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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 |
Appears in Collections: | Elements Staff Publications |
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