ALTER 01031 Trial: Update on Use of Anlotinib in Medullary Thyroid Cancer
Posted: Monday, May 17, 2021
The phase IIB multicenter ALTER trial, published in Clinical Cancer Research, evaluated the safety and efficacy of the novel multitarget tyrosine kinase inhibitor anlotinib in patients with medullary thyroid cancer. Ming Gao, PhD, and researchers from the Tianjin Clinical Research Center for Cancer in Tianjin, China, reported that median progression-free survival was significantly improved with the novel agent.
“These results indicate the potential application of anlotinib in patients with medullary thyroid cancer and support its approval as first tyrosine kinase inhibitor for the treatment of this disease in China,” noted the investigators. “Anlotinib may become the new choice for the treatment of medullary thyroid cancer.”
A total of 91 patients diagnosed with advanced or metastatic medullary thyroid cancer from 15 hospitals in China were enrolled and randomly assigned to the anlotinib group (62 patients) or the control group (29 patients). Patients in the treatment group received 12 mg once daily (days 1 to 14, every 3 weeks) or placebo.
The median progression-free survival with anlotinib was 20.7 months (confidence interval [CI] = 95%, 12.6–26.5 months) compared with the placebo (11.1 months, CI = 95%, 5.8–14.3 months; P = .029). The hazard ratio was 0.53 (CI = 95%, 0.30–0.95). After two cycles (6 weeks) of treatment, biochemical responses for serum calcitonin showed a significant difference compared with placebo (4,597.50 ng/L vs. 12,640.00 ng/L, P = .006).
The anlotinib group had a 48.4% objective response rate. Treatment-related adverse events included palmar-plantar erythrodysesthesia syndrome (62.9%), proteinuria (61.3%), and hypertriglyceridemia (48.4%) in the treatment group.
Disclosure: The study authors reported no conflicts of interest.