20 results on '"D. Rezek"'
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2. Quality of life, effectiveness and patient reported outcomes of antiemetic prophylaxis with NEPA within the German NIS AkyPRO: post-hoc analysis of patients receiving carboplatin-based chemotherapy
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J Schilling, R Lorenz, D Rezek, L Bauer, D Hornung, D Sattler, S Ackermann, and M Karthaus
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- 2020
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3. Quality of life, effectiveness and patient reported outcomes of antiemetic prophylaxis with NEPA within the German NIS AkyPRO: post-hoc analysis of patients receiving carboplatin-based chemotherapy
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E Müller, G. Kaltenecker, D Rezek, D Sattler, L Bauer, S Ackermann, J Schilling, D Hornung, R Lorenz, N Gazawi, and M Karthaus
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medicine.medical_specialty ,Chemotherapy ,medicine.drug_class ,business.industry ,medicine.medical_treatment ,Carboplatin ,language.human_language ,German ,chemistry.chemical_compound ,Quality of life (healthcare) ,chemistry ,Post-hoc analysis ,medicine ,language ,Antiemetic ,Intensive care medicine ,business - Published
- 2020
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4. Nachhaltigkeit in der ästhetischen Mammachirurgie
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H.-J. Künzig, K. Brunnert, and D. Rezek
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Gynecology ,medicine.medical_specialty ,media_common.quotation_subject ,Head and neck surgery ,medicine ,Surgery ,Art ,media_common - Abstract
Der Begriff Nachhaltigkeit steht fur Dauerhaftigkeit, langfristige Stabilitat und Zukunftsfahigkeit. Er stammt aus der Forstwirtschaft und bezeichnet eine verantwortungsvolle Nutzung der Walder mit der Vermeidung eines dauerhaften Kahlschlags. Die Politik des 20. Jh. hat diesen Begriff aufgenommen, unter der Zielrichtung einer enkelgerechten Zukunft. Das „Dreisaulenmodell“ kennt eine okologische, eine okonomische und eine soziale Nachhaltigkeit. Hier findet sich der Ubergang zur arztlichen Verpflichtung der Nachhaltigkeit in der asthetischen Chirurgie. Als elektive Chirurgie unterliegen die Wahleingriffe besonderer Sorgfaltspflicht. Okologische Nachhaltigkeit verpflichtet den Arzt zum atraumatischen operativen Vorgehen mit Berucksichtigung potenzieller operativer Folgemasnahmen. Okonomisch sollte die Auswahl moglichst „einfacher“, der Situation angepasster Techniken sein. Unter einer sozialen Komponente versteht sich nicht zuletzt die Verbesserung der Lebensqualitat fur die betroffene Person. Dabei darf die Eigenverantwortung des oder der Betroffenen nicht vergessen werden, wie z. B. Korperpflege und qualifizierte Nachkontrollen. Der Chirurg wiederum verpflichtet sich zur Anwendung bewahrter Techniken und Materialien vor dem Hintergrund qualifizierter Fortbildung. Wichtig ist die Qualitat der verwendeten Brustimplantate. Der Chirurg muss den entscheidenden Einfluss auf die Produkte zur Implantation haben. Als Hochrisikomedizinprodukte der Klasse 3 unterliegen die Brustimplantate strengen Sicherheitskontrollen. Ein modernes Implantat muss ein kohasives medizinisches Silikongel mit niedrigem Olanteil enthalten, mit einer dreischichtigen Hulle, die eine zuverlassige Barriereschicht zur Unterbindung der Gelmigration enthalt. Fur eine geeignete Implantatauswahl sind die Dimensionen wichtiger als ein bestimmtes Volumen. Eine schonende und hochsterile Implantation von Brustimplantaten ist essenziell fur die Nachhaltigkeit des Ergebnisses.
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- 2018
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5. Aktuelle Erkenntnisse zur Eigenfett Transplantation anhand der neuen Leitlinie 'Autologe Fetttransplantation'
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Lukas Prantl, G Bull, Gerhard Sattler, Hans-Oliver Rennekampff, C H Witzel, A Schönborn, D von Heimburg, Christian Herold, Norbert Pallua, N. Heine, Yves Harder, Peter M. Vogt, F Lampert, K. Ueberreiter, D Rezek, Ulrich Kneser, Ursula Mirastschijski, Daniel Müller, Riccardo E. Giunta, H.-G. Machens, T Schantz, and Raymund E. Horch
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Gynecology ,030222 orthopedics ,03 medical and health sciences ,medicine.medical_specialty ,0302 clinical medicine ,business.industry ,Fat grafting ,Medicine ,Orthopedics and Sports Medicine ,Surgery ,030230 surgery ,business - Abstract
Hintergrund: Die autologe Fetttransplantation ist eine in letzter Zeit zunehmend verbreitete operative Prozedur und umfasst die Entnahme, Bearbeitung und Transplantation von Fettgewebe sowie die fachgerechte Nachsorge. Dieser operative Eingriff ist ein Verfahren, das sowohl nach traumatischem, krankheits- oder altersbedingtem Volumenverlust der Weichteile als auch zur Weichteilaugmentation eingesetzt werden kann. Aufgrund der zunehmenden Anwendung aber noch bisher wenig definierten Variablen in der Fettgewinnung, Indikationsstellung und Art der Transplantation in der rekonstruktiven und asthetischen Chirurgie besteht ein groses Interesse an der Entwicklung einer Leitlinie. Methodik: In einer Konsensuskonferenz im Rahmen eines nominalen Gruppenprozesses der anwendenden Fachgesellschaften wurden alle im Delphi-Verfahren strittigen Punkte diskutiert und mit starken Konsens (>95%) beschlossen. Die Literatur der letzten 10 Jahre in den gangigen medizinischen Informationsportalen und Datenbanken wurde abgefragt, studiert und unter Berucksichtigung auch wichtiger alterer Arbeiten entscheidende Aussagen der Leitlinie belegt. Ergebnisse: Unter Einschluss aller relevanten Fachgesellschaften wurden hinsichtlich nachfolgender Punkte konsensbasierte Empfehlungen in Form dieser Leitlinie formuliert. 1. Definition, 2. Indikation/Kontraindikation, 3. Praoperative Masnahmen, 4. Entnahmetechniken, 5. Bearbeitungstechniken, 6. Transplantation, 7. Nachsorge, 8. Aufbewahrung und Lagerung, 9. Effizienz, 10. Dokumentation, 11. Bewertung der Sicherheit. Zusammenfassung: Klare Indikationsstellung und fachliche Expertise sind Grundvoraussetzung um die autologe Fetttransplantation durchzufuhren. Der Erfolg dieses operativen Eingriffs ist abhangig vom Einsatz der richtigen Methoden sowie der speziellen Instrumente und Materialen. Aufgrund der niedrigen Rate an postoperativen Komplikationen und Spatfolgen ist die autologe Fetttransplantation als sicheres Verfahren in der rekonstruktiven und asthetischen Medizin anzusehen. Teile dieses Artikels sind wortlich aus der Leitlinie entnommen 1
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- 2016
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6. Stellenwert der autologen Fetttransplantation in der ästhetischen Chirurgie des Mammakarzinoms
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D. Rezek
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Gynecology ,medicine.medical_specialty ,business.industry ,Head and neck surgery ,Medicine ,Surgery ,business - Abstract
Die autologe Fetttransplantation gilt als sekundar rekonstruktives Verfahren und hat als Therapieziel eine Verbesserung der Lebensqualitat. Beim Lipofilling wird autologes Fett in den Empfangersitus ubertragen, um die Weichteilkontur der Empfangerregion zu optimieren. Brustkrebs ist die haufigste Krebserkrankung der Frau. Dank individualisierter Behandlungsmethoden steigen zwar die Heilungsraten, aber immer mehr Frauen mussen viele Jahre mit den Ergebnissen und Folgen der Operation leben. Auch wenn die Operationsverfahren immer differenzierter und an den individuellen Situs adaptiert sind, kommt es zu Narben, Defekten oder Einziehungen und Volumenverlust der Brust, durch eine nachfolgende Radiatio werden diese haufig verstarkt. Autologes Fett eignet sich zur Verstarkung des Weichteilmantels und zur Verbesserung der Kontur sowie auch der Hautperfusion und zum Volumenausgleich. Damit eignet Fett sich zur Rekonstruktion der Brust sowohl nach Mastektomie und Lappenplastik oder nach haut- und nippelsparender Mastektomie und Implantateinlage. Auch nach brusterhaltender Therapie eines Mammakarzinoms konnen Defekte, Asymmetrien und Narbenkonstriktionen mit Eigenfett kompensiert werden. Zu beachten ist, dass Fett ausschlieslich in eine gesunde Brust transplantiert werden darf. Vor der autologen Fetttransplantation sollte ein Residualtumor oder ein Rezidiv sicher ausgeschlossen werden. Je langer die Karenzzeit zwischen der Onkochirurgie und dem Fetttransfer ist, desto hoher ist die Sicherheit. Der Erfolg dieser Methode ist von profunden Kenntnissen der Methode, einer sorgfaltigen Ausfuhrung jedes einzelnen Behandlungsschrittes abhangig. Gemessen wird er an Parametern wie unbeeintrachtigte Beurteilbarkeit der Brust in der Bildgebung, Volumenstabilitat und onkologische Sicherheit.
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- 2016
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7. Evaluation des Therapiemanagements und der Therapieadhärenz bei postmenopausalen Patientinnen mit hormonrezeptorpositivem Mammakarzinom, die mit Letrozol behandelt werden – die EvaluateTM-Studie
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P. Fasching, T. Fehm, S. Kellner, J. deWaal, M. Rezai, B. Baier, G. Baake, H. Kolberg, M. Guggenberger, M. Warm, N. Harbeck, R. Würstlein, J. Deuker, P. Dall, B. Richter, G. Wachsmann, C. Brucker, J. Siebers, N. Fersis, T. Kuhn, C. Wolf, H. Vollert, G. Breitbach, W. Janni, R. Landthaler, A. Kohls, D. Rezek, T. Noesslet, G. Fischer, S. Henschen, T. Praetz, V. Heyl, T. Kühn, T. Krauß, C. Thomssen, S. Kümmel, A. Hohn, H. Tesch, C. Mundhenke, A. Hein, C. Rauh, C. Bayer, A. Jacob, K. Schmidt, E. Belleville, P. Hadji, D. Wallwiener, E. Grischke, M. Beckmann, and S. Brucker
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Gynecology ,medicine.medical_specialty ,business.industry ,Endocrine therapy ,Medicine ,business - Abstract
Einleitung: Die EvaluateTM-Studie (Evaluation of therapy management and patient compliance in postmenopausal hormone receptor positive breast cancer patients receiving letrozole treatment) ist eine prospektive, nicht interventionelle Studie, die das Therapiemanagement und die Compliance im Rahmen der Routineversorgung unter einer Therapie mit Letrozol bei postmenopausalen Patientinnen mit einem invasiven, hormonrezeptorpositiven Mammakarzinom als Studienziel hatte. In dieser Publikation werden die Parameter bei Studieneinschluss berichtet. Material und Methoden: Von Januar 2008 bis Dezember 2009 wurden insges. 5045 Patientinnen in 310 Prufzentren in die EvaluateTM-Studie eingeschlossen. Zugelassen waren Patientinnen mit einem hormonrezeptorpositiven Mammakarzinom in der adjuvanten und metastasierten Therapiesituation. 373 Patientinnen mussten aus unterschiedlichen Grunden aus den Analysen ausgeschlossen werden. Ergebnisse: Insgesamt wurden 4420 Patientinnen in der adjuvanten und 252 Patientinnen in der palliativen (metastasierten) Situation in die Studie eingeschlossen. Bei 4181 Patientinnen in der adjuvanten Situation wurde direkt nach operativer Therapie mit einer Aromataseinhibitortherapie mit Letrozol begonnen (upfront). Bei 200 Patientinnen wurde zunachst Tamoxifen gegeben und in den Jahren 2 – 5 nach Diagnosestellung mit der Aromatasehemmertherapie mit Letrozol begonnen (switch), und bei 39 Patientinnen erst 6 – 10 Jahren nach Diagnosestellung (extended endocrine therapy). Die Patientinnen- und Tumorcharakteristika lagen ebenso wie die Begleiterkrankungen und die Begleitmedikation im Bereich des Erwarteten. Schlussfolgerung: Die Daten der EvaluateTM-Studie werden einen guten Einblick in das Therapiemanagement von postmenopausalen Patientinnen mit einem hormonrezeptorpositiven Mammakarzinom im Rahmen der Routineversorgung geben. Geplante Analysen beinhalten die Therapiepersistenz und die Zufriedenheit mit den Informationsstrukturen und dem Aufklarungsinhalt.
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- 2015
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8. Interest in integrative medicine among postmenopausal hormone receptor-positive breast cancer patients receiving letrozole treatment in the EvAluate-TM study
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CC Hack, PA Fasching, T Fehm, J de Waal, M Rezai, B Baier, G Baake, HC Kolberg, M Guggenberger, M Warm, N Harbeck, R Wuerstlein, JU Deuker, P Dall, B Richter, G Wachsmann, C Brucker, JW Siebers, N Fersis, T Kuhn, C Wolf, HW Vollert, GP Breitbach, W Janni, R Landthaler, A Kohls, D Rezek, T Noesselt, G Fischer, S Henschen, T Praetz, V Heyl, T Kühn, T Krauß, C Thomssen, A Hohn, H Tesch, C Mundhenke, A Hein, C Rauh, CM Bayer, A Jacob, K Schmidt, E Belleville, P Hadji, SY Brucker, D Wallwiener, D Paepke, S Kümmel, and MW Beckmann
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medicine.medical_specialty ,Chemotherapy ,030219 obstetrics & reproductive medicine ,business.industry ,Letrozole ,medicine.medical_treatment ,Alternative medicine ,Obstetrics and Gynecology ,Disease ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,030220 oncology & carcinogenesis ,Concomitant ,Internal medicine ,Maternity and Midwifery ,Physical therapy ,medicine ,Integrative medicine ,business ,Body mass index ,medicine.drug - Abstract
Background: Breast cancer patients make frequent use of complementary and alternative medicine (CAM), but few prospectively collected data are available specifically for postmenopausal breast cancer patients receiving adjuvant antihormonal therapy. The aim of the study was to identify the characteristics of patients who are interested in integrative medicine (IM). Methods: The EvAluate-TM study is a prospective noninterventional study, in which treatment with letrozole was evaluated in postmenopausal women with hormone receptor-positive primary breast cancer. 5,045 patients were enrolled at 339 certified breast centers. As part of the data collection process, patients were asked at the baseline about their interest in and information needs about IM. Results: 3,411 patients responded to the questionnaire on IM and took part in the analysis. 1,583 patients expressed an interest in IM. Relevant predictors of interest in IM were age, body mass index, tumor size, previous chemotherapy, and use of concomitant medications for other medical conditions. Interest in IM declined highly significantly (P < 0.001) with age. In addition, these women were mostly interested in receiving information about their disease from a physician. Conclusions: This study shows that postmenopausal women have a strong interest in IM. Information about IM should therefore be included in patient care for this patient group. Especially the patients receiving concomitant medication, which is one of the main predictors for women not being interested in IM, may need special attention. In addition, most patients were interested in obtaining the relevant information from their doctor, indicating that responsibility for this lies with the treating physicians.
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- 2016
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9. Ästhetische Chirurgie des Mammakarzinoms
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D. Rezek
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medicine.medical_specialty ,Plastic surgery ,Otorhinolaryngology ,business.industry ,Head and neck surgery ,Medicine ,Surgery ,business - Published
- 2016
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10. Quality of Life Effects of an Oral Fixed Combination of Netupitant and Palonosetron in Chemotherapy-Induced Nausea and Vomiting Prevention: Real-World Evidence in Patients with Breast Cancer Receiving Anthracycline-Cyclophosphamide-Based Chemotherapy.
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Schilling J, Kurbacher CM, Hanusch C, Busch S, Holländer M, Kreiss-Sender J, Rezek D, Flahaut E, and Karthaus M
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Introduction: In a prospective non-interventional study involving 2,173 patients, we showed that use of the oral fixed combination of netupitant 300 mg and palonosetron 0.5 mg (NEPA) for prevention of chemotherapy (Ctx)-induced nausea and vomiting has beneficial effects on the quality of life (QoL) of patients with various types of cancers receiving highly or moderately emetogenic Ctx. Here, we report on the effects on QoL, effectiveness, and tolerability of NEPA in patients with breast cancer exposed to anthracycline-cyclophosphamide (AC)-based Ctx., Methods: This is a post hoc subanalysis of a prospective non-interventional study in 1,197 patients with breast cancer receiving up to 3 cycles of doxorubicin or epirubicin plus cyclophosphamide and NEPA. NEPA administration was per the summary of product characteristics., Results: In cycle 1 of Ctx, a large proportion of patients (84%) reported "no impact on daily life" (NIDL) due to vomiting; 53% of patients reported NIDL due to nausea. The complete response rate was 86/88/81% in the acute/delayed/overall phase in cycle 1, and NEPA was well tolerated throughout the study., Conclusion: The real-world beneficial effects of NEPA prophylaxis on QoL were confirmed for patients with breast cancer receiving AC. NEPA was effective with a good safety profile in this patient population in clinical practice., Competing Interests: J.S.: honoraria, travel expenses, RIEMSER Pharma GmbH. C.M.K.: honoraria, Amgen, Eli Lilly, Novartis, Mundipharma, Pfizer, PharmaMar, RIEMSER, Roche, Tesaro; consulting or advisory role, Amgen, Axios, Eli Lilly, Hilotherm, Mundipharma, NewCo, Novartis, Pfizer, RIEMSER, Roche, Tesaro; research funding, AstraZeneca, Axios, MSD Sharp & Dohme (Merck), NewCo, Novartis, Pfizer, PharmaMar, RIEMSER, Seattle Genetics, Immunomedics; travel, accommodations, expenses, Amgen, Hexal, Immunomedics, Pfizer, PharmaMar, Tesaro, Teva Oncology. C.H.: advisory board, AstraZeneca, Lilly, Pfizer, Roche. S.B.: lectures, studies and support for congress participation, Amgen, Roche, Novartis, Pfizer, Riemser, Lilly, Clovis, GSK, Onkovis, AstraZeneca, MSD. M.H.: honoraria, Pfizer, AstraZeneca, iOMEDICO, MMF, Amgen; research funding, RIEMSER, Indivumed. J.K.-S. and D.R.: nothing to disclose. E.F.: RIEMSER employee. M.K.: ad board, travel grant, Helsinn Healthcare, RIEMSER Pharma GmbH., (Copyright © 2021 by S. Karger AG, Basel.)
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- 2022
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11. Influence of patient and tumor characteristics on therapy persistence with letrozole in postmenopausal women with advanced breast cancer: results of the prospective observational EvAluate-TM study.
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Wallwiener M, Nabieva N, Feisst M, Fehm T, de Waal J, Rezai M, Baier B, Baake G, Kolberg HC, Guggenberger M, Warm M, Harbeck N, Wuerstlein R, Deuker JU, Dall P, Richter B, Wachsmann G, Brucker C, Siebers JW, Popovic M, Kuhn T, Wolf C, Vollert HW, Breitbach GP, Janni W, Landthaler R, Kohls A, Rezek D, Noesselt T, Fischer G, Henschen S, Praetz T, Heyl V, Kühn T, Krauss T, Thomssen C, Hohn A, Tesch H, Mundhenke C, Hein A, Rauh C, Bayer CM, Schmidt K, Belleville E, Brucker SY, Hadji P, Beckmann MW, Wallwiener D, Kümmel S, Hartkopf A, and Fasching PA
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- Aged, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Middle Aged, Patient Dropouts, Prospective Studies, Treatment Outcome, Treatment Refusal, Aromatase Inhibitors therapeutic use, Breast Neoplasms drug therapy, Letrozole therapeutic use, Patient Compliance, Postmenopause
- Abstract
Background: Treatment of postmenopausal, hormone receptor-positive metastatic breast cancer (MBC) patients varies despite clear therapy guidelines, favoring endocrine treatment (ET). Aim of this study was to analyze persistence of palliative aromatase inhibitor (AI) monotherapy in MBC patients., Methods: EvAluate-TM is a prospective, multicenter, noninterventional study to evaluate treatment with letrozole in postmenopausal women with hormone receptor-positive breast cancer. To assess therapy persistence, defined as the time from therapy start to the end of the therapy (TTEOT), two pre-specified study visits took place after 6 and 12 months. Competing risk survival analyses were performed to identify patient and tumor characteristics that predict TTEOT., Results: Out of 200 patients, 66 patients terminated treatment prematurely, 26 (13%) of them due to causes other than disease progression. Persistence rate for reasons other than progression at 12 months was 77.7%. Persistence was lower in patients who reported any adverse event (AE) in the first 30 days of ET (89.5% with no AE and 56% with AE). Furthermore, patients had a lower persistence if they reported compliance problems in the past before letrozole treatment., Conclusions: Despite suffering from a life-threatening disease, AEs of an AI will result in a relevant number of treatment terminations that are not related to progression. Some subgroups of patients have very low persistence rates. Especially with regard to novel endocrine combination therapies, these data imply that some groups of patients will need special attention to guide them through the therapy process., Trial Registration: Clinical Trials Number: CFEM345DDE19.
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- 2019
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12. Autologous Lipotransfer - Daily Therapeutic Practice in Breast Cancer: An Intergroup Analysis Encompassing NOGGO, WSG, GBG, AWO Gyn and DGPRÄC.
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Kümmel A, Kümmel S, Blohmer JU, Faridi A, Nitz U, Loibl S, von Fritschen U, Rezek D, Hagemann F, Holtschmidt J, Botzenhardt S, and Reinisch M
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Background: Autologous fat transfer in breast reconstruction has become increasingly important in breast reconstructive surgery. Although the indication to obtain fat, the various operative procedures, and the risks for the patient have been addressed in a large number of studies, detailed information on the everyday use of autologous lipotransfer in breast units in Germany is still lacking., Methods: The objective of the study was to obtain primary data on the use of autologous lipotransfer to treat breast cancer patients in Germany and to determine measures for quality assurance in the daily practice. An online questionnaire concerning breast cancer and lipofilling was sent to specialists in gynecology and plastic surgery., Results: Two-thirds of the specialists who responded to the questionnaire use autologous lipotransfer for breast reconstruction and did not report an increase of local recurrence following lipotransfer. There were only small differences between gynecologists and plastic surgeons regarding the procedure and indication for lipotransfer. The method is highly accepted by patients and physicians, and both gynecologists and plastic surgeons rated the improvement achieved through lipofilling as 'high'., Conclusions: The lack of randomized controlled data, especially in high-risk patients, demonstrates the necessity for a registry study on this topic. Our survey describes, in detail, the indications for lipofilling as well as its appropriate application in breast cancer patients in Germany and may thereby reduce the present therapeutic uncertainties.
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- 2019
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13. Benchmarking of a checklist for the identification of familial risk for breast and ovarian cancers in a prospective cohort.
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Rhiem K, Bücker-Nott HJ, Hellmich M, Fischer H, Ataseven B, Dittmer-Grabowski C, Latos K, Pelzer V, Seifert M, Schmidt A, Rezek D, Groh U, Meinerz W, Crommelinck D, Hahnen E, Wesselmann S, and Schmutzler RK
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- BRCA1 Protein genetics, BRCA2 Protein genetics, Benchmarking, Breast Neoplasms epidemiology, Checklist, Female, Genetic Predisposition to Disease, Germany, Humans, Incidence, Middle Aged, Mutation, Ovarian Neoplasms epidemiology, Breast Neoplasms genetics, Medical History Taking, Ovarian Neoplasms genetics
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The detection of deleterious germline mutations in BRCA1 and BRCA2 considerably influences the clinical management of healthy and diseased carriers. Therefore, the identification of persons at risk who could uptake genetic counseling and testing is pivotal. We developed a checklist with validated criteria to improve the identification, and prospectively evaluate the incidence, of familial cancer history in 5091 breast cancer patients. The rate of 30.4% of patients at high genetic risk underpins the demand for care in risk identification and counseling. The easy-to-use instrument promotes the implementation and dissemination of risk counseling by physicians., (© 2019 Wiley Periodicals, Inc.)
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- 2019
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14. Influence of side-effects on early therapy persistence with letrozole in post-menopausal patients with early breast cancer: Results of the prospective EvAluate-TM study.
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Nabieva N, Fehm T, Häberle L, de Waal J, Rezai M, Baier B, Baake G, Kolberg HC, Guggenberger M, Warm M, Harbeck N, Wuerstlein R, Deuker JU, Dall P, Richter B, Wachsmann G, Brucker C, Siebers JW, Popovic M, Kuhn T, Wolf C, Vollert HW, Breitbach GP, Janni W, Landthaler R, Kohls A, Rezek D, Noesselt T, Fischer G, Henschen S, Praetz T, Heyl V, Kühn T, Krauss T, Thomssen C, Hohn A, Tesch H, Mundhenke C, Hein A, Hack CC, Schmidt K, Belleville E, Brucker SY, Kümmel S, Beckmann MW, Wallwiener D, Hadji P, and Fasching PA
- Subjects
- Aged, Breast Neoplasms pathology, Female, Germany, Humans, Middle Aged, Prospective Studies, Risk Factors, Time Factors, Treatment Outcome, Antineoplastic Agents adverse effects, Aromatase Inhibitors adverse effects, Breast Neoplasms drug therapy, Letrozole adverse effects, Medication Adherence, Postmenopause
- Abstract
Background: Endocrine treatment (ET) with an aromatase inhibitor (AI) is the treatment of choice in post-menopausal patients with hormone receptor-positive early breast cancer (EBC). However, adverse events (AEs) often lead to treatment discontinuation. This analysis aimed to identify side-effects that lead to patients failing to persist with letrozole treatment., Patients and Methods: Post-menopausal hormone receptor-positive EBC patients starting ET with letrozole were enroled in EvAluate-TM, a non-interventional study. Information regarding treatment compliance and persistence was gathered in months 6 and 12. Persistence was defined as the time from 30 d after the start to the end of treatment. The influence on persistence of musculoskeletal syndrome, menopausal disorder, sleep disorder and other AEs within the first 30 d was analysed using Cox regression analyses., Results: Among 3887 patients analysed, the persistence rate after 12 months was >85%. In all, 568 patients (14.6%) discontinued the treatment, 358 of whom (63.0%) did so only because of side-effects. The main AEs influencing persistence were musculoskeletal symptoms (hazard ratio [HR] 2.55; 95% confidence interval [CI], 1.90-3.42), sleep disorders (HR 1.95; 95% CI, 1.41-2.70) and other AEs (HR 2.03; 95% CI, 1.51-2.73). Menopausal disorder was not associated with non-persistence (HR 1.17; 95% CI, 0.74-1.84)., Conclusions: These results suggest that side-effects of AIs such as musculoskeletal syndrome and sleep disorder lead to ET discontinuation within the first treatment year in significant numbers of EBC patients. Compliance programmes adapted for subgroups that are at risk for early non-persistence might help to ensure the recommended therapy duration., Clinical Trials Number: CFEM345DDE19., (Copyright © 2018 Elsevier Ltd. All rights reserved.)
- Published
- 2018
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15. Trastuzumab without chemotherapy in the adjuvant treatment of breast cancer: subgroup results from a large observational study.
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Dall P, Koch T, Göhler T, Selbach J, Ammon A, Eggert J, Gazawi N, Rezek D, Wischnik A, Hielscher C, Schleif N, Cirrincione U, Hinke A, and Feisel-Schwickardi G
- Subjects
- Adult, Aged, Aged, 80 and over, Breast Neoplasms genetics, Breast Neoplasms pathology, Disease-Free Survival, Female, Humans, Middle Aged, Neoplasm Staging, Receptor, ErbB-2 genetics, Breast Neoplasms drug therapy, Breast Neoplasms epidemiology, Trastuzumab administration & dosage
- Abstract
Background: The topic of trastuzumab therapy without chemotherapy in early breast cancer (EBC) has been repeatedly discussed at international consensus meetings, but is compromised by the lack of solid evidence from clinical studies., Methods: An observational study database of patients with EBC receiving trastuzumab-containing (neo)adjuvant therapy was screened to identify those patients who did not receive cytostatic agents., Results: Of 3935 patients, 232 (6%) were identified who received no chemotherapy, being characterized by older age, worse performance status, and/or less aggressive histology. Relapse-free survival in this cohort was 84% (95% confidence interval [CI] 78-89%) at 3 years and 80% (95% CI 74-87%) at 5 years. However, these rates were significantly worse than those in the group of patients who received chemotherapy (hazard ratio 1.49; 95% CI 1.06-2.09; P = 0.022). A similar pattern was observed for overall survival, with marginally non-significant inferiority in the group receiving no chemotherapy (hazard ratio 1.56; 95% CI 1.00-2.44; P = 0.052). Survival rates in patients receiving no chemotherapy were 93% (95% CI 88-97%) and 87% (95% CI 81-93%) at 3 and 5 years, respectively. These findings were confirmed by a propensity score analysis accounting for selection bias., Conclusions: Trastuzumab plus chemotherapy should remain the preferred option in all patients with HER2-positive EBC with an indication for adjuvant treatment. However, a limited proportion of patients will need an alternative treatment approach, either because of contraindications or the patient's preference. In these selected patients, trastuzumab monotherapy, eventually combined with endocrine agents, might be a reasonable option offering favorable long-term outcomes by addressing the high-risk profile associated with HER2-positive disease.
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- 2018
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16. Influence of patient and tumor characteristics on early therapy persistence with letrozole in postmenopausal women with early breast cancer: results of the prospective Evaluate-TM study with 3941 patients.
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Nabieva N, Kellner S, Fehm T, Häberle L, de Waal J, Rezai M, Baier B, Baake G, Kolberg HC, Guggenberger M, Warm M, Harbeck N, Wuerstlein R, Deuker JU, Dall P, Richter B, Wachsmann G, Brucker C, Siebers JW, Fersis N, Kuhn T, Wolf C, Vollert HW, Breitbach GP, Janni W, Landthaler R, Kohls A, Rezek D, Noesselt T, Fischer G, Henschen S, Praetz T, Heyl V, Kühn T, Krauss T, Thomssen C, Hohn A, Tesch H, Mundhenke C, Hein A, Rauh C, Bayer CM, Jacob A, Schmidt K, Belleville E, Brucker SY, Kümmel S, Beckmann MW, Wallwiener D, Hadji P, and Fasching PA
- Subjects
- Aged, Antineoplastic Agents administration & dosage, Aromatase Inhibitors administration & dosage, Breast Neoplasms pathology, Breast Neoplasms psychology, Chemotherapy, Adjuvant, Female, Humans, Middle Aged, Postmenopause, Prospective Studies, Breast Neoplasms drug therapy, Letrozole administration & dosage, Medication Adherence
- Abstract
Background: Patients' compliance and persistence with endocrine treatment has a significant effect on the prognosis in early breast cancer (EBC). The purpose of this analysis was to identify possible reasons for non-persistence, defined as premature cessation of therapy, on the basis of patient and tumor characteristics in individuals receiving adjuvant treatment with letrozole., Patients and Methods: The EvAluate-TM study is a prospective, multicenter, noninterventional study in which treatment with the aromatase inhibitor letrozole was evaluated in postmenopausal women with hormone receptor-positive EBC in the early therapy phase. Treatment persistence was evaluated at two pre-specified study visits after 6 and 12 months. As a measure of early therapy persistence the time from the start to the end of treatment (TTEOT) was analyzed. Cox regression analyses were carried out to identify patient characteristics and tumor characteristics predicting TTEOT., Results: Out of the total population of 3941 patients with EBC, 540 (13.7%) events involving treatment cessation unrelated to disease progression were observed. This was due to drug-related toxicity in the majority of cases (73.5%). Persistence rates were 92.2%, 86.9%, and 86.3% after 6, 12, and 15 months, respectively. The main factors influencing premature treatment discontinuation were older age [hazard ratio (HR) 1.02/year], comorbidities (HR 1.06 per comorbidity), low body mass index, and lower tumor grade (HR 0.85 per grade unit)., Conclusion: These results support the view that older, multimorbid patients with low tumor grade and low body mass index are at the greatest risk for treatment discontinuation and might benefit from compliance and support programs., (© The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2018
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17. Interest in Integrative Medicine Among Postmenopausal Hormone Receptor-Positive Breast Cancer Patients in the EvAluate-TM Study.
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Hack CC, Fasching PA, Fehm T, de Waal J, Rezai M, Baier B, Baake G, Kolberg HC, Guggenberger M, Warm M, Harbeck N, Wuerstlein R, Deuker JU, Dall P, Richter B, Wachsmann G, Brucker C, Siebers JW, Fersis N, Kuhn T, Wolf C, Vollert HW, Breitbach GP, Janni W, Landthaler R, Kohls A, Rezek D, Noesslet T, Fischer G, Henschen S, Praetz T, Heyl V, Kühn T, Krauss T, Thomssen C, Hohn A, Tesch H, Mundhenke C, Hein A, Rauh C, Bayer CM, Jacob A, Schmidt K, Belleville E, Hadji P, Brucker SY, Wallwiener D, Kümmel S, Beckmann MW, and Paepke D
- Subjects
- Aged, Female, Germany, Humans, Integrative Medicine methods, Letrozole, Middle Aged, Prospective Studies, Antineoplastic Agents therapeutic use, Aromatase Inhibitors therapeutic use, Breast Neoplasms drug therapy, Nitriles therapeutic use, Postmenopause drug effects, Triazoles therapeutic use
- Abstract
Background: Breast cancer patients often use complementary and alternative medicine, but few prospectively collected data on the topic are available specifically for postmenopausal breast cancer patients. A large prospective study was therefore conducted within a noninterventional study in order to identify the characteristics of patients interested in integrative medicine., Methods: The EvAluate-TM study is a prospective, multicenter noninterventional study in which treatment with the aromatase inhibitor letrozole was evaluated in postmenopausal women with hormone receptor-positive primary breast cancer. Between 2008 and 2009, 5045 postmenopausal patients were enrolled at 339 certified breast centers in Germany. As part of the data collection process, patients were asked at the baseline about their interest in and information needs relating to integrative medicine., Results: Of the 5045 patients recruited, 3411 responded to the questionnaire on integrative medicine and took part in the analysis, 1583 patients expressed an interest in integrative medicine, and 1828 patients declared no interest. Relevant predictors of interest in integrative medicine were age, body mass index, tumor size, previous chemotherapy, and use of concomitant medications for other medical conditions. Interest in integrative medicine declined highly significantly ( P < .001) with age (<50 years, 74.1%; 50-60 years, 54.1%; >65 years, 38.0%). Patients in favor of integrative medicine were significantly less satisfied with the information received about individual treatments and antihormonal therapy. Patients with interest in integrative medicine were more often interested in rehabilitation and fitness, nutritional counseling, and additional support from self-help organizations. These women were mostly interested in receiving information about their disease and integrative medicine from a physician, rather than from other sources., Conclusions: This study shows that a considerable proportion of postmenopausal breast cancer patients are interested in integrative medicine. Information about integrative medicine should therefore be provided as part of patient care for this group. It was found that receiving concomitant medication for other medical conditions is one of the main predictors for women not being interested in integrative medicine. This group of patients may need special attention and individualized information about integrative medicine. Additionally, most patients were interested in obtaining the relevant information from their doctor.
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- 2017
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18. Trastuzumab in Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: Results of a Prospective, Noninterventional Study on Routine Treatment Between 2006 and 2012 in Germany.
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Dall P, Koch T, Göhler T, Selbach J, Ammon A, Eggert J, Gazawi N, Rezek D, Wischnik A, Hielscher C, Keitel S, Cirrincione U, Hinke A, and Feisel-Schwickardi G
- Subjects
- Aged, Breast Neoplasms pathology, Female, Germany, History, 21st Century, Humans, Prospective Studies, Trastuzumab administration & dosage, Trastuzumab pharmacology, Breast Neoplasms drug therapy, Receptor, ErbB-2 metabolism, Trastuzumab therapeutic use
- Abstract
Purpose: Trastuzumab is part of the standard treatment in patients with human epidermal growth factor receptor 2-positive early breast cancer in addition to (neo)adjuvant chemotherapy. This German prospective noninterventional study, which included major patient cohorts underrepresented in the pivotal randomized studies, examined the generalizability of the results of those studies., Patients and Methods: Between 2006 and 2012, 4,027 patients were enrolled and treated with trastuzumab; they were unselected regarding age or concomitant/sequential adjuvant chemotherapy. Long-term outcome data were obtained in yearly intervals. All analyses were descriptive in nature., Results: Among 3,940 evaluable patients, 26% were elderly (older than 65 years of age). More than half of the population had pN0 tumor stage. Ninety-four percent received chemotherapy: 78% as adjuvant treatment and 14% as neoadjuvant treatment, 2% both. Anthracyclines were administered in 87% and taxanes in 66%. Trastuzumab was stopped prematurely in 9% (because of cardiotoxicity in 3.5%). Recurrence-free survival was 90.0% (95% confidence interval [CI], 88.9%-91.1%) and 82.8% (95% CI, 81.2%-84.4%) after 3 and 5 years, respectively. The corresponding figures for overall survival were 96.8% (95% CI, 96.1%-97.6%) and 90.0% (95% CI, 88.6%-91.4%). Pathological primary tumor size, lymph node involvement, and hormone receptor status had the greatest independent effect on recurrence risk. Cardiac function toxicity of National Cancer Institute common toxicity criteria grade ≥2 and ≥3 was observed in 2.5% and less than 1% of patients, respectively., Conclusion: The maturing follow-up data seem to confirm the beneficial results of trastuzumab treatment for early breast cancer from the randomized studies. Moreover, these findings support use of trastuzumab-based therapy in patients groups less commonly included in the phase III trials (e.g., elderly patients and those with stage I disease). The Oncologist 2017;22:131-138 Implications for Practice: On the basis of the results of large pivotal phase III studies, the inclusion of trastuzumab in adjuvant treatment regimens for human epidermal growth factor receptor 2-positive breast cancer is standard of care. However, in these trials, elderly patients, those with comorbidities, and/or those with contraindications or refusal of cytotoxic chemotherapy are typically underrepresented. This study provides data on observed treatment options, outcomes, and risks in a wider, unselected patient population (including more than 1,000 patients with stage I disease), treated routinely in several institutions of varying size and location across Germany., (© AlphaMed Press 2017.)
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- 2017
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19. Factors Influencing Decision-Making for or against Adjuvant and Neoadjuvant Chemotherapy in Postmenopausal Hormone Receptor-Positive Breast Cancer Patients in the EvAluate-TM Study.
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Gaß P, Fasching PA, Fehm T, de Waal J, Rezai M, Baier B, Baake G, Kolberg HC, Guggenberger M, Warm M, Harbeck N, Wuerstlein R, Deuker JU, Dall P, Richter B, Wachsmann G, Brucker C, Siebers JW, Fersis N, Kuhn T, Wolf C, Vollert HW, Breitbach GP, Janni W, Landthaler R, Kohls A, Rezek D, Noesselt T, Fischer G, Henschen S, Praetz T, Heyl V, Kühn T, Krauss T, Thomssen C, Hohn A, Tesch H, Mundhenke C, Hein A, Rauh C, Bayer CM, Jacob A, Schmidt K, Belleville E, Hadji P, Brucker SY, Beckmann MW, Wallwiener D, Kümmel S, and Löhberg CR
- Abstract
Background: Decision-making for or against neoadjuvant or adjuvant chemotherapy in postmenopausal patients with hormone receptor-positive breast cancer does not follow any clear guidelines, and some patients may unnecessarily undergo chemotherapy and be exposed to the associated toxicity. The aim of this study was to identify the patient population for whom this issue may bear relevance., Methods: Patients being treated with letrozole in the prospective multicenter noninterventional EvAluate-TM study were recruited. The percentage of patients receiving chemotherapy and factors associated with chemotherapy administration were identified., Results: In all, 3,924 (37.4%) patients received chemotherapy before treatment with letrozole. Of these, 293 (20%) underwent neoadjuvant therapy. Younger age was predictive for both adjuvant and neoadjuvant therapy. Overall, decisions in favor of administering chemotherapy are more likely to be made in patients with a higher body mass index (BMI), and neoadjuvant chemotherapy is administered at a higher rate in women with a lower BMI. Concomitant medication influenced the overall decision-making regarding chemotherapy, irrespective of whether it was given on a neoadjuvant or adjuvant basis., Conclusion: There is an ongoing debate as to whether all of the many patients who receive chemotherapy actually benefit from it. Neoadjuvant chemotherapy is frequently administered in this patient population, and this should encourage further research to resolve current clinical and research issues.
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- 2016
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20. Paravalvular Regurgitation: Clinical Outcomes in Surgical and Percutaneous Treatments.
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Pinheiro CP, Rezek D, Costa EP, Carvalho ES, Moscoso FA, Taborga PR, Jeronimo AD, Abizaid AA, and Ramos AI
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- Adult, Aged, Aortic Valve surgery, Aortic Valve Insufficiency mortality, Bioprosthesis adverse effects, Echocardiography, Transesophageal, Female, Heart Valve Prosthesis adverse effects, Heart Valve Prosthesis Implantation methods, Heart Valve Prosthesis Implantation mortality, Hospitalization, Humans, Male, Middle Aged, Mitral Valve surgery, Mitral Valve Insufficiency mortality, Percutaneous Coronary Intervention mortality, Postoperative Complications mortality, Postoperative Complications surgery, Reoperation, Retrospective Studies, Risk Factors, Therapeutic Occlusion mortality, Time Factors, Treatment Outcome, Aortic Valve Insufficiency etiology, Aortic Valve Insufficiency surgery, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Insufficiency etiology, Mitral Valve Insufficiency surgery, Percutaneous Coronary Intervention methods, Therapeutic Occlusion methods
- Abstract
Background: Paravalvular regurgitation (paravalvular leak) is a serious and rare complication associated with valve replacement surgery. Studies have shown a 3% to 6% incidence of paravalvular regurgitation with hemodynamic repercussion. Few studies have compared surgical and percutaneous approaches for repair., Objectives: To compare the surgical and percutaneous approaches for paravalvular regurgitation repair regarding clinical outcomes during hospitalization and one year after the procedure., Methods: This is a retrospective, descriptive and observational study that included 35 patients with paravalvular leak, requiring repair, and followed up at the Dante Pazzanese Institute of Cardiology between January 2011 and December 2013. Patients were divided into groups according to the established treatment and followed up for 1 year after the procedure., Results: The group submitted to percutaneous treatment was considered to be at higher risk for complications because of the older age of patients, higher prevalence of diabetes, greater number of previous valve surgeries and lower mean creatinine clearance value. During hospitalization, both groups had a large number of complications (74.3% of cases), with no statistical difference in the analyzed outcomes. After 1 year, the percutaneous group had a greater number of re-interventions (8.7% vs 20%, p = 0.57) and a higher mortality rate (0% vs. 20%, p = 0.08). A high incidence of residual mitral leak was observed after the percutaneous procedure (8.7% vs. 50%, p = 0.08)., Conclusion: Surgery is the treatment of choice for paravalvular regurgitation. The percutaneous approach can be an alternative for patients at high surgical risk.
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- 2016
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