Darlene Dobkowski, MA

Data from a phase 2 trial shared during the 2021 Genitourinary Cancers Symposium suggested that among patients receiving lenvatinib (Lenvima) for renal cell carcinoma, using a higher starting dose enhanced health-related quality of life and extended the time to deterioration.1 

“Based on these findings, patients who received lenvatinib 18 mg starting dose had better quality of life and less severe symptoms than those who received lenvatinib 14 mg starting dose,” said Cristiane Decat Bergerot, PhD, MS, BS, a postdoctoral fellow at City of Hope National Medical Center in Duarte, California, during the virtual poster presentation. “In addition, participants who received lenvatinib 18 mg maintained quality of life and symptom control for longer than those who received lenvatinib 14 mg starting dose.”

In this phase 2, randomized, open-label trial, researchers compared the safety and efficacy of two different starting doses of lenvatinib — 18 mg per day (n = 172; median age, 61 years; 77% men) or 14 mg per day (n = 171; median age, 62 years; 75% men) — in patients with renal cell carcinoma who previously received one vascular endothelial growth factor-targeted treatment. Both starting doses of lenvatinib were given in combination with 5 mg of everolimus per day. Patients received treatment until unacceptable toxicity, disease progression, withdrawal of consent or the end of the study.

Researchers used three different instruments to measure health-related quality of life: Functional Assessment of Cancer Therapy-Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS), EQ-5D-3L and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Quality-of-life scores were measured at baseline, first day of the first cycle of treatment and at the end-of-treatment visit.

Average quality-of-life scores in patients assigned the 18 mg dose were higher compared with those assigned the 14 mg dose. In addition, the higher dose group had lower symptom severity compared with the lower dose group.

“Mean differences in favor of lenvatinib 18 mg were seen in most scales,” said Bergerot during the presentation. “However, none of these differences exceeded the minimally important difference for clinical significance.”

The median time to first deterioration was longer in patients assigned the 18 mg starting dose compared with those assigned the 14 mg starting dose in most scales including the FKSI-DRS total score (12 weeks vs. 15.71 weeks; HR = 1.3). This was also observed for EORTC QLQ-C30, which assessed emotional functioning (20.71 weeks vs. 34.86 weeks), social functioning (12.14 weeks vs. 16.29 weeks), dyspnea (20.29 weeks vs. 40.29 weeks), insomnia (15.43 weeks vs. 28.14 weeks) and financial difficulties (36.14 weeks vs. not estimable).

Patients assigned the 18 mg starting dose also had a longer time to definitive deterioration based on the FKSI-DRS total score (HR = 1.46; 56.43 weeks vs. 80.14 weeks). This was also observed for EORTC QLQ-C30 scores, which assessed factors such as physical functioning (HR = 1.65; 56.14 weeks vs. 99.57 weeks), cognitive functioning (HR = 1.44; 56.14 weeks vs. 72.29 weeks) and fatigue (HR = 1.59; 40.14 weeks vs. 72.29 weeks).

“In conclusion, these findings support the approved treatment of lenvatinib 18 mg starting dose in combination with everolimus as an effective treatment option for patients with renal cell carcinoma following one prior VEGF-targeted treatment while maintaining quality of life,” said Bergerot during the presentation.

1. Bergerot CD, Rha SY, Pal SK, et al. Health-related quality-of-life outcomes from a phase II open-label trial of two different starting doses of lenvatinib in combination with everolimus for treatment of renal cell carcinoma following one prior VEGF-targeted treatment. Presented at: 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium; February 11-13, 2021; virtual. Abstract 314.

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