Lenvatinib in Relapsed/Metastatic Adenoid Cystic Carcinoma: Real‐World Data From 17 Italian Centers

ABSTRACT Background Lenvatinib, a multi‐target tyrosine kinase inhibitor (MTKI), has demonstrated activity in recurrent or metastatic (R/M) adenoid cystic carcinoma (ACC) in phase II studies. Methods This multicenter, retrospective study included patients with R/M ACC treated with lenvatinib. The primary endpoint was the overall response rate (ORR). Results Fifty‐one patients were included across 17 Italian sites. Forty‐six patients (90%) were evaluated for response: the ORR was 21.7%, with 10 patients achieving a partial response; 24 patients had a stable disease resulting in a disease control rate of 73.9%. At least one treatment‐related adverse event (TRAE) was recorded in all patients. The most frequent TRAEs of grade > 3 were hypertension (25.5%), stomatitis (17.6%), and fatigue (15.7%); one grade 5 TRAE (bleeding) was reported. Median OS was 16.1 months (95% CI 12.2‐NR) with six‐month PFS at 75.7%. Conclusion Lenvatinib confirmed its activity in the real‐world population. A higher than expected rate of grade > 3 stomatitis was reported.