In a recent sub-analysis, lenvatinib was shown to improve both progression-free and overall survival in older patients with radioiodine-refractory thyroid cancer.
A new sub-analysis published in the Journal of Clinical Oncology is suggesting that lenvatinib may improve progression-free survival (PFS) and overall survival (OS) in older adults with radioiodine-refractory (RR) differentiated thyroid cancer. The findings showed that higher toxicities were observed in older patients. However, the authors concluded that lenvatinib should be considered for treatment of patients at any age with RR-DTC. Lenvatinib was shown to significantly prolong PFS compared with placebo in patients with RR-DTC in the phase III Study of Lenvatinib in Differentiated Cancer of the Thyroid (SELECT). The new subanalysis investigated the effect of age on the efficacy and safety of lenvatinib among patients with RR-DTC. The cohort included 392 patients (261 received lenvatinib 24 mg/day and 131 received placebo). Lenvatinib, which is a multikinase inhibitor, is one of two first-line therapies approved by the US Food and Drug Administration (FDA) for patients who are resistant to radioiodine treatment. “First, we found that in patients with RR-DTC who are over 65 not only does lenvatinib extend PFS, but prolongs OS as well. This is the first time an OS benefit has ever been shown in this disease,” said lead study author Marcia S. Brose, MD, PhD, associate professor of otorhinolaryngology and director of the Center for Rare Cancers and Personalized Therapy at the Abramson Cancer Center, University of Pennsylvania in Philadelphia. “Second, analysis was prospective and powered sufficiently to change clinical practice and suggests that lenvatinib should be used in this patient population.” For this current investigation, patients were divided into two groups (65 or younger and older than 65). The median age of the younger group was 56 years. For the older group, it was 71 years. Among the older cohort, those on placebo had an OS of 18.4 months. For patients receiving the drug, OS was not reached, but confidence intervals show the expected survival would exceed 22 months. In the younger cohort, OS was not reached for either group. The researchers found the younger lenvatinib-treated patients showed a significantly higher objective response rate (72% vs 55%) and longer time to first dose reduction (3.7 vs 1.5 months) when they were compared with the older patients. The younger patients also had a lower proportion of grade ≥ 3 treatment-related adverse events (67% vs 89%). Brose noted that there has been a belief that multikinase inhibitors should be withheld from older patients due to toxicity and other medical concerns. However, she said these results demonstrated just the opposite. Results of this study can have an immediate impact on clinical care. “The take-home message is twofold: First that patients over 65 survive longer when treated with lenvatinib, and that overall, with close attention to expected toxicities, this drug can be given and the side effects are manageable in this patient population,” Brose told OncoTherapy Network.