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ZusammenfassungWährend bei anderen soliden Tumoren Immuntherapie seit Jahren zum Therapiestandard gehört, steht sie bei Brustkrebs noch ganz am Anfang. Klinisch relevant ist sie beim triple-negativen Mammakarzinom (TNBC). Seit 2019 ist der PD-L1-Inhibitor (PD-L1: Programmed death-ligand 1) Atezolizumab als Erstlinientherapie beim metastasierten TNBC zugelassen. Vielversprechende Daten gibt es auch zur neoadjuvanten Therapie bei TNBC sowohl für Atezolizumab als auch für den PD1-Inhibitor Pembrolizumab. Studien beim luminalen frühen Mammakarzinom laufen derzeit. Eine kommentierte Übersicht.

The continuous availability of findings from new studies repeatedly results in updated treatment recommendations and guidelines. In the case of breast carcinoma in particular, several studies have been published in the last few years that have transformed how early and advanced breast carcinoma is being treated. However, this by no means means implies that there is agreement among all experts on specific issues. It is precisely the diversity of interpretation of guidelines and study findings that reflects the constantly changing available data and its complexity, as well as the availability of new drugs. In recent years, new substances such as pertuzumab, T-DM1, neratinib and capecitabine have become available to treat patients with early stages of breast carcinoma. Furthermore, the first results on the use of CDK4/6 inhibitors for adjuvant treatment have now been published. Last but not least, the use of multigene tests to avoid the necessity of chemotherapy in certain patients is still under discussion. This review summarises the state of the data and publishes the results of the survey completed by experts at the 2021 St. Gallen Breast Cancer Conference on early-stage breast cancer.

Der Einsatz oraler Tumortherapeutika insbesondere zur Therapie des Mammakarzinoms mit intensivem Beratungsbedarf und langen Einnahmezeitraumen gewinnt zunehmend an Bedeutung. Ein in Deutschland relativ neuer Ansatz ist der Einsatz speziell qualifizierten Pflegepersonals im Rahmen pflegerisch geleiteter Sprechstunden. Im Rahmen eines Workshop-Curriculums (WSC) zur Verbesserung der Handlungssicherheit wurden die Teilnehmer - Pflegekrafte und Arzte - vor, wahrend und nach WSC hinsichtlich der gemachten Erfahrungen befragt. Dabei zeigte sich bei Arzten und Pflegekraften ein groses Interesse an Informationen zu OTT sowie an der Etablierung pflegerisch geleiteter Sprechstunden

Zusammenfassung Ziel der Studie Brustkrebs beim Mann ist eine seltene Erkrankung, für die jedoch hochspezialisierte Versorgungsstrukturen zur Therapie des Brustkrebses der Frau zur Verfügung stehen. Bislang ist unbekannt, ob die Ausrichtung der Versorgungsstrukturen auf Frauen zu Defiziten in der Versorgung der betroffenen Männer führt. Daher ist es das Ziel der vorliegenden Untersuchung, mögliche Versorgungsdefizite aus der Perspektive der beteiligten Professionen zu identifizieren. Methodik Es wurden teilstandardisierte Leitfadeninterviews mit n = 23 Teilnehmer/innen sowie 2 Fokusgruppendiskussionen mit n = 7 bzw. n = 9 Teilnehmer/innen durchgeführt. Die Transkripte der Interviews und Fokusgruppendiskussionen wurden mittels qualitativer Inhaltsanalyse mit MAXQDA ausgewertet. Ergebnisse Einige Teilnehmer/innen sehen aufgrund des Erfahrungsmangels eigene Unsicherheiten in der Versorgung von Männern mit Brustkrebs. Häufig wird ein mangelndes Wissen bezüglich der Zuständigkeiten und Behandlungsmöglichkeiten, z. B. bei niedergelassenen Gynäkolog/innen, beklagt. Viele Befragte empfinden eine mangelnde interdisziplinäre Zusammenarbeit, v. a. in der Nachsorge. Einige Befragte sehen darüber hinaus einen Mangel an spezialisierten Rehabilitationseinrichtungen für Männer mit Brustkrebs. Schlussfolgerung Männer mit Brustkrebs profitieren trotz der Seltenheit der Erkrankung von den hochentwickelten Strukturen zur Brustkrebsversorgung in Deutschland. Dennoch zeigen sich Versorgungsdefizite aus der Sicht der behandelnden Professionen. Diese Datengrundlage kann in Kombination mit der Perspektive der Betroffenen und weiteren repräsentativen Daten dazu dienen, Praxis-Empfehlungen zur Verbesserung der Versorgungsqualität des männlichen Brustkrebses zu erarbeiten.

ZusammenfassungVom 14. bis 16. November 2019 fand in Lissabon die fünfte internationale Konsensuskonferenz ABC5 (Advanced Breast Cancer Fifth Consensus) zu Diagnostik und Behandlung des fortgeschrittenen Mammakarzinoms statt. Ziel ist es, die Behandlung der Patientinnen mit fortgeschrittenem Mammakarzinom weltweit auf evidenzbasierter Grundlage zu standardisieren und sicherzustellen, dass Patientinnen überall auf der Welt adäquat behandelt werden und Zugang zu neuen Therapien erhalten. Ein inhaltlicher Schwerpunkt lag dieses Jahr auf neuen Entwicklungen und Studienergebnissen beim fortgeschrittenen Mammakarzinom sowie der Präzisionsmedizin. Zudem ist die Zusammenarbeit mit den Patientenvertreterinnen aus aller Welt ein wichtiges Anliegen der ABC-Konferenz, weshalb in dem international zusammengesetzten ABC-Panel auch Patientenvertreterinnen sind. Im vorliegenden Manuskript werden die Abstimmungsergebnisse der ABC5-Panelisten vor Ort durch eine Arbeitsgruppe deutscher Brustkrebsexperten für den Therapiealltag in Deutschland kommentiert. Der Kommentierung liegen die Empfehlungen der Arbeitsgemeinschaft Gynäkologische Onkologie (AGO), Kommission „Mamma“, zugrunde. Sie erscheint sinnvoll, da in den ABC-Konsensus auch länderspezifische Besonderheiten einfließen.

The Advanced Breast Cancer Fifth International Consensus Conference (ABC5) which focuses on the diagnosis and treatment of advanced breast cancer was held in Lisbon on November 14 – 16, 2019. The aim of the conference is to standardize the treatment of advanced breast cancer worldwide using evidence-based data and to ensure that patients with advanced breast disease anywhere in the world are treated appropriately and have access to the latest therapies. This year, the emphasis was on new developments and study results from patients with advanced breast cancer as well as precision medicine. The collaboration with patient advocates from all over the globe is also an important goal of the ABC Conference, which is why the international ABC panel also included a number of patient advocates. We present a commentary on the voting results of the ABC5 panelists in Lisbon by a working group of German breast cancer specialists together with the implications for routine clinical care in Germany. The commentary is based on the recommendations of the Breast Commission of the German Gynecological Oncology Working Group (AGO). This commentary is useful, it includes country-specific features for the ABC consensus.

Background: Patients with triple-negative primary breast cancer (TNBC) who have residual invasive carcinoma after neoadjuvant chemotherapy have poor prognosis. Proven adjuvant approaches to reduce the risk of recurrence and improve outcome in patients with non-pathological complete response (non-pCR) are limited. Methods: From our institutional registry, a consecutive case series of patients with operable, unilateral, primary invasive noninflammatory early TNBC of stage I-IIIB and pathologically verified residual cancer cells (no pathological complete response) after neoadjuvant chemotherapy underwent adjuvant treatment with gemcitabine plus cisplatin combined with regional hyperthermia. For quality assurance, we analyzed feasibility, efficacy, and toxicity of all treated patients. Outcome was evaluated for the entire group of patients as well as for the subgroups of patients with or without lymph node involvement at baseline (cN0/ cN+). Results: From August 2012 to January 2019, we offered this treatment to 53 patients at our center as part of routine care. The median follow-up was 38 months. The majority of patients (64.2%) had cT2 tumors at baseline. Twenty-four patients (45%) were clinically node positive as evaluated by sonography. Thirty-nine patients (74%) had grade 3, and 14 patients (26%) had grade 2 tumors. Forty-one patients (76%) showed a regression grade 1 according to Sinn. Patients received a median of six treatment cycles of gemcitabine and cisplatin (range 1–6) combined with 12 applications of regional hyperthermia (median 12, range 2–12). Disease-free survival (DFS) at 3 years was 57.5%. In patients with no lymph node involvement at baseline (cN0), DFS at 3 years was significantly higher than in initially node-positive (cN+) patients (80 vs. 31%; p = 0.001). Overall survival (OS) at 3 years was 81.6%. In patients with no lymph node involvement at baseline (cN0), OS at 3 years was significantly higher than in node-positive (cN+) patients (93 vs. 70.4%; p = 0.02). Overall, grade 3/4 toxicities were leukopenia (38%), thrombocytopenia (4%), and anemia (4%). Conclusion: After standard neoadjuvant chemotherapy containing anthracycline plus cyclophosphamide followed by taxanes, addition of adjuvant gemcitabine plus cisplatin in combination with regional hyperthermia was safe and effective in TNBC patients with non-pCR.

COVID-19; Cancer; End-of life care (EOLC) COVID-19; Cáncer; Cuidados al final de la vida COVID-19; Càncer; Cures al final de la vida Background: Specialist palliative care team (SPCT) involvement has been shown to improve symptom control and end-of-life care for patients with cancer, but little is known as to how these have been impacted by the COVID-19 pandemic. Here, we report SPCT involvement during the first wave of the pandemic and compare outcomes for patients with cancer who received and did not receive SPCT input from multiple European cancer centres. Methods: From the OnCovid repository (N = 1318), we analysed cancer patients aged ⩾18 diagnosed with COVID-19 between 26 February and 22 June 2020 who had complete specialist palliative care team data (SPCT+ referred; SPCT− not referred). Results: Of 555 eligible patients, 317 were male (57.1%), with a median age of 70 years (IQR 20). At COVID-19 diagnosis, 44.7% were on anti-cancer therapy and 53.3% had ⩾1 co-morbidity. Two hundred and six patients received SPCT input for symptom control (80.1%), psychological support (54.4%) and/or advance care planning (51%). SPCT+ patients had more ‘Do not attempt cardio-pulmonary resuscitation’ orders completed prior to (12.6% versus 3.7%) and during admission (50% versus 22.1%, p

Molecular factors that drive metastasis in premenopausal patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2−), early breast cancer (EBC) are largely unknown. To identify markers/signatures contributing to metastasis, we analyzed molecular changes in tumors from premenopausal patients who developed metastasis (M1) and who did not (M0). Ninety-seven premenopausal patients with HR+/HER2− EBC were included (M1, n = 48, median distant metastasis-free survival (DMFS): 54 (7–184) months, M0, n = 49, median follow-up: 149 (121–191) months). Gene expression profiling on tumor RNA (Breast Cancer 360TM panel, Nanostring) was performed, followed by comprehensive bioinformatic and statistical analyses. Significantly enhanced ROR (risk of recurrence) scores and reduced signature scores of PGR (progesterone receptor), claudin-low, and mammary stemness were determined in M1. These differences were significantly associated with shorter DMFS in univariate survival analyses. Gene set enrichment analysis showed an enriched mTORC1 pathway in M1. Moreover, a metastasis signature of 19 differentially expressed genes (DEGs) that were DMFS-related was defined. Multivariate analysis including the four signatures, 19 DEGs, pN, and pT status, identified LRP2, IBSP, and SCUBE2 as independent prognostic factors. We identified prognostic gene signatures and single-gene markers for distant metastasis in premenopausal HR+/HER2− EBC potentially applicable in future clinical practice.

Immer haufiger kommt Brustkrebs auch bei jungen Frauen vor. Welche Besonderheiten sind bei diesen Patientinnen zu beachten? Wichtige „To-dos“ — vom Ansprechen der Famlienplanung bis zur Uberprufung der Adharenz einer endokrinen Therapie — erfahren Sie hier.

This year, the St. Gallen Consensus Conference on early breast cancer treatment standards took place for the third time in Vienna, Austria, which is where the next conference will also take place (next date: March 17–20, 2021!). Once again, more than 3,000 participants from over 100 countries came together, and, overall, the 2019 St. Gallen/Vienna conference was a great success. After 3 days of reviews conducted by a global faculty concerning the most important evidence published in the last 2 years, the Consensus votes’ challenge was to define the impact on routine everyday practice. This year, the conference’s main theme was the optimization of early breast cancer therapies by assessment of the magnitude of benefit, aiming at further refinement when compared to de-escalation and escalation, which were mainly the topic of the 2017 conference. Patient empowerment and the importance of shared decision-making were particularly emphasized. The traditional panel votes were moderated by Eric Winer from Harvard, and for the most part, they managed to clarify most of the critical questions. This brief report by Editors of Breast Care summarizes the results of the 2019 international panel votes with respect to locoregional and systemic treatment as a quick news update for our readers, but it expressly does not intend to replace the official St. Gallen Consensus publication that will follow shortly in Annals of Oncology.

Geburtshilfe und Frauenheilkunde 81(5), 526-538 (2021). doi:10.1055/a-1464-0953, Published by Thieme, Stuttgart

Background: Cancer patients are at increased risk of developing severe COVID-19 disease. Possible side effects of systemic therapy and the lack of clinical data on safety and efficacy of COVID-19 vaccination in cancer patients cause uncertainty regarding the vaccination. Here, we evaluated attitude towards and effects of COVID-19 vaccination in patients with breast or gynecological cancer. The aim was to improve counseling of our patients in clinical routine. Methods: Since March 15th 2021, patients who received one of the approved COVID-19 vaccines were routinely interviewed about immediate (0-2 days) and late side effects (within two weeks after vaccination). Clinical parameters such as current therapy, time interval between therapy administration and vaccination, and changes in the therapy schedule due to the vaccination were documented. Furthermore, the willingness of non-vaccinated patients to be vaccinated was assessed. The collected data were anonymously analyzed as a part of routine quality assurance. Results: By May 10th 2021, 111 out of 217 (51.1%) interviewed patients had received at least one shot of COVID-19 vaccine and 21 patients both shots. More than half of the vaccinated patients were >55y (60.2%;mean: 60.7y, range 30-92y);69% with UICC/ FIGO stage III/IV cancer. 74.6% received Conmirnaty (BioNTech/ Pfizer), 18.9% Vaxzevria (AstraZeneca) and 6.5% Covid-19 Vaccine Moderna. After the first shot, 33.3% of the patients described no side effects, 49.1% reported a local reaction (swelling or pain), 23.4% flu-like symptoms, 10.8% headache and 3.6% nausea. 11 patients had symptoms that lasted longer than two days. In 11 cases, COVID-19 vaccination had an impact on delivery of the systemic therapy (n=10 postponements of therapy and n=1 dose reduction). 61.3% of the non-vaccinated patients (in total n=118) were already registered to get vaccinated;32.8% chose to postpone vaccination for personal reasons;5% refused vaccination. Conclusions: Breast and gynecological cancer patients appear to tolerate COVID-19 vaccination well under systemic therapy and only in few cases the vaccination interfered with the treatment schedule. Updated results will be presented at the ESMO Congress. Legal entity responsible for the study: LMU University Hospital. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

Objective We assessed the value of breast ultrasound (US) performed at week 3 and 6 and at the end (EOT) of neoadjuvant therapy (NAT) for prediction of pathologic complete response (pCR, ypT0/is ypN0) in patients with HR+/HER2+, HR-/HER2-or HR-/HER2+ early breast cancer enrolled in the WSG-ADAPT subtrials. Methods US was performed at week 3 and 6 of NAT and at EOT in 401, 517, and 553 patients, respectively. Tumors with complete or partial response by US (RECIST 1.1) were classified as responders and those with stable or progressive disease as non-responders. Results pCR rate was higher in US responders than in non-responders. US tended to yield the highest positive predictive value in HR-/HER2+ (69%) and HR-/HER2-tumors (65%) at week 3, and the highest negative predictive value in HR+/HER2+ tumors at week 6 and at EOT (88.9% and 86.9%, respectively) and in HR-/HER2-tumors at EOT (87.9%). Multivariable analysis of patients with US at week 3 and 6 identified tumor subtype (HR-/HER2+ vs HR+/HER2+; odds ratio (OR) 2.77, 95%CI 1.45–5.29, and OR 4.17, 95%CI 2.26–7.68, respectively) and each 10% change in lesion dimension on US from baseline (OR 1.15, 95%CI 1.08–1.24, and OR 1.25, 95%CI 1.16–1.35, respectively) as parameters associated with pCR. Conclusions Our data support the use of week 3 and EOT US for prediction of pCR in response-guided NAT and in planning of breast-conserving surgery. Change in tumor diameter on US as a continuous variable could be a valuable alternative to categorical RECIST 1.1 criteria., Highlights • Timing of ultrasound may affect prediction of pathologic complete response (pCR). • Ultrasound predicts pCR in HR-tumors as early as at week 3 of neoadjuvant therapy. • Ultrasound predicts non-pCR in HR+/HER2+ tumors at week 6 of neoadjuvant therapy. • Early pCR prediction by ultrasound allows response-guided therapy in breast cancer.

Breast cancer research 23(1), 36 (2021). doi:10.1186/s13058-021-01413-y, Published by BioMed Central, London

We evaluated the role of early response after 3 weeks of neoadjuvant treatment (NAT) assessed by ultrasound (US), magnetic resonance imaging (MRI) and Ki‐67 dynamics for prediction of pathologic complete response (pCR) in different early breast cancer subtypes. Patients with HR+/HER2+, HR−/HER2− and HR−/HER2+ tumors enrolled into three neoadjuvant WSG ADAPT subtrials underwent US, MRI and Ki‐67 assessment at diagnosis and after 3 weeks of NAT. Early response was defined as complete or partial response (US, MRI) and ≥30% proliferation decrease or, What's new? In breast cancer, a pathologic complete response (pCR) after neoadjuvant therapy (NAT) can predict long‐term outcome. However, rates of pCR differ according to EBC subtype. So what is the most useful approach to determine early response? In this prospective study, the authors compared MRI, ultrasound, and Ki‐67 status after three weeks of NAT. They found that MRI and Ki‐67 had higher sensitivity than ultrasound in HR‐/HER2+ and HR‐/HER2‐ tumors, while all three methods were similar for HR+/HER2+ tumors. These findings could guide identification of candidates for therapy de‐escalation or escalation.

Background Patients with left-sided breast cancer have an increased risk of cardiovascular disease (CVD) after radiotherapy (RT). While the awareness of cardiac toxicity has increased enormously over the last decade, the role of individual baseline cardiac risks has not yet been systematically investigated. Aim of the present study was to evaluate the impact of baseline CVD risks on radiation-induced cardiac toxicity. Methods Two hundred ten patients with left-sided breast cancer treated in the prospective Save-Heart Study using a deep inspiration breath-hold (DIBH) technique were analysed regarding baseline risk factors for CVD. Three frequently used prediction tools (Procam, Framingham and Reynolds score) were applied to evaluate the individual CVD risk profiles. Moreover, 10-year CVD excess absolute risks (EAR) were estimated using the individual mean heart dose (MHD) of treatment plans in free breathing (FB) and DIBH. Results The individual baseline CVD risk factors had a strong impact on the 10-year cumulative CVD risk. The mean baseline risks of the non-diabetic cohort (n = 200) ranged from 3.11 to 3.58%, depending on the risk estimation tool. A large number of the non-diabetic patients had a very low 10-year CVD baseline risk of ≤1%; nevertheless, 8–9% of patients reached ≥10% baseline 10-year CVD risk. In contrast, diabetic patients (n = 10) had significantly higher baseline CVD risks (range: 11.76–24.23%). The mean 10-year cumulative risk (Framingham score) following RT was 3.73% using the DIBH-technique (MHD:1.42Gy) and 3.94% in FB (MHD:2.33Gy), after adding a 10-year-EAR of + 0.34%(DIBH) and + 0.55%(FB) to the baseline risks, respectively. Smoking status was one of the most important and modifiable baseline risk factors. After DIBH-RT, the 182 non-smoking patients had a mean 10-year cumulative risk of 3.55% (3.20% baseline risk, 0.35% EAR) as compared to 6.07% (5.60% baseline risk, 0.47% EAR) for the 28 smokers. Conclusion In the present study, all CVD prediction tools showed comparable results and could easily be integrated into daily clinical practice. A systematic evaluation and screening helps to identify high-risk patients who may benefit from primary prevention. This could result in an even higher benefit than from heart-sparing irradiation techniques alone.

Brain metastases (BMs) have a major impact on life expectancy and quality of life for many breast cancer patients. Knowledge about treatment patterns and outcomes is limited.We analysed clinical data of 1712 patients diagnosed with BMs from breast cancer between January 2000 and December 2016 at 80 institutions.Median age at diagnosis of BMs was 56 years (22-90 years). About 47.8% (n = 732) of patients had HER2-positive, 21.4% (n = 328) had triple-negative and 30.8% (n = 471) had hormone receptor (HR)-positive, HER2-negative (luminal-like) primary tumours. The proportion of patients with HER2-positive BMs decreased comparing the years 2000-2009 with 2010-2015 (51%-44%), whereas the percentage of patients with luminal-like tumours increased (28%-34%; p = 0.0331). Patients with BMs in the posterior fossa were more often HER2 positive (n = 169/314, 53.8%) than those diagnosed with triple-negative (n = 65/314, 20.7%) or luminal-like primary breast cancer (n = 80/314, 25.5%), (p 0.0001). Median overall survival (OS) time after development of BMs for the overall cohort was 7.4 months (95% confidence interval [CI]: 6.7-8.0 months). One-year survival rate was 37.7% (95% CI: 35.2-40.1). Patients with HER2-positive tumours had the longest median OS of 11.6 months (95% CI: 10.0-13.4) compared with 5.9 months (95% CI: 5.0-7.2) for patients with luminal-like and 4.6 months (95% CI: 3.9-5.4) for patients with triple-negative tumours. Patients with HER2-positive tumours who received anti-HER2 treatment had longer median OS than those without (17.1 months versus 7.2 months, p 0.0001).Prognosis of patients after developing BMs varies significantly according to the subtype. The outcome in this cohort is similarly poor in triple-negative and HR-positive/HER2-negative patients. Our results underline the high medical need for improvement of treatment and prevention strategies for BMs in breast cancer patients.

Male breast cancer (MBC) is rare and known as a typical woman’s disease. This study is part of the N-MALE project (Male breast cancer: patient’s needs in prevention, diagnosis, treatment, rehabilitation and follow-up-care) and aims to investigate how MBC patients (MBCP) feel about suffering from a “woman’s disease,” what character the stigmatization has, and how it can be prospectively reduced. Therefore, a mixed methods design is applied including data of N = 27 qualitative interviews with MBCP and quantitative data of N = 100 MBCP. Findings identify a diverse picture, as stigmatization varies between contexts and patients: Most stigmatization concentrates on sexual stigmatization and ignorance of MBC and mostly occurs in cancer care systems and work-related contexts. The level of stigmatization varies with age and amount of treatment methods received, as reported within the created typology of different MBCP stigma types. To prospectively reduce stigmatization in MBCP, more publicity of MBC is needed, as well as gender-neutral communication and information material.

The 5th International Consensus Conference for Advanced Breast Cancer (ABC5) took place on November 14–16, 2019, in Lisbon, Portugal. Its aim is to standardize the treatment of advanced breast cancer based on the available evidence and to ensure that all breast cancer patients worldwide receive adequate treatment and access to new therapies. This year, the conference focused on developments and study results in the treatment of patients with hormone receptor-positive/HER2-negative breast cancer as well as precision medicine. As in previous years, patient advocates from around the world were integrated into the ABC conference and had seats on the ABC consensus panel. In the present paper, a working group of German breast cancer experts comments on the results of the on-site ABC5 consensus votes by ABC panelists regarding their applicability for routine treatment in Germany. These comments take the recommendations of the Breast Committee of the Gynecological Oncology Working Group (Arbeitsgemeinschaft Gynäkologische Onkologie; AGO) into account. The report and assessment presented here pertain to the preliminary results of the ABC5 consensus. The final version of the statements will be published in Annals of Oncology and The Breast.

The fourth international advanced breast cancer consensus conference (ABC4) on the diagnosis and treatment of advanced breast cancer (ABC) headed by Professor Fatima Cardoso was once again held in Lisbon on November 2 – 4, 2017. To simplify matters, the abbreviation ABC will be used hereinafter in the text. In clinical practice, the abbreviation corresponds to metastatic breast cancer or locally far-advanced disease. This year the focus was on new developments in the treatment of ABC. Topics discussed included the importance of CDK4/6 inhibition in hormone receptor (HR)-positive ABC, the use of dual antibody blockade to treat HER2-positive ABC, PARP inhibition in triple-negative ABC and the potential therapeutic outcomes. Another major area discussed at the conference was BRCA-associated breast cancer, the treatment of cerebral metastasis, and individualized treatment decisions based on molecular testing (so-called precision medicine). As in previous years, close cooperation with representatives from patient organizations from around the world is an important aspect of the ABC conference. This cooperation was reinforced and expanded at the ABC4 conference. A global alliance was founded at the conclusion of the consensus conference, which aims to promote and coordinate the measures considered necessary by patient advocates worldwide. Because the panel of experts was composed of specialists from all over the world, it was inevitable that the ABC consensus also reflected country-specific features. As in previous years, a team of German breast cancer specialists who closely followed the consensus voting of the ABC panelists in Lisbon and intensively discussed the votes has therefore commented on the consensus in the context of the current German guidelines on the diagnosis and treatment of breast cancer 1, 2 used in clinical practice in Germany. The ABC consensus is based on the votes of the ABC panelists in Lisbon.

In Deutschland erkranken jahrlich zwischen 600 und 650 Manner an Brustkrebs. Aufgrund des geringen offentlichen Bewusstseins und fehlender Vorsorgeuntersuchungen wird die Erkrankung aber oft erst in einem fortgeschrittenen Stadium diagnostiziert.

Introduction With the introduction of the first trastuzumab biosimilar in the summer of 2018, biosimilar antibodies for breast cancer have found their way into the area of gynaecological oncology. The switch of anti-human epidermal growth factor receptor 2 (HER2) therapy from the reference drug Herceptin® to a biosimilar has presented challenges to the clinics. In addition to structural and organisational measures, training of employees as well as patient briefing and acceptance were major challenges. The study presented here records – within the context of quality assurance – how the switch to a trastuzumab biosimilar was implemented at four Bavarian university clinics in the Purchasing Association of Bavarian University Pharmacies. Materials/Methods Questionnaires on treatment figures and the switching process were sent to breast centres and pharmacies of four Bavarian university clinics between July and December 2019. The neoadjuvant, adjuvant and metastasised anti-HER2 therapy with trastuzumab with or without pertuzumab was recorded, evaluated and summarised. Results In the anti-HER2-therapy, trastuzumab was used intravenously (i. v.) and subcutaneously. Between July and December 2018, all four clinics in the Purchasing Association switched the i. v. trastuzumab therapy from the reference drug (Herceptin) to a biosimilar (for 2018: Kanjinti®). Over 200 patients were treated with trastuzumab i. v. in each of the two half-years of 2018 (before and after the switch). The spectrum of side effects and pCR rates under therapy with the biosimilar were comparable to the experiences made with the reference drug. Three out of four clinics provided training to employees and informed patients by means of a defined information leaflet. Patient acceptance was high. Summary The anti-HER2 therapy could be switched successfully and safely to trastuzumab biosimilars at the Bavarian university hospitals. This may serve as guideline for the further implementation of biosimilars. The structures necessary for this initial switching process have been prepared with trastuzumab as an example.

Background: Male breast cancer is rare. No information was available on how male breast cancer patients (MBCPs) experience the health care they receive in Germany in a setting that is tailored to women. The aim of this study was to explore the health care situation of MBCPs from their perspectives. Methods: The study follows a mixed-methods design, combining quantitative data from a standardized written questionnaire with qualitative data from personal interviews. Descriptive statistics (quantitative data) and qualitative content analysis (qualitative data) were used for data analysis. Results: Questionnaires completed by 100 and personal interviews of 27 MBCPs were analyzed. Several men reported mainly positive experiences while others experienced shortcomings. These included delays in diagnosis, health care provider uncertainty about treatment (tamoxifen, radiation therapy), experiences of stigmatization, and issues of continuity of care including unclear responsibilities for aftercare and access challenges to breast-cancer-specific care in gynecology settings. Conclusions: The awareness of male breast cancer needs to be increased among the public, health care providers and researchers in order to avoid delays in diagnosis and reduce stigmatization and uncertainty about treatment. Health care structures ensuring access to gynecology care and clear responsibilities for aftercare need to be established.

Goals: The WSG ADAPT trial program is one of the first new generation trials addressing the issue of individualization of (neo)-adjuvant decision-making in early breast cancer (EBC) in a subtype-specific manner. The first WSG ADAPT umbrella trial (NCT01779206) aimed to establish early predictive molecular surrogate markers for response after a short 3-week induction treatment and to omit chemotherapy in a large cohort of early high risk HR+/HER2- patients. The aim of the ADAPTlate phase-III-trial is to improve adjuvant therapy for patients at high risk for late disease recurrence, who have completed definite locoregional therapy (with or without neoadjuvant or adjuvant chemotherapy) and are under adjuvant endocrine treatment. This high-risk population does not derive optimal benefit from standard ET, often develops secondary resistance against ET and consequently late recurrences. With ADAPTlate, it is planned to evaluate whether patients with high-risk EBC derive additional benefit from adding abemaciclib to ET even 2-6 year after their initial diagnosis. Abemaciclib has been shown to improve outcome in metastatic breast cancer and recently, even in early breast cancer when given as part of primary therapy. Methods: WSG-ADAPTcycle is a prospective, multi-center, interventional, two-arm, non-blinded, randomized, controlled adjuvant phase III trial (NCT not yet assigned). It investigates whether patients with HR+/HER2- EBC identified as high-risk during screening (based on clinical or genomic risk) derive additional benefit from 2 years of the CDK4/6 inhibitor abemaciclib combined with ET compared to ET alone. Starting Q3 2020 (enrollment 36 months, 50 sites), 1250 patients will be screened and 903 randomized in a ratio 3:2 (602 to abemaciclib + ET; 301 to standard ET). Pre-/postmenopausal patients with histologically confirmed invasive HR+/HER2- EBC and 2-6 years after primary diagnosis, with either known high clinical risk (c/pN 2-3 OR high CTS score in pN 0-1 OR non-pCR after neoadjuvant chemotherapy in cN 1 or G3 tumors OR G3 and Ki-67 ≥ 40% in pN 0-1) or known high genomic risk (Oncotype Dx® / RS >25 in c/pN 0, RS >18 in c/pN 1 OR high risk Prosigna®, EPclin® or Mammaprint® in pN 0-1) or intermediate clinical, but unknown genomic risk (luminal B-like (G3 or Ki-67 ≥20%) in c/pN 0-1 AND Oncotype DX® in screening either RS >25 in c/pN 0 or RS >18 in c/p N1) will be eligible. Treatment duration is 2 years for the interventional abemaciclib + ET (premenopausal: AI+GnRH) arm, followed by at least 3-6 years ET alone. Patients in control arm will receive 5-8-years ET at investigator´s choice. ePROs are collected using CANKADO. Primary objective is to demonstrate superiority of invasive disease-free survival (iDFS) of abemaciclib + ET vs. standard ET. Secondary objectives include overall survival (OS), distant disease-free survival (dDFS), occurrence of CNS metastases, quality of life (EORTC QLQ-C30, QLQ-BR23, EQ-5D-5L) and translational research. Translational analyses: Exploratory tissue biomarker research will be conducted to assess alterations in molecular markers (e.g., ESR1, PIK3CA, CCND1, CDKN2A, RB1). In addition, ctDNA/ctRNA from optional blood samples will be assessed for mutations and gene expression relevant for HR+/HER2- EBC using the most appropriate technology at the time of testing. Conclusions: ADAPTlate seeks to evaluate whether enhancing ET with a CDK 4/6 inhibitor is superior to ET alone in patients with clinical or genomic high risk EBC even 2-6 years after their initial diagnosis. Translational research aims at assessing potential mechanisms of resistance to endocrine and/or CDK4/6 targeted therapy. Citation Format: Oleg Gluz, Tom Degenhardt, Norbert Marschner, Matthias Christgen, Hans Heinrich Kreipe, Ulrike Nitz, Ronald Kates, Timo Schinkoethe, Monika Graeser, Rachel Würstlein, Sherko Kuemmel, Nadia Harbeck, West German Study Group. Adaptlate -a randomized, controlled, open-label, phase-iii trial on adjuvant dynamic marker - adjusted personalized therapy comparing abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy in (clinical or genomic) high risk, hr+/her2- early breast cancer [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-01-02.

Schon im Jahr 1961 beschrieb Otto Braun-Falko das Phanomen des Haarverlustes unter Chemotherapie [1]. Heute, nach mehr als 55 Jahren, belastet die chemotherapieinduzierte Alopezie immer noch viele Krebspatienten — Manner wie Frauen –, die sich einer klassischen Tumortherapie unterziehen mussen. Moglicherweise kann der Haarausfall durch das sogenannte Scalp Cooling reduziert werden. Die US-amerikanische Food and Drug Administration hat kurzlich ein entsprechendes System zugelassen.

Kann es mithilfe von Kuhlkappen gelingen, die gefurchtete chemotherapiebedingte Alopezie zu vermeiden? In 2 Studien mit Brustkrebspatientinnen hat sich das Scalp-Cooling als effektiv erwiesen.

Welche Optionen haben Frauen mit bislang unbehandeltem Ostrogenrezeptor(ER)/Progesteronrezeptor(PR)- bzw. Hormonrezeptor(HR)-positivem und HER2-negativem Brustkrebs in fortgeschrittenem Stadium? Zwei aktuellen Studien zufolge scheinen diese Patientinnen von einer CDK4/6-Blockade zusatzlich zur Letrozol-Therapie zu profitieren.

Background: This study evaluates interventions offered to young breast cancer (BC) patients, including fertility preservation, genetic testing, and counseling for parenthood concerns, and analyzes the effect of BC on biographical issues. Methods: Women who were diagnosed with BC at the age of 18-40 years and who underwent treatment at the Breast Center, Ludwig-Maximilian University (LMU) in Munich between 2006 and 2013, were eligible for this study. Patients received a self-developed questionnaire which covered the following topics: fertility preservation, family planning, genetic testing, parenthood concerns and children's needs, partnership status, and employment situation. Results: Re-evaluating their initial decision on fertility preservation, 76.4% of patients reported satisfaction with their decision. After BC diagnosis, 45.8% reported to have maternal desire, but only 21.7% actually planned to have children. 41.7% of patients missed sufficient counseling regarding parenthood concerns. Analysis of individual employment situations showed that the time period until the return to work was longer in patients who received chemotherapy. The majority of patients (71.6%) did not report changes in their partnership status. Conclusion: Young BC survivors report a lack of communication related to parenthood concerns and future conception, but are satisfied with counseling regarding fertility preservation and genetics.

Die individualisierte Medizin ist bereits ein integraler Bestandteil der Therapie des fruhen sowie des metastasierten Mammakarzinoms. Hierfur ist neben individuellen Faktoren der Patientinnen das Wissen uber die Tumorbiologie, Prognosefaktoren und pradiktive Marker die Grundvoraussetzung. Die molekularen Subtypen (Luminal A, Luminal B, HER2-positiv, TNBC) haben klinische Relevanz und sind beim fruhen Mammakarzinom fur die Therapieentscheidung bezuglich einer (neo-)adjuvanten Therapie und auch in der Therapie des metastasierten Karzinoms nicht mehr wegzudenken. Fur die Vermeidung von Uber- und Untertherapie des fruhen Mammakarzinoms liefern gut validierte Biomarker wie uPA/PAI-1 oder die Genexpressionsanalysen zusatzliche therapierelevante Informationen uber die Tumorbiologie und Aggressivitat. Hinzu kommen neue zielgerichtete Substanzen, die eine effektive Therapie in Erganzung zur konventionellen endokrinen Therapie, HER2-gerichteten Therapie und Chemotherapie ermoglichen. Moderne Operations- und Bestrahlungsverfahren bilden zudem die Basis fur einen individualisierten Ansatz in der Lokaltherapie des primaren und metastasierten Mammakarzinoms. Auserdem fordern neue Subgruppen wie das BRCA-positive Mammakarzinom noch mehr Interdisziplinaritat und vorausschauende Therapieplanung. Insgesamt steigen somit die Komplexitat der Therapiekonzepte und damit der Anspruch an die Therapeuten und die beteiligten Disziplinen. Die beste Moglichkeit, Patientinnen eine moderne und individualisierte Therapie anbieten zu konnen, stellen klinische Studien dar. Daher sollten Studienoptionen fur die einzelne Patientin bereits in den praoperativen interdisziplinaren Tumorkonferenzen gepruft werden. Um den Studieneinschluss fur viele Patientinnen zu ermoglichen, sind der weitere Ausbau von zentrumsubergreifenden Netzwerken und die Intensivierung der interdisziplinaren Zusammenarbeit notig.

Differential efficacy of newly registered therapies in subgroups of metastatic breast cancer (mBC) is an important consideration for their subsequent use in clinical practice. Unfortunately, such subgroup analyses are often exploratory, rarely statistically adequately powered and may thus be misleading. In a systematic literature review, we evaluated differences in outcome (taking into account the diversity of available study data, inhomogeneous in- and exclusion criteria and subgroup-analyses) regarding progression free survival (PFS), time to progression (TTP), overall survival (OS) and visceral versus non-visceral disease. The impact of HER2- and hormone receptor-status was also considered. Methods: A systematic literature search (6362 hits) in the meta-Database PubMed (U.S. National Library of Medicine) was performed for the last 20 years. 257 studies (n=126.291) were included for further analysis. 69 studies had published data for visceral (i.e. presence of visceral metastases independent of the presence of other metastasis sites) vs. non-visceral (i.e. non-visceral metastases in the absence of visceral involvement) disease including phase III trials plus studies that had further used their data. Out of these 69 studies we selected n=16 studies (n=13.083) by considering (A) the information given in the medical product's professional information and (B) the decision of the U.S. Food and Drug Administration or the European Medicine Agency for the approval of the respective therapeutic agents which are now used in treatment of mBC. All selected 16 studies had looked at the endpoints mentioned above. In order to achieve comparability, we extracted the information of hazard ratios (HR), confidence intervals (CI) and times in weeks (if available) for PFS, TTP, OS of the entire study population, which was divided into three groups: HER2-positive, HER2-negative, unknown HER2 status. Results: No statistically significant difference in treatment response was found in mBC patients with visceral vs. non-visceral metastasis looking at HRs and CIs. Relevant, yet not statistically significant differences were found in the specific response of visceral metastases to modern combination therapies, especially in HER2-positive breast cancer: There was an increased benefit regarding OS using Lapatinib combined with Trastuzumab or Trastuzumab and Docetaxel combined with Pertuzumab. Additionally, in two chemotherapy trials, there was a numerical difference between therapy response in visceral vs. non-visceral metastases regarding PFS in the unknown HER2 group, and regarding OS in the HER2-negative group. Conclusions: Using a systemic literature search, we stratified published studies of the last 20 years considering HER2 and hormone receptor status with respect to metastasis pattern. In the subgroup analyses, we did not find any significant differences in response rates for visceral vs. non-visceral metastasis. For targeted therapies based on a biomarker, there seems to be a beneficial effect of combination therapies regarding OS in visceral disease. At the present time, metastasis localization should not be used as a predictive marker for choice of systemic therapy in mBC. Citation Format: Rachel Würstlein, Maximilian Bardenhewer, Alexander König, Thomas Kolben, Caroline Gehring, Nadia Harbeck. Does treatment response to new agents differ between visceral and non-visceral metastatic breast cancer: A systematic literature review of registration trials [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P3-13-07.

Vom 7. bis 9. November 2013 fand in Lissabon die zweite internationale Konsensuskonferenz ABC2 (Advanced Breast Cancer Second Consensus) zu Diagnostik und Behandlung des fortgeschrittenen Mammakarzinoms statt. Der inhaltliche Schwerpunkt lag auf dem inoperablen lokal fortgeschrittenen Mammakarzinom. Diagnostik und Therapie des metastasierten Mammakarzinoms waren bereits vor zwei Jahren anlasslich des ABC1-Konsensus diskutiert worden und wurden im Rahmen des diesjahrigen ABC2-Konsensus nur in einzelnen Fragestellungen aktualisiert. Wie schon vor zwei Jahren hat eine Arbeitsgruppe deutscher Brustkrebsexperten die Abstimmungsergebnisse der ABC-Panelisten unter besonderer Berucksichtigung der deutschen Leitlinien zu Diagnostik und Therapie des Mammakarzinoms (AGO-Empfehlungen, S3-Leitlinie) 1 2 mit Blick auf den Therapiealltag in Deutschland kommentiert. Ziel sowohl des ABC-Konsensus als auch der deutschen Kommentierung ist es, eine evidenzbasierte Grundlage fur die Therapieentscheidung zu schaffen.

Langzeitdaten bestatigen die Wirksamkeit des HER2-Antikorpers Trastuzumab in der Zweitlinie bei Patientinnen mit fruhem HER2-positivem Mammakarzinom. Auch 11 Jahre nach einer 1-jahrigen Therapie blieb das krankheitsfreie Uberleben im Vergleich zur Standardbehandlung verbessert.

Eine kanadische Studie stellt die Auffassung infrage, wonach das duktale Carcinoma in situ (DCIS) eine prainvasive Neoplasie darstellt. Folgt man den Ergebnissen, ahnelt das DCIS, was den Krankheitsverlauf betrifft, kleinen invasiven Karzinomen.

The developments in gene expression analysis have made it possible to sub-classify hormone receptor-positive (luminal) breast cancer in different prognostic subgroups. This sub-classification is currently used in clinical routine as prognostic signature (e.g. 21-gene Onoctype DX®, 70-gene Mammaprint®). As yet, the optimal method for sub-classification has not been defined. Moreover, there is no evidence from prospective trials. This review explores widely used genomic signatures in luminal breast cancer, making a critical appraisal of evidence from retrospective/prospective trials. It is based on systematic literature search performed using Medline (accessed September 2013) and abstracts presented at the Annual Meeting of American Society of Clinical Oncology and San Antonio Breast Cancer Symposium.Fortschritte bei Genexpressionsanalysen erlauben eine Einteilung des Hormonrezeptor-positiven (luminalen) Mammakarzinoms in verschiedene prognostische Untergruppen. Diese Subklassifikation wird in der klinischen Routine als prognostische Gensignatur (z.B. 21 Gene/Oncotype DX®, 70 Gene/Mammaprint®) genutzt. Die optimale Methode zur Sub-Klassifizierung ist jedoch noch nicht definiert. Bisher fehlt die Evidenz prospektiver Studien. Diese Übersichtsarbeit analysiert die am weitesten verbreiteten genomischen Signaturen im Sinne einer kritischen Bestandsaufnahme der aus retrospektiven/prospektiven Studien verfügbaren Evidenz. Diese Analyse basiert auf einer systematischen Literaturrecherche mittels Medline, sowie der bis September 2013 veröffentlichten Abstracts beim Annual Meeting of American Society of Clinical Oncology und San Antonio Breast Cancer Symposium.

12102Background: In triple-negative breast cancer (TNBC), pathological complete response (pCR, ypT0/is/ypN0) is associated with improved prognosis. The randomized prospective WSG-ADAPT TN phase II ...

PURPOSE: This study examined how patient information and patient involvement in treatment in the breast centers of North Rhine-Westphalia is perceived from the patients' point of view. We additionally investigated the differences between breast centers. MATERIAL AND METHODS: We conducted a retrospective postal survey of 3733 patients who underwent primary breast cancer surgery in one of the 51 breast centers during the period from February 1, 2007 to July 31, 2007. After discharge from hospital, patients were asked to fill in the Cologne Patient Questionnaire - Breast Cancer (CPQ-BC) which includes questions on the provision of information and shared decision-making. RESULTS: 3285 of the patients returned the completed questionnaire (response rate: 88 %). Most patients indicated that their information requirements had been met, with most information focussing on medical topics. In addition, the majority of the patients declared that they had been involved in the decision-making and that they participated actively in the treatment. CONCLUSION: Most patients with primary breast cancer consider the provision of information and shared decision-making to be good. There was clearly room for improvement with regard to the provision of information on topics other than medical matters and the active involvement of patients in the medical treatment process by physicians. Moreover, significant differences between breast centers were identified.