“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.”
This one small phase II study is not sufficient enough to provide supportive evidence for the use of Lenvima as medically necessary.
Per Lawrence (2019) in an article about the above study, “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.”
PEER REVIEWED PUBLICATION/LITERATURE:
Lawrence, L. (2019). Lenvatinib Active in Rare Adenoid Cystic Carcinoma. Cancer Therapy Advisor, accessed at: https://www.cancertherapyadvisor.com/home/cancer-topics/endocrine-cancer/adenoid-cystic-carcinoma-lenvatinib-active-treatment/.
Tchekmedyian, V., Sherman, E. J., Dunn, L., Tran, C., Baxi, S., Katabi, N., Antonescu, C. R., Ostrovnaya, I., Haque, S. S., Pfister, D. G., & Ho, A. L. (2019). Phase II Study of Lenvatinib in Patients With Progressive, Recurrent or Metastatic Adenoid Cystic Carcinoma. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 37(18), 15291537. https://doi.org/10.1200/JCO.18.01859.
REFERENCES UTILIZED:
Lenvima (lenvatinib) SGM QSET, Reference #1865-A.
NCCN Guidelines Version 1.2020 Head and Neck Cancers.