The safety and efficacy of transarterial chemoembolization combined with sorafenib and sorafenib mono-therapy in patients with BCLC stage B/C hepatocellular carcinoma.

Publisher: BioMed Central Country of Publication: England NLM ID: 100967800 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2407 (Electronic) Linking ISSN: 14712407 NLM ISO Abbreviation: BMC Cancer Subsets: MEDLINE

Original Publication: London : BioMed Central, [2001-

Carcinoma, Hepatocellular/*drug therapy ; Chemoembolization, Therapeutic/*methods ; Liver Neoplasms/*drug therapy ; Niacinamide/*analogs & derivatives ; Phenylurea Compounds/*administration & dosage; Adult ; Aged ; Carcinoma, Hepatocellular/blood ; Carcinoma, Hepatocellular/pathology ; Chemoembolization, Therapeutic/adverse effects ; Combined Modality Therapy ; Disease-Free Survival ; Drug-Related Side Effects and Adverse Reactions/classification ; Drug-Related Side Effects and Adverse Reactions/pathology ; Female ; Hepatitis B Surface Antigens/blood ; Humans ; Liver Neoplasms/blood ; Liver Neoplasms/pathology ; Male ; Middle Aged ; Neoplasm Staging ; Niacinamide/administration & dosage ; Niacinamide/adverse effects ; Phenylurea Compounds/adverse effects ; Prognosis ; Sorafenib ; Treatment Outcome

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.

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Keywords: Adverse events; Hepatocellular carcinoma; Portal vein tumor thrombus; Sorafenib; Transarterial chemoembolization

0 (Hepatitis B Surface Antigens)
0 (Phenylurea Compounds)
25X51I8RD4 (Niacinamide)
9ZOQ3TZI87 (Sorafenib)

Date Created: 20170914 Date Completed: 20180516 Latest Revision: 20220408

20231215

PMC5596482

10.1186/s12885-017-3545-5

28899349