OBJECTIVETo evaluate the effectiveness and toxicity of sorafenib for advanced hepatocellular carcinoma.

METHODSAccording to the Cochrane handbook for systematic review, two reviewers independently completed the whole process of literature search, study selection, data collection, and quality assessment. Seven electric databases(PubMed, Cochrane Library, Embase, Chinese Journal Full-text Database, Chinese Biomedical Literature Database, Chinese Scientific and Technical Journal Database, Chinese Medical Association Digital Periodicals Database) were searched and randomized controlled trials (RCT) of sorafenib in the treatment of advanced hepatocellular carcinoma were collected and analyzed.

RESULTSTwo RCT involving 828 patients were finally included. Compared with placebo, sorafenib significantly extended the overall survival and time to radiologic progression and improved the disease control rate. The main adverse effects were systemic, gastrointestinal, and dermatologic symptoms (grade 1 or 2 in severity), although the incidences were significantly higher in sorafenib groups than in control groups.

CONCLUSIONSorafenib is effective and safe for the treatment of advanced hepatocellular carcinoma.

Antineoplastic Agents ; adverse effects ; therapeutic use ; Benzenesulfonates ; adverse effects ; therapeutic use ; Carcinoma, Hepatocellular ; drug therapy ; Humans ; Liver Neoplasms ; drug therapy ; Niacinamide ; analogs & derivatives ; Phenylurea Compounds ; Pyridines ; adverse effects ; therapeutic use

OBJECTIVE: To compare the effects of medical ozone oil and urea ointment for prevention and treatment of hand-foot skin reaction (HFSR) caused by sorafenib in patients with hepatocellular carcinoma (HCC). METHODS: A total of 99 patients diagnosed with advanced HCC according to National Comprehensive Cancer Network (NCCN) who were scheduled to receive sorafenib treatment for the first time were enrolled in this study between April, 2018 and January, 2020. The patients were randomized into medical ozone oil group ( RESULTS: Eight patients were excluded for poor compliance or protocol violations, leaving a total of 91 patients for analysis, including 44 in medical ozone oil group and 47 in urea ointment group. Sixteen (36.4%) of patients in ozone oil group developed HFSR, a rate significantly lower than that in urea ointment group (57.4%; CONCLUSIONS Medical ozone oil can significantly reduce the incidence and severity of HFSR to improve the quality of life of HCC patients receiving sorafenib treatment.
Antineoplastic Agents/therapeutic use* ; Carcinoma, Hepatocellular/drug therapy* ; Hand-Foot Syndrome/prevention & control* ; Humans ; Liver Neoplasms/drug therapy* ; Niacinamide/therapeutic use* ; Ozone/therapeutic use* ; Phenylurea Compounds/adverse effects* ; Quality of Life ; Sorafenib/therapeutic use*

OBJECTIVETo observe the efficacy and side effects of transarterial chemoembolization (TACE) combined with sorafenib for advanced hepatocellular carcinoma (HCC).

METHODSForty patients with HCC were treated with sorafenib (400 mg bid) after TACE. The efficacy was evaluated according to RECIST 1.1 criteria, and side effects were assessed by NCI CTC 3.0 criteria.

RESULTSAmong the forty cases, one case achieved complete remission (CR), seven cases achieved partial remission (PR), nineteen cases achieved stable disease (SD) and thirteen cases had progressive disease (PD). The disease control rate (DCR) was 67.5%. The overall survival time was 1 - 18 months, and 1-year survival rate was 54.0%. The major adverse events were hand-foot skin reaction, diarrhea and thrombocytopenia.

CONCLUSIONThe combined therapy of TACE and sorafenib is effective and well tolerated for advanced HCC.

Adolescent ; Adult ; Aged ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Benzenesulfonates ; adverse effects ; therapeutic use ; Carcinoma, Hepatocellular ; pathology ; therapy ; Chemoembolization, Therapeutic ; adverse effects ; Combined Modality Therapy ; Diarrhea ; etiology ; Disease Progression ; Doxorubicin ; administration & dosage ; adverse effects ; analogs & derivatives ; Female ; Follow-Up Studies ; Humans ; Liver Neoplasms ; pathology ; therapy ; Male ; Middle Aged ; Neoplasm Staging ; Niacinamide ; analogs & derivatives ; Organoplatinum Compounds ; administration & dosage ; adverse effects ; Phenylurea Compounds ; Pyridines ; adverse effects ; therapeutic use ; Remission Induction ; Survival Rate ; Thrombocytopenia ; etiology ; Young Adult

PURPOSE: Sorafenib is an effective systemic agent for advanced hepatocellular carcinoma. To increase its efficacy, we evaluated the feasibility and benefit of sorafenib combined with radiotherapy. MATERIALS AND METHODS: From July 2007 to July 2011, 31 patients were treated with a daily dose of 800 mg of sorafenib and radiotherapy. Among them, 13 patients who received radiotherapy on the bone metastasis were excluded. Thirteen patients received 30-54 Gy of radiotherapy on the primary tumor (primary group) and 5 patients received 30-58.4 Gy on the measurable metastatic lesions (measurable metastasis group). Tumor responses at 1 month after the completion of radiotherapy and overall survival were evaluated. RESULTS: The in-field response rate was 100% in the primary group and 60% in the measurable metastasis group. A decrease of more than 80% in the tumor marker alpha-fetoprotein was observed in 7 patients in the primary group (54%). Toxicities of grades 3-4 were hand-foot syndrome in 3 (17%) patients, duodenal bleeding in 1 (6%) patient, thrombocytopenia in 3 (17%) patients and elevation of aspartate transaminase in 1 (6%) patient. The median overall survival was 7.8 months (95% confidence interval, 3.0-12.6). CONCLUSION: The combined treatment of sorafenib and radiotherapy was feasible and induced substantial tumor responses in the target lesions. The results of this study emphasize the importance of individualized approach in the management of advanced hepatocellular carcinoma and encourage the initiation of a controlled clinical trial.
Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use ; Carcinoma, Hepatocellular/drug therapy/pathology/*radiotherapy ; Chemotherapy, Adjuvant ; Feasibility Studies ; Female ; Humans ; Liver Neoplasms/drug therapy/pathology/*radiotherapy ; Male ; Niacinamide/administration & dosage/adverse effects/*analogs & derivatives/therapeutic use ; Phenylurea Compounds/administration & dosage/adverse effects/*therapeutic use ; Radiation Dosage ; Radiotherapy/adverse effects

Hepatocellular carcinoma (HCC) is a critical global health issue and the third most common cause of cancer-related deaths worldwide. The majority of patients who present HCC are already at an advanced stage and their tumors are unresectable. Sorafenib is a multi-kinase inhibitor of the vascular endothelial growth factor pathway and was recently introduced as a therapy for advanced HCC. Furthermore, studies have shown that oral sorafenib has beneficial effects on survival. However, many patients experience diverse side effects, and some of these are severe. Liver abscess development has not been previously documented to be associated with sorafenib administration in HCC. Here, we report the case of a HCC patient that developed a liver abscess while being treated with sorafenib.
Anti-Bacterial Agents/therapeutic use ; Antineoplastic Agents/adverse effects/*therapeutic use ; Carcinoma, Hepatocellular/*drug therapy/radiography ; Clostridium/isolation & purification ; Clostridium Infections/drug therapy/microbiology ; Humans ; Liver Abscess/etiology/*microbiology ; Liver Neoplasms/*drug therapy/radiography ; Male ; Middle Aged ; Niacinamide/adverse effects/*analogs & derivatives/therapeutic use ; Phenylurea Compounds/adverse effects/*therapeutic use ; Tomography, X-Ray Computed

OBJECTIVETo evaluate the safety and efficacy of the combination of transcatheter arterial chemoembolization (TACE) and sorafenib in treatment of hepatocellular carcinoma (HCC) with lung metastasis.

METHODSThirty HCC patients with lung metastasis were treated by the combination of TACE and sorafenib between Oct 2006 and May 2008, including 27 men and 3 women. The age of the patients ranged 32 to 73 years old. Sorafenib was administrated orally at 400 mg, twice daily (the less tolerant patients received 200 mg, bid.), if there was no counterindication, at 3 - 4 weeks after TACE, with every 4 weeks as a course of treatment. The efficacy was evaluated at the end of every course of treatment.

RESULTSThe metastatic lesions in the lung were diminished in 6 cases and stable diseases achieved in 8 cases. The primary liver tumors were stable in 22 cases, including 10 cases achieved by TACE before sorafenib treatment. Eight cases had slightly progressed liver tumors and were treated with 1 - 3 times of TACE in combination with sorafenib. Side effects included skin lesions in 7 cases, hair loss in 6 cases, fatigue in 18 cases, diarrhea in 6 cases, anemia and bone marrow suppression in 5 cases, high blood pressure in 2 cases, and gastrointestinal bleeding in 1 case.

CONCLUSIONThe combination of TACE and sorafenib can be used as an effective treatment for hepatocellular carcinoma patients with lung metastasis, which may stabilize the disease in some patients.

Adult ; Aged ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Benzenesulfonates ; adverse effects ; therapeutic use ; Carcinoma, Hepatocellular ; drug therapy ; secondary ; therapy ; Chemoembolization, Therapeutic ; methods ; Combined Modality Therapy ; Diarrhea ; chemically induced ; Fatigue ; chemically induced ; Female ; Humans ; Liver Neoplasms ; drug therapy ; pathology ; therapy ; Lung Neoplasms ; drug therapy ; secondary ; therapy ; Male ; Middle Aged ; Niacinamide ; analogs & derivatives ; Phenylurea Compounds ; Pyridines ; adverse effects ; therapeutic use

OBJECTIVETo evaluate the efficacy and analyze the prognostic factors of sorafenib treatment in patient with unresectable primary hepatocellular carcinoma (HCC).

METHODSDuring the period from December 2005 to March 2009, 50 patients with unresectable primary HCC of Child-Pugh status A were treated with sorafenib (400 mg, Bid). The tumor response was evaluated with CT or MRI imaging every 6 - 8 weeks according to the RECIST criteria. The overall survival (OS) and time to progression (TTP) were defined as the time from administration of sorafenib to the death or the last follow up and were evaluated by Kaplan-Meier method.

RESULTSThere was no PR or CR, but 28 patients (56.0%) achieved stable disease. The median follow up time was 15 months with a median OS of 14 months and median TTP of 4 months. The common adverse events were dermal reaction (68.0%, 34/50), diarrhea (52.0%, 26/50), hypertension (4.0%, 2/50), hair loss (14.0%, 7/50), myelosuppression (16.0%, 8/50), and liver dysfunction (20.0%, 10/50). However, most of the drug-related adverse events were grade I-II and reversible. The patients with lower tumor burden and without distant metastasis had better prognosis.

CONCLUSIONSoafenib is effective for unresectable primary HCC with tolerable toxicity. Tumor stage is a predominant prognostic factor.

Adult ; Aged ; Alopecia ; chemically induced ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Benzenesulfonates ; adverse effects ; therapeutic use ; Carcinoma, Hepatocellular ; drug therapy ; Chemoembolization, Therapeutic ; methods ; Diarrhea ; chemically induced ; Disease Progression ; Follow-Up Studies ; Humans ; Hypertension ; chemically induced ; Liver Neoplasms ; drug therapy ; Male ; Middle Aged ; Neoplasm Staging ; Niacinamide ; analogs & derivatives ; Phenylurea Compounds ; Pyridines ; adverse effects ; therapeutic use ; Skin Diseases ; chemically induced ; Survival Rate

OBJECTIVETo investigate the clinic predictors of efficacy and adverse events of sorafenib in treating with advanced hepatocellular carcinoma (HCC) patients.

METHODSFrom December 2008 to October 2011, 54 patients received sorafenib for unresectable or metastatic HCC. There were 46 male and 8 female patients. The mean age was 48.7 years (ranging from 21 to 77 years). Patients received sorafenib orally 400 mg twice daily on a continuous dosing schedule with 6 weeks counting as a single cycle. Tumor response was assessed according to the Response Evaluation Criteria in Solid Tumor and toxicity grading was performed using the National Cancer Institute Common Toxicity Criteria version 3.0. The relationship between different clinic variable factors and curative effects of sorafenib was analyzed by using Cox proportion hazard regression analysis.

RESULTSHCC was etiological related to HBV in 52 patients (96.3%). Following sorafenib therapy, 2 patients (3.7%) achieved a partial response and 24 patients (44.4%) achieved stable disease, with a disease control rate of 48.1%. The median time to progression (TTP) was 3.8 months. Multivariate analysis showed that greater Child and Eastern Cooperative Oncology Group (ECOG) grade were independent predictors of shorter TTP (HR = 1.361, 95%CI: 1.081 - 12.665, P = 0.041; HR = 1.449, 95%CI: 1.151 - 12.305, P = 0.032). The common adverse events were hand-foot syndrome (64.8%), alopecia (46.3%), and diarrhea (44.4%).

CONCLUSIONSSingle-agent sorafenib demonstrates good efficacy and acceptable tolerability in treating advanced HCC. The presents of Child class A and ECOG performance grade 0 predict better response to sorafenib in advanced HCC patients.

Adult ; Aged ; Antineoplastic Agents ; administration & dosage ; adverse effects ; therapeutic use ; Carcinoma, Hepatocellular ; drug therapy ; Female ; Humans ; Liver Neoplasms ; drug therapy ; Male ; Middle Aged ; Niacinamide ; administration & dosage ; adverse effects ; analogs & derivatives ; therapeutic use ; Phenylurea Compounds ; administration & dosage ; adverse effects ; therapeutic use ; Retrospective Studies ; Treatment Outcome ; Young Adult

OBJECTIVETo observe the efficacy and safety of sorafenib monotherapy in Chinese patients with advanced hepatocellular carcinoma (HCC).

METHODSThirty-eight patients with advanced HCC of Child-Pugh status A or B were included in this study. Patients received orally administered sorafenib at a dose of 400 mg twice a day on a continuous schedule. Adverse events were documented. The efficacy and safety were evaluated every four to six weeks.

RESULTSDuring the treatment, partial response (PR) was observed in 1 patient (2.6%), minor response (MR) in 5 (13.2%), stable disease (SD) in 16 (42.1%), and progressive disease (PD) in 16 (42.1%), respectively. The median oral administration time of sorafenib was 180 days (range, 15-550 d), and the mean overall survival was 370 days (range, 42-562 days). The median response duration was 169 days (range, 42-426 days). The mean overall survival of 22 patients with controlled disease (PR + MR + SD) was 428 days (95% CI 330-526 days). The most frequent adverse events were dermal reaction (27 cases, 71.1%), gastrointestinal reaction (25 cases, 65.8%), and constitutional symptoms (14 cases, 36.8%). Most of the drug related adverse events were mild and easily to manage and reversible.

CONCLUSIONSorafenib monotherapy is effective and tolerable in a part of Chinese patients with advanced hepatocellular carcinoma and liver function of Child-Pugh A or B, and may prolong their survival.

Adult ; Aged ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Benzenesulfonates ; adverse effects ; therapeutic use ; Carcinoma, Hepatocellular ; drug therapy ; pathology ; Diarrhea ; chemically induced ; Female ; Foot Dermatoses ; chemically induced ; Hand Dermatoses ; chemically induced ; Humans ; Liver Neoplasms ; drug therapy ; pathology ; Male ; Middle Aged ; Neoplasm Staging ; Niacinamide ; analogs & derivatives ; Phenylurea Compounds ; Protein Kinase Inhibitors ; adverse effects ; therapeutic use ; Pyridines ; adverse effects ; therapeutic use ; Remission Induction ; Survival Rate ; Syndrome ; Young Adult

Tumor lysis syndrome is rare in hepatocellular carcinoma (HCC), but it has been reported more frequently recently in response to treatments such as transcatheter arterial chemoembolization (TACE), radiofrequency thermal ablation (RFTA), and sorafenib. Tumor lysis syndrome induced by low-dose steroid appears to be very unusual in HCC. We report a patient with hepatitis-C-related liver cirrhosis and HCC in whom tumor lysis syndrome occurred due to low-dose steroid (10 mg of prednisolone). The patient was a 90-year-old male who presented at the emergency room of our hospital with general weakness and poor oral intake. He had started to take prednisolone to treat adrenal insufficiency 2 days previously. Laboratory results revealed hyperuricemia, hyperphosphatemia, and increased creatinine. These abnormalities fulfilled the criteria in the Cairo-Bishop definition of tumor lysis syndrome. Although the patient received adequate hydration, severe metabolic acidosis and acute kidney injury progressed unabated. He finally developed multiple organ failure, and died 3 days after admission. This was a case of tumor lysis syndrome caused by administration of low-dose steroid in a patient with HCC.
Acute Kidney Injury/pathology ; Aged, 80 and over ; Antineoplastic Agents/therapeutic use ; Carcinoma, Hepatocellular/*pathology/therapy ; Chemoembolization, Therapeutic ; Creatinine/blood ; Humans ; Liver Neoplasms/*pathology/*therapy ; Male ; Niacinamide/analogs & derivatives/therapeutic use ; Phenylurea Compounds/therapeutic use ; Steroids/adverse effects/therapeutic use ; Tomography, X-Ray Computed ; Tumor Lysis Syndrome/*diagnosis/drug therapy