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Efficacy of surufatinib in advanced Grade 3 neuroendocrine tumors: a real-world, national, multicenter study
Jian Wang1, Ning Zhang2, Yun Liang3
1Department of Medical Oncology, Qilu Hospital of Shandong University, Jinan, China.
Background:
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, p = 0.003). Combined treatment showed a numerical trend toward improved ORR (33.3% vs 16.0%, p = 0.08), but did not significantly prolong PFS compared to surufatinib monotherapy (9.7 vs 9.4 months, p = 0.64).
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.
Insights
Surufatinib shows promise for treating well-differentiated Grade 3 neuroendocrine tumors (G3 NETs). Lower Ki-67 index (≤30%) correlated with longer progression-free survival (PFS) in patients receiving this targeted therapy.
Area of Science:
- Oncology
- Pharmacology
- Medical Research
Background:
- Well-differentiated Grade 3 neuroendocrine tumors (G3 NETs) are a challenging group with few standard treatments.
- Surufatinib, a targeted therapy, has demonstrated effectiveness in lower-grade NETs, but its role in G3 NETs requires further investigation.
- Optimal patient selection for surufatinib in G3 NETs remains an area needing clarification.
Purpose of the Study:
- To assess the real-world effectiveness of surufatinib in patients with G3 NETs.
- To identify clinical factors influencing progression-free survival (PFS) in this patient cohort.
- To explore the impact of combination therapy versus monotherapy.
Main Methods:
- A retrospective, multicenter observational study involving 77 patients with unresectable or metastatic G3 NETs (Ki-67 > 20%) treated with surufatinib in China.
- Data collected between January 2021 and April 2024.
- Progression-free survival (PFS) was the primary endpoint, analyzed using multivariable Cox proportional hazards models to identify prognostic factors.
Main Results:
- The median PFS was 9.4 months, with an objective response rate (ORR) of 22.1%.
- Patients with a Ki-67 index ≤30% experienced significantly longer PFS (12.6 months) compared to those with Ki-67 > 30% (9.0 months; p=0.003).
- Combination therapy showed a trend towards higher ORR but did not significantly improve PFS compared to surufatinib monotherapy.
Conclusions:
- Surufatinib represents a potentially valuable treatment option for patients with G3 NETs.
- Further prospective studies with larger patient groups are necessary to confirm efficacy.
- Identifying predictive biomarkers is crucial for optimizing patient selection and treatment strategies.
