Please use this identifier to cite or link to this item: https://doi.org/10.1007/s00280-016-3112-9
Title: Occurrence of hepatotoxicity with pazopanib and other anti-VEGF treatments for renal cell carcinoma: an observational study utilizing a distributed database network
Authors: Shantakumar, S 
Nordstrom, B.L
Djousse, L
Hall, S.A
Gagnon, D.R
Fraeman, K.H
van Herk-Sukel, M
Chagin, K
Nelson, J
Keywords: alanine aminotransferase
alkaline phosphatase
aspartate aminotransferase
bevacizumab
bilirubin
pazopanib
sorafenib
sunitinib
antineoplastic agent
bevacizumab
carbanilamide derivative
indole derivative
nicotinamide
pazopanib
pyrimidine derivative
pyrrole derivative
sorafenib
sulfonamide
sunitinib
vasculotropin A
adult
aged
alanine aminotransferase blood level
alkaline phosphatase blood level
Article
aspartate aminotransferase blood level
bilirubin blood level
cancer chemotherapy
clinical practice
cohort analysis
drug safety
female
follow up
human
ICD-9
incidence
kidney carcinoma
liver toxicity
major clinical study
male
medical record review
middle aged
observational study
priority journal
retrospective study
side effect
analogs and derivatives
antagonists and inhibitors
Carcinoma, Renal Cell
Chemical and Drug Induced Liver Injury
comparative study
computer network
Kidney Neoplasms
pathology
Aged
Antineoplastic Agents
Bevacizumab
Carcinoma, Renal Cell
Chemical and Drug Induced Liver Injury
Cohort Studies
Computer Communication Networks
Female
Follow-Up Studies
Humans
Indoles
Kidney Neoplasms
Male
Middle Aged
Niacinamide
Phenylurea Compounds
Pyrimidines
Pyrroles
Retrospective Studies
Sulfonamides
Vascular Endothelial Growth Factor A
Issue Date: 2016
Publisher: Springer Verlag
Citation: Shantakumar, S, Nordstrom, B.L, Djousse, L, Hall, S.A, Gagnon, D.R, Fraeman, K.H, van Herk-Sukel, M, Chagin, K, Nelson, J (2016). Occurrence of hepatotoxicity with pazopanib and other anti-VEGF treatments for renal cell carcinoma: an observational study utilizing a distributed database network. Cancer Chemotherapy and Pharmacology 78 (3) : 559-566. ScholarBank@NUS Repository. https://doi.org/10.1007/s00280-016-3112-9
Rights: Attribution 4.0 International
Abstract: Purpose: To quantify the hepatic safety of pazopanib and comparator anti-vascular endothelial growth factor (VEGF) therapies in clinical practice among renal cell carcinoma (RCC) patients. Methods: A population-based cohort study of new anti-VEGF users was conducted in two US healthcare databases, Department of Veterans Affairs (VA) and an oncology practice network (Altos), and the PHARMO Database Network in The Netherlands. A common protocol was used to collect liver chemistry (LC) data from anti-VEGF initiation through 4 years of follow-up. In the VA population, suspected drug-induced liver injury (DILI) outcomes were investigated via chart review, with adjudication by hepatologists. Results: In Altos and VA, respectively, the total RCC patients were: pazopanib (156, 243), bevacizumab (122, 99), sorafenib (82, 249) and sunitinib (285, 751). PHARMO contained too few patients to be included. Few cases of alanine aminotransferase (ALT) ≥8× the upper limit of normal were seen across the anti-VEGF cohorts; incidence rates (per 100 person-years) ranged from 0 (sunitinib) to 8.2 (pazopanib) in Altos and from 0 (bevacizumab and sorafenib) to 2.1 (pazopanib) among VA patients. No cases of Hy’s law identified by combination LC elevations were seen in patients treated with pazopanib or bevacizumab; one case was observed in those treated with sorafenib, and two cases were found among sunitinib users. One case of adjudicated DILI was observed in a sunitinib-treated patient; none were found among patients treated with pazopanib, bevacizumab or sorafenib. Conclusions: Severe liver injury occurred infrequently during exposure to pazopanib and other anti-VEGF therapies in a population-based setting. © 2016, The Author(s).
Source Title: Cancer Chemotherapy and Pharmacology
URI: https://scholarbank.nus.edu.sg/handle/10635/179293
ISSN: 0344-5704
DOI: 10.1007/s00280-016-3112-9
Rights: Attribution 4.0 International
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