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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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 |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6738107</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2250620746</sourcerecordid><originalsourceid>FETCH-LOGICAL-c536t-6fd142f042be87fe355797f0b279f210d6656d9bc2c52d60c7633d7609d6e57c3</originalsourceid><addsrcrecordid>eNp1Uk1v1DAQjRCILoUfwAVZ4sIlMP6IHfeAhFbbFmklJNSeLcexN6kSe7GTlfZv8Qtx2LYUJE6e8bx5zzN-RfEWw0cMtP6UGGaYl4BlCRXwkj8rVriipMQ1Ec-LFQCIEiSBs-JVSnc5lVCLl8UZxYRJKtmq-Hkbe2_RPobJ9v7CRKun3i9XMQcBHRIirOzCHNH8FIlciA9xLmg0aq93drR-ukA5HI6pT8jFMKKpy12dThZR9H1zud2sb1Ca5vaIgkOD9Yffis0ilULUzi5JVujsXk_B2GGYBx2R0dH0Poz6dfHC6SHZN_fneXF7ublZX5fbb1df11-2pakon0ruWsyIA0YaWwtnaVUJKRw0REhHMLScV7yVjSGmIi0HIzilreAgW24rYeh58fnEu5-b0bYmjxb1oPaxH3U8qqB79XfF953ahYPigtYYRCb4cE8Qw4_ZpkmNfVrm0d6GOSlC8qcREIxn6Pt_oHd55XmNC4pzWTNgCyE-oUwMKUXrHh-DQS2OUCdHqOwItThCLczvnk7x2PFggQwgJ0DKJb-z8Y_0_1l_Ad4txLc</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2266984047</pqid></control><display><type>article</type><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><source>MEDLINE</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><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.</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
< 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. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c536t-6fd142f042be87fe355797f0b279f210d6656d9bc2c52d60c7633d7609d6e57c3</citedby><cites>FETCH-LOGICAL-c536t-6fd142f042be87fe355797f0b279f210d6656d9bc2c52d60c7633d7609d6e57c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6738107/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6738107/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31249394$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Evans, Thomas R. 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
< 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><subject>631/67</subject><subject>692/4028/67</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Cancer Research</subject><subject>Carcinoma, Hepatocellular - drug therapy</subject><subject>Carcinoma, Hepatocellular - urine</subject><subject>Creatinine</subject><subject>Creatinine - urine</subject><subject>Drug Resistance</subject><subject>Epidemiology</subject><subject>Hepatocellular carcinoma</subject><subject>Humans</subject><subject>Inhibitor drugs</subject><subject>Liver cancer</subject><subject>Liver Neoplasms - drug therapy</subject><subject>Liver Neoplasms - urine</subject><subject>Molecular Medicine</subject><subject>Oncology</subject><subject>Patients</subject><subject>Phenylurea Compounds - therapeutic use</subject><subject>Proteins</subject><subject>Proteinuria</subject><subject>Proteinuria - therapy</subject><subject>Quinolines - therapeutic use</subject><subject>Regression analysis</subject><subject>Sorafenib - therapeutic use</subject><subject>Statistical analysis</subject><subject>Targeted cancer therapy</subject><subject>Urine</subject><issn>0007-0920</issn><issn>1532-1827</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp1Uk1v1DAQjRCILoUfwAVZ4sIlMP6IHfeAhFbbFmklJNSeLcexN6kSe7GTlfZv8Qtx2LYUJE6e8bx5zzN-RfEWw0cMtP6UGGaYl4BlCRXwkj8rVriipMQ1Ec-LFQCIEiSBs-JVSnc5lVCLl8UZxYRJKtmq-Hkbe2_RPobJ9v7CRKun3i9XMQcBHRIirOzCHNH8FIlciA9xLmg0aq93drR-ukA5HI6pT8jFMKKpy12dThZR9H1zud2sb1Ca5vaIgkOD9Yffis0ilULUzi5JVujsXk_B2GGYBx2R0dH0Poz6dfHC6SHZN_fneXF7ublZX5fbb1df11-2pakon0ruWsyIA0YaWwtnaVUJKRw0REhHMLScV7yVjSGmIi0HIzilreAgW24rYeh58fnEu5-b0bYmjxb1oPaxH3U8qqB79XfF953ahYPigtYYRCb4cE8Qw4_ZpkmNfVrm0d6GOSlC8qcREIxn6Pt_oHd55XmNC4pzWTNgCyE-oUwMKUXrHh-DQS2OUCdHqOwItThCLczvnk7x2PFggQwgJ0DKJb-z8Y_0_1l_Ad4txLc</recordid><startdate>20190730</startdate><enddate>20190730</enddate><creator>Evans, Thomas R. Jeffry</creator><creator>Kudo, Masatoshi</creator><creator>Finn, Richard S.</creator><creator>Han, Kwang-Hyub</creator><creator>Cheng, Ann-Lii</creator><creator>Ikeda, Masafumi</creator><creator>Kraljevic, Silvija</creator><creator>Ren, Min</creator><creator>Dutcus, Corina E.</creator><creator>Piscaglia, Fabio</creator><creator>Sung, Max W.</creator><general>Nature Publishing Group UK</general><general>Nature Publishing Group</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7TO</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20190730</creationdate><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><author>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.</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. 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><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biological Science Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Evans, Thomas R. 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
< 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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source | MEDLINE; EZB-FREE-00999 freely available EZB journals; PubMed Central |
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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