Important publications and research related to TACE
Over the years, numerous important publications and research studies have contributed significantly to the field of Trans arterial Chemoembolization (TACE). TACE is a minimally invasive procedure used to treat liver cancer by delivering chemotherapy drugs directly to the tumor site. These publications and research have explored various aspects of TACE, including its efficacy, safety, patient selection criteria, combination therapies, and long-term outcomes. They have provided valuable insights into optimizing TACE protocols, identifying suitable candidates for the procedure, and refining treatment approaches.
| Publication/Research | Keypoints |
|---|---|
| Llovet JM, Real MI, Montaña X, Planas R, Coll S, Aponte J, et al. Arterial embo- lisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet 2002;359:1734–9. | Mean survival was significantly longer with cTACE (28.6 months) than with BSC (17.9 months; P = 0.009) |
| Lo CM, Henry Ngan H, Tso WK. Randomized controlled trial of transarterial Lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology 2002;35:1164–71. | cTACE has a benefit over BSC in terms of survival rate (57% vs. 32% at 1 year; 31% vs. 11% at 2 years; 26% vs. 3% at 3 years, respectively, P = 0.002) |
| Llovet JM, Bruix J. Systematic review of randomized trials for unresectable he- patocellular carcinoma: Chemoembolization improves survival. Hepatology 2003;37:429–42. (META-ANALYSIS) | Higher 2-year overall survival with cTACE (OR 0.53; 95% CI 0.32–0.89; P = 0.017) |
| PRECISION V multicenter RCT phase II trial | DEB-TACE (DC Bead® 300–500 μm followed by DC Bead® 500–700 μm) failed to show superiority over cTACE for the primary endpoint, which was tumor response on MRI 6 months after the procedure (P = 0.11) [39]. Notably, 27.8% of cTACE patients did not receive an embolic agent during the procedure. |
| PRECISION ITALIA STUDY GROUP phase III trial | No difference was found in tumor response, and the median time-to-progression was 9 months in both arms (DEB-TACE & cTACE). The 1- and 2-year survival rates were 86.2% and 56.8%, respectively, after DEB- TACE, and 83.5% and 55.4%, respectively, after cTACE (P = 0.949) |
| META-ANALYSIS (Facciorusso A - 2016) (4 RCT WITH 8 OBSERVATIONAL STUDIES) | Non-superiority of DEB-TACE over cTACE in terms of tumor response and survival |
| Guiu B, Deschamps F, Aho S, Munck F, Dromain C, Boige V, et al. Liver/biliary injuries following chemoembolisation of endocrine tumours and hepatocellular carcinoma: Lipiodol vs. drug-eluting beads. J Hepatol 2012;56:609–17. The authors recommended caution when using DEB- TACE in non-cirrhotic patients. | Biloma/parenchymal infarct was also strongly associated with DEB-TACE (OR 9.78; P = 0.002) and with NETs (OR 8.13; P = 0.04). In the cirrhotic HCC group, at least one liver/biliary injury was observed after 30.4% of DEB-TACE sessions versus after 4.2% of cTACE sessions (P < 0.001). |
| Monier A, Guiu B, Duran R, Aho S, Bize P, Deltenre P, et al. Liver and biliary damages following transarterial chemoembolization of hepatocellular carcinoma: comparison between drug-eluting beads and lipiodol emulsion. Eur Radiol 2017;27:1431–9. (3 months after cTACE and DEB-TACE) | DEB-TACE was associated with a significantly increased risk of hepatic damage (OR 3.13, 95% CI 1.74–5.63, P < 0.001) and biliary injuries (OR 4.53, 95% CI 2.37–8.67, P < 0.001) |
| Lee S, Kim KM, Lee SJ, Lee KH, Lee DY, Kim MD, et al. Hepatic arterial damage after transarterial chemoembolization for the treatment of hepatocellular carci- noma: comparison of drug-eluting bead and conventional chemoembolization in a retrospective controlled study. Acta Radiol 2017;58:131–9. | The incidence was significantly higher after DEB-TACE when analyzed per branch (OR 6.36; P < 0.001) and per patient (OR 3.15; P = 0.005), with doxorubicin dose as a possible risk factor. |
| Cucchetti A, Trevisani F, Cappelli A, Mosconi C, Renzulli M, Pinna AD, et al. Cost- effectiveness of doxorubicin-eluting beads versus conventional trans-arterial chemo-embolization for hepatocellular carcinoma. Dig Liver Dis 2016;48:798–805. | Despite longer (p = 0.001) in-hospital stay after cTACE, due to more frequent post-embolisation syndrome, global costs were non significantly lower with cTACE than with DEB-TACE. |
| PRECISION V multicenter RCT phase II trial | No significant difference (P = 0.86) in DEB-TACE and cTACE in the primary endpoint of serious AEs within 30 days of the procedure (20.4% and 19.4% after DEB-TACE and cTACE, respectively); however, more than 25% of cTACE patients did not have embolization. |
| PRECISION ITALIA STUDY GROUP phase III trial | Post-procedural pain was less frequent in the DEB-TACE arm. |
| META-ANALYSIS (Facciorusso A - 2016) (4 RCT WITH 8 OBSERVATIONAL STUDIES) | No statistically significant difference in AEs (OR 0.85, 95% CI 0.60–1.20, P = 0.36) |
| SHARP TRAIL | Sorafenib as standard of care |
| Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, et al. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular car- cinoma: a randomised phase 3 non-inferiority trial. Lancet 2018;391:1163–73. | Lenvatinib was demonstrated to be non-inferior to sorafenib:
the median survival did not differ significantly between the two groups (13.6 and 12.3 months for lenvatinib and sorafenib, respectively), and they had similar AE rates. |
| RESOURCE TRAIL | Regorafenib revealed survival benefit (as second line therapy) after Sorafenib |
| REACH TRAIL | Ramucirumab as second line therapy after Sorafenib |
| SPCAE AND TACE 2 TRAILS | Combination of TACE with Sorafenib No clinical benefit |
| BRISK-TA STUDY | Combination of TACE with Brivanib No clinical benefit |
| ORIENTAL STUDY | Combination of TACE with Antonio No clinical benefit |
| TACTICS TRAIL | Combination of TACE with Sorafenib (Started 3 weeks prior to TACE) Major Improvement in PFS based on new definition of untreatable progression |