Lenvatinib plus pembrolizumab may improve some health-related quality of life (HRQOL) outcomes, compared with sunitinib, in patients with advanced renal cell carcinoma (RCC).1

These results, from the phase 3 CLEAR trial, were reported in The Lancet Oncology.  

The trial (ClinicalTrials.gov Identifier: NCT02811861) enrolled 1069 patients with previously untreated, advanced RCC. They were randomly assigned to receive lenvatinib plus pembrolizumab (355 patients), lenvatinib plus everolimus (357 patients), or sunitinib (357 patients). 

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Prior results from this trial showed significantly longer progression-free survival and overall survival with lenvatinib-pembrolizumab vs sunitinib.2 Therefore, researchers evaluated HRQOL in these 2 treatment arms.

For their analysis, the researchers used the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index-Disease Related Symptoms (FKSI-DRS) questionnaire, the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) global health status/quality of life (GHS/QOL), and the EQ-5D-3L questionnaire. 

The questionnaires were administered at baseline and on day 1 of each subsequent 21-day treatment cycle. The median follow-up was 12.9 months.

There were no significant differences in the mean change from baseline between the lenvatinib-pembrolizumab arm and the sunitinib arm for:

  • FKSI-DRS total score (–1.75 vs –2.19; P =.58) 
  • EORTC QLQ-C30 GHS/QOL score (–5.93 vs –6.73; P =.48) 
  • EQ-5D-3L visual analogue scale (VAS) score (–4.96 vs –6.64; P =.14).

The median time to first deterioration was generally similar between the lenvatinib-pembrolizumab and sunitinib arms for:

  • FKSI-DRS — 9.14 weeks vs 12.14 weeks (hazard ratio [HR], 1.13; P =.20)  
  • EORTC QLQ-C30 GHS/QOL — 12.00 weeks vs 9.14 weeks (HR, 0.88; P =.17)  
  • EQ-5D-3L VAS — 9.43 weeks vs 9.14 weeks (HR, 0.83; P =.041).

However, the median time to definitive deterioration was significantly longer with lenvatinib-pembrolizumab than with sunitinib for:

  • FKSI-DRS — 134.14 weeks vs 117.43 weeks (HR, 0.70; P =.0081) 
  • EORTC QLQ-C30 GHS/QOL — 114.29 weeks vs 75.14 weeks (HR, 0.60; P <.0001) 
  • EQ-5D-3L VAS — 124.86 weeks vs 74.86 weeks (HR, 0.67; P =.0012).  

“Health-related quality-of-life data are a valuable tool to assist clinicians in selecting anticancer therapy for their patients,” the researchers wrote. “[T]hese data from CLEAR provide further support for administration of lenvatinib plus pembrolizumab in the first-line setting to patients with advanced renal cell carcinoma.” 

Disclosures:  This research was supported by Eisai and Merck Sharp & Dohme. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


1. Motzer R, Porta C, Alekseev B, et al. Health-related quality-of-life outcomes in patients with advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab or everolimus versus sunitinib (CLEAR): A randomised, phase 3 study. Lancet Oncol. Published online April 27, 2022. doi:10.1016/S1470-2045(22)00212-1

2. Motzer R, Alekseev B, Rha SY, et al. Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma. N Engl J Med. 2021;384(14):1289-1300. doi:10.1056/NEJMoa2035716

This article originally appeared on Cancer Therapy Advisor