Occurrence of hepatotoxicity with pazopanib and other anti-VEGF treatments for renal cell carcinoma: an observational study utilizing a distributed database network.
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, De...
| Publicado en: | Cancer Chemotherapy & Pharmacology Vol. 78; no. 3; pp. 559 - 567 |
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| Autores principales: | , , , , , , , , , , , , , |
| Formato: | research Journal Article |
| Publicado: |
Springer Nature
Sep2016
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=117881453&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 117881453 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 03445704 NO9 jtl: Cancer Chemotherapy & Pharmacology issn: 03445704 maglogo: N pubinfo: dt: Sep2016 vid: 78 iid: 3 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 117881453 117881453 NLM27438066 117881453 10.1007/s00280-016-3112-9 NLM27438066 PMC5010603 117881453 ppf: 559 ppct: 8 formats: tig: atl: Occurrence of hepatotoxicity with pazopanib and other anti-VEGF treatments for renal cell carcinoma: an observational study utilizing a distributed database network. aug: au: Shantakumar, Sumitra Nordstrom, Beth Djousse, Luc Hall, Susan Gagnon, David Fraeman, Kathy Herk-Sukel, Myrthe Chagin, Karen Nelson, Jeanenne Nordstrom, Beth L Hall, Susan A Gagnon, David R Fraeman, Kathy H van Herk-Sukel, Myrthe affil: Worldwide Epidemiology, R&D , GlaxoSmithKline , 150 Beach Road, #26-00 Gateway West Singapore 189720 Singapore sug: subj: Sulfonamides Therapeutic Use Kidney Neoplasms Drug Therapy Heterocyclic Compounds Therapeutic Use Antineoplastic Agents Therapeutic Use Carcinoma, Renal Cell Drug Therapy Heterocyclic Compounds Adverse Effects Sulfonamides Adverse Effects Carcinoma, Renal Cell Pathology Male Human Antineoplastic Agents Adverse Effects Urea Adverse Effects Middle Age Female Vascular Endothelial Growth Factor A Antagonists and Inhibitors Kidney Neoplasms Pathology Computer Communication Networks Prospective Studies Vitamin B Complex Adverse Effects Indoles Therapeutic Use Vitamin B Complex Aged Retrospective Design Urea Therapeutic Use Vitamin B Complex Therapeutic Use Indoles Adverse Effects Validation Studies Comparative Studies Evaluation Research Multicenter Studies Middle Aged: 45-64 years Aged: 65+ years Male Female ab: 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. pubtype: Academic Journal doctype: research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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