Atezolizumab-bevacizumab with or without cisplatin-based HAIC for unresectable HCC: A randomized phase II trial.
Yasuto Takeuchi, Masahiko Sue, Nozomi Miyake et al.
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In 30 seconds
This multicenter, open-label, randomized phase II trial compared sequential cisplatin hepatic arterial infusion chemotherapy (HAIC) followed by atezolizumab-bevacizumab with atezolizumab-bevacizumab alone in patients with unresectable hepatocellular carcinoma. Among 70 participants, the primary endpoint was not met: objective response rates were 45.7% vs. 28.6% (p = 0.095). Exploratory analyses found longer median progression-free survival with HAIC (8.3 vs. 6.6 months; HR 0.53; p = 0.036), while overall survival was similar. Grade 3-4 treatment-related adverse events occurred in 20.0% vs. 22.9%.
Key findings
- Objective response rate was numerically higher with cisplatin HAIC plus atezolizumab-bevacizumab, but the difference was not statistically significant: 45.7% vs. 28.6% (p = 0.095).
- Median progression-free survival was 8.3 vs. 6.6 months (HR 0.53; p = 0.036) in exploratory analyses.
- Median overall survival was 28.1 vs. 31.0 months (HR 0.95; p = 0.88).
- Grade 3-4 treatment-related adverse events occurred in 20.0% vs. 22.9% of patients.
Why it matters
The trial suggests that adding liver-directed cisplatin HAIC before standard systemic therapy may extend disease control in unresectable HCC without an apparent increase in severe treatment-related adverse events. However, the primary response endpoint was not met, and the progression-free survival result came from exploratory analyses. The findings therefore inform further evaluation rather than establish a new treatment standard.
What to keep in mind
The phase II trial enrolled 70 patients, and its primary endpoint was not met; the progression-free survival finding was exploratory.