- Response occurred in 15.6% of patients and stable disease occurred in 75.0%.
- Approximately half of patients discontinued treatment due to drug-related issues.
In a single-center phase II study reported in the Journal of Clinical Oncology, Tchekmedyian et al found that the multitargeted tyrosine kinase inhibitor lenvatinib was active in progressive recurrent or metastatic adenoid cystic carcinoma.
In the study, 32 evaluable patients at Memorial Sloan Kettering Cancer Center with recurrent or metastatic adenoid cystic carcinoma of any primary site and radiographic or symptomatic progression were treated with lenvatinib 24 mg orally per day. Any prior therapy except lenvatinib was allowed.
The primary endpoint was overall response rate. The study was to be considered positive if 4 or more responses occurred among a total of 32 patients. Overall, 78% of patients had adenoid cystic carcinoma of either the major or minor salivary glands, and 96.9% had distant metastases.
Five patients (15.6%) had confirmed objective response (all partial responses) and an additional 24 patients (75.0%) had stable disease. Median progression-free survival was 17.5 months. In total, 8 progression events were observed; 5 patients were taken off trial due to toxicity, 9 as a result of withdrawal of consent, and 6 at the treating physician’s discretion.
Overall, 23 patients required at least one dose modification and 18 (56%) of 32 patients discontinued lenvatinib for drug-related issues. The most common grade 3 or 4 adverse events were hypertension (28.1%) and oral pain (9.4%). Three grade 4 adverse events were observed, consisting of myocardial infarction, posterior reversible encephalopathy syndrome, and intracranial hemorrhage.
The investigators concluded, “This trial met the prespecified overall response rate primary endpoint, demonstrating antitumor activity with lenvatinib in [patients with recurrent or metastatic adenoid cystic carcinoma]. Toxicity was comparable to previous studies, requiring monitoring and management.”
Alan L. Ho, MD, PhD, of the Department of Medicine, Memorial Sloan Kettering Cancer Center, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Eisai and by a grant from the National Cancer Institute. The study authors’ full disclosures can be found at jco.ascopubs.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.