Efficacy and safety of first-line lenvatinib in patients with advanced or recurrent thymic carcinoma in the real-world setting

BACKGROUND: Thymic carcinoma is a rare thoracic malignancy with limited first-line treatment options. Lenvatinib has shown efficacy and tolerability in previously treated patients, but its role in chemotherapy-naive patients is unclear. METHODS: We conducted a retrospective, multicentre observational study across 31 Japanese institutions. Patients with advanced or recurrent thymic carcinoma who received lenvatinib between 23 March 2021 and 31 October 2022 were included. Data cut-off was 13 November 2024. Outcomes for chemotherapy-naive patients included objective response rate (ORR), progression-free survival (PFS), disease control rate (DCR), time to treatment failure (TTF), overall survival (OS), and adverse events (AEs). Subgroup analyses were stratified by age. RESULTS: Of 107 patients, 20 received lenvatinib as first-line therapy. Median observation was 23.6 months (interquartile range, 12.5-27.1). ORR was 50% (90% confidence interval [CI], 27.2-72.8%), and DCR 85% (95% CI, 62.1-96.8%). Median PFS, TTF, and OS were 10.9 months (95% CI, 5.6-17.1), 8.9 months (95% CI, 5.3-17.8), and 25.0 months (95% CI, 21.2-not reached). AEs occurred in 95% (Grade ≥ 3 in 60%); dose reductions and discontinuations occurred in 85% and 25%. Safety was consistent with prior reports. Older patients showed higher rates of Grade ≥ 3 AEs and discontinuation. CONCLUSIONS: In this real-world cohort, first-line lenvatinib demonstrated favourable efficacy and manageable safety, supporting its use in advanced or recurrent thymic carcinoma.