Key result
Lenvatinib increases the risk of all-grade hypertension ~2.4-fold compared to controls in cancer patients.
Why the study?
Published data regarding the overall risks and incidence of hypertension and proteinuria associated with lenvatinib remained unclear.
Does lenvatinib monotherapy increase the incidence and risk of hypertension and proteinuria in cancer patients compared to controls and across different dosing regimens?
Meta-Analysis (n=10,443)
Does lenvatinib monotherapy increase the incidence and risk of hypertension and proteinuria in cancer patients compared to controls and across different dosing regimens?
This meta-analysis demonstrates that lenvatinib therapy in cancer patients is associated with a high incidence and significantly increased risk of hypertension and proteinuria in a strongly dose-dependent manner, underscoring the need for intensive blood pressure and renal monitoring, particularly at doses ≥20 mg/day.
Intensive BP and proteinuria monitoring is warranted with lenvatinib; extends prior trial data on dose-dependent risks.
BACKGROUND: Published data regarding the overall risks and incidence of hypertension and proteinuria associated with lenvatinib remain unclear. METHODS: We performed a systematic review and meta-analysis to quantify the precise risks and incidence of lenvatinib-associated hypertension and proteinuria. We systematically searched PubMed, Cochrane Library, and Web of Science databases for studies on the incidence of hypertension and proteinuria, which were published until April 24, 2023. RESULTS: A total of 10 443 patients were included in the 64 studies identified from the literature. The incidence of all-grade and grade ≥3 hypertension was 50% (95% confidence interval [CI]: 43%-58%) and 14% (95% CI, 10%-18%) for patients treated with lenvatinib. The incidence of all-grade and grade ≥3 proteinuria was 32% (95% CI, 26%-38%) and 6% (95% CI, 4%-7%), respectively. Compared with controls, lenvatinib significantly increased the risk of all-grade hypertension (odds ratio [OR]: 2.4, 95% CI, 1.4-4.1), grade ≥3 hypertension (OR: 2.7, 95% CI, 1.2-6.0), all-grade proteinuria (OR: 3.5, 95% CI, 1.9-6.6), and grade ≥3 proteinuria (OR: 2.85, 95% CI, 1.5-5.3). Compared to low-dose lenvatinib (≤12 mg/day), high-dose lenvatinib (≥20 mg/day) treatment significantly increased the risks of all-grade hypertension (OR: 4.7, 95% CI, 4.2-5.2), grade ≥3 hypertension (OR: 7.7, 95% CI, 6.8-8.7), all-grade proteinuria (OR: 1.8, 95% CI, 1.6-2.0), and grade ≥3 proteinuria (OR: 1.7, 95% CI, 1.5-2.1). CONCLUSION: Our review revealed that lenvatinib treatment increases the risks of hypertension and proteinuria, particularly with high-dose lenvatinib.
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Shibutani et al. (2025) conducted a meta-analysis in Malignant neoplasms (including hepatocellular carcinoma, thyroid cancer, and other solid tumors) (n=10,443). Lenvatinib vs. Control (atezolizumab plus bevacizumab, sorafenib, or placebo) or low-dose lenvatinib (≤12 mg/day) was evaluated on All-grade hypertension (OR 2.40, 95% CI 1.41-4.09). Lenvatinib significantly increased the risk of all-grade hypertension (OR 2.40, 95% CI 1.41-4.09) and proteinuria (OR 3.50, 95% CI 1.87-6.57) compared to controls in cancer patients.
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