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Human Neuroendocrine Tumor Cell Lines as a Three-Dimensional Model for the Study of Human Neuroendocrine Tumor Therapy
Published on: August 14, 2012
Surufatinib in Advanced Well-Differentiated Neuroendocrine Tumors: A Multicenter, Single-Arm, Open-Label, Phase Ib/II
Jianming Xu1, Jie Li2, Chunmei Bai3
1Department of Gastrointestinal Oncology, The Fifth Medical Center, General Hospital of People's Liberation Army, Beijing, China. jmxu2003@yahoo.com.
Purpose:
No antiangiogenic treatment is yet approved for extrapancreatic neuroendocrine tumors (NET). Surufatinib (HMPL-012, previously named sulfatinib) is a small-molecule inhibitor targeting vascular endothelial growth factor receptors, fibroblast growth factor receptor 1 and colony-stimulating factor 1 receptor. We conducted a single-arm phase Ib/II study of surufatinib in advanced NETs.
Patients And Methods:
Patients with histologically well-differentiated, low or intermittent grade, inoperable or metastatic NETs were enrolled into a pancreatic or extrapancreatic NET cohort. Patients were treated with surufatinib 300 mg orally, once daily. The primary endpoints were safety and objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (version 1.1).
Results:
Of the 81 patients enrolled, 42 had pancreatic NETs and 39 had extrapancreatic NETs. Most patients had radiologic progression within 1 year prior to enrollment (32 patients in each cohort). In the pancreatic and extrapancreatic NET cohorts, ORRs were 19% [95% confidence intervals (CI), 9-34] and 15% (95% CI, 6-31), disease control rates were 91% (95% CI, 77-97) and 92% (95% CI, 79-98), and median progression-free survival was 21.2 months (95% CI, 15.9-24.8) and 13.4 months (95% CI, 7.6-19.3), respectively. The most common grade ≥3 treatment-related adverse events were hypertension (33%), proteinuria (12%), hyperuricemia (10%), hypertriglyceridemia, and diarrhea (6% for each), and increased alanine aminotransferase (5%).
Conclusions:
Surufatinib showed encouraging antitumor activity and manageable toxicities in patients with advanced NETs. Two ongoing phase III studies, validating the efficacy of surufatinib in patients with NETs, will contribute to the clinical evidence.
Insights
Surufatinib demonstrated promising antitumor effects and manageable safety in advanced neuroendocrine tumors (NET). Further phase III trials are ongoing to confirm efficacy in NET patients.
Area of Science:
- Oncology
- Pharmacology
Background:
- Extrapancreatic neuroendocrine tumors (NET) currently lack approved antiangiogenic treatments.
- Surufatinib is an investigational small-molecule inhibitor targeting VEGFR, FGFR1, and CSF1R.
Purpose of the Study:
- To evaluate the safety and objective response rate (ORR) of surufatinib in patients with advanced pancreatic and extrapancreatic NETs.
Main Methods:
- A single-arm phase Ib/II study enrolled patients with advanced, well-differentiated, low/intermittent grade, inoperable or metastatic NETs.
- Patients received surufatinib 300 mg orally once daily.
- Primary endpoints were safety and ORR per RECIST v1.1.
Main Results:
- The study included 81 patients (42 pancreatic NET, 39 extrapancreatic NET).
- Objective response rates (ORR) were 19% for pancreatic NET and 15% for extrapancreatic NET.
- Median progression-free survival was 21.2 months (pancreatic) and 13.4 months (extrapancreatic). Common grade ≥3 adverse events included hypertension and proteinuria.
Conclusions:
- Surufatinib exhibits encouraging antitumor activity and a manageable toxicity profile in advanced NET patients.
- Ongoing phase III studies aim to further validate surufatinib's efficacy in NET treatment.
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