PMID- 27038145 OWN - NLM STAT- MEDLINE DCOM- 20170428 LR - 20181202 IS - 1097-0215 (Electronic) IS - 0020-7136 (Linking) VI - 139 IP - 4 DP - 2016 Aug 15 TI - Early sorafenib-related adverse events predict therapy response of TACE plus sorafenib: A multicenter clinical study of 606 HCC patients. PG - 928-37 LID - 10.1002/ijc.30124 [doi] AB - 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. CI - (c) 2016 UICC. FAU - Zhao, Yan AU - Zhao Y AD - Department of Liver Disease and Digestive Interventional Radiology, Xijing Hospital of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China. FAU - Li, Hailiang AU - Li H AD - Department of Interventional Radiology, Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. FAU - Bai, Wei AU - Bai W AD - Department of Liver Disease and Digestive Interventional Radiology, Xijing Hospital of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China. FAU - Liu, Jueshi AU - Liu J AD - Department of Interventional Radiology and Vascular Surgery, Hunan Provincial People's Hospital, Changsha, China. FAU - Lv, Weifu AU - Lv W AD - Department of Radiology, Anhui Provincial Hospital, Hefei, China. FAU - Sahu, Sonia AU - Sahu S AD - Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston. FAU - Guan, Sheng AU - Guan S AD - Second Department of Interventional Radiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Qin, Xiao AU - Qin X AD - Department of Hepatobiliary Surgery & Vascular Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. FAU - Wang, Wenhui AU - Wang W AD - Department of Interventional Medicine, The First Affiliated Hospital of Lanzhou University, Lanzhou, China. FAU - Ren, Weixin AU - Ren W AD - Department of Interventional Radiology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China. FAU - Mu, Wei AU - Mu W AD - Department of Radiology, The Southwest Hospital, Third Military Medical University, Chongqing, China. FAU - Guo, Weidong AU - Guo W AD - Cancer Treatment Center, Baogang Hospital of Inner Mongolia, Baotou, China. FAU - Gu, Shanzhi AU - Gu S AD - Department of Interventional Radiology, Hunan Cancer Hospital of Central South University, Changsha, China. FAU - Ma, Yilong AU - Ma Y AD - Department of Interventional Therapy, Tumor Hospital of Guangxi Medical University, Nanning, China. FAU - Yin, Zhanxin AU - Yin Z AD - Department of Liver Disease and Digestive Interventional Radiology, Xijing Hospital of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China. FAU - Guo, Wengang AU - Guo W AD - Department of Liver Disease and Digestive Interventional Radiology, Xijing Hospital of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China. FAU - Wang, Wenjun AU - Wang W AD - Department of Liver Disease and Digestive Interventional Radiology, Xijing Hospital of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China. FAU - Wang, Yongji AU - Wang Y AD - Department of Medical Statistics, Fourth Military Medical University, Xi'an, China. FAU - Duran, Rafael AU - Duran R AD - Department of Radiology, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland. FAU - Fan, Daiming AU - Fan D AD - Department of Liver Disease and Digestive Interventional Radiology, Xijing Hospital of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China. AD - State Key Laboratory of Cancer Biology and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China. FAU - Zhang, Zhuoli AU - Zhang Z AD - Department of Radiology, Northwestern University, Chicago. FAU - Han, Guohong AU - Han G AD - Department of Liver Disease and Digestive Interventional Radiology, Xijing Hospital of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China. LA - eng PT - Journal Article PT - Multicenter Study PL - United States TA - Int J Cancer JT - International journal of cancer JID - 0042124 RN - 0 (Phenylurea Compounds) RN - 25X51I8RD4 (Niacinamide) RN - 9ZOQ3TZI87 (Sorafenib) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Carcinoma, Hepatocellular/diagnosis/etiology/mortality/*therapy MH - *Chemoembolization, Therapeutic/adverse effects/methods MH - Disease Progression MH - Female MH - Humans MH - Kaplan-Meier Estimate MH - Liver Neoplasms/diagnosis/etiology/mortality/*therapy MH - Male MH - Middle Aged MH - Neoplasm Staging MH - Niacinamide/administration & dosage/adverse effects/*analogs & derivatives MH - Phenylurea Compounds/*administration & dosage/adverse effects MH - Prognosis MH - Retrospective Studies MH - Sorafenib MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - biomarker OT - dermatologic adverse events OT - hepatocellular carcinoma OT - sorafenib OT - transarterial chemoembolization EDAT- 2016/04/03 06:00 MHDA- 2017/04/30 06:00 CRDT- 2016/04/03 06:00 PHST- 2015/11/25 00:00 [received] PHST- 2016/02/04 00:00 [revised] PHST- 2016/03/22 00:00 [accepted] PHST- 2016/04/03 06:00 [entrez] PHST- 2016/04/03 06:00 [pubmed] PHST- 2017/04/30 06:00 [medline] AID - 10.1002/ijc.30124 [doi] PST - ppublish SO - Int J Cancer. 2016 Aug 15;139(4):928-37. doi: 10.1002/ijc.30124.