The combination of transarterial chemoembolization (TACE), lenvatinib (Lenvima), and PD-1 checkpoint blockade demonstrated tolerable safety and efficacy in patients with unresectable advanced hepatocellular carcinoma (uHCC), according to data presented during the 2022 ASCO Gastrointestinal Cancers Symposium.
“There are few scientific trials to back up the safety and efficacy of TACE+ TKI+PD-1 antibody for the treatment of uHCC and conversion resection. In this study, we explored the safety and efficacy of the TACE+TKI+PD-1 antibody in uHCC,” the study authors wrote.
The prospective, multicenter, cohort study (NCT04997850) enrolled 38 patients who received TACE plus 12 mg of lenvatinib if their weight was 60 kg or higher, and 8 mg of lenvatinib for those who weighed less than 60 kg, plus camrelizumab and sintilimab. Individuals in the control group only received TACE.
To be eligible for the trial, patients had to be between the ages of 18 and 70, and have HCC confirmed by histopathology or cytology. Participants could not have had system treatment history, and needed an ECOG PS score of 0-1, Child-Pugh A/B, BCLC stage B/C.
The majority of study participants (92.1%) were male. Disease etiology categories consisted of the following: HBV, 76.3% (n=29); HCV, 2.6% (n=1); non-HBV or HCV, 21.1% (n=8). Thirty-six patients (94.7%) had an ECOG score of 0, while 2 patients (5.3%) had a score of 1. Nineteen patients (50%) had 1 tumor; 15 patients (39.5%) had 2 tumors; and 4 patients (10.5%) had 3.
Results showed that at a median follow-up of 33.34 weeks, the conversion resection rate was 50% (n=19), and the conversion success rate was 52.6% (n=20). Among the 19 patients who converted to resection, 5 achieved a complete pathological response and 1 had a major pathological response, per mRECIST criteria.
At 48 weeks, the overall survival (OS) rate was 96.4% (95% CI, 92.9-99.9%) and the progression-free survival (PFS) rate was 91.7% (95% CI, 85.8%-97.4%).
These findings support Chinese HCC guidelines, which recommend TACE, TKI and anti—PD-1 therapy for patients with intermediate or advanced HCC — a population that makes up more than 70% of HCC cases.
While there were no level 4 or 5 treatment-related adverse events (TRAEs), 22 patients experienced level 3 TRAEs. Three led to dose reduction and 0 had to stop therapy as a result of TRAEs.
The most common all-grade TRAEs were abdominal pain (71%; n=27), aspartate aminotransferase increase (65.8%; n=25), alanine aminotransferase increase (65.8%; n=25), and hypertension (57.9%; n=22).
“TACE + lenvatinib + PD-1 antibody is safe and effective, and conversion resection after triple-treatment is feasible for uHCC,” the authors concluded.
Zhang X, Zhu X, Liu C, et. al. The safety and efficacy of transarterial chemoembolization (TACE) + lenvatinib + programmed cell death protein a (PD-1) antibody of advanced unresectable hepatocellular carcinoma. Presented at: 2022 ASCO Gastrointestinal Cancers Symposium. Jan. 20-22, 2022.