Abstract
BackgroundTo compare oncological results and safety profile of balloon micro-catheter trans-arterial chemoembolization (b-TACE) and drug-eluting-microsphere (DEM-TACE) in patients with hepatocellular-carcinoma (HCC).MethodsThis is a case–control, retrospective, single-center study. Between January-2015/March-2019, 149 patients (131 males [87.9%]) with 226 HCC were treated, 22 patients (35 HCC; 19 [86.4%] males) with b-TACE and 127 with DEM-TACE (191 HCC, 112 [88.2%] males). Embolization protocol was standardized (sequential 100 ± 25 and 200 ± 25 μm microspheres). Results were evaluated by modified-response-evaluation-criteria-in-solid-tumor [mRECIST] at 1, 3–6 and 9–12 months and time to recurrence after complete response [TTR] at 1 years. Cox’s regression weighted with tumor dimensions was performed. Adverse events (AEs) were recorded.ResultsmRECIST oncological response at all time points (1, 3–6 and 9–12 months) for both treatments were similar, with the exception of Objective response rate at 9-12 months. Objective response at 1 and 3–6 months between b-TACE vs DEM-TACE [23/35 (65.7%) vs 119/191 (62.3%), 21/29 (72.4%) vs 78/136 (57.4%) (p > 0.05), respectively]. On the contrary, at 9–12 months, it was significantly higher in b-TACE subgroup than DEM-TACE (15/19 [78.9%] vs 48/89 [53.9%], p = 0.05). TTR for complete response at 1 year had a better trend for b-TACE vs DEM-TACE (278.0 days [196.0–342.0] vs 219.0 days [161.0–238.0], OR 0.68 [0.4–1.0], p = 0.10). The use of balloon micro-catheter reduced the relative risk of the event of recurrence by 0.63 [CI95% 0.38–1.04]; p = 0.07). No significant differences were found in AEs rate.Conclusionb-TACE showed a trend of better oncological response over DEM-TACE with and longer TTR with a similar adverse events rate, in patients presenting with larger tumors.
Highlights
To compare oncological results and safety profile of balloon micro-catheter trans-arterial chemoembolization (b-TACE) and drug-eluting-microsphere (DEM-TACE) in patients with hepatocellular-carcinoma (HCC)
Conclusion: b-TACE showed a trend of better oncological response over DEM-TACE with and longer time to recurrence (TTR) with a similar adverse events rate, in patients presenting with larger tumors
The only statistical difference variable between b-TACE and DEM-TACE cohorts was the median maximum diameter of Hepatocellular carcinoma (HCC) tumors treated in the B-TACE group compared to DEM-TACE arm (27.0 mm [confidential interval (CI) 95% 21.6– 32.4] vs 19.0 mm [CI 95% 17.0–20.0]; p < 0.0001; median difference: 8.0 mm [CI95% 4.0–12.0])
Summary
To compare oncological results and safety profile of balloon micro-catheter trans-arterial chemoembolization (b-TACE) and drug-eluting-microsphere (DEM-TACE) in patients with hepatocellular-carcinoma (HCC). BCLC algorithm treatment of choice of Intermediate stage (B stage) HCC is trans-arterial chemoembolization (TACE). The use of a balloon micro-catheter for temporary arterial occlusion has been proposed for TACE (named b-TACE procedure) [4]. The temporary arterial occlusion may enhance treatment success, due to its ability to redistribute flow towards lower resistance vascular territories (i.e. hyper-vascular HCC), allowing a pressure-gradient driven embolization [4] The increased accumulation of embolic particles within the tumor may lead to increased necrosis and increased rates of complete tumor response. To date there are no randomized controlled trials comparing TACE to b-TACE in terms of oncological response; some retrospective studies reported conflicting results. Maruyama et al [8], on the other hand, failed to demonstrate a difference in tumor control between the two techniques
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