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dc.contributor.authorYule, Michael S.
dc.contributor.authorThompson, Joshua
dc.contributor.authorLeesahatsawat, Khachonphat
dc.contributor.authorSousa, Mariana S.
dc.contributor.authorAnker, Stefan D.
dc.contributor.authorArends, Jann
dc.contributor.authorBalstad, Trude Rakel
dc.contributor.authorBrown, Leo R.
dc.contributor.authorBye, Asta
dc.contributor.authorDajani, Olav
dc.contributor.authorFallon, Marie
dc.contributor.authorHjermstad, Marianne Jensen
dc.contributor.authorJakobsen, Gunnhild
dc.contributor.authorMcDonald, James
dc.contributor.authorMcGovern, Josh
dc.contributor.authorRoeland, Eric J.
dc.contributor.authorSayers, Judith
dc.contributor.authorSkipworth, Richard J.E.
dc.contributor.authorOttestad, Inger
dc.contributor.authorPhilips, Iain
dc.contributor.authorSimpson, Melanie Rae
dc.contributor.authorSolheim, Tora S
dc.contributor.authorVagnildhaug, Ola Magne
dc.contributor.authorMcMillan, Donald
dc.contributor.authorLaird, Barry J
dc.contributor.authorDolan, Ross D.
dc.date.accessioned2024-09-25T07:48:53Z
dc.date.available2024-09-25T07:48:53Z
dc.date.issued2024-05-23
dc.description.abstractRegulatory agencies require evidence that endpoints correlate with clinical benefit before they can be used to approve drugs. Biomarkers are often considered surrogate endpoints. In cancer cachexia trials, the measurement of biomarkers features frequently. The aim of this systematic review was to assess the frequency and diversity of biomarker endpoints in cancer cachexia trials. A comprehensive electronic literature search of MEDLINE, Embase and Cochrane (1990–2023) was completed. Eligible trials met the following criteria: adults (≥18 years), prospective design, more than 40 participants, use of a cachexia intervention for more than 14 days and use of a biomarker(s) as an endpoint. Biomarkers were defined as any objective measure that was assayed from a body fluid, including scoring systems based on these assays. Routine haematology and biochemistry to monitor intervention toxicity were not considered. Data extraction was performed using Covidence, and reporting followed PRISMA guidance (PROSPERO: CRD42022276710). A total of 5975 studies were assessed, of which 52 trials (total participants = 6522) included biomarkers as endpoints. Most studies (n = 29, 55.7%) included a variety of cancer types. Pharmacological interventions (n = 27, 51.9%) were most evaluated, followed by nutritional interventions (n = 20, 38.4%). Ninety-nine different biomarkers were used across the trials, and of these, 96 were assayed from blood. Albumin (n = 29, 55.8%) was assessed most often, followed by C-reactive protein (n = 22, 42.3%), interleukin-6 (n = 16, 30.8%) and tumour necrosis factor-α (n = 14, 26.9%), the latter being the only biomarker that was used to guide sample size calculations. Biomarkers were explicitly listed as a primary outcome in six trials. In total, 12 biomarkers (12.1% of 99) were used in six trials or more. Insulin-like growth factor binding protein 3 (IGFBP-3) and insulin-like growth factor 1 (IGF-1) levels both increased significantly in all three trials in which they were both used. This corresponded with a primary outcome, lean body mass, and was related to the pharmacological mechanism. Biomarkers were predominately used as exploratory rather than primary endpoints. The most commonly used biomarker, albumin, was limited by its lack of responsiveness to nutritional intervention. For a biomarker to be responsive to change, it must be related to the mechanism of action of the intervention and/or the underlying cachexia process that is modified by the intervention, as seen with IGFBP-3, IGF-1 and anamorelin. To reach regulatory approval as an endpoint, the relationship between the biomarker and clinical benefit must be clarified.en_US
dc.identifier.citationYule, Thompson, Leesahatsawat, Sousa, Anker, Arends, Balstad, Brown, Bye, Dajani, Fallon, Hjermstad, Jakobsen, McDonald, McGovern, Roeland, Sayers, Skipworth, Ottestad, Philips, Simpson, Solheim, Vagnildhaug, McMillan, Laird, Dolan. Biomarker endpoints in cancer cachexia clinical trials: Systematic Review 5 of the cachexia endpoint series. Journal of Cachexia, Sarcopenia and Muscle. 2024en_US
dc.identifier.cristinIDFRIDAID 2274318
dc.identifier.doi10.1002/jcsm.13491
dc.identifier.issn2190-5991
dc.identifier.issn2190-6009
dc.identifier.urihttps://hdl.handle.net/10037/34856
dc.language.isoengen_US
dc.publisherWileyen_US
dc.relation.journalJournal of Cachexia, Sarcopenia and Muscle
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2024 The Author(s)en_US
dc.rights.urihttps://creativecommons.org/licenses/by/4.0en_US
dc.rightsAttribution 4.0 International (CC BY 4.0)en_US
dc.titleBiomarker endpoints in cancer cachexia clinical trials: Systematic Review 5 of the cachexia endpoint seriesen_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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Attribution 4.0 International (CC BY 4.0)
Med mindre det står noe annet, er denne innførselens lisens beskrevet som Attribution 4.0 International (CC BY 4.0)