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dc.contributor.authorRini, BI
dc.contributor.authorMoslehi, JJ
dc.contributor.authorBonaca, M
dc.contributor.authorSchmidinger, M
dc.contributor.authorAlbiges, L
dc.contributor.authorChoueiri, TK
dc.contributor.authorMotzer, RJ
dc.contributor.authorAtkins, MB
dc.contributor.authorHaanen, J
dc.contributor.authorMariani, M
dc.contributor.authorWang, J
dc.contributor.authorHariharan, S
dc.contributor.authorLarkin, J
dc.coverage.spatialUnited States
dc.date.accessioned2022-08-19T10:34:26Z
dc.date.available2022-08-19T10:34:26Z
dc.date.issued2022-06-10
dc.identifier.citationJournal of Clinical Oncology, 2022, 40 (17), pp. 1929 - 1938en_US
dc.identifier.issn0732-183X
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/5281
dc.identifier.eissn1527-7755
dc.identifier.eissn1527-7755
dc.identifier.doi10.1200/JCO.21.01806
dc.description.abstractPURPOSE: Both immune checkpoint inhibitors (ICIs) and vascular endothelial growth factor receptor (VEGFR) inhibitors are approved for advanced renal cell carcinoma treatment and can cause cardiovascular events (CVs); thus, combination therapy could lead to major adverse CV events (MACE). Cardiac serum biomarker assessment and imaging, including left ventricular ejection fraction (LVEF) monitoring, can be used to evaluate MACE. METHODS: To our knowledge, the JAVELIN Renal 101 trial, assessing avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma, is the first randomized study of ICI plus VEGFR inhibitor treatment to include prospective serial cardiac monitoring of LVEF and serum cardiac biomarkers. RESULTS: MACE (defined as grade ≥ 3 CV AEs) occurred in 31 patients (7.1%) in the combination arm and 17 patients (3.9%) in the sunitinib arm. Patients in the combination arm who had high baseline troponin T values were at higher risk of MACE versus patients with low values (MACE in 6/35 v 7/135, respectively; relative risk, 3.31; 95% CI, 1.19 to 9.22). This association was not observed in patients treated with sunitinib. Other CV baseline risk factors and serum cardiac biomarkers were not significantly predictive for MACE, although a trend toward an association with dyslipidemia was seen in the combination arm. No clinical value of on-treatment routine monitoring of LVEF in relation to MACE was observed. Although LVEF decline was significantly more frequent in the combination arm, most patients recovered, and decline was not associated with other significant cardiac events or symptoms. CONCLUSION: Patients with high baseline troponin T levels receiving ICI and VEGFR combinations may need to be monitored more closely for MACE. Routine monitoring of LVEF in asymptomatic patients is not recommended.
dc.formatPrint-Electronic
dc.format.extent1929 - 1938
dc.languageeng
dc.language.isoengen_US
dc.publisherLIPPINCOTT WILLIAMS & WILKINSen_US
dc.relation.ispartofJournal of Clinical Oncology
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/en_US
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectCarcinoma, Renal Cell
dc.subjectCardiovascular System
dc.subjectHumans
dc.subjectImmune Checkpoint Inhibitors
dc.subjectKidney Neoplasms
dc.subjectProspective Studies
dc.subjectRandomized Controlled Trials as Topic
dc.subjectSunitinib
dc.subjectTroponin T
dc.subjectVascular Endothelial Growth Factor A
dc.subjectVentricular Function, Left
dc.titleProspective Cardiovascular Surveillance of Immune Checkpoint Inhibitor-Based Combination Therapy in Patients With Advanced Renal Cell Cancer: Data From the Phase III JAVELIN Renal 101 Trial.en_US
dc.typeJournal Article
dcterms.dateAccepted2022-01-20
dc.date.updated2022-08-19T10:33:12Z
rioxxterms.versionVoRen_US
rioxxterms.versionofrecord10.1200/JCO.21.01806en_US
rioxxterms.licenseref.startdate2022-06-10
rioxxterms.typeJournal Article/Reviewen_US
pubs.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/35239416
pubs.issue17
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.)
pubs.publication-statusPublished
pubs.volume40
dc.contributor.icrauthorLarkin, James
icr.provenanceDeposited by Mr Arek Surman (impersonating Prof James Larkin) on 2022-08-19. Deposit type is initial. No. of files: 1. Files: Prospective Cardiovascular Surveillance of Immune Checkpoint Inhibitor-Based Combination Therapy in Patients With Advanced R.pdf


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