TACE and conformal radiotherapy

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)

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;

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.

Informations de copyright

© 2023 The Authors.

Déclaration de conflit d'intérêts

CF, LC, IA, XM, ER, CP, LM, FO, YT, JG, HR, JE, AR, PH, JFB, ENK, DA, AGP, EF-P, and HA did not receive any grants or funding. P Merle reports grants or funding from Roche, AstraZeneca, MSD, Eisai, Bayer, and Ipsen. P Mathurin reports grants or funding from Ipsen, Eisai, Abbvie, Sanofi, Gilead Sciences, Pfizer, Evive Biotech, Novo Nordisk, Bayer Healthcare, Surrozen, and Intercept. Please refer to the accompanying ICMJE disclosure forms for further details.