medwireNews: Patients who receive lenvatinib plus pembrolizumab for advanced renal cell carcinoma (RCC) report similar or better health-related quality of life (HRQoL) than those who receive sunitinib, show data from the phase 3 CLEAR trial.
Conversely, the secondary analysis, presented at the 2021 ASCO Annual Meeting by Robert Motzer, from the Memorial Sloan Kettering Cancer Center in New York, USA, found that people who received lenvatinib plus everolimus had similar or worse HRQoL to those who received sunitinib.
The primary analysis of the CLEAR trial revealed that both first-line lenvatinib combinations improved progression-free survival (PFS) relative to sunitinib in patients with advanced RCC. When this efficacy data was combined with safety and HRQoL data in the current analysis, the results “support [lenvatinib] plus [pembrolizumab] as first-line therapy for patients with advanced RCC,” Motzer said.
For the study, 355 patients were randomly assigned to receive lenvatinib 20 mg/day plus pembrolizumab 200 mg every 3 weeks, 357 were given lenvatinib 18 mg/day plus everolimus 5 mg/day, and 357 received sunitinib 50 mg/day, given on a 4-week on, 2-week off schedule.
HRQoL was assessed using the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index – Disease Related Symptoms (FKSI-DRS) questionnaire, the EORTC QLQ-C30 tool, and the EuroQoL EQ-5D-3L questionnaire at baseline and on day 1 of each subsequent 3-week cycle.
Motzer reported that patients who received lenvatinib plus everolimus generally had similar HRQoL scores to those who received sunitinib. The only exceptions were pain, appetite loss, diarrhea, and global health status on the EORTC-QLQ-C30 questionnaire, which were all significantly worse with the lenvatinib combination after a mean 46 weeks (15 cycles) of follow-up.
Notably, for diarrhea the least squares mean difference score was greater than 5, at 5.26, “which may be considered clinically significant,” the presenter remarked.
By comparison, people in the lenvatinib plus pembrolizumab group reported a significantly better overall physical functioning score and had significantly better fatigue, dyspnea and constipation symptom scores at week 46 relative to those who received sunitinib. Overall change from baseline was similar between the two groups for the rest of the scales assessed.
Motzer and colleagues also looked at time to deterioration of HRQoL and found that lenvatinib plus pembrolizumab significantly delayed time to first deterioration of physical function, dyspnea, appetite loss, and EQ-5D VAS relative to sunitinib.
For time to definitive deterioration, nearly all HRQoL comparisons significantly favored lenvatinib plus pembrolizumab, suggesting that “patients who received [lenvatinib] plus [pembrolizumab] had longer maintenance of quality of life and symptom control than those in the sunitinib group,” Motzer remarked.
For example, median time to definitive deterioration of the FKSI-DRS total score was 134.1 versus 117.4 weeks with lenvatinib plus pembrolizumab versus sunitinib. For the EORTC-QLQ-C30 Global health score it was 114.3 versus 75.1 weeks, and for the EQ-5D-3L VAS it was 124.9 versus 74.9 weeks, all significant differences.
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