OBJECTIVETo investigate the synergetic effect of general therapy of Chinese herbal medicine with surgical operation.

METHODSFourty-two patients in the integrative group were treated with jiedu xiaozheng yin for 7 days before operation, and fuzheng yiliu recipe after operation for 2 years, and 30 patients in the control group underwent operation alone. Their cellular immune function, survival rate and recurrence rate were compared and analyzed.

RESULTSThe accumulative survival rate of 6-month, 12-month, 24-month and 36-month in the integrative group was 97.6%(41/42), 85.7%(36/42), 52.3% (22/42) and 45.5(17/42)% respectively and those in the control group 96.7% (29/30), 83.3% (25/30), 50.0% (15/30) and 30.0% (9/30), respectively, among them the 36-month survival rate was significantly different between the two groups (P < 0.05). The 24-month recurrence rate in the two groups was 54.8% and 80.0% respectively, the difference between the two was significant (P < 0.05).

CONCLUSIONAdministration of compound Chinese herbal medicine in peri-operational period has definite effect on primary hepatic carcinoma in III stage, it can improve patients' immune function, decrease the recurrence rate and increase the cumulative survival rate.

Adult ; Animals ; Carcinoma, Hepatocellular ; drug therapy ; immunology ; mortality ; surgery ; Combined Modality Therapy ; Drug Administration Schedule ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Liver Neoplasms ; drug therapy ; immunology ; mortality ; surgery ; Male ; Middle Aged ; Phytotherapy ; Survival Rate

BACKGROUNDTransarterial chemoembolization (TACE) is the most widely used primary treatment for unresectable hepatocellular carcinoma (HCC) due to its survival benefit, though its clinical effect is still far from satisfactory. Jiedufang (JDF) granule preparation is a commonly used Chinese herbal medicine formula for HCC. The aim of this study was to evaluate the effect of combined therapy with TACE and JDF granule preparation in treatment of unresectable HCC on survival.

METHODSA retrospective study of TACE was performed in 165 patients with unresectable HCC who were admitted between January 2002 and December 2007 in Changhai Hospital, Shanghai, China. Of the 165 patients, 80 patients (study group) received combined therapy consisting of TACE and a long-term maintenance treatment with oral JDF granule preparation, and the remaining 85 patients (control group) received TACE alone. The survival rates of both groups were calculated by the Kaplan-Meier method. Factors possibly affecting survival were assessed by multivariate analysis in the Cox proportional hazard model, such as maximum tumor size, number of lesions, portal vein invasion, and etc.

RESULTSThe median overall survival was 9.2 months (95% CI: 6.94 - 11.46) in the study group versus 5.87 months (95% CI: 4.21 - 7.52) in the control group. In the study group,survival rates of the 1-, 2- and 3-year follow-up were 41.2%, 18.4%, and 9.6%, respectively. Significant independent prognostic factors identified by the Cox regression analysis were as follows: serum hepatitis B surface antigen (HBsAg) (P = 0.014), maximum tumor size (P = 0.027), number of lesions (P < 0.001), portal vein invasion (P < 0.001), and the therapy model (P = 0.006).

CONCLUSIONCombination therapy of TACE and JDF granule preparation may significantly prolong survival of patients with unresectable HCC.

Adult ; Aged ; Antineoplastic Agents ; therapeutic use ; Carcinoma, Hepatocellular ; drug therapy ; mortality ; pathology ; therapy ; Chemoembolization, Therapeutic ; methods ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Liver Neoplasms ; drug therapy ; mortality ; pathology ; therapy ; Male ; Middle Aged ; Retrospective Studies ; Survival Rate ; Treatment Outcome

OBJECTIVETo investigate the effects of Chinese medicine (CM) herbal treatment based on syndrome differentiation on patients with unresectable hepatocellular carcinoma (HCC).

METHODSA total of 94 patients with unresectable HCC were reviewed between June 2008 and June 2011. Survival analysis was performed between patients who received CM with/without non-curative antitumor treatments of Western medicine (WM) (CM group, 30 cases) and patients who were not treated with CM but with non-curative antitumor treatments of WM or supportive treatment alone (non-CM group, 64 cases). Then, survival analysis was performed between patients treated with CM combined with non-curative antitumor treatments of WM (combination therapy group, 25 cases) and patients with non-curative antitumor treatments of WM alone (non-curative antitumor treatments group of WM, 52 cases). The survival analysis was performed by Kaplan-Meier method and prognostic factors for overall survival (OS) were assessed by the Cox proportional hazards regression model.

RESULTSThe median survival time (MST), 1- and 2-year survival rates of the CM group and the non-CM group were 36 months, 76.7%, 56.1% and 12 months, 48.4%, 26.6%, respectively. The Log-rank test revealed significant difference between the two groups in OS (P<0.01). Cox proportional multivariate analysis revealed that CM was an independent favorable prognostic factor for OS. The MST, 1- and 2-year survival rates of combination therapy group and non-curative antitumor treatments group of WM were 36 months, 76.0%, 55.5% and 13 months, 55.8%, 30.8%, respectively. There was significant difference in OS between the two groups (P=0.004).

CONCLUSIONSCM herbs based on syndrome differentiation have positive effects on survival of patients with unresectable HCC. Furthermore, combination therapy of CM and WM are recommended in HCC treatment.

Adult ; Aged ; Carcinoma, Hepatocellular ; drug therapy ; mortality ; surgery ; Combined Modality Therapy ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Kaplan-Meier Estimate ; Liver Neoplasms ; drug therapy ; mortality ; surgery ; Male ; Middle Aged ; Multivariate Analysis ; Prognosis ; Survival Analysis ; Syndrome

OBJECTIVETo evaluate the influence of sirolimus on the long-term survival of patients after orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC).

METHODSClinic data of 165 consecutive patients who underwent OLT for HCC from February 2005 to March 2012 was analyzed retrospectively. Among them, 94 patients were treated with a sirolimus-based immunosuppressive protocol after OLT, while the other 71 patients with a FK506-based protocol. Postoperative survival time, survival, disease-free survival (DFS) and tumor recurrence rates between the two groups were compared.

RESULTSThe 2 groups were comparable in all clinicopathologic parameters. The sirolimus-based group had higher patient survival rates than the control group at 1-year (87% vs. 97%, P = 0.03), 2-year (80% vs. 88%), 3-year (76% vs. 85%) and 5-year (63% vs. 75%). The 1-year, 2-year, 3-year and 5-year recurrence rates were 12% vs. 3%, 17% vs. 9%, 21% vs. 9% (P = 0.04) and 31% vs. 16% (P = 0.03). Early and mid-HCC (I - II stage) of 131 cases (control group 61 cases, sirolimus-based group of 70 patients). The 1-year, 2-year, 3-year and 5-year survival rates were 90% vs. 97% , 80% vs. 90%, 78% vs. 86% and 65% vs. 82% (P = 0.04) and recurrence rates were 10% vs. 3%, 16% vs. 8%, 18% vs. 8% and 29% vs. 11% (P = 0.01).

CONCLUSIONThe sirolimus-based immunosuppressive protocol reduce long-term postoperative recurrence rate and improve the survival rate of patients after OLT for HCC significantly (especially early-mid HCC).

Adult ; Carcinoma, Hepatocellular ; drug therapy ; mortality ; surgery ; Female ; Humans ; Immunosuppressive Agents ; therapeutic use ; Liver Neoplasms ; drug therapy ; mortality ; surgery ; Liver Transplantation ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; Retrospective Studies ; Sirolimus ; therapeutic use ; Survival Rate ; Tacrolimus ; therapeutic use

Transcatheter arterial chemoinfusion (TACI) is the main treatment modality for advanced hepatocellular carcinoma (HCC). However, the therapeutic efficacy of TACI according to anti-cancer agents and prognostic factors for advanced HCC (TNM stage IVa) has not been previously clarified. A total of 127 patients with TNM stage IVa HCC were divided into intra-arterial Adriamycin (Group I) and intra-arterial Cisplatin (Group II) infused groups, according to the anticancer agents that were used. We compared the therapeutic efficacy of TACI applied anticancer agents, and we also analyzed the prognostic factors which influenced the survival rates. Chi-square test, t- test, Cox's proportional hazard regression model, and Kaplan- Meier method were performed. The overall survival was significantly different (10.0 vs 5.7 months, respectively) and the results favored Group I. On univariate analysis, the significant prognostic factors included age, portal vein thrombosis (PVT), tumor size (diameter< 5 cm), type of tumor, the reduction rate (tumor size & alpha- fetoprotein) after 3 months of chemotherapy, serum albumin level, serum alkaline phosphatase level and total serum bilirubin levels at the time of diagnosis. After repeated chemotherapy, Group I showed better survival (14.0 vs 7.9 months). However, there was no statistical difference in the survival rate of the two groups for cases involving large tumors, PVT and diffuse type of HCC. Group I showed better survival than Group II. However, when the other prognostic factors were taken into consideration, there was no significant difference in the survival rate of the two groups, except for the cases with small or nodular HCC.
Adult ; Aged ; Antineoplastic Agents/*administration & dosage/adverse effects ; Carcinoma, Hepatocellular/*drug therapy/mortality ; Cause of Death ; Female ; Humans ; *Infusions, Intra-Arterial ; Liver Neoplasms/*drug therapy/mortality ; Male ; Middle Aged ; Prognosis ; Research Support, Non-U.S. Gov't ; Survival Rate ; alpha-Fetoproteins/analysis

INTRODUCTIONMost hepatocellular carcinomas (HCC) develop in a background of underlying liver disease including chronic hepatitis B. However, the effect of antiviral therapy on the long-term outcome of patients with hepatitis B virus (HBV)-related HCC treated with chemoembolization is unclear. This study aimed to evaluate the survival benefits of anti-HBV therapy after chemoembolization for patients with HBV-related HCC.

METHODSA total of 224 HCC patients who successfully underwent chemoembolization were identified, and their survival and other relevant clinical data were reviewed. Kaplan-Meier and Cox regression analyses were performed to validate possible effects of antiviral treatment on overall survival (OS).

RESULTSThe median survival time (MST) was 15.9 (95% confidence interval [CI], 9.5-27.7) months in the antiviral group and 9.6 (95% CI, 7.8-13.7) months in the non-antiviral group (log-rank test, P = 0.044). Cox multivariate analysis revealed that antiviral treatment was a prognostic factor for OS (P = 0.008). Additionally, a further analysis was based on the stratification of the TNM tumor stages. In the subgroup of early stages, MST was significantly longer in the antiviral-treatment group than in the non-antiviral group (61.8 months [95% CI, 34.8 months to beyond the follow-up period] versus 26.2 [95% CI, 14.5-37.7] months, P = 0.012). Multivariate analysis identified antiviral treatment as a prognostic factor for OS in the early-stage subgroup (P = 0.006). However, in the subgroup of advanced stages, MST of the antiviral-treated group was comparable to that of the non-antiviral group (8.4 [95% CI, 5.2-13.5] months versus 7.4 [95% CI, 5.9-9.3] months, P = 0.219). Multivariate analysis did not indicate that antiviral treatment was a significant prognostic factor in this subgroup.

CONCLUSIONAntiviral treatment is associated with prolonged OS time after chemoembolization for HCC, especially in patients with early-stage tumors.

Antiviral Agents ; Carcinoma, Hepatocellular ; Chemoembolization, Therapeutic ; Drug Therapy, Combination ; Hepatitis B virus ; Hepatitis B, Chronic ; Humans ; Liver Neoplasms ; Mortality ; Neoplasm Staging ; Prognosis ; Retrospective Studies

OBJECTIVETo investigate the therapeutic effects of Jiedu granules, a Chinese medicine (CM) compound, plus cinobufacini injection, which was extracted from skin of Bufo bufo gargarizans Cantor, to prevent the recurrence of hepatocellular carcinoma (HCC) after surgical resection.

METHODSIn this case-control trial, a total of 120 patients who stayed in Changhai Hospital were enrolled from December 2001 to December 2006. Sixty patients were treated with Jiedu granules plus cinobufacini injection to prevent tumor recurrence after operation (CM group) and 60 patients were treated with transcatheter arterial chemoembolization (TACE) after operation (TACE group). Progression-free survival (PFS) and overall survival (OS) rates were determined to evaluate the therapeutic effects of post-operative management of patients with HCC.

RESULTSPFS in the CM group was 18.07 months [95% confidence interval (CI): 12.49-23.65] and the 1-, 2-, 3-, 4- and 5-year PFS rates were 61%, 39%, 26%, 22% and 12%, respectively. PFS in the TACE group was 8.03 months (95% CI: 6.63-9.44) and the 1-, 2-, 3-, 4- and 5-year PFS rates were 34%, 11%, 7%, 2% and 0%, respectively. There was significant difference in survival rate between the two groups (P<0.01). The mean survival time (MST) of patients in the CM group was 49.53 months versus 39.90 months of the TACE group. The 1-, 2-, 3-, 4- and 5-year survival rates were 90%, 82%, 80%, 70% and 63%, respectively, in the CM group, and 79%, 70%, 60%, 60% and 36%, respectively, in the TACE group. There was significant difference in survival time between the two groups (P=0.045).

CONCLUSIONSJiedu granules plus cinobufacini injection, a combination that is commonly used for post-operation management of HCC, can postpone tumor recurrence and metastasis, prolong the survival time and increase the survival rate of post-surgical patients with HCC. However, these findings need to be confirmed in a prospective, randomized controlled trial.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Amphibian Venoms ; administration & dosage ; Carcinoma, Hepatocellular ; drug therapy ; mortality ; surgery ; Case-Control Studies ; Chemoembolization, Therapeutic ; methods ; Combined Modality Therapy ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Humans ; Injections, Intra-Arterial ; Liver Neoplasms ; drug therapy ; mortality ; surgery ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; prevention & control ; Retrospective Studies ; Young Adult

BACKGROUND/AIMS: It has been shown that the drug-eluting beads loaded with doxorubicin (DEBDOX) are effective for the treatment of hepatocellular carcinoma (HCC). However, the optimal safety and efficacy still remain to be established by using various bead sizes, doxorubicin doses, and the degree of stasis.The aim of this study was to determine the optimal safety and efficacy of DEBDOX in the treatment of HCC. METHODS: Analysis of a 503-patient prospective, multicenter, multinational Bead Registry Database from 2007 to 2010 identified 206 patients who had been treated for HCC with DEBDOX. Primary endpoints were to compare safety, tolerance, response rates, and overall survival based on bead size (100-300, 300-500, 500-700, and 700-900 microm), number of vials, doxorubicin dose, and degree of stasis. RESULTS: In total, 206 patients underwent 343 treatments. The use of all four bead sizes was similar based on Child-Pugh class and Okuda stage, with a significantly higher use (50%) of beads of size 100-300 microm in patients with portal vein thrombosis (P=0.05). Significant differences were seen for the number of median treatments, median doxorubicin dose, lobar infusion), and degree of complete stasis. The rate of adverse events was higher for larger beads than for smaller beads (28% vs. 16%; P=0.02). CONCLUSIONS: Bead size and dose may vary according to disease distribution. Smaller beads offer the opportunity for repeated treatments, a larger cumulative dose delivery, a lesser degree of complete stasis, and fewer adverse events.
Adult ; Aged ; Aged, 80 and over ; Antibiotics, Antineoplastic/*administration & dosage/adverse effects ; Carcinoma, Hepatocellular/*drug therapy/mortality ; Dose-Response Relationship, Drug ; Doxorubicin/*administration & dosage/adverse effects ; Drug Carriers/*chemistry ; Female ; Humans ; Liver Neoplasms/*drug therapy/mortality ; Male ; Middle Aged ; Particle Size ; Prospective Studies ; Severity of Illness Index

BACKGROUND/AIMS: Transarterial chemoembolization (TACE) has long been used as a palliative therapy for unresectable hepatocellular carcinoma (HCC). High-dose hepatic arterial infusion chemotherapy (HAIC) has showed favorable outcomes in patients with intractable, advanced HCC. The aim of this study was to compare the effectiveness and safety of high-dose HAIC and conventional TACE using doxorubicin for advanced HCC. METHODS: The high-dose HAIC group comprised 36 patients who were enrolled prospectively from six institutions. The enrollment criteria were good liver function, main portal vein invasion (including vascular shunt), infiltrative type, bilobar involvement, and/or refractory to prior conventional treatment (TACE, radiofrequency ablation, or percutaneous ethanol injection), and documented progressive disease. Patients received 5-fluorouracil (500 mg/m2 on days 1~3) and cisplatin (60 mg/m2 on day 2 every 4 weeks) via an implantable port system. In the TACE group, 31 patients with characteristics similar to those in the high-dose HAIC group were recruited retrospectively from a single center. Patients underwent a transarterial infusion of doxorubicin every 4~8 weeks. RESULTS: Overall, 6 patients (8.9%) achieved a partial response and 20 patients (29.8%) had stable disease. The objective response rate (complete response+partial response) was significantly better in the high-dose HAIC group than in the TACE group (16.7% vs. 0%, P=0.030). Overall survival was longer in the high-dose HAIC group than in the TACE group (median survival, 193 vs. 119 days; P=0.026). There were no serious adverse effects in the high-dose HAIC group, while hepatic complications occurred more often in the TACE group. CONCLUSIONS: High-dose HAIC appears to improve the tumor response and survival outcome compared to conventional TACE using doxorubicin in patients with intractable, advanced HCC.
Antibiotics, Antineoplastic/*administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Carcinoma, Hepatocellular/drug therapy/mortality/*therapy ; Chemoembolization, Therapeutic ; Cisplatin/administration & dosage ; Doxorubicin/*administration & dosage ; Fluorouracil/administration & dosage ; Humans ; Infusions, Intra-Arterial ; Liver Neoplasms/drug therapy/mortality/*therapy ; Magnetic Resonance Imaging ; Prospective Studies ; Retrospective Studies ; Severity of Illness Index ; Survival Rate ; Tomography, X-Ray Computed

OBJECTIVE: To retrospectively compare treatment of hepatocellular carcinoma (HCC) with transarterial chemoembolization (TACE) using gelatin sponges or microspheres plus lipiodol-doxorubicin vs. doxorubicin-loaded drug-eluting beads (DEB). MATERIALS AND METHODS: A total of 158 patients with HCC received TACE from November 2010 to November 2011 were enrolled in this study, including 64 (40.5%) received TACE with lipiodol-doxorubicin and gelatin sponges (group A), 41 (25.9%) received TACE with lipiodol-doxorubicin and microspheres (group B), and 53 (33.5%) received TACE with doxorubicin-loaded DEB (group C). Tumor response and adverse events (AEs) were evaluated. RESULTS: No significant difference was found at baseline among the three groups. The doxorubicin dosage in group C was significantly (p < 0.001) higher compared to the dose used in groups A or B (median, 50 mg vs. 31 mg or 25 mg). Significantly (p < 0.001) more patients in group C achieved complete response compared to those in groups A or B (32.1% vs. 6.3% or 2.4%). Significantly (p < 0.001) less patients in group C had progressive disease compared to those in groups A or B (34.0% vs. 57.8% or 68.3%). Minor AEs were more common in groups A and B compared to group C, with rates of 54.7%, 34.1%, and 5.7%, respectively. CONCLUSION: In patients with HCC, TACE with DEB offers better safety and efficacy profiles compared to either TACE with gelatin sponges or TACE with microspheres.
Abdominal Pain/etiology ; Adult ; Aged ; Antibiotics, Antineoplastic/*administration & dosage/adverse effects ; Carcinoma, Hepatocellular/*drug therapy/mortality ; Chemoembolization, Therapeutic ; Disease-Free Survival ; Doxorubicin/*administration & dosage/adverse effects ; Drug Carriers/*chemistry ; Ethiodized Oil/chemistry ; Female ; Fever/etiology ; Follow-Up Studies ; Gelatin/chemistry ; Humans ; Kaplan-Meier Estimate ; Liver Neoplasms/*drug therapy/mortality ; Male ; Microspheres ; Middle Aged ; Retrospective Studies