Combination TACE and SBRT for Unresectable Single Large HCC: Results from a Prospective Phase II Trial
Mené entre 2014 et 2020 sur 32 patients atteints d'un carcinome hépatocellulaire de stade précoce A (selon la classification "Barcelona Clinic Liver Cancer") et non opérable (durée médiane de suivi : 37 mois), cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse objective, d'un traitement combinant chimioembolisation transartérielle et radiothérapie corporelle stéréotaxique
Purpose: Patients with hepatocellular carcinoma (HCC) at Barcelona Clinic Liver Cancer (BCLC) early stage A not suitable for surgery are first considered for ablation. Nonetheless, objective responses and long-term results for ablation in tumors > 3-4cm are suboptimal creating an unmet clinical need. This phase II trial studies combination of transarterial chemoembolization (TACE) and stereotactic body radiation therapy (SBRT) for BCLC A patients with a solitary HCC from 4-7 cm. Methods and Materials: Eligible patients were BCLC A, Child-Pugh score ≤7, ECOG 0 presenting with a single HCC from 4-7 cm not suitable for resection or liver transplantation. Treatment consisted of two sessions of drug-eluting bead (DEB)-TACE within 1 month followed by immediate SBRT. SBRT delivered 35-50 Gy in 5 fractions. The primary end-point was best objective response rate (ORR) by mRECIST. Secondary endpoints were overall survival (OS), progression free survival (PFS), and toxicity. Results: From 2014-2020, 32 were enrolled in a single institution with median follow up of 37 months. 30 patients had at least one post-treatment scan to assess response. ORR in the target lesion was 91%: 63% complete response (CR; n=20), 28% partial response (n=9), and 3% progression of disease (n=1). Median time to CR was 10.1 months. Median OS was not yet reached and median PFS was 35 months. Patients achieving CR had a trend towards improved PFS (p=0.09). Toxicity was low. Conclusions: This Phase II trial shows very promising ORR when combining TACE+SBRT in large, unresectable HCC which translates into excellent OS and PFS. These results provide the rationale for exploring this combination in larger phase II-III clinical trials and a space where SBRT might offer unique clinical advantage.
International Journal of Radiation Oncology, Biology, Physics 2022