Today in the Journal of Clinical Oncology
, researchers at the University of Pennsylvania (UPenn) published a study showing the benefit of using Lenvima (lenvatinib) in both younger and elderly thyroid cancer patients refractory to radiation therapy. The study was led by Marcia Brose, M.D., Ph.D., associate professor of Otorhinolaryngology and member of UPenn's Abramson Cancer Center.
The news that the drug is effective in elderly patients is particularly encouraging, given the limited options currently available to that patient population.
In 2015, the U.S. Food and Drug Administration (FDA) approved lenvatinib for treating patients with locally recurrent or metastatic, progressive, radioactive iodine refractory differentiated thyroid cancer. The approval was based on data showing an improvement in progressive-free survival (PFS). Today’s work published by Brose et al is the first to confirm the drug also improves overall survival.
The randomized, double-blind, phase 3 clinical trial had patients with radioiodine-refractory differentiated thyroid cancer stratified by age (≤ 65 or > 65 years), and given lenvatinib 24 mg/day (n = 261) or placebo (n = 131). The primary end point was PFS and secondary end points included overall survival, objective response rate, and safety.
PFS improved in patients receiving lenvatinib in comparison to placebo in both groups. In the younger group (median age 56 years), patients receiving lenvatinib had a PFS of 20.2 months compare to 3.2 months in the placebo group (P
< .001). In the older group, patients receiving lenvatinib had a PFS of 16.7 months compare to 3.7 months in the placebo group (P
In the secondary endpoints, overall survival has not been reached in the elderly group treated with lenvatinib, while those given placebo had an overall survival of 18.4 months (P
= .020). In the younger group, overall survival had not been reached in either treatment group.
Comparing the older lenvatinib treated patients to the younger lenvatinib treated patients, the younger group showed significantly higher objective response rate (72% v
= .0038), longer time to first dose reduction (3.7 v
1.5 months), and lower proportion of grade ≥ 3 treatment-related adverse events (67% v
< .001) compared with the elderly group.
Per a news release by UPenn, Dr. Brose talked about the significant impact this study may have on older patients with thyroid cancer.
“There’s a belief that these drugs should be withheld from older patients due to concerns about toxicity and other medical concerns, but our results show just the opposite,” Brose said. “Not only do older patients benefit from these drugs, but they generally tolerate them well.”
Brose MS, Worden FP, Newbold KL, Guo M, Hurria A. Effect of Age on the Efficacy and Safety of Lenvatinib in Radioiodine-Refractory Differentiated Thyroid Cancer in the Phase III SELECT Trial. J Clin Oncol.
Published online ahead of print, June 14, 2017. https://ascopubs.org/doi/full/10.1200/JCO.2016.71.6472