Early Sorafenib-Related Adverse Events Predict Therapy Response of TACE plus Sorafenib: A Multicenter Clinical Study of 606 HCC Patients

ABSTRACT

The purpose of our study was to test the hypothesis that sorafenib-related dermatologic adverse events (AEs) as an early biomarker can predict the long-term outcomes following the combination therapy of transarterial chemoembolization (TACE) plus sorafenib (CTACES). The intermediate-stage hepatocellular carcinoma patients who received either CTACES or TACE-alone treatment were consecutively included into analysis. In the CTACES group, patients with ≥ grade 2 dermatologic AEs within the first month of sorafenib initiation were defined as responders; whereas those with < grade 2 were defined as nonresponders. In the CTACES group, the median overall survival (OS) of the responders was significantly longer than that of nonresponders (28.9 months vs. 16.8 months, respectively; P = 0.004). Multivariate analysis demonstrated that nonresponders were significantly associated with an increased risk of death compared with responders (HR = 1.9; 95% confidence Interval-CI: 1.3-2.7; P = 0.001). The survival analysis showed that the median OS was 27.9 months (95% CI: 25.0-30.8) among responders treated with CTACES vs.18.3 months (95% CI: 14.5-22.1) among those who received TACE-alone (P = 0.046). The median time to progression was 13.1 months (95% CI: 4.4-21.8) in the CTACES group, a duration that was significantly longer than that in the TACE-alone group [5 months (95% CI: 6.4-13.3), P = 0.014]. This study demonstrated that sorafenib-related dermatologic AEs are clinical biomarkers to identify responders from all of the patients for CTACES therapy. Sorafenib-related dermatologic AEs, clinical biomarkers, can predict the efficacy of CTACES in future randomized controlled trials. This article is protected by copyright. All rights reserved.

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