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).
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.
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.
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.
The oncologist. 2022 Jul 26 [Epub ahead of print]
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
Instituto Unity de Ensino e Pesquisa, Centro de Câncer de Brasília, Brasília, DF, Brazil., Yonsei Cancer Center, Yonsei University Health System, Seoul, Republic of Korea., Department of Medical Oncology & Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA., Szpital Specjalistyczny Ludwika Rydygiera, Kraków, Poland., Moscow City Oncology Hospital #62 of Moscow Healthcare Department, Moscow, Russia., P.A. Hertzen Moscow Oncological Research Institute, Moscow, Russia., University of Adelaide, Adelaide, South Australia, Australia., 12 de Octubre University Hospital, Madrid, Spain., Asan Medical Center, Seoul, Republic of Korea., Department of Oncology, Tampere University Hospital, Tampere, Finland., Prof Dr Ion Chiricuta Cancer Institute and Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania., Department of Oncology, Tom Baker Cancer Center, University of Calgary, Calgary, Alberta, Canada., Department of Medical Oncology, Beatson West of Scotland Cancer Centre, Glasgow, UK., RTI Health Solutions, Research Triangle Park, NC, USA., Eisai, Inc., Nutley, NJ, USA., Eisai Europe Ltd., Hertfordshire, UK., Medical Oncology Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, Madrid, Spain.