Surufatinib in Chinese patients with locally advanced or metastatic differentiated thyroid cancer and medullary thyroid cancer: A multicenter, open-label, Phase II trial.

Surufatinib in Chinese patients with locally advanced or metastatic differentiated thyroid cancer and medullary thyroid cancer: A multicenter, open-label, Phase II trial.:

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Surufatinib in Chinese patients with locally advanced or metastatic differentiated thyroid cancer and medullary thyroid cancer: A multicenter, open-label, Phase II trial.

Thyroid. 2020 Feb 19;:

Authors: Chen JY, Ji QH, Bai C, Zheng X, Zhang Y, Shi F, Li X, Tang PZ, Xu Z, Huang R, Huang T, Pan Y, Fan S, Zhou J, Su W

Abstract

Background Thyroid cancer is the most common endocrine tumor with an increasing incidence. Limited treatment options are available for patients with advanced or recurrent metastatic disease, resulting in a poor prognosis. Surufatinib targets multiple kinases (vascular endothelial growth factor receptors, fibroblast growth factor receptor-1 and colony stimulating factor-1 receptor) involved in tumor angiogenesis and tumor immune evasion. Surufatinib has demonstrated promising antitumor activity in various advanced solid tumors. This study aimed to determine the objective response rate (ORR) of surufatinib in patients with locally advanced or distant metastatic differentiated thyroid cancer (DTC), or medullary thyroid cancer (MTC). Methods This Phase II, open-label study by Simon's two-stage design was conducted at 10 sites across China. Patients with radioiodine (RAI)-refractory DTC with locally advanced disease or distant metastasis (DTC1); who received limited initial surgery and then developed locally advanced, unresectable recurrences, and were not considered candidates for RAI therapy due to residual normal thyroid tissue (DTC2); or with MTC with locally advanced disease or distant metastasis were enrolled. A total of 59 patients were enrolled (26 in DTC1, 6 in DTC2, 27 in MTC), and received 300 mg surufatinib daily in 28-day cycles. The primary endpoint was ORR as determined by the investigators. Results Overall ORR was 23.2% (95% confidence interval [CI], 12.98-36.42): 21.7% in DTC1, 33.3% in DTC2 and 22.2% in the MTC cohort. Forty-nine patients achieved disease control (87.5%; 95% CI, 75.93-94.82): 87.0% in DTC1, 83.3% in DTC2, and 88.9% in the MTC cohort. Median time to response was 59.0 days, and 59.0, 85.5 and 59.0 days in the DTC1, DTC2 and MTC cohorts. Overall median progression-free survival was 11.1 months (95% CI, 5.98-16.69); 11.1 months in DTC1 and MTC cohorts, while the DTC2 cohort had not reached the median at the data cut-off. The most common treatment-emergent adverse events grade ≥3 were hypertension (20.3%), proteinuria (11.9%), and then elevated blood pressure, hypertriglyceridemia, and pulmonary inflammation (5.1% each). Conclusions Surufatinib demonstrated promising efficacy with a tolerable and manageable safety profile for patients with locally advanced or metastatic MTC, RAI-refractory DTC, or locally advanced, unresectable recurrences unable to receive RAI.

PMID: 32075524 [PubMed - as supplied by publisher]