PMID- 32587360 OWN - NLM STAT- MEDLINE DCOM- 20210315 LR - 20210618 IS - 1532-1827 (Electronic) IS - 0007-0920 (Print) IS - 0007-0920 (Linking) VI - 123 IP - 6 DP - 2020 Sep TI - Axitinib plus immune checkpoint inhibitor: evidence- and expert-based consensus recommendation for treatment optimisation and management of related adverse events. PG - 898-904 LID - 10.1038/s41416-020-0949-9 [doi] AB - With the recent approval of the combinations of axitinib with the immune checkpoint inhibitor (ICI) pembrolizumab or avelumab for first-line treatment of advanced renal cell carcinoma, guidance on how to distinguish between immune-related adverse events (AEs) caused by ICI versus axitinib-related AEs is necessary to optimise therapy with axitinib-ICI combinations. The recommendations here are based on (1) systematic review of published evidence, (2) discussion among experts in the field and (3) a survey to obtain expert consensus on specific measures for therapy management with the combinations axitinib/avelumab and axitinib/pembrolizumab. The experts identified areas of AEs requiring unique management during treatment with axitinib-ICI combinations that were not covered by current recommendations. Diarrhoea, hepatic toxicity, fatigue and cardiovascular AEs were found to be applicable to such specialised management. Triage between immune-suppressive and supportive measures is a key component in therapy management. Clinical monitoring and experience with both classes of agents are necessary to manage this novel therapeutic approach. We focused on AEs with an overlap between axitinib and ICI therapy. Our recommendations address AE management of axitinib-ICI combinations with the aim to improve the safety of these therapies. FAU - Grunwald, Viktor AU - Grunwald V AUID- ORCID: 0000-0003-2083-7687 AD - Interdisciplinary GU Oncology, West German Cancer Center Essen, Clinic for Urology and Clinic for Medical Oncology, University Hospital Essen, Essen, Germany. viktor.gruenwald@uk-essen.de. FAU - Voss, Martin H AU - Voss MH AD - Memorial Sloan Kettering Cancer Center, New York, NY, USA. FAU - Rini, Brian I AU - Rini BI AD - Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA. FAU - Powles, Thomas AU - Powles T AD - Barts Cancer Institute, Queen Mary University of London, London, UK. FAU - Albiges, Laurence AU - Albiges L AD - Gustave Roussy Institute, Universite Paris Saclay, Villejuif, France. FAU - Giles, Rachel H AU - Giles RH AD - International Kidney Cancer Coalition, Duivendrecht, The Netherlands. FAU - Jonasch, Eric AU - Jonasch E AD - The University of Texas MD Anderson Cancer Center, Houston, TX, USA. LA - eng GR - P30 CA008748/CA/NCI NIH HHS/United States GR - not applicable/Pfizer (Pfizer Inc.)/ GR - Not applicable/Pfizer (Pfizer Inc.)/ PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Review DEP - 20200626 PL - England TA - Br J Cancer JT - British journal of cancer JID - 0370635 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Immune Checkpoint Inhibitors) RN - C9LVQ0YUXG (Axitinib) RN - DPT0O3T46P (pembrolizumab) RN - KXG2PJ551I (avelumab) SB - IM MH - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects MH - Axitinib/*administration & dosage/adverse effects MH - Carcinoma, Renal Cell/*drug therapy MH - Consensus MH - Humans MH - Immune Checkpoint Inhibitors/*administration & dosage/adverse effects MH - Kidney Neoplasms/*drug therapy MH - Triage PMC - PMC7492460 COIS- V.G. received commercial research grants from AstraZeneca, Bristol-Myers Squibb, Novartis, Pfizer and MSD; travel/accommodation costs from Bristol-Myers Squibb, Ipsen, Roche, Pfizer and AstraZeneca; was a consultant/advisory board member for AstraZeneca, Bayer, Bristol-Myers Squibb, EUSA Pharma, Ipsen, Pfizer, MSD, Lilly, PharmaMar, Novartis, Nanobiotix, Merck KGaA/EMD Serono, Janssen-Cilag, Exelixis, Roche, Eisai and Cerulean. M.H.V. received commercial research grants from Bristol-Myers Squibb, Pfizer and Genentech/Roche; honoraria from Novartis; travel/accommodation costs from Eisai, Novartis, Takeda and AstraZeneca; was a consultant/advisory board member for Alexion Pharmaceuticals, Bayer, Calithera Biosciences, Corvus Pharmaceuticals, Exelixis, Eisai, GlaxoSmithKline, Natera, Novartis and Pfizer. E.J. received commercial research grants from Exelixis, Novartis and Pfizer; was a consultant/advisory board member for Eisai, Exelixis, Genentech, Ipsen, Novartis and Pfizer. T.P. received research funding from AstraZeneca, Roche, MSD, Bristol-Myers Squibb; was a consultant/advisory board member for Novartis, Bristol-Myers Squibb, Ipsen, Roche, Pfizer, Astellas Pharma, Seattle Geneticis, Merck, MSD, AstraZeneca, Exelixis and Peloton Therapeutics. L.A. received research funding from Bristol-Myers Squibb; was a consultant/advisory board member for Novartis, Amgen, Bristol-Myers Squibb, Ipsen, Roche, Pfizer, Astellas Pharma, Merck, MSD, AstraZeneca, Exelixis, Corvus Pharmaceuticals and Peloton Therapeutics; received travel, accommodations and expenses from Bristol-Myers Squibb and MSD. R.H.G. is the volunteer chair of a nonprofit organisation that receives designated project funding from Pfizer, Bristol-Myers Squibb, Ipsen, Eisai, Exelixis, MSD, Novartis, Roche, Merck and the Merck/Pfizer Alliance. She has not received any funds personally from any of the above. B.I.R. received a research grant and personal fee from Pfizer, Merck, Bristol-Myers Squibb, AVEO Pharmaceuticals and Roche. He received personal fees from Surface Oncology, Aravive, Synthorx and 3D Medicines. EDAT- 2020/06/27 06:00 MHDA- 2021/03/16 06:00 PMCR- 2020/06/26 CRDT- 2020/06/27 06:00 PHST- 2020/03/18 00:00 [received] PHST- 2020/06/04 00:00 [accepted] PHST- 2020/05/12 00:00 [revised] PHST- 2020/06/27 06:00 [pubmed] PHST- 2021/03/16 06:00 [medline] PHST- 2020/06/27 06:00 [entrez] PHST- 2020/06/26 00:00 [pmc-release] AID - 10.1038/s41416-020-0949-9 [pii] AID - 949 [pii] AID - 10.1038/s41416-020-0949-9 [doi] PST - ppublish SO - Br J Cancer. 2020 Sep;123(6):898-904. doi: 10.1038/s41416-020-0949-9. Epub 2020 Jun 26.