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

Thomas R.Jeffry Evans, Masatoshi Kudo, Richard S. Finn, KwangHyub Han, Ann Lii Cheng, Masafumi Ikeda, Silvija Kraljevic, Min Ren, Corina E. Dutcus, Fabio Piscaglia, Max W. Sung

Research output: Contribution to journalArticle

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 (R2: 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.

Original languageEnglish
JournalBritish journal of cancer
DOIs
Publication statusPublished - 2019 Jan 1

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Proteinuria
Hepatocellular Carcinoma
Creatinine
Urine
Proteins
Urine Specimen Collection
lenvatinib
sorafenib
Physiologic Monitoring
Regression Analysis
Clinical Trials
Sensitivity and Specificity

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Evans, Thomas R.Jeffry ; Kudo, Masatoshi ; Finn, Richard S. ; Han, KwangHyub ; Cheng, Ann Lii ; Ikeda, Masafumi ; Kraljevic, Silvija ; Ren, Min ; Dutcus, Corina E. ; Piscaglia, Fabio ; Sung, Max W. / 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. In: British journal of cancer. 2019.
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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 (R2: 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.",
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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. / Evans, Thomas R.Jeffry; Kudo, Masatoshi; Finn, Richard S.; Han, KwangHyub; Cheng, Ann Lii; Ikeda, Masafumi; Kraljevic, Silvija; Ren, Min; Dutcus, Corina E.; Piscaglia, Fabio; Sung, Max W.

In: British journal of cancer, 01.01.2019.

Research output: Contribution to journalArticle

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T2 - analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma

AU - Evans, Thomas R.Jeffry

AU - Kudo, Masatoshi

AU - Finn, Richard S.

AU - Han, KwangHyub

AU - Cheng, Ann Lii

AU - Ikeda, Masafumi

AU - Kraljevic, Silvija

AU - Ren, Min

AU - Dutcus, Corina E.

AU - Piscaglia, Fabio

AU - Sung, Max W.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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 (R2: 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.

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