The following is a summary of “Pathological response following neoadjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma: a cross-trial, patient-level analysis,” published in the October 2024 issue of Oncology by D’Alessio et al.
Neoadjuvant immune checkpoint inhibitors (ICIs) before liver resection led to pathological tumor regression in patients with hepatocellular carcinoma.
Researchers conducted a retrospective study to describe pathological responses after preoperative ICIs therapy for hepatocellular carcinoma.
They performed a cross-trial, patient-level analysis of pooled data from patients with hepatocellular carcinoma receiving ICI therapy before liver resection across 5 clinical trials and standardized observational protocols conducted in 12 tertiary referral centers in the USA, UK, and Taiwan. Eligible patients were adults (aged ≥18 years) diagnosed with hepatocellular carcinoma by tissue core biopsy, a Liver Imaging Reporting and Data System score of 5 on imaging, or both, with an Eastern Cooperative Oncology Group performance status score of 0–1, and no extrahepatic spread or previous ICI treatment. The pathological response was defined as the percentage of non-viable tumors in the resected specimen, with major pathological response defined as at least 70% tumor regression and pathological complete response defined as 100% tumor regression.
The results showed that 111 patients, with data on pathological response, were available for 104 (94%) patients. Patients primarily received immune checkpoint inhibitor combinations (76 [69%]), with a median treatment duration of 1.4 months (IQR 0.7–2.9). Major pathological response was observed in 33 (32%) patients, and pathological complete response was observed in 19 (18%). Radiological overall response (OR) was associated with major pathological response, with 23 (74%) of 31 patients showing major pathological response compared to 10 (14%) of 73 patients without radiological response (P<0.0001). Median relapse-free survival for the entire cohort was 43.6 months (95% CI 28.3-not evaluable), significantly longer in patients with major pathological response than those without (not reached [95% CI not evaluable-not evaluable] vs. 28.3 months [12.8–43.8]; HR 0.26 [0.10–0.66]; P=0.0024).
They concluded that a threshold of at least 90% tumor regression after neoadjuvant ICIs therapy could predict improved relapse-free survival following liver resection, warranting validation in phase 3 RCTs.
Source: thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00457-1/fulltext
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