KEY TAKEAWAYS
- The phase 4 trial aimed to assess the safety and efficacy of TACE +donafenib in real-world patients with intermediate to advanced HCC.
- The results showed effective TACE and donafenib treatment for intermediate to advanced HCC, with good tumor response and manageable adverse reactions.
Previously, patients with liver cancer ineligible for surgery primarily received sorafenib and alternative treatments. Donafenib, an advanced iteration of sorafenib, has demonstrated superior overall survival in advanced hepatocellular carcinoma(HCC) compared to sorafenib.
Jinlong Song and the team conducted a study that aimed to assess the safety and effectiveness of combining transarterial chemoembolization (TACE) with donafenib in real-world patients with intermediate to advanced HCC.
A prospective analysis of 27 patients with intermediate or advanced primary HCC, conducted at Shandong Cancer Hospital and Institute, included 19 cases treated with TACE combined with donafenib and 9 cases treated with TACE combined with donafenib and programmed death-1 (PD-1) inhibitor, as of December 2021.
TACE was administered as required, with TKI medication initiated within two and three days post-TACE and/or plus PD-1, respectively. Radiological response was assessed using computed tomography (CT) or magnetic resonance imaging (MRI) at baseline and every 6-12 weeks post-treatment initiation. Tumor response was evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST).
As of the data cutoff on September 30th, 2022, the median follow-up duration was 5.6 (range: 0.9–18) months. Median progression-free survival (PFS) was 9.9 months (95% CI: 5.7-14.1), with a median time to response (mTTR) of 1.3 months (95% CI: 1.1-2.3).
The median overall survival (OS) was not reached. According to mRECIST criteria, the objective response rate (ORR) was 51.9% (14/27), and the disease control rate (DCR) was 88.9% (24/27). About 4 patients (14.8%) successfully underwent conversion therapy, all achieving R0 resection, 1 patient achieved a complete pathological response (CPR), while 3 achieved a major pathological response (PR). All treatment-related adverse events (TRAEs) were well tolerated, with no serious AEs or treatment-related deaths observed.
The combination of TACE and donafenib showed effectiveness in treating intermediate to advanced unresectable HCC, demonstrating favorable tumor response, a high surgical conversion rate, and manageable adverse reactions.
The trial was sponsored by Shandong Cancer Hospital.
Source: https://cslide.ctimeetingtech.com/tat2024/attendee/confcal/show/session/6
Clinical Trial: https://www.chictr.org.cn/showprojEN.html?proj=142744
Song J, and Li J. (2024) “Analysis of the safety and effectiveness of TACE combined with donafenib in the treatment of intermediate and advanced hepatocellular carcinoma.” Presented at ESMO-TAT 2024.
