Search

Objective: To investigate the efficacy of the augmented reality (AR) app "Negami" as an active exploration training for the treatment of spatial neglect. Improvements of the ipsilesional attention and orientation bias (and resulting contralesional neglect) will be examined in stroke patients with spatial neglect and compared with a control group., Design: Randomized controlled trial with an experimental Negami group, consisting of patients with spatial neglect, and a group of neglect patients receiving standard neglect therapy., Setting: Three rehabilitation hospitals., Participants: Twenty right hemispheric stroke patients with spatial neglect (N=20)., Intervention: Over a period of 2 weeks, both groups received 5 training sessions per week (à 25 minutes). Neglect behavior was assessed weekly over a 5-week period, with the Negami therapy group receiving a second follow-up assessment at 1-to-2-month intervals after completion of training., Main Outcome Measures: Letter Cancellation, Bells Test, Copying Task, Line Bisection Task, and a self-developed "Exploration Test"., Results: Both groups improved significantly. While the Negami therapy group improved in 4 of 5 neglect tests used, the standard therapy group improved in only 1 of these tests. We observed significantly better improvement in the Negami group already after the first week of training. This difference was also significant after the end of the training as well as 1 week after the end of training and remained stable 1-2 months after the end of treatment., Conclusion: Negami can be used as an effective alternative or addition to current standard neglect therapy, and may even be superior to it., (Copyright © 2023 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Prof. Dr. med. Nina Ditsch: MSD, Roche, AstraZeneca, TEVA, Mentor, and MCI Healthcare. Prof. Dr. med. Michael Untch: Presentations, travel grants, all paid to his institution from: Abbvie, Amgen GmbH München, AstraZeneca, BMS, Celgene GmbH München, Daiji Sankyo, Eisai GmbH München, Janssen Cilag, Johnsen & Johnsen, Lilly Deutschland, Lilly Int., MSD Merck, Mundipharma, Myriad Genetics GmbH Zürich, Odonate, Pfizer GmbH Berlin, PUMA Biotechnology, Riemser, Roche Pharma AG, Grenzach Wyhlen, Sanofi Aventis Deutschland GmbH, Sividon Diagnostics Köln, TEVA Pharmaceuticals Ind. Ltd., and Berlin Pharmaceutical Industry. Prof. Dr. med. Cornelia Kolberg-Liedtke: Consulting: Phaon Scientific, Novartis, Pfizer, Pfizer, Novartis, SurgVision, Carl Zeiss Meditec, Amgen, and Onkowissen; presentations: Roche, Novartis, Pfizer, Lilly, Pfizer, Novartis, Roche, Genomic Health, Amgen, AstraZeneca, Riemser, Carl Zeiss Meditec, TEVA, Theraclion Janssen-Cilag, GSK, LIV Pharma, and Theramex; travel grants: Carl Zeiss Meditec, LIV Pharma, Novartis, Amgen, Pfizer, and Daiichi Sankyo. Prof. Dr. med. Christian Jackisch: Roche, AstraZeneca, and Novartis. Dr. David Krug: Merck Sharp & Dome. Prof. Dr. med. Michael Friedrich: Roche, Pfizer, AstraZeneca, and Novartis. Prof. Dr.med. Wolfgang Janni: Research grants and/or honoraria from: Sanofi-Aventis, Novartis, Roche, Pfizer, AstraZeneca, Chugai, GSK, Eisai, Cellgene, Lilly, Janssen, and Menarini. Prof. Dr. med. Volkmar Müller: Speaker honoraria from Amgen, AstraZeneca, Daiichi-Sankyo, Eisai, Pfizer, MSD, Novartis, Roche, Teva, and Seattle Genetics; consultancy honoraria from Genomic Health, Hexal, Roche, Pierre Fabre, Amgen, ClinSol, Novartis, MSD, Daiichi-Sankyo, Eisai, Lilly, Tesaro, and Nektar; institutional research support from Novartis, Roche, Seattle Genetics, and Genentech. Prof. Dr. med. Ute-Susann Albert: Lectures and/or consulting: Medexo GmbH, Institut für Versicherungsmedizin (IMV), and Pfizer. PD Dr. Malgorzata Banys-Paluchowski: Pfizer, Roche, Novartis, and Eli Lilly. Dr. med. Ingo Bauerfeind: Aurikamed and J. Eickeler. Prof. Dr. med. Jens-Uwe Blohmer: Honoraria: Amgen, AstraZeneca, Genomic Health Recipient, MSD Oncology, Myriad Genetics, Novartis, Pfizer, Roche, and Sonoscape; travel, accommodations, expenses: Pfizer and Roche. Prof. Dr. med. Wilfried Budach: No conflicts of interest. Prof. Dr. med. Peter Dall: Advisory boards: Olympus, Roche, Novartis, and Tesaro; congress support: Roche; lecture fees: Amgen and Roche. Prof. Dr. med. Ingo Diel: No conflicts of interest regarding this manuscript. PD Dr. med. Eva Maria Fallenberg: GE-Healthcare, Siemens, ECR, EUSOBI, ESOR, KCR, and DFG. Prof. Dr. med. Peter A. Fasching: Grants from Novartis, Biontech, and Cepheid; personal fees from Novartis, Roche, Pfizer, Celgene, Daiichi-Sankyo, AstraZeneca, Merck Sharp & Dohme, Myelo Therapeutics, Macrogenics, Eisai, Puma, and Lilly. Prof. Dr. med. Tanja Fehm: AstraZeneca, Celegene, Pfizer, Novartis, Roche, Teva, and Daichii Sankyo. Prof. Dr. med. Bernd Gerber: No conflicts of interest. PD Dr. med. Oleg Gluz: Honoraria for lectures and/or consulting: Celgene, Roche, Genomic Health, Amgen, Pfizer, Novartis, Lilly, Nanostring, Eisai, and MSD; travel grants: Celgene, Roche, and Daiichi Sankyo. Prof. Dr. Volker Hanf: No conflicts of interest regarding this manuscript. Prof. Dr. med. Nadia Harbeck: Honoraria for lectures and/or consulting: Agendia, Amgen, AstraZeneca, BMS, Celgene, Daiichi-Sankyo, Genomic Health, Lilly, MSD, Novartis, Odonate, Pierre Fabre, Pfizer, Roche, Sandoz/Hexal, and Seattle Genetics; Minority shareholder: Westdeutsche Studiengruppe (WSG). Prof. Dr. med. Jörg Heil: No conflicts of interest. Prof. Dr. med. Jens Huober: Research grants: Celgene, Novartis, and Hexal; lecture honoraria: Lilly, Novartis, Roche, Pfizer, AstraZeneca, MSD, Celgene, Eisai, and Abbvie; consulting: Lilly, Novartis, Roche, Pfizer, Hexal, AstraZeneca, MSD, Celgene, and Abbvie; travel expenses: Roche, Pfizer, Novartis, Celgene, and Daiichi. Herr Prof. Dr. med. habil. Hans H. Kreipe: Reimbursement for attending symposia: Ventana; other expenses (advisory boards, lectures): AMGEN, AstraZeneca, Genomic Health, Lilly, and Roche Pharma. Prof. Dr.med. Thorsten Kühn: Celgene, Roche, and Pfizer. Prof. Dr. med. Sherko Kümmel: Roche, Genentech, Novartis, AstraZeneca, Amgen, Celegene, SOMATEX, Daiichi Sankyo, Puma Biotechnologx, pfm medical, Pfizer, and MSD Oncology. Prof. Dr. med. Sibylle Loibl: Abbvie, Amgen, AstraZeneca, Celgene, Novartis, Pfizer, Roche, Seattle Genetics, PriME/Medscape, Chugai, Teva, Vifor, Daiichi-Sankyo, Lilly, Samsung, Eirgenix, BMS, Puma, MSD, and Immunomedics. Prof. Dr. med. Diana Lüftner: Advisory boards/oral presentations: Amgen, AstraZeneca, Celegene, Lilly, Loreal, MSD, Mundipharma, Mylan, Novartis, Pfizer, Roche, Teva, and Tesaro. Prof. Dr. med. Michael Lux: Lilly, Pfizer, Roche, MSD, Hexal, Novartis, AstraZeneca, Eisai, Medac, and Genomic Health for advisory boards, lectures, and travel support. Prof. Dr. med. Nicolai Maass: No conflicts of interest. Prof. Dr. med. Volker Moebus: Amgen, Celegene, Roche, Myelotherapeutics, Roche, and Amgen. Prof. Dr. med. Christoph Mundhenke: Not specified. Prof. Dr. Tjoung-Won Park-Simon: Advisory role or expert testimony and lecture honoraria: Roche, AstraZeneca, Tesaro, Pfizer, Daichii, Lilly, and MSD; participation in clinical trials: Roche, AstraZeneca, Tesaro, Pfizer Daichii, Lilly, MSD, Novartis, and Seattle Genetics; other financial relationships, e.g., travel: Roche, AstraZeneca, Tesaro, Pfizer, Lilly, MSD, and Novartis. Prof. Dr. med. Toralf Reimer: grants from German Cancer Aid and Else Kroener-Fresenius-Stiftung; personal fees from Pfizer, Roche, Novartis, and AstraZeneca, outside the submitted work. PD. Dr. med. Kerstin Rhiem: AstraZeneca, Tesaro, Pfizer, and Roche. Prof. Dr. med. Achim Rody: Roche, Pfizer, Novartis, Celgen, Novartis, Genomic Health/Exact Sciences, AstraZeneca, Eisai, MSD, Hexal, and Amgen. Prof. Dr. med. Markus Schmidt: Honoraria: AstraZeneca, Novartis, Pfizer, and Roche; consulting or advisory role: AMGEN, AstraZeneca, BioNTech, Eisai, Lilly, Myelo Therapeutics, Novartis, Pantarhei Bioscience, Pfizer, and Roche; travel, accommodations, expenses: BioNTech, Pantarhei Bioscience, Pfizer, and Roche; patents, royalties, other intellectual property: Patent issued EP2951317. Prof. Dr. med. Andreas Schneeweiss: Grants: Celgene, Roche, Abbvie, and Molecular Partner; personal fees: Roche, AstraZeneca, Celgene, Pfizer, Novartis, MSD, Tesaro, and Lilly. Prof. Dr. med. Christine Solbach: Travel, accommodations: Roche, Novartis, AstraZeneca, Amgen, Celgene, Hexal, Daiichi Sankyo, Dialog Service GmbH, Lilly, Pfizer, MSD Oncology, ESAI, Gedon Richter, Mylan, and Tesaro. Prof. Dr. med. Erich-Franz Solomayer: Roche, AstraZeneca, Pfizer Roche, Amgen, Celgen, Tesaro, AstraZeneca, Pfizer, Storz, Erbe, Gedeon Richter, Eisai, Medac, MSD, Vifor, Teva, and Ethikon. Prof. Dr. med. Elmar Stickeler: Consulting: Novartis, Pfizer, AstraZeneca, Roche, and Tesoro; honoraria: Novartis, Pfizer, AstraZeneca, and Roche. Prof. Dr. med. Christoph Thomssen: Advisory boards, lectures: Amgen, AstraZeneca, Celgen, Daiichi-Sankyo, Eisai, Lilly, MSD, Mundipharma, Medapharm, Novartis, Pfizer, Pierre-Fabre, Roche, Tesaro, and Vifor. PD Dr. Isabell Witzel: Not specified. Prof. Dr. med. Achim Wöckel: Amgen, AstraZeneca, Aurikamed, Celgene, Eisai, Lilly, Novartis, Pfizer, Roche, and Tesaro. PD. Dr. med. Marc Thill: Advisory board: Amgen, AstraZeneca, Celgene, ClearCut, Clovis, Daiichi Sankyo, Exact Sciences, Lilly, MSD, Neodynamics, Novartis, Pfizer, pfm Medical, Pierre-Fabre, Roche, and Tesaro; manuscript support: Amgen, Celgene, and Roche; travel expenses: Amgen, Art Tempi, AstraZeneca, Celgene, Clovis, Connect Medica, Daiichi Sankyo, Exact Sciences, Hexal, I-Med-Institute, Lilly, MCI, MSD, Novartis, Pfizer, pfm Medical, Roche, and Tesaro; congress costs: Amgen, AstraZeneca, Celgene, Daiichi Sanyko, Hexal, Novartis, Pfizer, and Roche; lectures: Amgen, Art Tempi, AstraZeneca, Celgene, Clovis, Connect Medica, Exact Sciences, Hexal, I-Med-Institute, Lilly, MCI, MSD, Novartis, OnkoLive, Pfizer, pfm Medical, and Roche; trial funding: Exact Sciences.

Aim: The aim of this official guideline published by the German Society of Gynecology and Obstetrics (DGGG) and coordinated with the German Society of Urology (DGU) and the German Society of Reproductive Medicine (DGRM) is to provide consensus-based recommendations, obtained by evaluating the relevant literature, on counseling and fertility preservation for prepubertal girls and boys as well as patients of reproductive age. Statements and recommendations for girls and women are presented below. Statements or recommendations for boys and men are not the focus of this guideline., Methods: This S2k guideline was developed at the suggestion of the guideline commission of the DGGG, DGU and DGRM and represents the structured consensus of representative members from various professional associations (n = 40)., Recommendations: The guideline provides recommendations on counseling and fertility preservation for women and girls which take account of the patient's personal circumstances, the planned oncologic therapy and the individual risk profile as well as the preferred approach for selected tumor entities.

Aim: The Neoadjuvant PI3K inhibition in HER2 OverExpressing Breast cancEr (NeoPHOEBE) trial evaluated the efficacy and safety of buparlisib, a pan-phosphatidylinositol 3-kinase (PI3K) inhibitor, plus trastuzumab and paclitaxel as neoadjuvant treatment for human epidermal growth factor receptor-2 positive (HER2+) breast cancer., Methods: NeoPHOEBE was a neoadjuvant, phase II, randomised, double-blind study. Women with HER2+ breast cancer were randomised within two independent cohorts by PIK3CA mutation status and, in each cohort stratified by oestrogen receptor (ER) status to receive buparlisib or placebo plus trastuzumab (first 6 weeks) followed by buparlisib or placebo with trastuzumab and paclitaxel. Primary end-point was pathological complete response (pCR) rate; key secondary end-point was objective response rate (ORR) at 6 weeks. Exploratory end-points were evaluation of Ki67 levels and change in tumour infiltrating lymphocytes (TILs) in intermediate biopsies at day 15., Results: Recruitment was suspended mainly due to liver toxicity after enrolment of 50 of the planned 256 patients. In each arm (buparlisib n = 25; placebo n = 25) 21 patients (84%) had wild type PIK3CA and 4 patients (16%) had mutant PIK3CA. Overall, pCR rate was similar between buparlisib and placebo arms (32.0% versus 40%; one-sided P = 0.811). A trend towards higher ORR (68.8% versus 33.3%; P = 0.053) and a significant decrease in Ki67 (75% versus 26.7%; P = 0.021) was observed in buparlisib versus placebo arm in the ER+ subgroup (P interaction  = 0.03)., Conclusions: Addition of the pan-PI3K inhibitor buparlisib to taxane-trastuzumab-based therapy in HER2+ early breast cancer was not feasible. However, the higher ORR and Ki67 reduction in the ER+, HER2+ subgroup indicates a potential role for PI3K-targeted therapy in this setting and may warrant further investigation with better-tolerated second-generation PI3K inhibitors., Trial Registration Identifier: NCT01816594., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Aim: To analyze how patients experience Stereotactic guided vacuum-assisted breast biopsy (VABB) both physically and mentally., Patients and Methods: Two hundred and eleven consecutive women underwent VABB using one of two different biopsy devices (ATEC® and Mammotome®). Patients were queried using a questionnaire., Results: One hundred and eighty-nine patients were included. 90% would again prefer VABB over a surgical biopsy. Average grading for the condition during the procedure was 2.5 (very good to good) and 2.1 (very good) for the condition the week following VABB. Minor complications were mentioned in 37%. (>90% pain and hematoma). 97% of the women were satisfied by the cosmetic results. Patients with malignant histology and younger age experienced the procedure significantly worse. A significant higher rate of minor complications was found in younger patients and in the ATEC® group., Conclusion: VABB is a physical and mental stressor to the women. Nonetheless, the majority of women indeed prefer the VABB., (Copyright© 2014 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.)

Breast cancer centres - certified in accordance with the criteria of the German Cancer Association and the German Mastology Association - are established throughout Germany. Although the setting up of centres and the subsequent need for certification are associated with a marked increase in costs, initial data show positive effects on quality. Certified centres are cost-effective from the point of view of health economics - they lead to improved quality in processes and results without creating any increase in costs for the funding bodies. However, the organization of the necessary structures, with interdisciplinary treatment, documentation and quality-assurance measures, requires considerable resources. Increasing consolidation of inpatient services is also involved, while shortening of the patients' hospitalization periods is leading to reduced remuneration from the funding bodies. The current cost deficits, which have resulted from the increased resources required, need to be recouped through additional charges. It will only be possible to maintain the high quality achieved if additional charges become available to cover the centres' added costs. Good data are increasingly becoming available as a basis for negotiations on charges - e.g., with regard to the quality of results and the National Cancer Plan - as well as clear support from patients.

The transcription factor T-box-expressed-in-T-cells (T-bet) is required for T(H)1 lymphocyte differentiation, regulates the IL-12-induced expression of the T(H)1-specific cytokine IFNgamma and may be dysregulated in asthmatics. The modulatory role of extracellular signal-regulated kinase (ERK)-1/-2, p38mitogen-activated protein kinase (MAPK) and dexamethasone on IL-12 induced T-bet and IFNgamma expression was assessed in peripheral blood lymphocytes of 10 atopic asthmatics and 10 nonatopic normals. IFNgamma production was dependent on phosphorylation of ERK-1/-2 and p38MAPK, as examined by PD098059, an inhibitor of the upstream activator of MAPKkinase (MKK-1), and SB203580, an inhibitor of p38MAPK. The inhibitory effect of PD098059 on IFNgamma release was decreased in asthmatic T-cells compared with normals. The IL-12-induced T-bet expression and the inhibitory effect of SB203580 were increased in asthmatic T-cells compared with normals. Dexamethasone blocked the IL-12-induced T-bet expression in asthmatic T-cells completely and decreased IL-12-induced IFNgamma release by approximately 50%, which occurred to the same extent in asthmatic and normal T-cells. In conclusion, (1) p38MAPK-pathway rather than ERK-pathway may play a more basic role in the regulation of the increased T-bet expression in asthma, and (2) ERK- and p38MAPK-activation modulate IFNgamma expression independently of T-bet and this regulatory role of ERK-1/-2 on IFNgamma release is impaired in asthma. The therapeutic benefit of dexamethasone on T-bet and IFNgamma production seems to be critical.