Abstract 715P
Background
Surgical resection is the main treatment for hepatocellular carcinoma (HCC) in China. While more than 70% of HCC are in the intermediate or advanced stages at diagnosis and are unresectable; For those patients, transarterial chemoembolization (TACE) is the main conversion therapy to improve the resectability rate and to diminish postoperative relapse. But its success rate is only about 10%; Both Lenvatinib and PD-1 inhibitors (immune checkpoint inhibitors) are indicated for unresectable HCC (uHCC); The purpose of this study was to assess the safety and efficacy of Lenvatinib combined with TACE and PD-1 inhibitors (Len-TAP) versus TACE alone as conversion therapy for patients with initially uHCC.
Methods
This is a multicenter, prospective, cohort study. Key Eligibility Criteria:18-70 years old; HCC confirmed by radiographic or histology; No systemic treatment history; BCLC stage B/C. The conversion therapy includes Len-TAP (Lenvatinib followed by TACE and Camrelizumab/Sintilimab) and TACE alone. Their adverse events (AEs), response rate, conversion-resection rate, and survival outcome were compared.
Results
From October 2020 to March 2022, 71 patients were enrolled in both groups. Until April 2022, the Len-TAP group had a higher rate of Grade 3 AEs (P<0.001), there were no level 4 or 5 TRAEs in both groups. At 16±1 weeks, the ORR based on mRECIST was 78.9% and 16.9% in the Len-TAP and TACE groups (P<0.001). The Len-TAP group had a better conversion resection rate (50.7% vs 15.5%,P<0,001) than TACE group. The median PFS were 531±81.2 and 224±33.3 days(P<0.001), and the 1 year OS rate was 93.3% and 64.3%(P=0.002) in the Len-TAP and TACE groups. Table: 715P
| Len-TAP, n (%) | TACE, n (%) | P value | |
| Baseline | |||
| Age, years | 54.4±11.0 | 58.8±8.6 | 0.163 |
| Gender-male | 68(95.8) | 62(87.3) | 0.070 |
| Etiology | 0.419 | ||
| HBV | 60(84.5) | 56(78.9) | |
| HCV | 1(1.4) | 3(4.2) | |
| ECOG PS | 0.546 | ||
| 0 | 64(90.1) | 66(93.0) | |
| 1 | 7(9.9) | 5(7.0) | |
| BCLC stage | 0.865 | ||
| B | 30(42.3) | 31(43.7) | |
| C | 41(57.7) | 40(56.3) | |
| AEs | <0.001 | ||
| Grade 3 AEs | 38(53.5) | 13(18.3) | |
| Outcomes | <0.001 | ||
| Median PFS, days | 531±81.2 | 224±33.3 | |
| Conversion resection rate | 36(50.7) | 11(15.5) | <0.001 |
| mRECIST | |||
| ORR | 56(78.9) | 12(16.9) | <0.001 |
| DCR | 67(94.4) | 31(43.7) | <0.001 |
| RECIST 1.1 | |||
| ORR | 27(38.0) | 5(7.0) | <0.001 |
| DCR | 61(93.0) | 20(28.1) | <0.001 |
Conclusions
Lenvatinib combined with TACE and PD-1 inhibitors was safe and effective, which can improve resectability rate and prolong overall survival for patient with uHCC.
Clinical trial identification
NCT04997850.
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.