https://doi.org/10.55788/3824e19c
Prof. Ming Kuang (Sun Yat-sen University, China) and colleagues designed the multicentre, randomised-controlled, phase 2 RAISE trial (NCT03732105) to evaluate the efficacy of post-operative radiotherapy in patients with HCC who had a narrow margin after resection [1]. The 148 participants were randomised 1:1 to intensity-modulated radiotherapy, 50 Gy in 25 fractions, or to the control arm (active monitoring). RFS was the primary endpoint.
The 24-month RFS rates were 78.7% and 58.4%, significantly favouring the radiotherapy arm over the control arm (HR 0.55; 95% CI 0.30–0.99; P=0.043). Prof. Kuang noted that the rate of marginal intra-hepatic recurrence was higher in the control arm than in the experimental arm (17.6% vs 6.8%).
“Various any-grade adverse events were more frequently seen among patients on radiotherapy, including neutropenia, ALT and AST elevations, hypoalbuminaemia, nausea, and diarrhoea,” said Prof. Kuang. “However, there were no clear differences with respect to the occurrence of grade 3 or 4 adverse events between study arms.”
In conclusion, the current phase 2 study revealed that post-operative radiotherapy may improve RFS in patients with HCC with narrow surgical margins after curative resection.
- Kuang M, et al. Adjuvant radiotherapy after curative resection of hepatocellular carcinoma with narrow margin (<1 cm): a phase 2 multicenter, randomized controlled trial (RAISE). Abstract 722, ASCO Gastrointestinal Cancers Symposium 2024, 18–20 January, San Francisco, CA, USA.
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