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A higher starting dose of Lenvima, compared with a lower starting dose, prolonged the time that patients with renal cell carcinoma experienced negative effects on factors including social and physical functioning, financial difficulties and cogitative functioning over time.
Initiating 18 milligrams of Lenvima (lenvatinib) daily improved health-related quality of life compared to a 14-miligram daily dose of the drug in patients with renal cell carcinoma, according to data presented at the 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium.
“Based on these findings, patients who received (Lenvima) 18 milligram starting dose had better quality of life and less severe symptoms than those who received (Lenvima) 14 milligram starting dose,” said Cristiane Decat Bergerot, a postdoctoral fellow at City of Hope National Medical Center in Duarte, California, during a virtual presentation of the data. “In addition, participants who received (Lenvima) 18 milligrams maintained quality of life and symptom control for longer than those who received (Lenvima) 14 mg starting dose.”
Lenvima is a kinase inhibitor, a drug that can help control the growth of cancer cells and potentially prevent the growth of new blood vessels that allow a tumor to grow. Vascular endothelial growth factor-targeted therapies are often used to treat patients with renal cell carcinoma, but they can lead to side effects such as fatigue.
“Metastatic renal cell carcinoma and its treatments are commonly associated with symptoms that impact patients’ health-related quality of life,” the study authors wrote on the poster. “Preserving (health-related quality of life) is thus an important goal during (renal cell carcinoma) management.”
In this phase 2 trial, researchers compared the safety and efficacy of two different starting doses of Lenvima — 18 milligrams per day (172 patients; median age, 61 years; 77% men) or 14 milligrams per day (171 patients; median age, 62 years; 75% men) — in patients with renal cell carcinoma who previously received treatment with one vascular endothelial growth factor-targeted.
Both starting doses of Lenvima were given in combination with 5 milligrams of everolimus per day, another drug used in advanced renal cell carcinoma when treatment with Nexavar (sorafenib) or Sutent (sunitinib) was not successful. 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 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 milligram dose were higher compared to those assigned the 14 milligram dose. In addition, the higher dose group had lower symptom severity compared with the lower dose group.
“Mean differences in favor of lenvatinib 18 (milligrams) 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 in quality of life (or the first instance in quality of life decline) was longer in patients assigned the higher starting dose compared to those assigned the lower starting dose in most scales. Some of these scales assessed emotional functioning, social functioning, dyspnea (difficulty breathing), insomnia and financial difficulties.
Patients assigned the higher starting dose also had a longer time to definitive deterioration (the time at which a significant decline in quality of life has been observed) with several scales including those assessing physical functioning, cognitive functioning and fatigue.
“In conclusion, these findings support the approved treatment of (Lenvima) 18 (milligrams) starting dose in combination with everolimus as an effective treatment option for patients with renal cell carcinoma following one prior (vascular endothelial growth factor)-targeted treatment while maintaining quality of life,” concluded Bergerot.
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