Outcome by Age With Lenvatinib in Radioiodine-Refractory Differentiated Thyroid Cancer
As reported in the Journal of Clinical Oncology by Brose et al, a prespecified analysis of the phase III double-blind SELECT trial of lenvatinib (Lenvima) vs placebo in radioiodine-refractory differentiated thyroid cancer showed progression-free survival benefits in both older and younger lenvatinib patients. In the SELECT trial, reported in 2015, lenvatinib increased progression-free survival, the primary endpoint, by 14.7 months vs placebo.
Study Details
The current analysis assessed outcomes in patients aged ≤ 65 vs > 65 years. In the trial, 392 patients were randomized 2:1 to receive lenvatinib at 24 mg/d (n = 261) or placebo (n = 131).
In total, 155 lenvatinib patients and 81 placebo patients were aged ≤ 65 years and 106 and 50 patients were aged > 65 years. Median ages in both treatment groups were 56 years in the younger subgroup and 71 years in the older subgroup. Placebo patients were permitted to cross over to lenvatinib at disease progression.
Progression-Free and Overall Survival
Median progression-free survival was 20.2 months vs 3.2 months (hazard ratio [HR] = 0.19, P < .001) among younger patients and 16.7 months vs 3.7 months (HR = 0.27, P < .001) among older patients. No significant difference was observed with age within either treatment group.
At primary data cutoff, median follow-up was 17.1 months, and median overall survival had not been reached in either treatment group. In an age-stratified analysis, median overall survival (18.4 months) was reached only in older placebo patients. Older lenvatinib patients had improved overall survival vs older placebo patients (HR = 0.53, P = .020). In the placebo group, younger patients had improved overall survival vs older patients (HR, 0.48, P = .010), whereas there was no difference between younger and older patients in the lenvatinib group (HR = 0.78, P = .30).
Differences by Age in Lenvatinib Group
In the lenvatinib group, younger patients had a significantly higher objective response rate (72% vs 55%, P = .0038), a longer time to first dose reduction (3.7 vs 1.5 months), and a lower incidence of grade ≥ 3 treatment-related adverse events (67% vs 89%, P < .001) vs older patients.
The investigators concluded: “This subanalysis demonstrated improved [progression-free survival] with lenvatinib treatment versus placebo in both age groups, although higher toxicity was observed in older patients. Despite the allowance of crossover after disease progression, the [overall survival] benefit was observed in older patients, suggesting that lenvatinib should be considered for treatment of patients of any age with [radioiodine-refractory differentiated thyroid cancer].
This study was supported by Eisai.
Marcia S. Brose, MD, PhD, of Abramson Cancer Center, Perelman School of Medicine, is the corresponding author of the Journal of Clinical Oncology article.
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®.
