Abstract
BACKGROUND: The REMORA trial demonstrated efficacy and safety of lenvatinib in patients previously treated for advanced thymic carcinoma. However, more data regarding its use in clinical practice are required. METHODS: This multicenter retrospective study included consecutive patients with advanced thymic carcinoma who began lenvatinib treatment between 23 March 2021 and 31 October 2022. The primary outcome was the objective response rate in the previously treated group, with threshold and expected values based on the results of the REMORA trial and trials of other key drugs. Subgroup analyses were carried out based on REMORA trial eligibility criteria or age. RESULTS: Eighty-seven patients were enrolled in the previously treated group [median age, 64 years (range 38-79 years); 56 (64%) males]. Most patients [82 (94%)] had a performance status of 0 or 1; 51 (59%) met the trial eligibility criteria. The objective response rate and the disease control rate were 30% [90% confidence interval (CI) 21.3% to 39.1%] and 93% (95% CI 84.6% to 97.2%), respectively. The median progression-free survival, time to treatment failure, and overall survival were 10.2 months (95% CI 7.0-13.2 months), 11.6 months (95% CI 6.9-17.0 months), and not reached (NR; 95% CI 18.3 months-NR), respectively. Seventy-three patients (84%) required dose reduction owing to adverse events, including hypertension (22%), proteinuria (20%), and palmar-plantar erythrodysesthesia syndrome (16%). Twenty patients (23%) discontinued lenvatinib due to adverse events, including anorexia (6%), left ventricular systolic dysfunction (2%), and fatigue or malaise (2%). Two patients (2%) died of adverse events. Trial-eligible patients had significantly longer progression-free survival than that in trial-ineligible patients (14.7 months versus 7.7 months; P = 0.03). The incidence of adverse events was higher in older patients. CONCLUSIONS: The primary endpoint was unmet; however, lenvatinib demonstrated relatively favorable efficacy and safety in patients with previously treated thymic carcinoma, even in real-world clinical practice involving diverse populations.