New light was shed on the use of TACE and SIRT in the treatment of hepatocellular carcinoma (HCC) by data from clinical trials presented at the International Liver Congress 2013 in Amsterdam, the Netherlands.
Transarterial chemoembolization (TACE) is a technique in which small particles designed to block blood vessels mixed or coated with chemotherapeutic drugs are injected directly into an artery supplying the tumor. This has become a standard treatment in selected patients with HCC.
New data has identified a scoring system which defines those HCC patients who achieve the most benefit from TACE. An Assessment for Retreatment with TACE (or ART-score) was developed based on the impact of the initial TACE session on parameters of liver function and tumor response, and their impact on overall survival (overall survival; log rank test).
The ART-score differentiated two groups (0-1.5 points; ≥2.5 points) with distinct differences in prognosis (median overall survival: 23.7 months vs 6.6 months; P< 0.001) which was confirmed in an independent external validation cohort. In addition, a higher ART-score was associated with major adverse events after the second TACE session (P=0.011).
“These findings represent an important discovery as they will enable physicians to identify and treat those HCC patients who will benefit from repeat TACE sessions. Furthermore, rounds of ineffective treatment, as well as any associated side effects and complications, can be avoided for those patients who are not likely to respond,” said Markus Peck-Radosavljevic, MD, and vice-secretary of the European Association for the Study of the Liver (EASL).
While TACE is the standard-of-care treatment for intermediate-stage HCC, selective Internal Radiotherapy Treatment (SIRT) is more commonly used to treat patients with advanced-stage HCC and patients who are poor candidates for or have failed TACE. However, data from SIRTACE, a separate, open-label, multi-center pilot study suggest that a single-session of SIRT is as safe and effective as multiple sessions of TACE in a typical TACE patient cohort with unresectable HCC.
Patients were randomized to receive either TACE (n=15) or SIRT (n=13). Patients received a mean of 3.4 TACE interventions (median 2; range 1-11) or 1 SIRT procedure. Treatment response was assessed by local (using RECIST 1.0) and independent central (RECIST 1.1 and mRECIST) review. Median progression-free survival (RECIST 1.1) was 5.5 months (95%CI: 1.6- not reached) for TACE and 4.1 months (95%CI: 2.3-9.9) for SIRT (P=0.411). Overall survival did not differ by procedure (P=0.244).
Finally, the SORAMIC European multicenter phase II clinical trial evaluated the efficacy and safety of using a combination of SIRT and sorafenib for the treatment of HCC. Data from its interim safety analysis confirmed that using SIRT as a sequential approach followed by an escalation scheme for sorafenib does not lead to increased toxicity. Interim analysis of the data showed a total number of adverse events of 196 and 220 in the combination and control arm, with grade 3-5 adverse events reaching 42 and 49, respectively (P>0.05).