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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)

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 c...

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Autores principales: Comito, Tiziana, Loi, Mauro, Franzese, Ciro, Clerici, Elena, Franceschini, Davide, Badalamenti, Marco, Teriaca, Maria Ausilia, Rimassa, Lorenza, Pedicini, Vittorio, Poretti, Dario, Solbiati, Luigi Alessandro, Torzilli, Guido, Ceriani, Roberto, Lleo, Ana, Aghemo, Alessio, Santoro, Armando, Scorsetti, Marta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9689962/
https://www.ncbi.nlm.nih.gov/pubmed/36421345
http://dx.doi.org/10.3390/curroncol29110692
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author Comito, Tiziana
Loi, Mauro
Franzese, Ciro
Clerici, Elena
Franceschini, Davide
Badalamenti, Marco
Teriaca, Maria Ausilia
Rimassa, Lorenza
Pedicini, Vittorio
Poretti, Dario
Solbiati, Luigi Alessandro
Torzilli, Guido
Ceriani, Roberto
Lleo, Ana
Aghemo, Alessio
Santoro, Armando
Scorsetti, Marta
author_facet Comito, Tiziana
Loi, Mauro
Franzese, Ciro
Clerici, Elena
Franceschini, Davide
Badalamenti, Marco
Teriaca, Maria Ausilia
Rimassa, Lorenza
Pedicini, Vittorio
Poretti, Dario
Solbiati, Luigi Alessandro
Torzilli, Guido
Ceriani, Roberto
Lleo, Ana
Aghemo, Alessio
Santoro, Armando
Scorsetti, Marta
author_sort Comito, Tiziana
collection PubMed
description 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.
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spelling pubmed-96899622022-11-25 Stereotactic Radiotherapy after Incomplete Transarterial (Chemo-) Embolization (TAE\TACE) versus Exclusive TAE or TACE for Treatment of Inoperable HCC: A Phase III Trial (NCT02323360) Comito, Tiziana Loi, Mauro Franzese, Ciro Clerici, Elena Franceschini, Davide Badalamenti, Marco Teriaca, Maria Ausilia Rimassa, Lorenza Pedicini, Vittorio Poretti, Dario Solbiati, Luigi Alessandro Torzilli, Guido Ceriani, Roberto Lleo, Ana Aghemo, Alessio Santoro, Armando Scorsetti, Marta Curr Oncol Article 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. MDPI 2022-11-16 /pmc/articles/PMC9689962/ /pubmed/36421345 http://dx.doi.org/10.3390/curroncol29110692 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Comito, Tiziana
Loi, Mauro
Franzese, Ciro
Clerici, Elena
Franceschini, Davide
Badalamenti, Marco
Teriaca, Maria Ausilia
Rimassa, Lorenza
Pedicini, Vittorio
Poretti, Dario
Solbiati, Luigi Alessandro
Torzilli, Guido
Ceriani, Roberto
Lleo, Ana
Aghemo, Alessio
Santoro, Armando
Scorsetti, Marta
Stereotactic Radiotherapy after Incomplete Transarterial (Chemo-) Embolization (TAE\TACE) versus Exclusive TAE or TACE for Treatment of Inoperable HCC: A Phase III Trial (NCT02323360)
title Stereotactic Radiotherapy after Incomplete Transarterial (Chemo-) Embolization (TAE\TACE) versus Exclusive TAE or TACE for Treatment of Inoperable HCC: A Phase III Trial (NCT02323360)
title_full Stereotactic Radiotherapy after Incomplete Transarterial (Chemo-) Embolization (TAE\TACE) versus Exclusive TAE or TACE for Treatment of Inoperable HCC: A Phase III Trial (NCT02323360)
title_fullStr Stereotactic Radiotherapy after Incomplete Transarterial (Chemo-) Embolization (TAE\TACE) versus Exclusive TAE or TACE for Treatment of Inoperable HCC: A Phase III Trial (NCT02323360)
title_full_unstemmed Stereotactic Radiotherapy after Incomplete Transarterial (Chemo-) Embolization (TAE\TACE) versus Exclusive TAE or TACE for Treatment of Inoperable HCC: A Phase III Trial (NCT02323360)
title_short Stereotactic Radiotherapy after Incomplete Transarterial (Chemo-) Embolization (TAE\TACE) versus Exclusive TAE or TACE for Treatment of Inoperable HCC: A Phase III Trial (NCT02323360)
title_sort stereotactic radiotherapy after incomplete transarterial (chemo-) embolization (tae\tace) versus exclusive tae or tace for treatment of inoperable hcc: a phase iii trial (nct02323360)
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9689962/
https://www.ncbi.nlm.nih.gov/pubmed/36421345
http://dx.doi.org/10.3390/curroncol29110692
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