Image-Guided High-Dose-Rate Brachytherapy Versus cTACE for Unresectable HCC
Results of a phase II trial suggest that image-guided high-dose-rate (HDR) brachytherapy (iBT) may lead to better outcomes than conventional transarterial embolization (cTACE) in treating unresectable hepatocellular carcinoma (HCC).
The authors were interested in exploring the value of iBT in treating unresectable HCC because iBT has several unique features, including not being restricted by tumor size or heat sink. Additionally, PVT is not a contraindication.
The open-label study was intended to determine whether a multicenter, phase III trial is warranted. The study involved 77 patients and took place at a single center. After randomization, the patients were treated with either iBT or cTACE as either single or repeated interventions, with crossover permitted depending on clinical need. To be included in the study, patients needed a Child-Pugh score of ≤ 8 points, absence of portal vein thrombosis (PVT) at the affected liver lobe, and ≤ 4 lesions. Time to untreatable progression (TTUP) was the primary endpoint of the trial.
There were 20 patients categorized as BCLC-A (iBT/cTACE 8/12), 35 as BCLC-B (16/19), and 22 as BCLC-C (13/9). The 1-, 2-, and 3-year TTUP probabilities for iBT compared with cTACE were 67.5% versus 55.2%, 56.0% versus 27.4%, and 29.5% versus 11.0%, respectively, with an adjusted hazard ratio (HR) of 0.49 (95% confidence interval 0.27-0.89; P = 0.019). The trend favoring iBT was also seen in the 1-, 2-, and 3-year time to progression rates for iBT versus cTACE, which were 56.0% versus 28.2%, 23.9% versus 6.3%, and 15.9% versus 6.3%, respectively, with an adjusted HR of 0.49 (0.29-0.85; P = 0.011). Also of note, the 1-, 2-, and 3-year overall survival rates were 78.4% versus 67.7%, 62.0% versus 47.3%, and 36.7% versus 27.0%, respectively, with an adjusted HR of 0.62 (0.33-1.16; P = 0.136).
“This explorative phase II trial showed a superior outcome of iBT compared with cTACE in HCC, notably in patients with BCLC-B/ BCLC-C and supports proceeding to a phase III trial,” the authors concluded.
Mohnike K, Steffen IG, Seidensticker M, et al. Radioablation by Image-Guided (HDR) Brachytherapy and Transarterial Chemoembolization in Hepatocellular Carcinoma: A Randomized Phase II Trial. Cardiovasc Intervent Radiol. 2019 Feb;42(2):239-249.