Dataset Information

Short-term imaging response after drug-eluting embolic trans-arterial chemoembolization delivered with the Surefire Infusion System® for the treatment of hepatocellular carcinoma.

ABSTRACT:

Purpose

To review the initial imaging responses after drug-eluting embolic trans-arterial chemoembolization (DEE-TACE) delivered with the Surefire Infusion System ® for the treatment of hepatocellular carcinoma (HCC).

Methods

Single center retrospective evaluation of patients who underwent DEE-TACE for HCC, delivered with SIS. Information was gathered from available medical records. Treatment response rates were assessed using the modified Response Evaluation Criteria in Solid Tumors criteria. Assessment of adverse events was categorized per Common Terminology Criteria for Adverse Events version 4.03.

Results

Twenty-two patients with 39 hepatocellular carcinoma lesions were treated with the surefire infusion system. Complete response was demonstrated in 32% of patients and 54% of lesions after a single treatment session. Overall disease response was demonstrated in 91% of patients and 85% of lesions after a single treatment. No grade 3 or higher elevations in liver function tests were demonstrated in the short-term.

Conclusion

SIS delivered DEE-TACE leads to a higher than expected initial response in patients with HCC.

SUBMITTER: Kim AY

PROVIDER: S-EPMC5580978 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe combination therapy of trans-arterial chemoembolization (TACE) and sorafenib were proved to be one of the effective methods for intermediate and advanced hepatocellular carcinoma (HCC). Although it has been confirmed that the combination therapy can prolong survival for advanced HCC effectively, the therapeutic efficacy and safety are still controversial and the clinical value has not been determined. This meta-analysis aims to evaluate the efficacy and safety of combination therapy and discuss the optimal timing of combination for better clinical benefits.Data sourcesPubMed, EMBASE, the Cochrane Library, MEDLINE, and Web of Science were systematically reviewed to search for relevant studies published before May 15, 2021. Studies comparing the efficacy and safety of TACE + sorafenib with TACE + placebo / alone were adopted. Two reviewers independently extracted study outcomes. The data were analyzed through fixed/random-effect meta-analysis models with Review Manager (Version 5. 3) software.Results7 randomized controlled trials (RCTs) were included with 1464 patients with unresectable HCC (734 in TACE + sorafenib group and 730 in TACE + placebo or alone group). Meta-analysis showed that objective response rate (ORR) and disease control rate (DCR) were slightly improved in TACE + sorafenib group (ORR: risk ratio = 1.24; 95% confidence interval: 1.08-1.42; P = 0.002; DCR: risk ratio = 1.09; 95% confidence interval: 1.01-1.18; P = 0.02). The combination therapy obviously improved time to progression (TTP) (hazard ratio: 0.73; 95% confidence interval: 0.55-0.96; P = 0.03) and progression-free survival (PFS) (hazard ratio 0.62; 95% confidence interval: 0.52-0.73, P < 0.00001) but not overall survival (OS) (hazard ratio: 0.93; 95% confidence interval: 0.59-1.46; P = 0.75) or time to untreatable progression (TTUP) (hazard ratio: 0.76; 95% confidence interval: 0.31-1.89; P = 0.56). In addition, the incidence of adverse reactions (AEs) in combination group were higher than TACE + placebo / alone group. Furthermore, the subgroup analysis showed that the heterogeneity of TTP was notably decreased (pre-TACE: P = 0.12, I2 = 48%; post-TACE: P = 0.58, I2 = 0%), and the hazard ratio was 0.59 (95% confidence interval: 0.51-0.68; P < 0.00001) in pre-TACE subgroup which indicated that combination before TACE significantly prolonged TTP but not in combination after TACE (hazard ratio: 0.88; 95% confidence interval: 0.62-1.24; P = 0.46). In term of AEs, sensitivity analysis indicated that the risk ratio for hand-foot skin reaction, diarrhea, rash/desquamation, and hypertension was 7.41, 2.58, 2.14, 1.55 in pre-TACE subgroup respectively and was 11.34, 3.26, 3.61, 4.11 in post-TACE subgroup respectively (All P < 0.05).ConclusionThe combination of TACE and sorafenib significantly can improve TTP and PFS, and reduce the level of risk of adverse reactions of unresectable HCC, especially in the combination before TACE.