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

Br J Cancer. 2019 Jul;121(3):218-221. doi: 10.1038/s41416-019-0506-6. Epub 2019 Jun 28.


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.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Carcinoma, Hepatocellular / drug therapy*
  • Carcinoma, Hepatocellular / urine
  • Creatinine / urine*
  • Humans
  • Liver Neoplasms / drug therapy*
  • Liver Neoplasms / urine
  • Phenylurea Compounds / therapeutic use*
  • Proteinuria / therapy*
  • Quinolines / therapeutic use*
  • Sorafenib / therapeutic use*


  • Phenylurea Compounds
  • Quinolines
  • Sorafenib
  • Creatinine
  • lenvatinib

Associated data

  • ClinicalTrials.gov/NCT01761266