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The Advent of Perioperative Immunotherapy in Early-Stage Hepatocellular Carcinoma
Even with optimal surgical resection, up to 80% of patients with early-stage hepatocellular carcinoma (HCC) experience recurrence, particularly those with bulky tumors or vascular invasion. Numerous adjuvant therapies, including atezolizumab and bevacizumab, have failed to improve outcomes. The role for perioperative immunotherapy remains underinvestigated. Now, the partially industry-sponsored, multicenter, randomized, phase 2/3 CARES-009 trial, conducted in China, has compared perioperative camrelizumab (a PD-1 inhibitor) plus rivoceranib (an antiangiogenic tyrosine kinase inhibitor) with surgery alone. Camrelizumab and rivoceranib are not FDA-approved. The study included 294 patients with early-stage HCC. The primary end point was event-free survival (EFS). About 75% of patients had hepatitis B liver disease, very different from Western populations with more metabolic dysfunction–associated steatohepatitis and hepatitis C liver disease.
Key results were:
- Perioperative camrelizumab plus rivoceranib significantly improved EFS compared with surgery alone (median: 42 vs. 19 months).
- Nearly all patients underwent definitive surgical resection (92% vs. 98%), and all were R0 (negative margin) resections.
- Grade ≥3 treatment-related adverse events were significantly more common with perioperative therapy (38% vs. 0%), including 2 deaths during neoadjuvant therapy.
Comment
The opportunity to improve event-free survival in early-stage hepatocellular carcinoma by almost 2 years is intriguing. Camrelizumab and rivoceranib are unavailable in the United States, but that may change on the basis of these data. Until then, we should consider the approved immunotherapy regimens more often in the perioperative setting for certain intermediate-stage, high-risk tumors. Toxicity is a concern as in practice some real-world patients that would be cured with surgery alone may not make it to surgery. The EFS results are striking, but the mature overall survival data will be critical to determine if the efficacy of this regimen justifies its toxicity.
Citation(s)
Author:
Wang Z et al.
Title:
Perioperative camrelizumab plus rivoceranib versus surgery alone in patients with resectable hepatocellular carcinoma at intermediate or high risk of recurrence (CARES-009): A randomised phase 2/3 trial.
Source:
Lancet
2025
Nov
1; [e-pub].
(Abstract/FREE Full Text)
Empfohlen von
Suneel D. Kamath, M.D.