70 years, and physical functioning decreased in the same period by 13.4 points in patients aged 65 years and by 15.9 points in patients 65 to 70 years. In both groups, at t4 global health status exceeded baseline by 6 points, and physical functioning was 1.3 points under baseline in patients 65 years old and 3 points under baseline in patients 65 to 70 years. There was a trend to more fatigue in elderly patients and to more nausea and vomiting while receiving chemotherapy in younger patients at t3. There was a higher dropout rate in patients aged 65 to 70 years (25.7%) than in patients aged 65 years (16.2%).There were only small or trivial differences in QoL in patients aged 65 years versus 65 to 70 years who were receiving adjuvant chemotherapy, although the dropout rate from chemotherapy was notably higher in elderly breast cancer patients.

OBJECTIVE: To study how genetics may play a role in determining risk of chemotherapy-related amenorrhea (CRA) in young women with breast cancer. DESIGN: A genome-wide association study SETTING: A pooled cohort including participants in three clinical trials (SUCCESS A, B or C) testing chemotherapy for early stage breast cancer PATIENTS: Premenopausal women ≤45 years enrolled in one of these three trials were included if they had at least one menstrual case report form after chemotherapy ended, and if they were of European ancestry. Forms during and up to three months after receipt of gonadotropin-releasing hormone agonist were excluded. INTERVENTION(S): None MAIN OUTCOMES MEASURE(S): The association of single nucleotide polymorphisms (SNPs) with post-chemotherapy menstruation adjusted for trial/arm, age, tamoxifen use, and nodal status. RESULTS: The median age of the 1168 women was 41 years (range 19–45). Among these, 457 (39%) never resumed menses after chemotherapy. Older age, tamoxifen use, and node-negative disease were associated with increased risk of CRA. Adjusting for these, rs147451859, in an intron of PPCDC (phosphopantothenoylcysteine decarboxylase), and rs17587029, located 5’upstream of RPS20P11 (ribosomal protein S20 pseudogene 11), were associated with post-chemotherapy menstruation (relative risk, RR 1.74, 95% CI 1.43 − 2.12, p= 6.38 × 10(−9), and RR 1.84, 95% CI 1.48 – 2.28, p=2.4×10(−8), respectively). CONCLUSION: Genetic variation may contribute to risk of CRA. Better prediction of who will experience CRA may inform reproductive and treatment decision-making in young women with cancer.

BackgroundIn this study based on the BRENDA data, we investigated the impact of endocrine ± chemotherapy for luminal A, nodal positive breast cancer on recurrence free (RFS) and overall survival (OS). In addition, we analysed if tumor size of luminal A breast cancer influences survival in patients with the same number of positive lymph nodes.MethodsIn this retrospective multi-centre cohort study data of 1376 nodal-positive patients with primary diagnosis of luminal A breast cancer during 2001-2008 were analysed. The results were stratified by therapy and adjusted by age, tumor size and number of affected lymph nodes.ResultsIn our study population, patients had a good to excellent prognosis (5-year RFS: 91% and tumorspecific 5-year OS 96.5%). There was no significant difference in RFS stratified by patients with only endocrine therapy and with endocrine plus chemo-therapy. Patients with 1-3 affected lymph nodes had no significant differences in OS treated only with endocrine therapy or with endocrine plus chemotherapy, independent of tumor size. Patients with large tumors and more than 3 affected lymph nodes had a significant worse survival as compared to the small tumors. However, despite the worse prognosis of those, adjuvant chemotherapy failed in order to improve RFS.ConclusionsAccording to our data, nodal positive patients with luminal A breast cancer have, if any, a limited benefit of adjuvant chemotherapy. Tumor size and nodal status seem to be of prognostic value in terms of survival, however both tumor size as well as nodal status were not predictive for a benefit of adjuvant chemotherapy.

In high-risk early breast cancer, adjuvant taxane-Gemcitabine combinations result in a recurrence-free survival similar to single-agent taxanes. However, haematologic toxicities and need for dose reductions are more frequent in combinations. Which option ultimately provides a better quality of life (QoL) is unknown. We compared the QoL curves before, during, and up to one year after three cycles of Fluorouracil–epirubicin–cyclophosphamide followed by three cycles of Docetaxel–Gemcitabine or Docetaxel. Overall, 3691 women with recent R0-resection of a primary epithelial breast cancer participated in the nationwide SUCCESS A clinical trial. The centres sent QoL questionnaires of the European Organisation for Research and Treatment of Cancer before and up to 15 months after randomisation to Docetaxel–Gemcitabine versus Docetaxel. Multilevel analysis by chemotherapy arm estimated the QoL time curves, questionnaire return, and dropout. The combination caused one-point higher global QoL (95% confidence ±1; p = 0.05) and 1.1 lower odds of adherence to the outcome (95% confidence 1.0–1.1; p = 0.23) than the monotherapy. In both groups, a 10-point decrease during therapy preceded a 16-point increase after chemotherapy (p

Tumorbefallene Resektionsrander beim Mammakarzinom und beim duktalen Carcinoma in situ (DCIS) haben einen negativen Effekt auf die Prognose und gehen nachweislich mit einem erhohten Lokalrezidivrisiko einher, sodass tumorfreie Resektionsrander eingefordert werden mussen. Ein mikroskopisch freier Schnittrand bei invasiven Karzinomen – „no cells on ink“ – auch mit begleitendem DCIS wird inzwischen als ausreichend angesehen. Dies gilt fur alle Tumortypen und ist unabhangig vom Alter der Patientin. Die Voraussetzung stellt eine leitliniengerechte adjuvante Strahlen- und Systemtherapie dar. Dieses Vorgehen wird in den amerikanischen Leitlinien sowie von der Arbeitsgemeinschaft Gynakologische Onkologie (AGO) bereits empfohlen, ist in der aktuell gultigen deutschen S3-Leitlinie von 2012 jedoch noch nicht verankert. Beim reinen DCIS sollte aktuell noch ein tumorfreier Schnittrand von 2 mm erreicht werden, wenn nach brusterhaltender Operation nachbestrahlt wird.

One of the most common complications in breast conserving surgery is seroma formation. The origin of seroma formation remains unclear. While intraoperative radiotherapy (IORT) has been shown to be an alternative to whole breast irradiation, the influence on seroma production is unclear. Therefore, this analysis compares seroma production in patients with breast conserving surgery with or without IORT as tumour bed boost during breast conserving surgery. A retrospective analysis of seroma production in patients with nodal-negative (pN0sn) pT1/2 primary breast cancer treated between September 2010 and October 2013 at the Breast Cancer Centre, University Hospital Ulm was performed. Patients with neoadjuvant chemotherapy, previous breast/axillary surgery or more than one intervention were excluded. IORT was applied as a tumour bed boost with 50-kV X-rays (Intra beam®) delivering 9 Gy at the applicator surface. Seroma formation was measured using wound drains placed in breast and in axilla. Data of 152 patients (99 −IORT; 53 +IORT) were available for analysis. No significant differences between patients with or without IORT with regard to seroma production and number of days until drain removal were found (all p > 0.05). Patients with IORT encountered no increased seroma production and removal of the drains was not delayed compared to patients with breast conserving surgery only. Our results indicate that IORT does not increase the seroma production compared to surgery alone.

Background: The grade of recommendation for adjuvant dose-dense chemotherapy in patients with high risk primary breast cancer is heterogeneous among international guidelines. Understanding the impact on quality of life (QOL) by adjuvant dose dense chemotherapy in comparison to standard adjuvant chemotherapy is thereby a crucial factor, especially if the benefit is potentially low. This study aims to assess the impact on QOL by adjuvant dose dense chemotherapy in the prospective randomized multi-center ADEBAR trial. Methods: QOL was assessed at baseline (t1), before cycle 4 FEC (Epirubicin 60mg/m2 i.v. d 1 + 8, 5-Fluoruracil 500mg/m2 i.v. d 1 + 8, Cyclophosphamide 75mg/m2 p.o. d 1–14, q4w x 6) and cycle 5 EC-DOC (Epirubicin 90mg/m2 plus Cyclophosphamide 600mg/m2 q3w x 4, sequentially followed by Docetaxel 100mg/m2 q3w x 4) (t2), 4 weeks after chemotherapy (t3), 6 weeks after radiation (t4) and 1 year after baseline (t5) using the European Organization for Research and Treatment for Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and the Breast Cancer-Specific Module (QLQ-BR23). A multivariate mixed model was fitted to test for differences between the two treatment arms. Primary endpoint was global QOL, secondary endpoints physical functioning, nausea&vomiting, fatigue and systemic therapy side effects. A minimum clinically meaningful difference was considered to be 10 points. Results: 1306 patients were recruited between 3/2002 and 5/2005 675 were assigned to the FEC and 688 to the EC-DOC arm. Compliance to QOL assessment was 74% at baseline and 58% four weeks after therapy, but dropped to 11% after one year follow up. After the beginning of treatment global QOL dropped in both arm by 3 to 4 points. In the EC-DOC arm QOL dropped further at t3 by 7 points and stayed stable in the FEC arm. 6 weeks after radiation QOL exceeded baseline in both arms by 6 to 8 points. The differences between treatment arms were strongest at t3 (54.1 vs. 49.7) but did not reach clinical relevance at any point in time. Physical functioning, nausea vomiting, fatigue and systemic therapy side effects followed with some minor exceptions similar patterns, but showed higher amplitudes. Conclusion: In conclusion we could not detect a statistically significant difference between the two treatment arms in QOL parameters, indicating that dose dense adjuvant chemotherapy did not impact QOL at a clinically relevant level compared to standard adjuvant chemotherapy. Citation Format: Schwentner L, Harbeck N, Singer S, Eichler M, Rack B, Forstbauer H, Wischnik A, Scholz C, Fink V, Huober J, Friedl T, Weissenbacher T, Härtl K, Kiechle M, Janni W. Short term quality of life with epirubicin-fluorouracil-cyclophosphamid (FEC) and sequential epirubicin/cyclophosphamid-docetaxel (EC-DOC) chemotherapy in patients with primary breast cancer – Results from the prospective multi-center randomized Adebar trial. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P1-12-03.

In den letzten Jahrzehnten ist die Pravalenz von Krebserkrankungen in Deutschland deutlich angestiegen, wahrend die Mortalitat bei vielen Entitaten gesunken ist. Dieser Trend fuhrt zu einer wachsenden Anzahl an Patientinnen in der onkologischen Nachsorge. Wahrend die Therapien heutzutage im Allgemeinen auf evidenzbasierten Masnahmen beruhen, stutzen sich die Empfehlungen zur Nachsorge mangels groser randomisierter Studien meist auf Konsensempfehlungen. Wahrend ein Lokalrezidiv haufig kurativ behandelt werden kann, besteht nach Detektion von Fernmetastasen meist nur die Moglichkeit einer palliativen Therapie. Die Herausforderung besteht daher in der Verknupfung sinnvoller medizinischer Masnahmen zur Erkennung eines Rezidivs bzw. symptomatischer Fernmetastasen unter Berucksichtigung der Bedurfnisse und der Lebensqualitat der Patientin. Der Artikel gibt einen Uberblick uber die aktuellen Empfehlungen zur Nachsorge von Patientinnen mit gynakologischen Tumoren, einschlieslich des Mammakarzinoms.

HER2-zielgerichtete Therapien haben die Behandlung und Prognose des HER2-positiven Mammakarzinoms revolutioniert. HER2 ist bei 15–20 % der Mammakarzinompatientinnen uberexprimiert und war ursprunglich mit einer schlechteren Prognose assoziiert. HER2 gehort zur Familie der HER-Rezeptoren, die eine wichtige Rolle bei Zellwachstum und -differenzierung spielen. HER2-zielgerichtete Therapien sind direkt gegen den HER2-Rezeptor gerichtet. Neben dem monoklonalen Antikorper Trastuzumab stehen inzwischen weitere HER2-zielgerichtete Therapien zur Verfugung, wie Lapatinib, Pertuzumab oder TDM-1. Trotz der deutlichen Prognoseverbesserung des HER2-positiven Mammakarzinoms durch Trastuzumab, sowohl in der metastasierten als auch in der adjuvanten Situation, werden De-novo- und erworbene Resistenzen gegenuber Trastuzumab beobachtet. Durch die Kombination zweier HER2-zielgerichteter Substanzen und deren synergistische Wirkungen wegen unterschiedlicher Angriffspunkte am HER2-Rezeptor kann eine weitere Verbesserung der Wirksamkeit der Anti-HER2-Therapie erreicht werden. Die AGO empfiehlt derzeit bereits als Erstlinientherapie des HER2-positiven metastasierten Mammakarzinoms eine Chemotherapie mit Docetaxel in Kombination mit Trastuzumab und Pertuzumab (++).Studien untersuchen aktuell verschiedene Kombinationen der dualen HER2-Blockade in unterschiedlichen Situationen.

Purpose The tumor biology of older breast cancer patients (oBCP) is usually less aggressive, however applied adjuvant treatment is often less potent resulting in an impaired disease free survival and overall survival in this group. This study tries to answer the following questions for the biological subtypes of oBCP (70+ y): (1) Is there a significant difference in the distribution of the biological subtypes of oBCP vs younger breast cancer patients (yBCP; 50–69 y)? (2) Which biological subtype has the highest rate of non-guideline-adherent-treatment (GL−) among oBCP? (3) Is a single GL− (i.e. radiotherapy/surgery/endocrine-therapy/chemotherapy) significantly associated with the survival outcome in each biological subgroup? Methods Between 1992 and 2008 the BRENDA (‘BRENDA’ = quality of BREast caNcer care unDer evidence-bAsed guidelines) study group recorded medical data of 17 participating certified breast cancer centers in Germany. We performed a retrospective multi-center database analysis of 5632 patient records. Guideline-adherent-treatment (GL+) of oBCP(n = 1918) was compared to GL+ of yBCP(n = 3714). Results OBCP were more likely to have hormone receptor positive (HR+) and HER2 neu negative (HER2−) breast cancer (77.5% vs 74.5%). The rate of GL− was significantly different (p The survival parameters for HR+/HER2− and TNBC were significantly worse in case of GL− regarding chemotherapy, and if applicable endocrine therapy. A similar association only existed in HR−/HER2+ tumors for GL− for radiotherapy and in HR+/HER2+ tumors for chemotherapy. Conclusions Beside the significantly different distribution of biological subtypes in the age groups there is an association between biological subtype, and GL+ influencing survival parameters in oBCP.

About 20% of all breast cancer patients have a human epidermal growth factor receptor 2 (HER2)-positive breast tumor. This entity underwent an impressive change in prognosis, with notable improvement of progression-free survival and overall survival. Due to more aggressive tumors and no specific therapy, HER2 overexpression was historically seen as a negative prognostic marker, with worse prognosis and increased risk of recurrent disease. Trastuzumab, the first anti-HER2 antibody, revolutionized the systemic therapy options in HER2-positive breast cancer and initiated several targeted therapies and more personalized treatment strategies. Over the years, multiple HER2-targeting drugs stepped into clinical practice, for the curative as well as the metastatic situation. This review summarizes the targeted treatment options in HER2-positive breast cancer and their current impact in the clinical routine. Results of the most outstanding trials in HER2-targeted therapies and important ongoing trials are subsequently described for an up-to-date overview.