Photo Credit: Mohammed Haneefa Nizamudeen
Phase 2 study shows postoperative radiotherapy improved recurrence-free survival in patients with hepatocellular carcinoma.
In a phase 2 study, postoperative radiotherapy improved recurrence-free survival (RFS) in patients with hepatocellular carcinoma (HCC) who had received curative resection with a narrow surgical margin (<1 cm). The authors argue that combining adjuvant radiotherapy and systemic immunotherapy may lead to even more promising outcomes.
Ming Kuang, MD, PhD, Sun Yat-sen University, China, and colleagues designed the multicenter, randomized-controlled, phase 2 RAISE trial (NCT03732105) to evaluate the efficacy of postoperative radiotherapy in patients with HCC who had a narrow margin after resection.1 The 148 participants were randomized 1:1 to intensity-modulated radiotherapy, 50 Gy in 25 fractions, or to the control arm. RFS was the primary endpoint.
The 24-month RFS rates were 78.7% and 58.4%, significantly favoring the radiotherapy arm over the control arm (HR 0.55; 95% CI 0.30–0.99; P=0.043). Dr. Kuang noted that the rate of marginal intrahepatic 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, hypoalbuminemia, nausea, and diarrhea,” said Dr. 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 postoperative radiotherapy may improve RFS in patients with HCC with narrow surgical margins after curative resection.
Medical writing support was provided by Robert van den Heuvel.
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