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      Axitinib plus Immuncheckpoint-Inhibitor: evidenz- und expertenbasierte Konsensusempfehlungen für die Behandlungsoptimierung und das Management von therapieassoziierten Nebenwirkungen


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          Die kürzlich erfolgte Zulassung der Kombinationstherapien von Axitinib mit den Immuncheckpoint-Inhibitoren (ICI) Pembrolizumab oder Avelumab zur First-Line-Therapie des fortgeschrittenen Nierenzellkarzinoms macht Handlungsempfehlungen zur Differenzierung zwischen immunbezogenen Nebenwirkungen (adverse events, AEs), die durch ICI verursacht werden, und Axitinib-bezogenen AEs erforderlich, um die Therapie mit Axitinib-ICI-Kombinationen zu optimieren. Die hier vorgestellten Empfehlungen basieren auf einer systematischen kritischen Überprüfung der veröffentlichten Evidenzlage und einer Diskussion unter Experten auf diesem Gebiet sowie einer Umfrage mit dem Ziel, einen Expertenkonsens über spezifische Maßnahmen für das Therapiemanagement mit den Kombinationstherapien von Axitinib/Avelumab und Axitinib/Pembrolizumab zu erhalten. Die Experten identifizierten AE-Bereiche, bei denen ein spezielles Management während der Behandlung mit Axitinib-ICI-Kombinationstherapien notwendig ist und die von den aktuellen Empfehlungen nicht abgedeckt werden. Nebenwirkungen, die ein solches spezialisiertes Management erfordern, sind Diarrhoe, Lebertoxizität, Fatigue und kardiovaskuläre AEs. Die Triage zwischen immunsuppressiven und supportiven Maßnahmen ist ein zentrales Element des Therapiemanagements. Dieser neuartige Therapieansatz erfordert ein klinisches Monitoring und Erfahrungen mit beiden Wirkstoffklassen. In der vorliegenden Arbeit liegt der Schwerpunkt auf AEs, die Überschneidungen zwischen der Axitinib- und der ICI-Therapie aufweisen. Unsere Empfehlungen beziehen sich auf das Management von AEs, die unter der Behandlung mit Axitinib-ICI-Kombinationen auftreten, und haben zum Ziel, die Sicherheit dieser Therapien zu verbessern.

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          Most cited references30

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          Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.

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            Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma.

            Nivolumab, a programmed death 1 (PD-1) checkpoint inhibitor, was associated with encouraging overall survival in uncontrolled studies involving previously treated patients with advanced renal-cell carcinoma. This randomized, open-label, phase 3 study compared nivolumab with everolimus in patients with renal-cell carcinoma who had received previous treatment.
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              Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline

              Purpose To increase awareness, outline strategies, and offer guidance on the recommended management of immune-related adverse events in patients treated with immune checkpoint inhibitor (ICPi) therapy. Methods A multidisciplinary, multi-organizational panel of experts in medical oncology, dermatology, gastroenterology, rheumatology, pulmonology, endocrinology, urology, neurology, hematology, emergency medicine, nursing, trialist, and advocacy was convened to develop the clinical practice guideline. Guideline development involved a systematic review of the literature and an informal consensus process. The systematic review focused on guidelines, systematic reviews and meta-analyses, randomized controlled trials, and case series published from 2000 through 2017. Results The systematic review identified 204 eligible publications. Much of the evidence consisted of systematic reviews of observational data, consensus guidelines, case series, and case reports. Due to the paucity of high-quality evidence on management of immune-related adverse events, recommendations are based on expert consensus. Recommendations Recommendations for specific organ system-based toxicity diagnosis and management are presented. While management varies according to organ system affected, in general, ICPi therapy should be continued with close monitoring for grade 1 toxicities, with the exception of some neurologic, hematologic, and cardiac toxicities. ICPi therapy may be suspended for most grade 2 toxicities, with consideration of resuming when symptoms revert to grade 1 or less. Corticosteroids may be administered. Grade 3 toxicities generally warrant suspension of ICPis and the initiation of high-dose corticosteroids (prednisone 1 to 2 mg/kg/d or methylprednisolone 1 to 2 mg/kg/d). Corticosteroids should be tapered over the course of at least 4 to 6 weeks. Some refractory cases may require infliximab or other immunosuppressive therapy. In general, permanent discontinuation of ICPis is recommended with grade 4 toxicities, with the exception of endocrinopathies that have been controlled by hormone replacement. Additional information is available at www.asco.org/supportive-care-guidelines and www.asco.org/guidelineswiki .

                Author and article information

                Karger Kompass Onkologie
                S. Karger AG
                December 2020
                30 November 2020
                : 7
                : 4
                : 180-189
                [_a] aInterdisziplinäre Urogenitale Onkologie, Westdeutsches Tumorzentrum Essen, Klinik für Urologie und Klinik für Internistische Onkologie, Universitätsklinik Essen, Essen, Deutschland
                [_b] bMemorial Sloan Kettering Cancer Center, New York, New York, USA
                [_c] cCleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, USA
                [_d] dBarts Cancer Institute, Queen Mary University of London, London, United Kingdom
                [_e] eGustave Roussy Institute, Université Paris Saclay, Villejuif, Frankreich
                [_f] fInternational Kidney Cancer Coalition, Duivendrecht, Niederlande
                [_g] gThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA
                Author notes
                *Viktor Grünwald, Interdisziplinäre Urogenitale Onkologie, Westdeutsches Tumorzentrum Essen, Klinik für Urologie und Klinik für Internistische Onkologie, Universitätsklinik Essen, Hufelandstraße 55, 45147 Essen, viktor.gruenwald@uk-essen.de
                513091 Kompass Onkol 2020;7:180–188
                © 2020 S. Karger GmbH, Freiburg © 2020 S. Karger GmbH, Freiburg

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                Page count
                Figures: 4, Pages: 10
                Self URI (application/pdf): https://www.karger.com/Article/Pdf/513091
                Self URI (text/html): https://www.karger.com/Article/FullText/513091
                Self URI (journal page): https://www.karger.com/SubjectArea/Oncology

                Oncology & Radiotherapy,Pathology,Surgery,Obstetrics & Gynecology,Pharmacology & Pharmaceutical medicine,Hematology


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