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Title of Journal: Eur J Clin Pharmacol

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Abbravation: European Journal of Clinical Pharmacology

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Springer Berlin Heidelberg

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DOI

10.1016/j.ando.2015.07.616

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1432-1041

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Offlabel use of anticancer drugs in eastern Switz

Authors: M Joerger C SchaerThuer D Koeberle K MatterWalstra J GibbonsMarsico S Diem B Thuerlimann T Cerny
Publish Date: 2014/03/11
Volume: 70, Issue: 6, Pages: 719-725
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Abstract

Prevalence data on the offlabel use OLU of anticancer drugs are limited despite OLU being controversial for medical pharmacoeconomic and ethical reasons We therefore quantified and characterized the OLU of anticancer drugs and compared OLU based on the national drug label with international treatment recommendationsWe prospectively collected data on patients receiving systemic anticancer therapy between October and December 2012 at hospitals affiliated with the Eastern Switzerland Oncology Network Individual data on patient characteristics tumor disease and systemic treatment were collected and each individual treatment was compared with the national drug label and international treatment guidelinesA total of 985 consecutive patients receiving 1737 anticancer drug treatments were included in the study Overall 324  of all patients received at least one offlabel drug corresponding to 272  of all anticancer drugs administered Major reasons for OLU were the lack of approval for the specific disease entity 157  and modified application of the anticancer drug 10  OLU that was unsupported by the current European Society for Medical Oncology ESMO treatment recommendations was rare 66  but higher for bevacizumab 296  due to its use in treating advanced ovarian cancer beyond the secondline setting and advanced breast cancer beyond the firstline setting and for lenalidomide 226  due to its use in treating NonHodgkin lymphomaBased on data collected on our patient cohort OLU of anticancer drugs in a European clinical setting applies to onethird of all cancer patients ESMOunsupported use of chemotherapies or molecularlytargeted drugs is rare opposing concerns that the offlabel use of newer anticancer drugs is a substantial clinical problem

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