Recommendations on managing lenvatinib and everolimus in patients with advanced or metastatic renal cell carcinoma
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1a Medical Oncology Department , Ramón y Cajal University Hospital , Madrid , Spain.
Introduction:
There are several second-line treatment options for patients with renal cell carcinoma after first-line failure of a tyrosine kinase inhibitor, especially with the recent approvals of cabozantinib, nivolumab, and the lenvatinib plus everolimus combination. A lack of reliable biomarkers and an overall lack of prospective head-to-head comparisons make it a challenge to choose a second-line treatment in the clinic. Areas covered: In this review/meta-opinion, we describe the safety profile of the lenvatinib plus everolimus combination in renal cell carcinoma. The combination of lenvatinib plus everolimus has achieved the highest rates of objective responses and the longest progression free and overall survival in cross-comparison trials. At the same time, the safety profile of this combination, including the rate of total and severe adverse events, the percentage of dose reductions required, and the rate of treatment discontinuation, was less favorable compared with available monotherapy options, suggesting that better management could help to maximize the activity of this combination while protecting patients from undue harm. Expert opinion: Herein, we aim to postulate multidisciplinary recommendations on the advice to offer to patients and caregivers before starting treatment and how to manage the combination from the perspective of daily clinical practice.
Insights
The lenvatinib plus everolimus combination shows superior efficacy for advanced renal cell carcinoma (RCC) after first-line tyrosine kinase inhibitor failure. However, careful patient management is crucial due to its less favorable safety profile compared to monotherapies.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trial Analysis
Background:
- Several second-line treatments for renal cell carcinoma (RCC) are available post-tyrosine kinase inhibitor (TKI) failure.
- Recent approvals include cabozantinib, nivolumab, and the lenvatinib plus everolimus combination.
- Choosing optimal second-line therapy is challenging due to limited biomarkers and head-to-head comparisons.
Purpose of the Study:
- To review and provide expert opinion on the safety profile of the lenvatinib plus everolimus combination in RCC.
- To postulate multidisciplinary recommendations for managing this combination in clinical practice.
- To guide patient and caregiver counseling before initiating treatment.
Main Methods:
- Review of existing clinical trial data and meta-opinion.
- Cross-comparison analysis of efficacy and safety data.
- Expert consensus on clinical management strategies.
Main Results:
- Lenvatinib plus everolimus demonstrated superior objective response rates, progression-free survival, and overall survival in cross-comparison trials.
- This combination exhibited a less favorable safety profile, with higher rates of adverse events and treatment discontinuation compared to monotherapies.
- Dose reductions were more frequently required with the combination therapy.
Conclusions:
- The lenvatinib plus everolimus combination is a highly active second-line treatment for advanced RCC.
- Proactive and multidisciplinary management is essential to mitigate toxicity and optimize patient outcomes.
- Informed patient counseling regarding efficacy and safety is critical before treatment initiation.
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