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

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, 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

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.

Keywords: EORTC QLQ-C30; FKSI-DRS; VEGF; patient-reported outcomes; phase II.

© The Author(s) 2022. Published by Oxford University Press.

Figures

Figure 1.
Figure 1.
Overall least-squares mean differences between treatments. *Indicates statistically significant differences (P < .05).
Figure 2.
Figure 2.
Time to first deterioration: hazard ratios.
Figure 3.
Figure 3.
Kaplan–Meier plots of time to first deterioration. A. FKSI-DRS total score. B. EORTC QLQ-C30 Global Health Status/QOL Score. C. EORTC QLQ-C30 Physical Functioning Score. D. EORTC QLQ-C30 Emotional Functioning Score. E. EORTC QLQ-C30 Fatigue Score. F. EORTC QLQ-C30 Nausea and Vomiting Score.
Figure 3.
Figure 3.
Kaplan–Meier plots of time to first deterioration. A. FKSI-DRS total score. B. EORTC QLQ-C30 Global Health Status/QOL Score. C. EORTC QLQ-C30 Physical Functioning Score. D. EORTC QLQ-C30 Emotional Functioning Score. E. EORTC QLQ-C30 Fatigue Score. F. EORTC QLQ-C30 Nausea and Vomiting Score.
Figure 3.
Figure 3.
Kaplan–Meier plots of time to first deterioration. A. FKSI-DRS total score. B. EORTC QLQ-C30 Global Health Status/QOL Score. C. EORTC QLQ-C30 Physical Functioning Score. D. EORTC QLQ-C30 Emotional Functioning Score. E. EORTC QLQ-C30 Fatigue Score. F. EORTC QLQ-C30 Nausea and Vomiting Score.
Figure 4.
Figure 4.
Time to definitive deterioration: hazard ratios.
Figure 5.
Figure 5.
Kaplan–Meier plots of time to definitive deterioration. A. FKSI-DRS Total Score. B. EORTC QLQ-C30 Global Health Status/QOL Score. C. EORTC QLQ-C30 Physical Functioning Score. D. EORTC QLQ-C30 Emotional Functioning Score. E. EORTC QLQ-C30 Fatigue Score. F. EORTC QLQ-C30 Nausea and Vomiting Score.
Figure 5.
Figure 5.
Kaplan–Meier plots of time to definitive deterioration. A. FKSI-DRS Total Score. B. EORTC QLQ-C30 Global Health Status/QOL Score. C. EORTC QLQ-C30 Physical Functioning Score. D. EORTC QLQ-C30 Emotional Functioning Score. E. EORTC QLQ-C30 Fatigue Score. F. EORTC QLQ-C30 Nausea and Vomiting Score.
Figure 5.
Figure 5.
Kaplan–Meier plots of time to definitive deterioration. A. FKSI-DRS Total Score. B. EORTC QLQ-C30 Global Health Status/QOL Score. C. EORTC QLQ-C30 Physical Functioning Score. D. EORTC QLQ-C30 Emotional Functioning Score. E. EORTC QLQ-C30 Fatigue Score. F. EORTC QLQ-C30 Nausea and Vomiting Score.

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Source: PubMed

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