Transarterial Infusion Chemotherapy with FOLFOX for Advanced Hepatocellular Carcinoma: A Multi-Center Propensity Score Matched Analysis of Real-World Practice

Abstract

Background: To compare the treatment effectiveness and safety among transarterial infusion chemotherapy (TAI) with FOLFOX regimen, transarterial chemoembolization (TACE), and sorafenib in patients with BCLC stage C hepatocellular carcinoma (HCC). Methods: The data of consecutive patients with BCLC stage C HCC treated with TAI, TACE, or sorafenib from January 2015 to December 2018 at three centers were retrospectively analyzed. Propensity-score matched (PSM) analysis was pairwise performed (TAI vs. TACE and TAI vs. sorafenib) to reduce selection bias. Treatment effectiveness and safety were evaluated and compared using the Kaplan-Meier method, log-rank test, Cox regression models, and I‡2 test. Findings: The median overall survival (OS) in the matched TAI group was significantly longer than the sorafenib group (19*6 months vs. 7*5 months, p=0*009), and the TACE group (estimated 27*8 months vs. 6*6 months, p<0*001). The difference in median progression-free survival (PFS) between the matched TAI and sorafenib groups was not significant (5*8 months vs. 2*3 months, p=0*219). The median PFS in the matched TAI group was significantly longer than the TACE group (6*5 months vs. 2*8 months, p<0*001). The objective response rate (ORR) in the matched TAI group was significantly higher than the sorafenib group (36*4% vs. 0*0%, p<0*001) and the TACE group (48*7% vs. 4*7%, p<0*001). The incidences of adverse events (AEs) were similar among these three groups. Interpretation: TAI with FOLFOX regimen was an effective and safe therapy that improved survival of patients with BCLC stage C HCC. Funding Statement: This study was supported by the National Natural Science Foundation of China (No. 81871985); Natural Science Foundation of Guangdong Province (No. 2018A0303130098 and No. 2017A030310203); Medical Scientific Research Foundation of Guangdong Province (No. A2017477); Science and Technology Planning Project of Guangzhou (No. 201903010017 and No. 201904010479); Clinical Trials Project (5010 Project) of Sun Yat-sen University (No. 5010-2017009). Declaration of Interests: All authors declared no conflicts of interest. Ethics Approval Statement: This study was conducted according to the ethical guidelines of the 1975 Declaration of Helsinki, and it was reviewed and approved by the Institutional Review Board at the Sun Yat-sen University Cancer Center (No. B2018-126-01). Informed consent was obtained from each patient for the data to be used for research.