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TACE and conformal radiotherapy vs. TACE alone for hepatocellular carcinoma: A randomised controlled trial.
Féray, Cyrille; Campion, Loic; Mathurin, Philippe; Archambreaud, Isabelle; Mirabel, Xavier; Bronowicki, Jean Pierre; Rio, Emmanuel; Perret, Christophe; Mineur, Laurent; Oberti, Frédéric; Touchefeu, Yann; Gournay, Jérôme; Regnault, Hélène; Edeline, Julien; Rode, Agnès; Hillion, Patrick; Blanc, Jean Frédéric; Khac, Eric Nguyen; Azoulay, Daniel; Luciani, Alain; Preglisasco, Athena Galetto; Faurel-Paul, Elodie; Auble, Hélène; Mornex, Françoise; Merle, Philippe.
Afiliação
  • Féray C; Centre Hepato-Biliaire, Hôpital Paul Brousse, APHP, Université Paris-Saclay, INSERM 1193, Villejuif, France.
  • Campion L; Department of Biostatistics, Institut de Cancérologie de l'Ouest, Université Nantes, INSERM U307, Nantes, France.
  • Mathurin P; Service des Maladies de l'Appareil Digestif, Hôpital Huriez, Université Lille, INSERM 1286, Lille, France.
  • Archambreaud I; Institut des Maladies de l'Appareil Digestif, Hôtel-Dieu, Nantes, France.
  • Mirabel X; Department of Radiation Oncology, Centre Oscar Lambret, Lille, France.
  • Bronowicki JP; Department of Gastroenterology and Hepatology, CHU Nancy-Brabois, Nancy, France.
  • Rio E; Department of Radiation Oncology, Institut de Cancérologie de l'Ouest, Saint Herblain, France.
  • Perret C; Radiology Department, Hôtel-Dieu, Nantes, France.
  • Mineur L; Digestive Oncology, Institut Sainte Catherine, Avignon, France.
  • Oberti F; Department of Gastroenterology and Hepatology, Centre Hospitalo-universitaire, Angers, France.
  • Touchefeu Y; Institut des Maladies de l'Appareil Digestif, Hôtel-Dieu, Nantes, France.
  • Gournay J; Institut des Maladies de l'Appareil Digestif, Hôtel-Dieu, Nantes, France.
  • Regnault H; Department of Gastroenterology and Hepatology, Hôpital Henri Mondor, APHP, Université Paris Est, Creteil, France.
  • Edeline J; Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.
  • Rode A; Radiology Department, Hôpital de la Croix-Rousse, Hospice Civil de Lyon; Lyon, France.
  • Hillion P; Department of Gastroenterology and Hepatology, Centre Hospitalo-universitaire, Dijon, France.
  • Blanc JF; Department of Gastroenterology and Hepatology, Hôpital Sud Haut-Lévêque, Bordeaux, France.
  • Khac EN; Department of Gastroenterology and Hepatology, Centre Hospitalo-universitaire, Université Amiens, Amiens, France.
  • Azoulay D; Centre Hepato-Biliaire, Hôpital Paul Brousse, APHP, Université Paris-Saclay, INSERM 1193, Villejuif, France.
  • Luciani A; Radiology Department, Hôpital Henri Mondor, APHP, Créteil, France.
  • Preglisasco AG; Radiology Department, Hôpital Henri Mondor, APHP, Créteil, France.
  • Faurel-Paul E; Direction de la Recherche Medicale, Hôtel-Dieu, Nantes, France.
  • Auble H; Direction de la Recherche Medicale, Hôtel-Dieu, Nantes, France.
  • Mornex F; Department of Radiation Oncology, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Université Claude Bernard Lyon, EMR 3738, Lyon, France.
  • Merle P; Hepatology and Gastroenterology Unit, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Université Claude Bernard, INSERM U1052, Lyon, France.
JHEP Rep ; 5(4): 100689, 2023 Apr.
Article em En | MEDLINE | ID: mdl-36937990
Background & Aims: Transcatheter arterial chemoembolisation (TACE) is recommended for patients with hepatocellular carcinoma devoid of macrovascular invasion or extrahepatic spread but not eligible for curative therapies. We compared the efficacy and safety of the combination of a single TACE and external conformal radiotherapy (CRT) vs. classical TACE. Methods: TACERTE was an open-labelled, randomised controlled trial with a 1:1 allocation rate to two or three TACE (arm A) or one TACE + CRT (arm B). Participants had a mean age of 70 years, and 86% were male. The aetiology was alcohol in 85%. The primary endpoint was liver progression-free survival (PFS) in the intention-to-treat population. The typical CRT schedule was 54 Gy in 18 sessions of 3 Gy. Results: Of the 120 participants randomised, 64 were in arm A and 56 in arm B; 100 participants underwent the planned schedule and defined the 'per-protocol' group. In intention-to-treat participants, the liver PFS at 12 and 18 months were 59% and 19% in arm A and 61% and 36% in arm B (hazard ratio [HR] 0.69; 95% CI 0.40-1.18; p = 0.17), respectively. In the per-protocol population, treated liver PFS tended to be better in arm B (HR 0.61; 95% CI 0.34-1.06; p = 0.081) than in arm A. Liver-related grade III-IV adverse events were more frequent in arm B than in arm A. Median overall survival reached 30 months (95% CI 23-35) in arm A and 22 months (95% CI 15.7-26.2) in arm B. Conclusions: Although TACE + CRT tended to improve local control, this first Western randomised controlled trial showed that the combined strategy failed to increase PFS or overall survival and led more frequently to liver-related adverse effects. Impact and implications: Hepatocellular carcinoma is frequently treated by arterial embolisation of the tumour and more recently by external radiotherapy. We tried to determine whether combination of the two treatments (irradiation after embolisation) might produce interesting results. Our results in this prospective randomised study were not able to demonstrate a beneficial effect of combining embolisation and irradiation in these patients. On the contrary, we observed more adverse effects with the combined treatment. Clinical Trials Registration: NCT01300143.
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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2023 Tipo de documento: Article