Low-Dose Versus High-Dose Lenvatinib in Radioiodine Refractory Differentiated Thyroid Cancer-A Real-World Safety and Efficacy Analysis.

IF 3 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Clinical Endocrinology Pub Date : 2025-02-04 DOI:10.1111/cen.15214

Jeepalem Sai Moulika, Kunal Ramesh Chandekar, Shubha Gadde Ravindra, Priyanka G B, Sanjana Ballal, Madhavi Tripathi, Swayamjeet Satapathy, Chandrasekhar Bal

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引用次数: 0

Abstract

Objective: Lenvatinib, a tyrosine kinase inhibitor, is approved for the treatment of radioiodine refractory differentiated thyroid cancer (RR-DTC) at a dose of 24 mg/day. Given its significant toxicity profile, the present study aimed to compare the safety and efficacy of initial low-dose lenvatinib to that of higher starting doses in patients with RR-DTC.

Methods: This retrospective study included patients with RR-DTC who were classified as: Group-A: patients receiving 10mg/day, and Group-B: patients receiving ≥ 14mg/day of lenvatinib as starting dose. Safety, radiological response (as per RECIST 1.1) and progression-free survival (PFS) outcomes were analysed and compared.

Results: A total of 105 patients with RR-DTC were included in this study (Group-A: 60, Group-B: 45). The study found that Group-B experienced significantly higher rates of drug interruptions (68.9% vs 48.3%, p = 0.035) and dose reductions (60% vs 11.7%; p < 0.001) compared to Group-A. Adverse events such as hand-foot skin reaction (77.8% vs 58.3%), diarrhea (28.9% vs 11.7%), hepatotoxicity (33.3-40% vs 11.7-18.3%), and electrolyte imbalance (15.6% vs 3.3%) were also more frequent in Group-B (p-values < 0.05). However, both groups showed similar objective response rates (47.1% vs 46.3%; p = 0.936) and comparable PFS outcomes (restricted mean survival time at 24 months: 22.8 vs 21.4 months, p = 0.128).

Conclusions: The study suggests that starting with lower doses of lenvatinib, followed by dose escalation if tolerated, may offer a safer approach with significantly lower rates of drug interruptions and dose reductions, with comparable efficacy in RR-DTC patients. Further validation by larger prospective trials is warranted.

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低剂量Lenvatinib与高剂量Lenvatinib治疗放射性碘难治性分化甲状腺癌的安全性和有效性分析。

目的：Lenvatinib是一种酪氨酸激酶抑制剂，被批准用于治疗放射性碘难治性分化型甲状腺癌（RR-DTC），剂量为24mg /天。鉴于lenvatinib具有明显的毒性，本研究旨在比较RR-DTC患者初始低剂量lenvatinib与初始高剂量lenvatinib的安全性和有效性。方法：回顾性研究纳入RR-DTC患者，分为：a组：起始剂量为10mg/天的患者，b组：起始剂量≥14mg/天的lenvatinib患者。安全性、放射反应（根据RECIST 1.1）和无进展生存期（PFS）结果进行了分析和比较。结果：共纳入RR-DTC患者105例（A组60例，b组45例）。研究发现，b组的药物中断率（68.9% vs 48.3%, p = 0.035）和剂量减少率(60% vs 11.7%；结论：研究表明，从低剂量lenvatinib开始，然后在耐受情况下增加剂量，可能是一种更安全的方法，药物中断率和剂量减少率显著降低，对RR-DTC患者具有相当的疗效。有必要通过更大规模的前瞻性试验进一步验证。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Endocrinology 医学-内分泌学与代谢

CiteScore

6.40

自引率

3.10%

发文量

192

审稿时长

1 months

期刊介绍： Clinical Endocrinology publishes papers and reviews which focus on the clinical aspects of endocrinology, including the clinical application of molecular endocrinology. It does not publish papers relating directly to diabetes care and clinical management. It features reviews, original papers, commentaries, correspondence and Clinical Questions. Clinical Endocrinology is essential reading not only for those engaged in endocrinological research but also for those involved primarily in clinical practice.