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Stereotactic Radiotherapy after Incomplete Transarterial (Chemo-) Embolization (TAE\TACE) versus Exclusive TAE or TACE for Treatment of Inoperable HCC: A Phase III Trial (NCT02323360)

Authors :
Tiziana Comito
Mauro Loi
Ciro Franzese
Elena Clerici
Davide Franceschini
Marco Badalamenti
Maria Ausilia Teriaca
Lorenza Rimassa
Vittorio Pedicini
Dario Poretti
Luigi Alessandro Solbiati
Guido Torzilli
Roberto Ceriani
Ana Lleo
Alessio Aghemo
Armando Santoro
Marta Scorsetti
Source :
Current Oncology, Vol 29, Iss 11, Pp 8802-8813 (2022)
Publication Year :
2022
Publisher :
MDPI AG, 2022.

Abstract

Background: Hepatocellular carcinoma (HCC) is the most frequent liver malignancy and a leading cause of cancer death in the world. In unresectable HCC patients, transcatheter arterial (chemo-) embolization (TAE/TACE) has shown a disease response in 15–55% of cases. Though multiple TAE/TACE courses can be administered in principle, Stereotactic Body Radiotherapy (SBRT) has emerged as an alternative option in the case of local relapse following multiple TAE/TACE courses. Methods: This is a single-center, prospective, randomized, controlled, parallel-group superiority trial of SBRT versus standard TAE/TACE for the curative treatment of the intermediate stage of HCC after an incomplete response following TAE/TACE (NCT02323360). The primary endpoint is 1-year local control (LC): 18 events were needed to assess a 45% difference (HR: 0.18) in favor of SBRT. The secondary endpoints are 1-year Progression-Free Survival (PFS), Distant Recurrence-Free Survival (DRFS), Overall Survival (OS) and the incidence of acute and late complications. Results: At the time of the final analysis, 40 patients were enrolled, 19 (49%) in the TAE/TACE arm and 21 (51%) in the SBRT arm. The trial was prematurely closed due to slow accrual. The 1- and 2-year LC rates were 57% and 36%. The use of SBRT resulted in superior LC as compared to TAE/TACE rechallenge (median not reached versus 8 months, p = 0.0002). PFS was 29% and 16% at 1 and 2 years, respectively. OS was 86% and 62% at 1 year and 2 years, respectively. In the TAE arm, PFS was 13% and 6% at 1 and 2 years, respectively. In the SBRT arm, at 1 and 2 years, PFS was 37% and 21%, respectively. OS at 1 and 2 years was 75% and 64% in the SBRT arm and 95% and 57% in the TACE arm, respectively. No grade >3 toxicity was recorded. Conclusions: SBRT is an effective treatment option in patients affected by inoperable HCC experiencing an incomplete response following ≥1 cycle of TAE/TAC.

Details

Language :
English
ISSN :
17187729 and 11980052
Volume :
29
Issue :
11
Database :
Directory of Open Access Journals
Journal :
Current Oncology
Publication Type :
Academic Journal
Accession number :
edsdoj.3952ea917853480d816d006a980d5279
Document Type :
article
Full Text :
https://doi.org/10.3390/curroncol29110692