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Anlotinib shows promise for treating medullary thyroid cancer
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The novel tyrosine kinase inhibitor anlotinib was shown to provide adequate therapeutic benefits for tumor reduction in adults with locally advanced and metastatic medullary thyroid carcinoma, according to findings from a phase 2 clinical trial published in Thyroid.
“The only way to cure [medullary thyroid carcinoma] is the complete resection of thyroid tumor and any locoregional metastases. For progressive or symptomatic metastatic [medullary thyroid carcinoma] that cannot be treated with local management, systemic therapy should be considered,” Yihebali Chi, MD, PhD, of the National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital at the Chinese Academy of Medical Sciences and Peking Union Medical College, China, and colleagues wrote. “In a [phase 1] study, anlotinib showed manageable toxicity and broad-spectrum antitumor potential.”
For the phase 2 study, Chi and colleagues enrolled 58 adults (median age 46.9 years, 41.4% women) with histologically confirmed unresectable or metastatic (89.7%) medullary thyroid cancer at eight institutions in China from July 2013 to July 2014. Participants had at least one measured lesion, life expectancy of at least 3 months and serum calcitonin serum level greater than 500 pg/mL. Participants were asked to orally administer 12 mg anlotinib per day on a repeating regimen of 2 weeks of medication and 1 week off. Tumor assessments were recorded every 6 weeks.
During follow-up (median 9.8 months), the researchers observed progression free survival rates of 92.2%, 87.8% and 84.5% at 24, 36 and 48 weeks, respectively. They also reported survival rates of 89.7%, 78.6% and 76.4% at 12, 24 and 36 months, although overall survival had not been reached. In addition, disease control rate was 93.1% (95% CI, 88.09-99.58), and the objective response rate was 56.9% (95% CI, 44.15-69.64).
“Currently, only vandetanib and cabozantinib have been approved for [medullary thyroid carcinoma] treatment by the FDA. However, due to lack of clinical evidence to support their use in Chinese patients, both vandetanib and cabozantinib have not been approved in China,” the researchers wrote. “Anlotinib has demonstrated promising antitumor effects in patients with [medullary thyroid carcinoma] in a [phase 1] study. The [phase 2] study presented here further confirms the antitumor activity of anlotinib in patients with locally advanced or metastatic [medullary thyroid carcinoma].”
Calcitonin response was also recorded, with a response available for evaluation at 12 weeks in 87.9% of participants. In 45 participants, the researchers observed statistically significant decreases in serum calcitonin values from baseline.
As for the toxicity of anlotinib, the researchers noted that hand-foot syndrome (79.31%), hypertriglyceridemia (46.55%), cholesterol elevation (43.1%) and fatigue (41.38%) were the most reported adverse side effects.
“Treatment with anlotinib was generally well tolerated. The majority of [adverse events] were manageable according to standard clinical practice alone or in combination with anlotinib dose interruptions or dose reductions,” the researchers wrote. “The high frequency of lipid metabolism dysfunction including hypertriglyceridemia and cholesterol elevations was consistent with safety data in the [phase 1] study of anlotinib, most of which were asymptomatic and reversible. However, careful monitoring of lipids is required.” – by Phil Neuffer
Disclosure: The authors report no relevant financial disclosures.
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