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).
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