For patients with renal cell carcinoma (RCC) who have previously been treated with a vascular endothelial growth factor (VEGF)-targeted agent, a new study suggests favorable outcomes with an 18 mg/day starting dose of lenvatinib given with everolimus. Study results were presented in a poster presentation at the American Society of Clinical Oncology 2021 Genitourinary Cancers Symposium.

In this analysis of a phase 2 clinical trial ( Identifier: NCT03173560), patients with RCC were evaluated for outcomes that included health-related quality-of-life (HRQOL) and time-to-deterioration (TTD) based on a comparison of lenvatinib starting dosages. After stratification by risk status and prior therapy, patients were randomly assigned to receive lenvatinib at a starting dose of either 18 mg/day or 14 mg/day, given in combination with everolimus (5 mg/day). Assessments at baseline and at later time points were made using FKSI-DRS, EORTC QLQ-C30, and EQ-5D-3L scales.

A total of 171 patients were assigned to receive a starting dose of 18 mg/day of lenvatinib, and 172 were assigned to receive 14 mg/day of this agent. Patients receiving the higher starting dose of lenvatinib reported superior HRQOL scores for many metrics compared with patients started on the lower dosage. Mean estimates of changes from baseline were generally better with the higher dosage, but a threshold for a minimally important difference for clinical significance was not met.

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Diarrhea severity reportedly worsened at both dosage levels. However, based on most scales that were examined, the median TTD was longer for the higher-dosage group. The median time to first deterioration using the FKSI-DRS total score was 15.71 weeks for the higher-dosage group and 12.00 weeks for the lower-dosage group.

The study investigators concluded that the 18-mg starting dose of lenvatinib, combined with everolimus, maintained HRQOL and was effective for treating patients with RCC who had 1 prior VEGF-based therapy.

Disclosures: Multiple authors declared affiliations with or received funding from the pharmaceutical industry. Please refer to the original abstract for a full list of disclosures.


Bergerot CD, Rha SY, Pal SK, et al. Health-related quality-of-life outcomes from a phase II open-label trial of two different starting doses of lenvatinib in combination with everolimus for treatment of renal cell carcinoma following one prior VEGF-targeted treatment. J Clin Oncol. 2021;39(suppl 6):abstr 314. doi:10.1200/JCO.2021.39.6_suppl.314