179P - Regorafenib combined with transarterial chemoembolization (TACE) for unresectable hepatocellular carcinoma (HCC) with previous systematic treatment: A preliminary investigation of safety and efficacy

Background

HCC is the fourth most common malignancy in China, and ranks second by mortality rate. Most patients have already reached advanced stage when diagnosed. TACE in combination with first-lined systematic therapy has been explored as an effective treatment for unresectable HCC. However, it has not been reported the safety and efficacy of Regorafenib combined with TACE, as a second-lined therapy. In this multicenter retrospective study, we preliminarily investigated the safety and efficacy of a combination with Regorafenib and TACE therapy in patients with unresectable HCC.

Methods

We reviewed the medical data of 38 patients with progression after prior treatment of Sorafenib and/or Lenvatinib from Jan 2019 to Apr 2020 at 4 tertiary centers in China. Patients were treated with TACE initially after enrollment. 5-7 days after the first TACE, patients started taking Regorafenib PO for 3 weeks on/1 week off. All patients were required to be followed up regularly and TACE was repeated as needed. The overall survival (OS), time to progression (TTP), progression-free survival (PFS), drugs safety, adverse events (AEs) were observed. OS was calculated from date of first TACE to death. TTP was calculated from date of first TACE to progression. Adverse events were evaluated by Clavien classification. Drugs safety was investigated according to CTCAE v4.03.

Results

Baseline patient characteristics are presented in the table Table: 179P

Baseline patient characteristics

Baseline characteristic	Total (n=38)
Age (years)	59.4±9.19
Sex, n (%)
Male	32 (84.2%)
ECOG, n (%)
0	21 (55.3%)
1	13 (34.2%)
2	4 (10.5%)
BCLC, n (%)
B	18 (47.4%)
C	20 (52.6%)
Hepatitis, n (%)
HBV	32 (84.2%)
HCV	2 (5.3%)
No	4 (10.5%)
Maximum tumor size (cm)	3.75 (2.5, 7.5)
Tumor number, n (%)
1	4 (10.5%)
≥2	34 (89.5%)
AFP (μg/L)	50.85 (6.64, 1210)
Extrahepatic metastasis, n (%)	13 (34.2%)
Portal vein invasion, n (%)	12(31.6%)
Prior Local Therapy, n (%)
Surgery	13 (34.2%)
Ablation	20 (52.6%)
TACE	36 (94.7%)
Radiotherapy	6 (15.8%)
Follow-up, months(range)	5.6 (1.7,17.0)
Prior Systemic Therapy, n(%) Sorafenib Lenvatinib Lenvatinib Sequential to Sorafenib	33 (86.8%) 1(2.6%) 4(10.5%)

. After enrollment, all patients were treated with conventional TACE, with an average of 3 sessions. The initial daily dose of Regorafenib was 80mg (26.3%), 120mg (44.7%) and 160mg (28.9%), respectively. Within all the study population, the overall incidence of AEs was 47.4%, and the most common AE was hand-foot syndrome (15.8%). The incidence of grade 3/4 AEs was 15.8%, and only 5 patients were halted due to intolerance. No patient experienced severe complications after the procedure. By now, the median duration of follow-up was 5.6 months and median OS was 14.3 months. The median PFS and TTP were 7.4 months (95%CI:3.0, 11.8) and 9.1 months(95%CI:5.4, 12.8), respectively.

Conclusions

Regardless of the retrospective nature, the present study as the first up-to-date real-world evidence indicates that Regorafenib combined with TACE was clinically effective and tolerable in subsequent to prior systemic therapy for unresectable HCC. Additional prospective large-scale studies are required to further verify our conclusion.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.