PMID- 28899349 OWN - NLM STAT- MEDLINE DCOM- 20180516 LR - 20220408 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 17 IP - 1 DP - 2017 Sep 12 TI - The safety and efficacy of transarterial chemoembolization combined with sorafenib and sorafenib mono-therapy in patients with BCLC stage B/C hepatocellular carcinoma. PG - 645 LID - 10.1186/s12885-017-3545-5 [doi] LID - 645 AB - BACKGROUND: Sorafenib and transarterial chemoembolization (TACE) are recommended therapies for advanced hepatocellular carcinoma (HCC), but their combined efficacy remains unclear. METHODS: Between August 2004 and November 2014, 104 patients with BCLC stage B/C HCC were enrolled at the Affiliated Tumor Hospital of Guangxi Medical University, China. Forty-eight patients were treated with sorafenib alone (sorafenib group) and 56 with TACE plus sorafenib (TACE + sorafenib group). Baseline demographic/clinical data were collected. The primary outcomes were median overall survival (OS) and progression-free survival (PFS). Secondary outcomes were overall response rate (ORR) and sorafenib-related adverse events (AEs). Baseline characteristics associated with disease prognosis were identified using multivariate Cox hazards regression. RESULTS: The mean age of the 104 patients (94 males; 90.38%) was 49.02 +/- 12.29 years. Of the baseline data, only albumin level (P = 0.028) and Child-Pugh class (P = 0.017) differed significantly between groups. Median OS did not differ significantly between the sorafenib and TACE + sorafenib groups (18.0 vs. 22.0 months, P = 0.223). Median PFS was significantly shorter in the sorafenib group than that in the TACE + sorafenib group (6.0 vs. 8.0 months, P = 0.004). Six months after treatments, the ORRs were similar between the sorafenib and TACE + sorafenib groups (12.50% vs. 18.75%, P = 0.425). The rates of grade III-IV adverse events in sorafenib and TACE + sorafenib groups were 29.2% vs. 23.2%, respectively. TACE plus sorafenib treatment (HR = 0.498, 95% CI = 0.278-0.892), no vascular invasion (HR = 0.354, 95% CI = 0.183-0.685) and Child-Pugh class A (HR = 0.308, 95% CI = 0.141-0.674) were significantly associated with better OS, while a larger tumor number was predictive of poorer OS (HR = 1.286, 95% CI = 1.031-1.604). TACE plus sorafenib treatment (HR = 0.461, 95% CI = 0.273-0.780) and no vascular invasion (HR = 0.557, 95% CI = 0.314-0.988) were significantly associated with better PFS. CONCLUSIONS: Compared with sorafenib alone, combining TACE with sorafenib might prolong survival and delay disease progression in patients with advanced HCC. FAU - Wu, Fei-Xiang AU - Wu FX AD - Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, He Di Rd #71, Nanning, 530021, People's Republic of China. AD - Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China. AD - Key Laboratory of Early Prevention and Treatment for Regional High Frequency Tumor, Ministry of Education, Nanning, China. FAU - Chen, Jie AU - Chen J AD - Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, He Di Rd #71, Nanning, 530021, People's Republic of China. FAU - Bai, Tao AU - Bai T AD - Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, He Di Rd #71, Nanning, 530021, People's Republic of China. FAU - Zhu, Shao-Liang AU - Zhu SL AD - Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, He Di Rd #71, Nanning, 530021, People's Republic of China. FAU - Yang, Tian-Bo AU - Yang TB AD - Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, He Di Rd #71, Nanning, 530021, People's Republic of China. FAU - Qi, Lu-Nan AU - Qi LN AD - Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, He Di Rd #71, Nanning, 530021, People's Republic of China. FAU - Zou, Ling AU - Zou L AD - Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, He Di Rd #71, Nanning, 530021, People's Republic of China. FAU - Li, Zi-Hui AU - Li ZH AD - Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, He Di Rd #71, Nanning, 530021, People's Republic of China. FAU - Ye, Jia-Zhou AU - Ye JZ AD - Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, He Di Rd #71, Nanning, 530021, People's Republic of China. FAU - Li, Le-Qun AU - Li LQ AD - Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, He Di Rd #71, Nanning, 530021, People's Republic of China. lilequn2016@aliyun.com. AD - Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China. lilequn2016@aliyun.com. AD - Key Laboratory of Early Prevention and Treatment for Regional High Frequency Tumor, Ministry of Education, Nanning, China. lilequn2016@aliyun.com. LA - eng PT - Journal Article DEP - 20170912 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 RN - 0 (Hepatitis B Surface Antigens) RN - 0 (Phenylurea Compounds) RN - 25X51I8RD4 (Niacinamide) RN - 9ZOQ3TZI87 (Sorafenib) SB - IM MH - Adult MH - Aged MH - Carcinoma, Hepatocellular/blood/*drug therapy/pathology MH - Chemoembolization, Therapeutic/adverse effects/*methods MH - Combined Modality Therapy MH - Disease-Free Survival MH - Drug-Related Side Effects and Adverse Reactions/classification/pathology MH - Female MH - Hepatitis B Surface Antigens/blood MH - Humans MH - Liver Neoplasms/blood/*drug therapy/pathology 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 - Sorafenib MH - Treatment Outcome PMC - PMC5596482 OTO - NOTNLM OT - Adverse events OT - Hepatocellular carcinoma OT - Portal vein tumor thrombus OT - Sorafenib OT - Transarterial chemoembolization COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: This study was approved by the Institutional Review Board of Guangxi Medical University and was conducted in accordance with the Declaration of Helsinki and internationally accepted ethical guidelines. During their admission for surgery, the patients enrolled in this study provided written informed consent for their information to be stored in hospital databases and used for research. CONSENT FOR PUBLICATION: Not applicable. COMPETING INTERESTS: The authors declare that they have no competing interests. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2017/09/14 06:00 MHDA- 2018/05/17 06:00 PMCR- 2017/09/12 CRDT- 2017/09/14 06:00 PHST- 2016/07/20 00:00 [received] PHST- 2017/08/14 00:00 [accepted] PHST- 2017/09/14 06:00 [entrez] PHST- 2017/09/14 06:00 [pubmed] PHST- 2018/05/17 06:00 [medline] PHST- 2017/09/12 00:00 [pmc-release] AID - 10.1186/s12885-017-3545-5 [pii] AID - 3545 [pii] AID - 10.1186/s12885-017-3545-5 [doi] PST - epublish SO - BMC Cancer. 2017 Sep 12;17(1):645. doi: 10.1186/s12885-017-3545-5.