Circulating biomarkers and outcome from a randomised phase II trial of sunitinib vs everolimus for patients with metastatic renal cell ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2016-02-23

AUTHORS

Martin H Voss, David Chen, Mahtab Marker, A Ari Hakimi, Chung-Han Lee, James J Hsieh, Jennifer J Knox, Maurizio Voi, Robert J Motzer

ABSTRACT

Background:RECORD-3 assessed non-inferiority of progression-free survival (PFS) with everolimus vs sunitinib in previously untreated patients with metastatic renal cell carcinoma. Baseline plasma sample collection and randomised design enabled correlation of circulating biomarkers with efficacy.Methods:Samples were analysed for 121 cancer-related biomarkers. Analyses of biomarkers categorised patients as high or low (vs median) to assess association with first-line PFS (PFS1L) for each treatment arm. A composite biomarker score (CBS) incorporated biomarkers potentially predictive of PFS1L with everolimus.Results:Plasma samples from 442 of the 471 randomised patients were analysed. Biomarkers were associated with PFS1L for everolimus alone (29), sunitinib alone (9) or both (12). Everolimus-specific biomarkers (CSF1, ICAM1, IL-18BP, KIM1, TNFRII) with hazard ratio ⩾1.8 were integrated into a CBS (range 0–5). For CBS low (0–3, n=291) vs high (4–5, n=151), PFS1L differed significantly for everolimus but not for sunitinib. There was no significant difference in PFS1L between everolimus and sunitinib in the high CBS patient cohort.Conclusions:Baseline levels of multiple soluble biomarkers correlated with benefit from everolimus and/or sunitinib, independent of clinical risk factors. A similar PFS1L was observed for both treatments among patients with high CBS score. More... »

PAGES

642-649

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/bjc.2016.21

DOI

http://dx.doi.org/10.1038/bjc.2016.21

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1040730926

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26908330


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