Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma

Background Proteinuria monitoring is required in patients receiving lenvatinib, however, current methodology involves burdensome overnight urine collection. Methods To determine whether the simpler urine protein:creatinine ratio (UPCR) calculated from spot urine samples could be accurately used for...

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Veröffentlicht in:British journal of cancer 2019-07, Vol.121 (3), p.218-221
Hauptverfasser: Evans, Thomas R. Jeffry, Kudo, Masatoshi, Finn, Richard S., Han, Kwang-Hyub, Cheng, Ann-Lii, Ikeda, Masafumi, Kraljevic, Silvija, Ren, Min, Dutcus, Corina E., Piscaglia, Fabio, Sung, Max W.
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container_end_page 221
container_issue 3
container_start_page 218
container_title British journal of cancer
container_volume 121
creator Evans, Thomas R. Jeffry
Kudo, Masatoshi
Finn, Richard S.
Han, Kwang-Hyub
Cheng, Ann-Lii
Ikeda, Masafumi
Kraljevic, Silvija
Ren, Min
Dutcus, Corina E.
Piscaglia, Fabio
Sung, Max W.
description Background Proteinuria monitoring is required in patients receiving lenvatinib, however, current methodology involves burdensome overnight urine collection. Methods To determine whether the simpler urine protein:creatinine ratio (UPCR) calculated from spot urine samples could be accurately used for proteinuria monitoring in patients receiving lenvatinib, we evaluated the correlation between UPCR and 24-hour urine protein results from the phase 3 REFLECT study. Paired data (323 tests, 154 patients) were analysed. Results Regression analysis showed a statistically significant correlation between UPCR and 24-hour urine protein ( R 2 : 0.75; P  
doi_str_mv 10.1038/s41416-019-0506-6
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Jeffry ; Kudo, Masatoshi ; Finn, Richard S. ; Han, Kwang-Hyub ; Cheng, Ann-Lii ; Ikeda, Masafumi ; Kraljevic, Silvija ; Ren, Min ; Dutcus, Corina E. ; Piscaglia, Fabio ; Sung, Max W.</creator><creatorcontrib>Evans, Thomas R. Jeffry ; Kudo, Masatoshi ; Finn, Richard S. ; Han, Kwang-Hyub ; Cheng, Ann-Lii ; Ikeda, Masafumi ; Kraljevic, Silvija ; Ren, Min ; Dutcus, Corina E. ; Piscaglia, Fabio ; Sung, Max W.</creatorcontrib><description>Background Proteinuria monitoring is required in patients receiving lenvatinib, however, current methodology involves burdensome overnight urine collection. Methods To determine whether the simpler urine protein:creatinine ratio (UPCR) calculated from spot urine samples could be accurately used for proteinuria monitoring in patients receiving lenvatinib, we evaluated the correlation between UPCR and 24-hour urine protein results from the phase 3 REFLECT study. Paired data (323 tests, 154 patients) were analysed. Results Regression analysis showed a statistically significant correlation between UPCR and 24-hour urine protein ( R 2 : 0.75; P  &lt; 2 × 10 −16 ). A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria. Using this UPCR cut-off value to determine the need for further testing could reduce the need for 24-hour urine collection in ~74% of patients. Conclusion Incorporation of UPCR into the current algorithm for proteinuria management can enable optimisation of lenvatinib treatment, while minimising patient inconvenience. Clinical trial registration NCT01761266</description><identifier>ISSN: 0007-0920</identifier><identifier>EISSN: 1532-1827</identifier><identifier>DOI: 10.1038/s41416-019-0506-6</identifier><identifier>PMID: 31249394</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>631/67 ; 692/4028/67 ; Biomedical and Life Sciences ; Biomedicine ; Cancer Research ; Carcinoma, Hepatocellular - drug therapy ; Carcinoma, Hepatocellular - urine ; Creatinine ; Creatinine - urine ; Drug Resistance ; Epidemiology ; Hepatocellular carcinoma ; Humans ; Inhibitor drugs ; Liver cancer ; Liver Neoplasms - drug therapy ; Liver Neoplasms - urine ; Molecular Medicine ; Oncology ; Patients ; Phenylurea Compounds - therapeutic use ; Proteins ; Proteinuria ; Proteinuria - therapy ; Quinolines - therapeutic use ; Regression analysis ; Sorafenib - therapeutic use ; Statistical analysis ; Targeted cancer therapy ; Urine</subject><ispartof>British journal of cancer, 2019-07, Vol.121 (3), p.218-221</ispartof><rights>The Author(s) 2019</rights><rights>2019. 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Jeffry</creatorcontrib><creatorcontrib>Kudo, Masatoshi</creatorcontrib><creatorcontrib>Finn, Richard S.</creatorcontrib><creatorcontrib>Han, Kwang-Hyub</creatorcontrib><creatorcontrib>Cheng, Ann-Lii</creatorcontrib><creatorcontrib>Ikeda, Masafumi</creatorcontrib><creatorcontrib>Kraljevic, Silvija</creatorcontrib><creatorcontrib>Ren, Min</creatorcontrib><creatorcontrib>Dutcus, Corina E.</creatorcontrib><creatorcontrib>Piscaglia, Fabio</creatorcontrib><creatorcontrib>Sung, Max W.</creatorcontrib><title>Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma</title><title>British journal of cancer</title><addtitle>Br J Cancer</addtitle><addtitle>Br J Cancer</addtitle><description>Background Proteinuria monitoring is required in patients receiving lenvatinib, however, current methodology involves burdensome overnight urine collection. Methods To determine whether the simpler urine protein:creatinine ratio (UPCR) calculated from spot urine samples could be accurately used for proteinuria monitoring in patients receiving lenvatinib, we evaluated the correlation between UPCR and 24-hour urine protein results from the phase 3 REFLECT study. Paired data (323 tests, 154 patients) were analysed. Results Regression analysis showed a statistically significant correlation between UPCR and 24-hour urine protein ( R 2 : 0.75; P  &lt; 2 × 10 −16 ). A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria. Using this UPCR cut-off value to determine the need for further testing could reduce the need for 24-hour urine collection in ~74% of patients. Conclusion Incorporation of UPCR into the current algorithm for proteinuria management can enable optimisation of lenvatinib treatment, while minimising patient inconvenience. 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Jeffry ; Kudo, Masatoshi ; Finn, Richard S. ; Han, Kwang-Hyub ; Cheng, Ann-Lii ; Ikeda, Masafumi ; Kraljevic, Silvija ; Ren, Min ; Dutcus, Corina E. ; Piscaglia, Fabio ; Sung, Max W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c536t-6fd142f042be87fe355797f0b279f210d6656d9bc2c52d60c7633d7609d6e57c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>631/67</topic><topic>692/4028/67</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Cancer Research</topic><topic>Carcinoma, Hepatocellular - drug therapy</topic><topic>Carcinoma, Hepatocellular - urine</topic><topic>Creatinine</topic><topic>Creatinine - urine</topic><topic>Drug Resistance</topic><topic>Epidemiology</topic><topic>Hepatocellular carcinoma</topic><topic>Humans</topic><topic>Inhibitor drugs</topic><topic>Liver cancer</topic><topic>Liver Neoplasms - drug therapy</topic><topic>Liver Neoplasms - urine</topic><topic>Molecular Medicine</topic><topic>Oncology</topic><topic>Patients</topic><topic>Phenylurea Compounds - therapeutic use</topic><topic>Proteins</topic><topic>Proteinuria</topic><topic>Proteinuria - therapy</topic><topic>Quinolines - therapeutic use</topic><topic>Regression analysis</topic><topic>Sorafenib - therapeutic use</topic><topic>Statistical analysis</topic><topic>Targeted cancer therapy</topic><topic>Urine</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Evans, Thomas R. 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Jeffry</au><au>Kudo, Masatoshi</au><au>Finn, Richard S.</au><au>Han, Kwang-Hyub</au><au>Cheng, Ann-Lii</au><au>Ikeda, Masafumi</au><au>Kraljevic, Silvija</au><au>Ren, Min</au><au>Dutcus, Corina E.</au><au>Piscaglia, Fabio</au><au>Sung, Max W.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma</atitle><jtitle>British journal of cancer</jtitle><stitle>Br J Cancer</stitle><addtitle>Br J Cancer</addtitle><date>2019-07-30</date><risdate>2019</risdate><volume>121</volume><issue>3</issue><spage>218</spage><epage>221</epage><pages>218-221</pages><issn>0007-0920</issn><eissn>1532-1827</eissn><abstract>Background Proteinuria monitoring is required in patients receiving lenvatinib, however, current methodology involves burdensome overnight urine collection. Methods To determine whether the simpler urine protein:creatinine ratio (UPCR) calculated from spot urine samples could be accurately used for proteinuria monitoring in patients receiving lenvatinib, we evaluated the correlation between UPCR and 24-hour urine protein results from the phase 3 REFLECT study. Paired data (323 tests, 154 patients) were analysed. Results Regression analysis showed a statistically significant correlation between UPCR and 24-hour urine protein ( R 2 : 0.75; P  &lt; 2 × 10 −16 ). A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria. Using this UPCR cut-off value to determine the need for further testing could reduce the need for 24-hour urine collection in ~74% of patients. Conclusion Incorporation of UPCR into the current algorithm for proteinuria management can enable optimisation of lenvatinib treatment, while minimising patient inconvenience. Clinical trial registration NCT01761266</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>31249394</pmid><doi>10.1038/s41416-019-0506-6</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record>
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subjects 631/67
692/4028/67
Biomedical and Life Sciences
Biomedicine
Cancer Research
Carcinoma, Hepatocellular - drug therapy
Carcinoma, Hepatocellular - urine
Creatinine
Creatinine - urine
Drug Resistance
Epidemiology
Hepatocellular carcinoma
Humans
Inhibitor drugs
Liver cancer
Liver Neoplasms - drug therapy
Liver Neoplasms - urine
Molecular Medicine
Oncology
Patients
Phenylurea Compounds - therapeutic use
Proteins
Proteinuria
Proteinuria - therapy
Quinolines - therapeutic use
Regression analysis
Sorafenib - therapeutic use
Statistical analysis
Targeted cancer therapy
Urine
title Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma
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