Hepatocellular carcinoma in Child-Pugh C cirrhosis: prognostic factors and survival benefit of nontransplant treatments.

A retrospective multicenter study was conducted to clarify the survival benefit of nontransplant treatments for patients with hepatocellular carcinoma (HCC) associated with Child-Pugh C cirrhosis. Data on 436 patients, including 203 treated patients with HCC, were collected from 20 institutions in Japan. Cox's proportional hazards model corrected for bias by propensity score analysis clearly showed the following as significant independent prognostic factors, including all four nontransplant treatments examined: transarterial chemoembolization, hepatic arterial infusion chemotherapy, percutaneous ethanol injection therapy, radiofrequency ablation, hepatitis B virus, number of tumors, log α-fetoprotein, encephalopathy, ascites and prothrombin time.

Hepatitis C virus relapse was suppressed by long-term self-injection of low-dose interferon in patients with chronic hepatitis C after pegylated interferon plus ribavirin treatment.

Aim: The recommended treatment for chronic hepatitis C is a combination of pegylated interferon (PEG IFN) plus ribavirin (RBV). However, the sustained virological response (SVR) rate of PEG IFN-RBV therapy was approximately 50% in patients with genotype 1b and a high viral load. Thus, we compared the efficiencies and side-effects of PEG IFN-RBV and self-injected low-dose natural (n) IFN-α in patients with hepatitis C virus (HCV).

A randomized phase II trial of intra-arterial chemotherapy using SM-11355 (Miriplatin) for hepatocellular carcinoma.

Background: SM-11355 is a platinum complex developed to treat hepatocellular carcinoma (HCC) via administration into the hepatic artery as a sustained-release suspension in iodized oil. We conducted a multicenter phase II trial in patients with HCC to evaluate the efficacy and safety of SM-11355, using a Zinostatin stimalamer suspension in iodized oil as a reference.

Methods: Patients with unresectable HCC were randomized 2:1 to receive administration of the SM-11355 or Zinostatin stimalamer suspension into the hepatic artery.

Double-Filtration Plasmapheresis plus Interferon-β for HCV-1b Patients with Non-Sustained Virological Response to Previous Combination Therapy.

Background And Aims: Double-filtration plasmapheresis (DFPP) together with interferon (IFN) administration produces a substantial reduction in the viral load during the early stages of treatment.

Methods: Based on their responses to previous pegylated IFN and ribavirin (PEG-IFN/RBV) therapy, 20 patients were divided into null virological response (NVR; n = 12) and relapse (n = 8) groups. DFPP was used in combination with IFN-β/RBV with subsequent administration of PEG-IFN-α2a/RBV therapy (DFPP + IFN-β/RBV then PEG-IFN/RBV).

Effect of vitamin K2 on the recurrence of hepatocellular carcinoma.

Unlabelled: Hepatocellular carcinoma (HCC) is characterized by frequent recurrence, even after curative treatment. Vitamin K2, which has been reported to reduce HCC development, may be effective in preventing HCC recurrence. Patients who underwent curative ablation or resection of HCC were randomly assigned to receive placebo, 45 mg/day, or 90 mg/day vitamin K2 in double-blind fashion.

A conundrum for randomized controlled trials: experience from a small hepatocellular carcinoma trial.

Objective: The aim of this study was to explore why patients accepted or declined to participate in a randomized clinical trial, which was subsequently discontinued because of a low recruitment rate.

Methods: Forty-one patients were invited to participate in a randomized clinical trial that aimed to compare local ablation therapies and surgery to treat small asymptomatic hepatocellular carcinomas. These patients were then asked to answer a questionnaire that assessed patient perception and reasons for accepting or declining to enroll in the randomized clinical trial.

Transarterial chemotherapy alone versus transarterial chemoembolization for hepatocellular carcinoma: a randomized phase III trial.

Background/aims: Transcatheter arterial chemoembolization (TACE) is a combination of transarterial infusion chemotherapy (TAI) and embolization, and has been widely used to treat patients with hepatocellular carcinoma (HCC). However, since the impact of adding embolization on the survival of patients treated with TAI had never been evaluated in a phase III study, we conducted a multi-center, open-label trial comparing TACE and TAI to assess the effect of adding embolization on survival.

Methods: Patients with newly diagnosed unresectable HCC were randomly assigned to either a TACE group or a TAI group.

Validation of a new prognostic staging system for hepatocellular carcinoma: a comparison of the biomarker-combined Japan Integrated Staging Score, the conventional Japan Integrated Staging Score and the BALAD Score.

Objectives: The conventional Japan Integrated Staging (c-JIS) score has been reported to effectively stratify patients with hepatocellular carcinoma (HCC). Recently, two new staging systems, the biomarker-combined JIS (bm-JIS) score and the BALAD score, have been proposed. Both staging systems include three tumor markers: alpha-fetoprotein (AFP), lens culinaris agglutinin-reactive AFP and des-gamma-carboxy prothrombin specific for HCC.

A new prognostic staging system for hepatocellular carcinoma: value of the biomarker combined Japan integrated staging score.

Objectives: The Japan Integrated Staging (JIS) score has been reported to have good stratification ability in patients with hepatocellular carcinoma (HCC). However, the JIS score could not estimate malignant grade of HCC. The aim of this study was to evaluate the performance of a new staging system: the biomarker combined JIS (bm-JIS) which includes three tumor markers: alpha-fetoprotein (AFP), Lens culinaris agglutinin-reactive AFP and des-gamma-carboxy prothrombin with the conventional JIS score.

Diagnostic accuracy of imaging for liver cirrhosis compared to histologically proven liver cirrhosis. A multicenter collaborative study.

Objective: To evaluate the diagnostic accuracy of liver cirrhosis by imaging modalities, including CT, MRI and US, compared to results obtained from histopathological diagnoses of resected specimens.

Materials And Methods: CT, MRI and US examinations of 142 patients with chronic liver disease who underwent surgery for complicated hepatocellular carcinoma (<3 cm in diameter) in 10 institutions were blindly reviewed in a multicenter study by three radiologists experienced in CT, MRI and US. The images were evaluated for five imaging parameters (irregular or nodular liver surface, blunt liver edge, liver parenchymal abnormalities, liver morphological changes and manifestations of portal hypertension) using a severity scale.

Severe complications of radiofrequency ablation therapy for hepatocellular carcinoma: an analysis of 3,891 ablations in 2,614 patients.

Objective: To clarify information on and frequency of complications as well as mortality rate after radiofrequency ablation (RFA) for hepatocellular carcinoma.

Methods: The results of a questionnaire obtained mainly from members of the Osaka Liver Cancer Study Group at 43 departments of 38 facilities were analyzed in order to clarify the current status of RFA, and information on and frequency of complications and death occurring after RFA.

Results: Between January 1999 and May 2002, a total of 3,891 RFA therapies were performed percutaneously in 2,542 patients, laparoscopically in 23, and operatively in 49 (2,614 patients in total).

Randomized, double-blind, placebo-controlled trial of bovine lactoferrin in patients with chronic hepatitis C.

Several studies have suggested that lactoferrin administration may decrease the serum level of hepatitis C virus (HCV) RNA in patients with chronic hepatitis C. The aim of the present study was to confirm the efficacy of orally administered bovine lactoferrin (bLF) in patients with chronic hepatitis C. The patients with chronic hepatitis C randomly received either oral bLF at a dose of 1.

A proposal of the modified liver damage classification for hepatocellular carcinoma.

Objective: The purpose of this study was to evaluate the validity of the two common classifications for assessing liver function; the Child-Pugh classification and the liver damage classification. We also examined the feasibility of the modified liver damage classification.

Methods: A total of 2306 HCC patients diagnosed between 1990 and 2002 were categorized according to the three classifications.

[Comparison of treatment methods for hepatocellular carcinoma--based on JIS score].

It is well known that prognosis of patients with hepatocellular carcinoma (HCC) depends not only cancer spread, but also on liver disease stage. The Japan Integrated Staging (JIS) scoring system, which combines TNM stage and Child-Pugh stage, is superior to CLIP Score in the discriminatory ability of the prognosis in 3,934 patients with HCC. Therefore, it is also useful in the comparison of the treatment results between treatment modalities or between institutions.

Validation of a new prognostic staging system for hepatocellular carcinoma: the JIS score compared with the CLIP score.

The Japan Integrated Staging score (JIS score), which combines the Child-Turcotte-Pugh classification and tumor-node-metastasis staging, has been proposed as a better prognostic staging system for hepatocellular carcinoma (HCC) than the Cancer of the Liver Italian Program (CLIP) scoring system. In this study, validation was performed among a larger patient population. A total of 4,525 consecutive patients with HCC who had been diagnosed at five institutions were included.