Search

Research question Does complete resection of endometriosis improve embryo quality as assessed by morphokinetic parameters using time-lapse microscopy? Design For this retrospective study we analysed 237 fertilised, cultured and transferred embryos from 128 fresh IVF and/ or ICSI transfer cycles. Endometriosis was confirmed or excluded by laparoscopy. Patients were stimulated with recombinant FSH using GnRH agonist and antagonist protocols. After fertilisation, a time-lapse incubation system was used for observation. Embryo quality was assessed using the KIDScore™ D3 and D5 implantation data algorithm. Results The analysis showed a median KIDScore™ D5 of 2.6 (on a scale of 1 to 9.9) for embryos from patients with endometriosis without complete resection. The control group without endometriosis achieved a score of 6.8 (p = 0.003). The median score for embryos from endometriosis patients with complete resection was 7.2, which was a significant increase compared to embryos from patients without complete resection (p = 0.002). We observed an effect size of r = 0.4 for complete resection versus no resection of endometriosis using the KIDScore™ D5. There were no differences in KIDScore™ D3 between the three patient groups. Pregnancy and miscarriage rates showed the same clinical trends. In three of our four case series of patients who underwent IVF/ ICSI cycles before and after complete resection, we found a marked improvement in embryo quality after complete resection. Conclusions Complete resection of endometriosis could significantly improve the otherwise poor embryo quality of patients undergoing IVF-procedures. The data, therefore, strongly support recommending surgery to patients with endometriosis prior to assisted reproduction.

ZusammenfassungIm vergangenen Jahr wurden für viele Patientinnen mit Mammakarzinom in frühem Krankheitsstadium neue und effektive Optionen für eine weitere Verbesserung der Behandlungsergebnisse gezeigt. Für Patientinnen mit hormonrezeptorpositiver Erkrankung zeigte sich ein signifikanter Zusatzeffekt durch den Einsatz des CDK4/6-Inhibitors Abemaciclib zusätzlich zur endokrinen adjuvanten Therapie. Bei triple-negativer Erkrankung wurden Daten für 2 Therapieprinzipien gezeigt. Patientinnen mit fortgeschrittener Erkrankung (Stadium 2 und 3) profitieren von dem neoadjuvanten Einsatz des Immuncheckpoint-Inhibitors Pembrolizumab unabhängig von der PD‑L1-Expression in Kombination mit einer Standardchemotherapie. Bei BRCA1- oder BRCA2-Mutation wurde ein eindrucksvoller Benefit durch den Einsatz des PARP-Inhibitors Olaparib gezeigt, wenn die neoadjuvante Therapie nicht zur gewünschten Remission geführt hat. Weitere Daten betreffen translationale Fragestellungen beim HER2-positiven Mammakarzinom sowie neoadjuvante Therapieansätze mit dem oralen SERD Giredestrant und dem PARP-Inhibitor Talazoparib. In dieser Übersichtsarbeit werden die Ergebnisse der wichtigsten Studienergebnisse dieses Jahres vorgestellt und bewertet.

Purpose We aimed to explore the trajectory of financial difficulties among breast cancer survivors in the German health system and its association with migration background. Methods In a multicentre prospective study, breast cancer survivors were approached four times (before surgery, before and after adjuvant therapy, five years after surgery) and asked about their migration history and financial difficulties. Migrants were defined as born/resided outside Germany or having citizenship/nationality other than German. Financial difficulties were ascertained with the financial difficulties item of the European Organisation for Research and Treatment of Cancer Core Instrument (EORTC QLQ-C30) at each time-point (cut-off > 17). Financial difficulties were classified in trajectories: always (every time-point), never (no time-point), initial (first, not fourth), delayed (only fourth), and acquired (second and/or third, not first). A logistic regression was conducted with the trajectories of financial difficulties as outcome and migration background as exposure. Age, trends in partnership status, and educational level were considered as confounders. Results Of the 363 participants included, 49% reported financial difficulties at at least one time-point. Financial difficulties were reported always by 7% of the participants, initially by 5%, delayed by 10%, and acquired by 21%. Migrants were almost four times more likely to report delayed (odds ratio [OR] = 3.7; 95% confidence interval [CI] 1.3, 10.5) or acquired (OR = 3.6; 95% CI 1.6, 8.4) financial difficulties compared to non-migrant participants. Conclusion Survivors with a migration background are more likely to suffer from financial difficulties, especially in later stages of the follow-up. A linguistically/culturally competent active enquiry about financial difficulties and information material regarding supporting services/insurances should be considered.

ZusammenfassungÜber viele Jahrzehnte war die komplette Ausräumung der axillären Lymphknoten im Sinne einer Axilladissektion ein Standardverfahren in der Therapie des Mammakarzinom. Die Zielsetzung lag in der Bestimmung des histologischen Nodalstatus für die Festlegung der adjuvanten Therapie sowie in der Sicherung der lokoregionären Tumorkontrolle. Neben der Diskussion zur Optimierung der Therapiestrategien in der systemischen Behandlung und in der Strahlentherapie fokussieren aktuelle Diskussionen insbesondere auch auf die Verbesserung der chirurgischen Maßnahmen beim Mammakarzinom. Unter Berücksichtigung der zunehmenden Bedeutung der neoadjuvanten Chemotherapie erfährt die operative Behandlung des Mammakarzinoms sowohl im Bereich der Brust als auch im Bereich der Achselhöhle einen Wandel. Basierend auf der derzeitigen Datenlage wird die SLNE vor einer neoadjuvanten Chemotherapie grundsätzlich nicht empfohlen. Demgegenüber wird die operative axilläre Intervention – von der SLNE über die TAD bis zur ALND – nach der neoadjuvanten Chemotherapie als Vorgehen der Wahl zum axillären Staging angesehen. Zur Verringerung der Falsch-negativ-Rate des operativen Stagings der Axilla bei pN+CNB vor NACT und ycN0 nach NACT sind Targeted axillary Dissection (TAD), die Entfernung von > 2 SLNs (SLNE, kein ungezieltes axilläres Sampling), die Immunhistochemie zur Detektion von isolierten Tumorzellen oder Mikrometastasen und die Markierung von positiven Lymphknoten vor NACT als Standard anzusehen. In dem aktuellen Update zur operativen axillären Intervention wird auf die Bedeutung von isolierten Tumorzellen und Mikrometastasen nach neoadjuvanter Chemotherapie und die klinischen Konsequenzen einer mittels SLNE und TAD diagnostizierten Low Volume residual Disease eingegangen und ein Überblick bez. der diesjährigen AGO-Empfehlungen zum operativen Management der Axilla im Rahmen der Primäroperation und im Zusammenhang mit der neoadjuvanten Chemotherapie gegeben.

Background: Palbociclib is currently the most commonly used cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) for patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) in Europe since its approval in 2017. However, large-scale assessments of palbociclib utilization and subsequent clinical outcomes in real-world settings are limited. Documentation of longitudinal treatment patterns and effectiveness following initiation of first-line (1L) palbociclib + aromatase inhibitor (AI) in more heterogeneous, real-world patient populations are needed to complement clinical trial findings. Trial Design: This is an observational cohort study using retrospective data abstracted from the medical records of patients with HR+/HER2- ABC who initiated 1L treatment (index date) with palbociclib + AI (September 2016-July 2020) or AI monotherapy (January 2010 to July 2020) as 1L therapy for ABC. Patients' study index dates will be at least 12 months before the data abstraction date to allow a minimum potential follow-up of at least 12 months. Patients who died within < 12 months after the index date will remain eligible. Eligibility Criteria: Adult patients who received a de novo or a recurrent diagnosis of locally advanced BC (i.e., not amenable to curative therapy) or metastatic BC will be included. Patients who participated in a clinical trial for ABC, had evidence of prior other malignant neoplasm, received any CDK4/6i for early stage disease, and received other CDK4/6i for ABC will be excluded. Study Aims: This study aims to describe patient characteristics, treatment patterns, and clinical outcomes among patients with HR+/HER2- ABC in Europe who received 1L CDK4/6i treatment. Key outcomes of interest include real-world tumor response, real-world progression-free survival, and overall survival. An exploratory objective will be to compare clinical outcomes between patients treated with 1L palbociclib + AI versus AI monotherapy. Statistical Methods: All study measures will be summarized descriptively. Time-to-event outcomes will be estimated using the Kaplan-Meier method. Direct covariate matching at the site-level and inverse probability weighting using propensity scores is planned to account for differences in baseline patient and clinical characteristics between treatment groups in the exploratory comparative analysis. Target Accrual: Data abstraction is anticipated to begin in September 2021. Data will be abstracted for up to 2,400 eligible patients. Approximately 60 total sites from across Germany, Spain, and the United Kingdom and, if feasible, from other European countries will be recruited. Citation Format: Ernest H. Law, Elena Galve-Calvo, Achim Wöckel, Rohan Parikh, Samantha K. Kurosky, Valerie Derrien Ansquer, Gaelle Frugier, Keith L. Davis, Elizabeth J. Esterberg, Olga Oikonomidou. European treatment patterns and outcomes associated with first-line CDK4/6 inhibition and hormonal therapies assessed in a real-world non-interventional study (EUCHARIS) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-19-04.

Background: Ribociclib (RIB; a selective CDK4/6 inhibitor) + endocrine therapy (ET; aromatase inhibitor or fulvestrant along with ovarian suppression in pre- and perimenopausal patients [pts]) received USFDA and EMA approval for pre-, peri- and postmenopausal pts with HR+, HER2- advanced breast cancer (ABC) based on results from phase 3 MONALEESA (ML) trials. In ML-2 trial, first-line treatment (tx) with RIB + letrozole (LET) vs placebo (PBO) + LET significantly improved median progression-free survival (mPFS) in postmenopausal pts with HR+, HER2- ABC. In ML-3 and ML-7 trials, RIB + ET vs PBO + ET showed a significant improvement in mPFS and overall survival among pts with HR+, HER2- ABC, irrespective of menopausal status, line of tx and combination partner. Real-world evidence on the effectiveness, safety, and tolerability of RIB + ET in pts with HR+, HER2- ABC would help to gain insight into routine clinical practice. Methods: RIBANNA is a prospective, noninterventional study ongoing in Germany since October 2017. Pre-, peri- and postmenopausal pts who received first-line tx with RIB + ET, or ET alone or chemotherapy (CT) for HR+, HER2- ABC in accordance with German tx guidelines were included. Data from routine clinical practice in all 3 cohorts, including further lines of sequential therapy, were collected. The third interim analysis data from RIBANNA study was presented in SABCS 2020. Fourth interim analysis data will be presented during SABCS 2021. Results: Till February 11, 2021, 2594 pts were included in the study (RIB + ET, n = 2183; ET, n = 229; CT, n = 182) and the enrollment was stopped; however, pt follow-up will be continued for an additional 4 years. For the fourth interim analysis, full analysis set (comprising all pts, except screening failures and locked pts, who received at least one dose of study medication [safety analysis set] and for whom ≥ 1 post-baseline evaluation was recorded) included 2131 pts (RIB + ET, n = 1814 [81.2%]; ET, n = 175 [73.8%]; CT, n = 142 [72.1%]), while the safety analysis set comprised 2452 pts (RIB + ET, n = 2062 [92.3%]; ET, n = 216 [91.1%]; CT, n = 174 [88.3%]). Until last patient first visit, among 2594 treated pts (including screening failures), data from first-line (1L) tx are available for 2452 pts (94.5%), from second-line (2L) tx for 343 pts (13.2%), and from third-line (3L) tx for 74 pts (2.9%, Table 1). Overall, 23.9%, 27.9%, and 43.4% of pts discontinued the study in RIB + ET, ET, and CT cohorts, respectively. The fourth interim analysis is planned in October 2021, and the final baseline demographic data as well as updated information on safety will be presented during SABCS 2021. Conclusion: RIBANNA study showed diverse population characteristics among pts who received RIB tx in a real-world setting. The data from fourth interim analysis, which is planned in October 2021, including final baseline demographic data and updated safety data will be presented. Table 1. Patient disposition following last patient first visit on February 11, 2021PatientsTotal. (N = 2594). n (%)RIB + AI/FUL (n = 2183). n (%)ET (n = 229). n (%)CT. (n = 182). n (%)Includeda2594 (100.0)2183 (100.0)229 (100.0)182 (100.0)Treated (including screening failures)2452 (94.5)2062 (94.5)216 (94.3)174 (95.6)1L therapyb2452 (94.5)2062 (94.5)216 (94.3)174 (95.6)2L therapyb343 (13.2)264 (12.1)36 (15.7)43 (23.6)3L therapyb74 (2.9)53 (2.4)10 (4.4)11 (6.0)4L therapyb7 (0.3)7 (0.3)0 (0.0)0 (0.0)Discontinued studyc664 (25.6)521 (23.9)64 (27.9)79 (43.4)aAll pts signing informed consent form, bNumber of data set available till February11, 2021, cEnd of documentation with reason other than ‘end of study. Citation Format: Diana Lüftner, Cosima Brucker, Thomas Decker, Peter Fasching, Thomas Göhler, Christian Jackisch, Jan Janssen, Andreas Köhler, Kerstin Lüdtke-Heckenkamp, Marion van Mackelenbergh, Frederik Marmé, Arnd Nusch, Beate Rautenberg, Toralf Reimer, Marcus Schmidt, Rudolf Weide, Pauline Wimberger, Naiba Nabieva, Christian Roos, Achim Wöckel. Real-world efficacy of ribociclib + aromatase inhibitor/fulvestrant, or endocrine monotherapy, or chemotherapy as first-line treatment in women with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) locally advanced or metastatic breast cancer: Fourth interim analysis from the RIBANNA study [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P1-18-15.

Introduction: Gynecomastia is a benign proliferation of the glandular tissue of the breast in males. Depending on the age, it can be considered a physiological condition. Prepubertal unilateral gynecomastia is a rare phenomenon. There are only a few case reports described through the last few years. Case Presentation: We report the clinical appearance and management of prepubertal idiopathic unilateral gynecomastia in a 9-year-old boy. We further include a literature review of 14 cases from 2011 to 2021. In contrast to pubertal gynecomastia, prepubertal gynecomastia and especially unilateral prepubertal gynecomastia are extremely rare conditions. Most cases remain idiopathic. Conclusion: Chromosomal and genetic testing, as well as oncological, endocrine diagnostic and tests for liver and kidney function should be performed. In case of idiopathic prepubertal gynecomastia, surgery is an important part of therapy since patients suffer from their atypical and rare phenotype.