The multitargeted tyrosine kinase inhibitor lenvatinib had antitumor activity in patients with recurrent or metastatic adenoid cystic carcinoma (ACC), but required active monitoring and management for adverse events, according to results from a phase II study.1

The study included 32 evaluable patients with confirmed disease who received oral lenvatinib 24 mg per day. Patients could have prior treatment but no prior treatment with lenvatinib.

The majority of patients achieved stable disease (75%). Five patients achieved a partial response (15.6%), meeting the study’s primary end point. Two patients discontinued therapy because of toxicity (6.3%), and one had disease progression as best response.

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Median progression-free survival was 17.5 months (95% CI, 7.2 months to not reached) with 8 progression events observed. Other patients were removed from the study because of toxicity (5 individuals), withdrawal of consent (9 individuals), or physician’s discretion (6 individuals).

Response rates and progression-free survival data “represent the best outcomes observed to date among all the VEGFR-targeting TKI studies reported in ACC,” the researchers wrote.

Twenty-three of 32 patients required at least one dose reduction and more than half (18 of 32) discontinued lenvatinib for drug-related issues. The most common grade 3/4 adverse events were hypertension (28.1%) and oral pain (9.4%). One patient had grade 4 myocardial infarction; one had grade 4 posterior reversible encephalopathy syndrome; and one had intracranial hemorrhage.

“A limitation of this study is the single-arm design, because deciphering the benefits of treatment is difficult without a placebo control, and future randomized trials are warranted,” the researchers wrote. “The ongoing challenge is to optimize patient selection for therapy and manage drug toxicities to preserve quality of life and safety while maximizing therapeutic benefit.”


  1. Tchekmedyian V, Sherman EJ, Dunn L, et al. Phase II study of lenvatinib in patients with progressive, recurrent or metastatic adenoid cystic carcinoma [published online April 2, 2019].  J Clin Oncol. doi: 10.1200/JCO.18.01859