Anlotinib shows promise for radioiodine-refractory differentiated thyroid carcinoma

The multikinase inhibitor anlotinib appears to have promising antitumour activity in the treatment of locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma (RAIR-DTC) while having an acceptable safety profile, as shown in a phase II study.

The study included 113 adult patients with pathologically confirmed locally advanced or metastatic RAIR-DTC. These patients were randomly assigned to receive 12-mg anlotinib (n=76) or placebo (n=37) once daily on day 1 to 14 every 3 weeks. Patients on placebo had the option to receive open-label anlotinib after disease progression.

There was a higher proportion of patients in the placebo group than in the anlotinib group (78 percent vs 57 percent; p=0.040). Moreover, patients in the placebo group had a significantly higher sum of the longest diameter of all target lesions (median, 65.2 vs 37.9 mm; p=0.040) and were more likely to have target lesion size sum at baseline of ≥60 mm (58 percent vs 36 percent; p=0.026) when compared with those in the anlotinib group.

Over a median follow-up of 35.9 months, the primary endpoint of progression-free survival (PFS) was significantly longer with anlotinib than with placebo (median PFS, 40.5 months, 95 percent confidence interval [CI], 28.3–not estimable vs 8.4 months, 95 percent CI, 5.6–13.8). Treatment with anlotinib was associated with an almost 80-percent reduction in the risk of death or progression (hazard ratio [HR], 0.21, 95 percent CI, 0.12–0.37; p<0.001).

Data for overall survival was immature, although there was a trend of benefit seen with anlotinib (HR, 0.57, 95 percent CI, 0.29–1.12).

Adverse events (AE) occurred in all patients on anlotinib, with eight (10.5 percent) patients discontinuing treatment due to AEs.