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Health-Related Quality of Life Outcomes With Two Different Starting Doses of Lenvatinib in Combination With Everolimus for Previously Treated Renal Cell Carcinoma

Authors
 Cristiane Bergerot Sun Young Rha  ;  Sumanta Pal  ;  Piotr Koralewski  ;  Daniil Stroyakovskiy  ;  Boris Alekseev  ;  Francis Parnis  ;  Daniel Castellano  ;  Jae Lyun Lee  ;  Kaisa Sunela  ;  Tudor Ciuleanu  ;  Daniel Heng  ;  Hilary Glen  ;  Jinyi Wang  ;   Lee Bennett  ;   Janice Pan  ;  Karen O'Hara  ;  Javier Puente 
Citation
 ONCOLOGIST, Vol.28(1) : 59-71, 2023-01 
Journal Title
ONCOLOGIST
ISSN
 1083-7159 
Issue Date
2023-01
MeSH
Antineoplastic Agents* / administration & dosage ; Carcinoma, Renal Cell* / drug therapy ; Carcinoma, Renal Cell* / pathology ; Everolimus / therapeutic use ; Humans ; Kidney Neoplasms* / drug therapy ; Kidney Neoplasms* / pathology ; Quality of Life ; Vascular Endothelial Growth Factor A
Keywords
EORTC QLQ-C30 ; FKSI-DRS ; VEGF ; patient-reported outcomes ; phase II
Abstract
Background: Preserving health-related quality of life (HRQOL) is an important goal during renal cell carcinoma treatment. We report HRQOL outcomes from a phase II trial (NCT03173560).

Patients and methods: HRQOL data were collected during a multicenter, randomized, open-label phase II study comparing the safety and efficacy of 2 different starting doses of lenvatinib (18 mg vs. 14 mg daily) in combination with everolimus (5 mg daily), following one prior vascular endothelial growth factor-targeted treatment. HRQOL was measured using 3 different instruments-FKSI-DRS, EORTC QLQ-C30, and EQ-5D-3L-which were all secondary endpoints. Change from baseline was assessed using linear mixed-effects models. Deterioration events for time to deterioration (TTD) analyses were defined using established thresholds for minimally important differences in the change from baseline for each scale. TTD for each treatment arm was estimated using the Kaplan-Meier method.

Results: Baseline characteristics of the 343 participants randomly assigned to 18 mg lenvatinib (n = 171) and 14 mg lenvatinib (n = 172) were well balanced. Least-squares mean estimates for change from baseline were favorable for the 18 mg group over the 14 mg group for the FKSI-DRS and most EORTC QLQ-C30 scales, but differences between treatments did not exceed the minimally important thresholds. Median TTD was longer among participants in the 18 mg group than those in the 14 mg group for most scales.

Conclusions: Participants who received an 18 mg lenvatinib starting dose had favorable HRQOL scores and longer TTD on most scales compared with those who received a 14 mg starting dose.
Files in This Item:
T202300934.pdf Download
DOI
10.1093/oncolo/oyac142
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Rha, Sun Young(라선영) ORCID logo https://orcid.org/0000-0002-2512-4531
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/193581
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