Early sorafenib-related adverse events predict therapy response of TACE plus sorafenib: A multicenter clinical study of 606 HCC patients

Yan Zhao, Hailiang Li, Wei Bai, Jueshi Liu, Weifu Lv, Sonia Sahu, Sheng Guan, Xiao Qin, Wenhui Wang, Weixin Ren, Wei Mu, Weidong Guo, Shanzhi Gu, Yilong Ma, Zhanxin Yin, Wengang Guo, Wenjun Wang, Yongji Wang, Rafael Duran, Daiming FanZhuoli Zhang, Guohong Han*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

22 Scopus citations


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 (TACE-S). The intermediate-stage hepatocellular carcinoma patients who received either TACE-S or TACE-alone treatment were consecutively included into analysis. In the TACE-S 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 TACE-S 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 TACE-S 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 TACE-S 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 TACE-S therapy. Sorafenib-related dermatologic AEs, clinical biomarkers, can predict the efficacy of TACE-S in future randomized controlled trials.

Original languageEnglish (US)
Pages (from-to)928-937
Number of pages10
JournalInternational Journal of Cancer
Issue number4
StatePublished - Aug 15 2016


  • biomarker
  • dermatologic adverse events
  • hepatocellular carcinoma
  • sorafenib
  • transarterial chemoembolization

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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