Efficacy of surufatinib in advanced Grade 3 neuroendocrine tumors: a real-world, national, multicenter study
Jian Wang, Ning Zhang, Yun Liang, Jiang Long, Yihebali Chi, Suzhen Zhang, Chunmei Bai, Yu Wang, Yinying Wu, Hanguang Hu, Weiyu Hu, Li Huang, Ying Liu, Huifang Lv, Shanai Song, Aili Suo, Xiangling Wang, Lin Zhang, Liming Zhu, Jie Chen, Jing HaoBackground:
Well-differentiated Grade 3 neuroendocrine tumors (G3 NETs) represent a heterogeneous entity with limited therapeutic standards. Surufatinib, a small-molecule inhibitor, has shown efficacy in G1/G2 NETs, but its specific role in the G3 subpopulation and optimal patient selection strategies remain to be elucidated.
Objectives:
This study aimed to evaluate the real-world efficacy of surufatinib in G3 NETs and identify the factors that influenced progression-free survival (PFS).
Design:
A national, multicenter, retrospective observational study.
Methods:
We analyzed data from 77 patients with unresectable or metastatic G3 NETs (Ki-67 > 20%) treated with surufatinib across 15 centers in China between January 2021 and April 2024. The reporting of this study conforms to the STROBE statement. The primary endpoint was PFS. A multivariable Cox proportional hazards model was used to explore prognostic factors.
Results:
The median Ki-67 index was 30% (range: 22%−70%), and 49 patients were of pancreatic origin. A total of 11 patients were treatment-naïve, and 27 patients received surufatinib-based combination therapy. The overall median PFS was 9.4 months (95% confidence interval: 8.5–13.0), and the objective response rate (ORR) was 22.1%. Patients with a Ki-67 index ⩽ 30% had longer PFS than the Ki-67 > 30% group (12.6 vs 9.0 months, hazard ratio = 0.270,
Conclusion:
Surufatinib was a promising therapeutic option for G3 NETs. Prospective, larger-scale cohorts are warranted to confirm the efficacy and address the predictive markers for better patient selection.