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

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• 作者：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 Fan ; Zhuoli Zhang and Guohong Han
• 刊名：International Journal of Cancer
• 出版年：2016
• 出版时间：15 August 2016
• 年：2016
• 卷：139
• 期：4
• 页码：928-937
• 全文大小：328K
• ISSN：1097-0215

文摘

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.