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. 2025 Jun;102(6):721-729.
doi: 10.1111/cen.15214. Epub 2025 Feb 4.

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

Jeepalem Sai Moulika  1 , Kunal Ramesh Chandekar  1 , Shubha Gadde Ravindra  1 , Priyanka G B  1 , Sanjana Ballal  1 , Madhavi Tripathi  1 , Swayamjeet Satapathy  1 , Chandrasekhar Bal  1
Affiliations

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

Jeepalem Sai Moulika et al. Clin Endocrinol (Oxf). 2025 Jun.

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.

Keywords: Efficacy; Lenvatinib; Low‐dose; Radioiodine Refractory Differentiated Thyroid Cancer (RR‐DTC); Safety.

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References

    1. F. Bray, M. Laversanne, H. Sung, et al., “Global Cancer Statistics 2022: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries,” CA: A Cancer Journal for Clinicians 74 (2024): 229–263.
    1. F. Rezaei, A. Mazidimoradi, Z. Pasokh, S. P. Dehghani, L. Allahqoli, and H. Salehiniya, “Temporal Trends of Thyroid Cancer Between 2010 and 2019 in Asian Countries by Geographical Region and SDI, Comparison With Global Data,” AGING MEDICINE 6 (2024): 386–426.
    1. C. Panato, S. Vaccarella, L. Dal Maso, et al., “Thyroid Cancer Incidence in India Between 2006 and 2014 and Impact of Overdiagnosis,” Journal of Clinical Endocrinology & Metabolism 105 (2020): 2507–2514.
    1. Z. W. Baloch, S. L. Asa, J. A. Barletta, et al., “Overview of the 2022 WHO Classification of Thyroid Neoplasms,” Endocrine Pathology 33 (2022): 27–63.
    1. L. Davies and H. G. Welch, “Thyroid Cancer Survival in the United States: Observational Data From 1973 to 2005,” Archives of Otolaryngology–Head & Neck Surgery 136 (2010): 440–444.

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