A randomised, phase II study of nintedanib or sunitinib in previously untreated patients with advanced renal cell cancer: 3-year results

Eisen, T., Loembé, A.-B., Shparyk, Y., MacLeod, N., Jones, R.J. , Mazurkiewicz, M., Temple, G., Dressler, H. and Bondarenko, I. (2015) A randomised, phase II study of nintedanib or sunitinib in previously untreated patients with advanced renal cell cancer: 3-year results. British Journal of Cancer, 113(8), pp. 1140-1147. (doi:10.1038/bjc.2015.313) (PMID:26448178) (PMCID:PMC4647871)

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Abstract

background:  This exploratory study evaluated the safety/efficacy of nintedanib or sunitinib as first-line therapy in patients with advanced renal cell carcinoma (RCC). methods:  Ninety-six patients were randomised (2:1) to either nintedanib (200 mg twice daily) or sunitinib (50 mg kg−1 once daily (4 weeks on treatment; 2 weeks off)). Primary endpoint was progression-free survival (PFS) at 9 months. P-values reported are descriptive only; the study was not powered for such comparisons. results:  Progression-free survival at 9 months was comparable between nintedanib and sunitinib (43.1% vs 45.2%, respectively; P=0.85). Median PFS was 8.4 months in each group (hazard ratio (HR), 1.12; 95% confidence interval (CI): 0.70–1.80; P=0.64). Median overall survival was 20.4 and 21.2 months for nintedanib and sunitinib, respectively (HR, 0.92; 95% CI: 0.54–1.56; P=0.76). Overall incidence of any grade adverse events (AEs) was comparable (90.6% vs 93.8%); AEs grade 3 were lower with nintedanib than sunitinib (48.4% vs 59.4%). Nintedanib was associated with lower incidences of some AEs typical of antiangiogenic tyrosine kinase inhibitors (TKIs): hypertension, hypothyroidism, hand–foot syndrome, cardiac disorders and haematological abnormalities. conclusions:  In patients with advanced RCC, nintedanib has promising efficacy and similar tolerability to sunitinib, and a manageable safety profile with fewer TKI-associated AEs.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Jones, Professor Robert
Authors: Eisen, T., Loembé, A.-B., Shparyk, Y., MacLeod, N., Jones, R.J., Mazurkiewicz, M., Temple, G., Dressler, H., and Bondarenko, I.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cancer Sciences
Journal Name:British Journal of Cancer
Publisher:Nature Publishing Group
ISSN:0007-0920
ISSN (Online):1532-1827
Copyright Holders:Copyright © 2015 Cancer Research UK
First Published:First published in British Journal of Cancer 113(8):1140-1827
Publisher Policy:Reproduced under a Creative Commons License

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