1155P - Updated results of surufatinib plus transarterial embolization versus surufatinib monotherapy in neuroendocrine tumor with liver metastasis: A prospective, randomized, controlled trial

Background

The liver is the predominant site for metastases in neuroendocrine tumors (NETs). Surufatinib (SUR), an oral tyrosine kinase inhibitor, is endorsed as a systemic therapeutic standard for advanced NETs. Transarterial embolization (TAE) stands as the principal local intervention for inoperable hepatic metastatic NETs. This study was executed to assess the efficacy and safety of combined surufatinib with TAE versus surufatinib monotherapy in patients with hepatic metastases from NETs.

Methods

This was a prospective, randomized, controlled trial including patients (pts, ≥18 years) with liver metastatic NETs (Grade 1 or 2), and at least one RECIST 1.1-measurable hepatic lesion. A total of up to 123 participants are to be enrolled, all with an ECOG performance status 0 to 2, and an expected survival exceed 12 weeks. Pts were randomly assigned (1:1) to receive SUR (300 mg daily) plus TAE, or SUR alone. The primary endpoint was PFS, with secondary endpoints including intrahepatic response rate (iHRR), ORR, DCR, OS and incidence of adverse events.

Results

As of April 2024, 29 pts were enrolled, with 15 allocated to SUR + TAE group. Primary tumor sites included the pancreas (19/29), duodenum (3/29), stomach (2/29), liver (3/29), rectum (1/29), and appendix (1/29), with a median Ki-67 index of 10% (range: 1-15%). With a median follow-up of 7.9 months, the median PFS and OS were not mature. In 20 evaluable pts, 7 achieved a partial response (PR) and 11 maintained stable disease (SD), while only 2 patient exhibited disease progression (PD). Compared to SUR group, the ORR in SUR + TAE group showed improved tendency (22.2% vs. 45.5%, p=0.279). The DCR reached 100% in the SUR+TAE group, surpassing the 77.8% observed in the SUR group. Median PFS and OS have not yet been attained. The incidence of treatment-related adverse events, such as hypertension, proteinuria, and diarrhea, was similar between groups, with one case of grade 3 proteinuria in each but no grade 4 events.

Conclusions

The combination of surufatinib and TAE shows promising superior efficacy compared to surufatinib monotherapy, heralding a promising therapeutic advance for neuroendocrine tumors with liver metastasis.

Clinical trial identification

ChiCTR2300071991.

Editorial acknowledgement

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.