Anlotinib Shows PFS Improvements in Patients With Thyroid Cancer

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Patients had longer median progression-free survival rates with anlotinib vs with placebo in a phase 2 trial, but overall survival data were still immature.

3D rendering of thyroid cancer: ©SciePro - stock.adobe.com

3D rendering of thyroid cancer: ©SciePro - stock.adobe.com

Anlotinib, an orally administered tyrosine kinase inhibitor, showed promising results in treating locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma (RAIR-DTC), according to findings from a phase 2 trial.1

Patients who received anlotinib (n = 76) compared with placebo (n = 37) had longer median progression-free survival (PFS) rates at 40.5 months vs 8.4 months. While immature, overall survival (OS) rates for patients treated with anlotinib still trended positively, and anlotinib reduced the risk of death by 43%.

“This randomized controlled trial demonstrated that anlotinib could significantly extend the PFS of patients with locally advanced or metastatic RAIR-DTC. The toxicities are manageable and tolerable in long term treatment,” authors of the study wrote in findings published in Clinical Cancer Research.

The study enrolled 146 patients between September 2015 and August 2018. Seventy-six patients were placed in the anlotinib arm, and 37 patients were placed in the placebo arm. The median age of patients in the anlotinib arm was 56 (range,50.5-63.0),and the median age in the placebo arm was 57 (range,51.0-64.0). Forty-three patients in the anlotinib arm were female (57%), and 29 patients in the placebo arm were female (78%).

The median duration of treatment in both groups was 24.4 months (interquartile range [IQR], 13.3-37.3 months) and 8.1 months (IQR, 5.3-14.0 months), respectively. In the anlotinib group, 48 patients discontinued treatment. Reasons included disease progression (50%), death (4%), adverse events (AEs; 17%), withdrawing consent (21%), and others (8%). In the placebo group, 32 patients discontinued treatment, with the main cause as disease progression (88%).

At the data cutoff, 26% of patients in the anlotinib arm and 38% of patients in the placebo arm died. Median OS in the anlotinib group was not reached (95% CI, 50.7 to not evaluable [NE]) vs 52.8 months in the placebo group (95% CI, 24.8-NE). Tumor shrinkage was observed in 95% of patients in the anlotinib group, and the overall response rate was 59.2%. In the placebo group, no tumor response was observed.

Eight patients (11%) in the anlotinib group ended treatment due to AEs compared with 9 patients in the placebo group. Twenty-six patients (34%) in the anlotinib arm had their doses reduced, while 1 patient (3%) in the placebo arm had their dose reduced. The primary AEs that led to dose reductions between arms included palmar-plantar erythrodysesthesia syndrome (9%), hypertension (8%), and proteinuria (5%).

“In accordance with the performance in the treatment of [medullary thyroid carcinoma], anlotinib showed an acceptable safety and tolerability profile in the context of long-term treatment,” study authors wrote.1

An observational study (NCT05994365) enrolling an estimated 380 patients is further evaluating anlotinib for the treatment of RAIR-DTC. The study has an estimated completion date of December 2028.2

REFERENCES:
  1. Chi Y, Zheng X, Zhang Y, et al. Anlotinib in locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma: A randomized, double-blind, multicenter phase Ⅱtrial. [published online ahead of print, 2023 Aug 18]. Clin Cancer Res. 2023;CCR-22-3406. doi:10.1158/1078-0432.CCR-22-3406
  2. Study of anlotinib hydrochloride capsules in the treatment of locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma. ClinicalTrials.gov. Updated August 16, 2023. Accessed October 6, 2023. https://tinyurl.com/4ebdwp49 
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