Trial reportThe Journal of clinical endocrinology and metabolism2022
A Randomized Study of Lenvatinib 18 mg vs 24 mg in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer.
Trial report in The Journal of clinical endocrinology and metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
44 citing papers in PubMed, 1 synthesis or guideline pooled it.
- 2025 American Thyroid Association Management Guidelines for Adult Patients with Differentiated Thyroid Cancer.Thyroid : official journal of the American Thyroid Association · 2025Guideline
- Population pharmacokinetic-pharmacodynamic modeling of serum biomarkers as predictors of tumor dynamics following lenvatinib treatment in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC).CPT: pharmacometrics & systems pharmacology · 2024Trial
- Health-related quality-of-life analyses from a multicenter, randomized, double-blind phase 2 study of patients with differentiated thyroid cancer treated with lenvatinib 18 or 24 mg/day.Cancer medicine · 2023Trial
- Magnitude of Survival Benefit Associated With Tyrosine Kinase Inhibitors in Advanced Thyroid Carcinoma: A Systematic Review and Meta-Analysis Incorporating Updated Long-Term Evidence From SELECT (Lenvatinib) and COSMIC-311 (Cabozantinib) Trials.World journal of oncology · 2026Review
- Development of a sensitive plasma lenvatinib quantification method and validation in thyroid cancer patients.Journal of the Endocrine Society · 2026Article
- Multidisciplinary team diagnosis and treatment of well-differentiated thyroid carcinoma: current landscape and future prospects.The oncologist · 2026Review
- How to manage radioiodine-refractory thyroid cancer in the era of precision medicine.Drugs in context · 2026Review
- Real-world clinical experience of reduced-dose initiation of lenvatinib in Japanese patients with radioiodine-refractory differentiated thyroid cancer.Endocrine journal · 2025Article
- Lenvatinib for unresectable anaplastic thyroid cancer: real-world experiences in multi-institutional study.Endocrine · 2025Observational
- Optimizing Lenvatinib Therapy for Prognostic Improvement in Advanced Thyroid Cancer.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Combination Therapy With Olaparib Plus Lenvatinib in a Patient WithJCO precision oncology · 2025Article
- Article
- Gender impact on safety and efficacy in lenvatinib treated patients with radioiodine-refractory differentiated thyroid cancer (GISEL study).European thyroid journal · 2025Observational
- Review
- Effects of lenvatinib on glucose, cholesterol, triglycerides and estimated cardiovascular risk in patients with advanced thyroid cancer.Endocrine · 2025Article
- Did selective kinase inhibitors change the management of patients with radioiodine-refractory thyroid cancer?European thyroid journal · 2025Article
- Real-world lenvatinib use in metastatic thyroid cancer: early dose intensity and side effect profile in an Australian centre.Endocrine oncology (Bristol, England) · 2025Article
- Lenvatinib in advanced thyroid, salivary gland, endometrial, and hepatocellular carcinomas: a real-world study on treatment duration and toxicity management.Therapeutic advances in medical oncology · 2025Article
- Predictive factors for first dose reduction and interruption of lenvatinib after beginning of the standard dose in Japanese patients with thyroid cancer.Cancer chemotherapy and pharmacology · 2024Article
- Histology-Specific Clinical Trial of Lenvatinib and Pembrolizumab in Patients with Sarcoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Article
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLenvatinib is a multikinase inhibitor approved to treat radioiodine-refractory differentiated thyroid cancer (RR-DTC) at a starting dose of 24 mg/day. This study explored, in a double-blinded fashion, whether a starting dose of 18 mg/day would provide comparable efficacy with reduced toxicity.
methodsPatients with RR-DTC were randomized to lenvatinib 24 mg/day or 18 mg/day. The primary efficacy endpoint was objective response rate as of week 24 (ORRwk24); the odds ratio noninferiority margin was 0.4. The primary safety endpoint was frequency of grade ≥3 treatment-emergent adverse events (TEAEs) as of week 24. Tumors were assessed using RECIST v1.1. TEAEs were monitored and recorded.
resultsThe ORRwk24 was 57.3% (95% CI 46.1, 68.5) in the lenvatinib 24-mg arm and 40.3% (95% CI 29.3, 51.2) in the lenvatinib 18-mg arm, with an odds ratio (18/24 mg) of 0.50 (95% CI 0.26, 0.96). As of week 24, the rates of TEAEs grade ≥3 were 61.3% in the lenvatinib 24-mg arm and 57.1% in the lenvatinib 18-mg arm, a difference of -4.2% (95% CI -19.8, 11.4).
conclusionA starting dose of lenvatinib 18 mg/day did not demonstrate noninferiority compared to a starting dose of 24 mg/day as assessed by ORRwk24 in patients with RR-DTC. The results represent a clinically meaningful difference in ORRwk24. The safety profile was comparable, with no clinically relevant difference between arms. These results support the continued use of the approved starting dose of lenvatinib 24 mg/day in patients with RR-DTC and adjusting the dose as necessary.
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