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Multicenter Study
. 2025 Jul;47(7):2040-2047.
doi: 10.1002/hed.28124. Epub 2025 Mar 3.

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

Francesca Caspani  1 , Stefano Cavalieri  1   2 , Ester Orlandi  3   4 , Cristiana Bergamini  1 , Carlo Resteghini  1 , Elena Colombo  1 , Arianna Ottini  1 , Imperia Nuzzolese  1 , Salvatore Alfieri  5 , Aurora Mirabile  6 , Alessandra Cassano  7   8 , Paolo Bossi  9   10 , Toni Ibrahim  11 , Maria Chiara Cau  12 , Massimo Ghiani  12 , Federica Bertolini  13 , Rossana Ingargiola  3 , Giulia Fontana  3 , Lisa Licitra  1   2 , Laura D Locati  1
Affiliations
Multicenter Study

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

Francesca Caspani et al. Head Neck. 2025 Jul.

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.

Keywords: MTKI; adenoid cystic carcinoma; lenvatinib; salivary gland cancer; systemic therapy.

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References

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