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Aim: Hepatic arterial infusion chemotherapy (HAIC) with cisplatin is beneficial to patients with advanced hepatocellular carcinoma (HCC) treated with sorafenib. This study aimed to examine the effect of HAIC with cisplatin before radiofrequency ablation (RFA) in patients with HCC. Methods: This was a multicenter, single‐blinded, randomized controlled study (UMIN000007267). Early‐stage HCC patients were randomly assigned (1:1) to receive HAIC with cisplatin before RFA therapy (HAIC group) or RFA monotherapy (non‐HAIC group). The primary end‐point was recurrence‐free survival. Efficacy analysis and safety analysis followed the intention‐to‐treat principle. Results: Between August 2012 and July 2016, 74 patients were recruited. A total of 70 eligible patients were randomly assigned to the HAIC group (n = 35) and non‐HAIC group (n = 35). Recurrence‐free survival rates at 1 (3) year in the HAIC group and non‐HAIC group were 82.9% (54.3%) and 74.3% (34.3%), respectively (hazard ratio [HR], 0.597; 95% confidence interval [CI], 0.320–1.091; p = 0.094]. Subgroup analysis showed that the beneficial effect of HAIC was observed in patients with a single nodule and Child–Pugh score 5. Intrahepatic distant recurrence‐free survival rate in the HAIC group was significantly better than that in the non‐HAIC group (HR, 0.468; 95% CI, 0.235–0.896; p = 0.022). Adverse events were observed in just two patients in the HAIC group (6%) – grade 2 cholecystitis and grade 2 hyperkalemia. Conclusions: HAIC with cisplatin before RFA did not significantly decrease recurrence in patients with early‐stage HCC. However, it might be effective in preventing intrahepatic distant recurrence. [ABSTRACT FROM AUTHOR]

Objective: To determine the relationship between treatment outcomes and hand-foot syndrome (HFS), and the relationship between survival rate and post-progression treatment after sorafenib therapy. Methods: The study assessed 314 patients with advanced hepatocellular carcinoma (HCC) treated with sorafenib at 5 general hospitals in Kagawa Prefecture, Japan. Results: At the start of sorafenib therapy, 23.6% of the patients had HCC of a Child-Pugh class other than A. The initial sorafenib dose was 800 mg in 9.2% of the patients and 400 mg in 64.3%. Time to progression was 129 days (95% CI: 87.3-170.7) and the median overall survival (OS) was 392 days (95% CI: 316.0-468.0). The OS of the patients with Child- Pugh class A HCC was significantly better than that of the patients with Child-Pugh class B HCC (p < 0.0001). The survival curves for Child-Pugh class A-5 points and class A-6 points were significantly different, with that for class A-5 points being better (p < 0.0001). A significant difference was observed between the patients who exhibited HFS and those who did not, with the former exhibiting a better survival rate (p < 0.001). In addition, the survival rate of the patients who received post-progression treatment after sorafenib therapy was significantly better than that of the patients who did not (p < 0.001). Conclusion: In sorafenib therapy, patients with HFS and those who received post-progression treatment exhibited good OS. [ABSTRACT FROM AUTHOR]

Background/Aims: The efficacy of gemcitabine (GEM) on unresectable pancreatic cancer has been reported. However, in elderly patients, severe toxicities are frequently observed. In this study we aimed to assess the efficacy of low-dose GEM on unresectable pancreatic cancer in elderly patients. Methods: We reviewed 68 elderly patients (≥65 years) with unresectable pancreatic cancer. Thirty-six patients were treated with low-dose GEM (600-800 mg/m2; GEM group), and the other 32 received best supportive care (BSC group). Results: Median survival was 7.6 and 2.3 months in the GEM and BSC groups, respectively. In the GEM group, the median survival period was longer in 24 patients showing partial response or stable disease than in 12 patients showing progressive disease (11.4 vs. 5.3 months). Furthermore, the patients showing progressive disease had better 6-month survival than patients in the BSC group. Thirteen patients (36%) developed severe toxicities (grade 3 or 4). Low-dose GEM, stage of disease and performance status were associated with the prognosis. Conclusions: Low-dose GEM may improve the prognosis of elderly patients with unresectable pancreatic cancer. Furthermore, frequencies of severe toxicity seem lower in patients treated with low-dose GEM compared with previous reports. Copyright © 2011 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Objective. Several treatment strategies for patients with chronic hepatitis C have been compared mainly in terms of their efficacy, and it has been found that pegylated interferon (IFN) plus ribavirin has become the standard therapy, but aged patients may not tolerate ribavirin and the cost-effectiveness of treatment should also be further considered. We conducted a study to evaluate the efficacy, safety, and cost-effectiveness of consensus IFN monotherapy with high-dose induction for patients with chronic hepatitis C in clinical practice. Material and Methods. We consecutively enrolled 104 patients with chronic hepatitis C. Patients were scheduled to receive 12 or 18 jig of consensus IFN daily for 2 weeks, then three times a week for 22 weeks. Efficacy, safety, and cost-effectiveness were assessed. A Markov model was developed to investigate cost-effectiveness in patients with chronic hepatitis C treated by different IFN-based treatment strategies. Results. Of the 104 study patients, a sustained virological response (SVR) was achieved in 66 (63%). Logistic regression analysis revealed that genotype 2, lower hepatitis C virus RNA levels, and patient age were independently associated with SVR. The response rate was significantly higher in patients with genotype 2 (51/66, 77%) versus genotype 1 (15/38, 40%). Cost-effectiveness analysis in patients with genotype 2 revealed that high-dose induction with consensus IFN monotherapy was as highly cost-effective as pegylated IFN plus ribavirin. Conclusion. Consensus IFN monotherapy with high-dose induction shows high efficacy and cost-effectiveness in chronic hepatitis C patients with genotype 2 infection. Thus, it may be a reliable alternative in aged patients and for those excluded from standard combination therapy. [ABSTRACT FROM AUTHOR]

Objective. After implantation of drug-eluting stents (DES), two or more anti-thrombotic agents are required. The risk of upper gastrointestinal bleeding (UGIB) in cases of DES implantation is thought to be significant. However, the incidence of UGIB has not yet been investigated in DES-implanted patients. This study aimed to investigate the incidence of UGIB after DES implantation and the awareness among cardiologists about this complication. Material and methods. Subjects were 397 consecutive patients implanted with DES from August 2004 to September 2007 at two institutions. Endoscopic examinations were performed on DES-implanted patients who presented with hematemesis and/or tarry stools. The concomitant use of acid-suppressing agents was left to the cardiologists. In addition, 37 cardiologists were administered a questionnaire regarding UGIB after DES implantation. Results. Low-dose aspirin and ticlopidine were prescribed in all patients. Forty-six patients had a past history of peptic ulcer. Acid-suppressing agents were concomitantly prescribed to 224 patients (56%) including 32 patients (70%) with a past history of peptic ulcer. UGIB due to gastric ulcers developed in 5 cases (1.3%). One case had received a half dose of H2-RA. No bleeding occurred in patients who received proton pump inhibitors (PPI). The incidence of UGIB was 4.0 per 1000 patient-years. The cardiologists who were surveyed recognized the risk of UGIB after DES implantation and the necessity for its prevention. However, they indicated that adequate management for preventing this complication has not been established. Conclusions. This study reassuringly demonstrated a low incidence of UGIB after DES implantation. Further study regarding the prophylaxis for UGIB after DES implantation is necessary. [ABSTRACT FROM AUTHOR]

Background/Aims: The prevalence of reflux esophagitis, which might lead to development of Barrett’s esophagus and esophageal adenocarcinoma, has been increasing. The aim of this study was to assess risk factors for reflux esophagitis. Methods: We conducted a cross-sectional study of 1,495 Japanese subjects undergoing health checkups (822 males and 673 females; median age 50 years) at a tertiary care center. Results: One hundred and twenty-seven subjects (8%) had reflux esophagitis and hiatal hernia was observed in 292 subjects (20%). Reflux esophagitis (13 vs. 3%) and hiatal hernia (28 vs. 9%) were more frequent in males than females. Significant differences in clinical backgrounds were observed between females and males. Multivariate logistic regression analyses revealed that hiatal hernia (OR 6.63, 95% CI 2.47–17.8; p = 0.0002) was associated with reflux esophagitis in females. In males, age (per 1-year increment: OR 0.96, 95% CI 0.94–0.99; p = 0.007), hiatal hernia (OR 3.16, 95% CI 2.05–4.87; p < 0.0001) and waist circumference (per 1-cm increase: OR 1.09, 95% CI 1.02–1.15; p = 0.006) were associated with reflux esophagitis. Conclusions: Abdominal obesity may be an important risk factor for reflux esophagitis in males compared with females. Copyright © 2010 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

HbA1c is an important marker for glycemic control; however, not only plasma glucose levels but also RBCs' lifespan determines the value. Some of interferon-free, direct-acting antiviral regimens for hepatitis C are combined with ribavirin, which causes hemolytic anemia. Hemolytic anemia shortens the RBCs' lifespan and lowers HbA1c levels. We monitored HbA1c levels in 28 patients during and after antiviral therapy with daily sofosbuvir (400 mg) plus weight-based ribavirin for hepatitis C. Five cases (18%) had antidiabetic medication. The hemoglobin concentration, 13.9 ± 1.4 g/dl at the baseline, significantly fell to 12.0 ± 1.3 g/dl at the 4th week of treatment (P < 0.001). It hardly declined further during the treatment and immediately recovered after the end of treatment. Although there was no significant change in the random plasma glucose levels, the HbA1c level, 5.8% ± 0.7% at the baseline, gradually declined to 4.3% ± 0.7% (- 1.5% ± 0.7%, P < 0.001) at the end of treatment. It partly recovered to 4.8% ± 0.6% at the 4th week after treatment, then further increased to 6.2% ± 0.9% at the 12th week, and eventually returned to 5.7% ± 0.7%, which was similar to the value at baseline. Conclusions: interferon-free, direct-acting antiviral regimen combined with ribavirin temporally causes artificial declines in HbA1c levels. Disclosure: A. Moriya: None. Y. Iwasaki: None. M. Ando: None. [ABSTRACT FROM AUTHOR]

Background & Aims Roles of alcohol consumption in non-alcoholic fatty liver disease are still controversial, although several cross-sectional studies have suggested the beneficial effect of light to moderate drinking on fatty liver. We analyzed the longitudinal relationship between drinking pattern and fatty liver. Methods We included 5297 Japanese individuals (3773 men and 1524 women) who underwent a baseline study in 2003 and follow-up at least once from 2004 to 2006. Generalized estimating equation was used to estimate any association between drinking pattern and fatty liver assessed by ultrasonography. Results At baseline, 1179 men (31.2%) and 235 women (15.4%) had fatty liver; 2802 men (74.2%) and 436 women (28.6%) reported alcohol consumption. At the latest follow-up, 348 of 2594 men (13.4%) and 101 of 1289 women (7.8%) had newly developed fatty liver; 285 of 1179 men (24.2%) and 70 of 235 women (29.8%) demonstrated a remission of fatty liver. In men, drinking 0.1–69.9 g/week (odds ratio, 0.79 [95% confidence interval, 0.68–0.90]), drinking 70.0–139.9 g/week (0.73 [0.63–0.84]), drinking 140.0–279.9 g/week (0.69 [0.60–0.79]), and drinking ⩾280.0 g/week (0.68 [0.58–0.79]) were inversely associated with fatty liver after adjusting for obesity, exercise, and smoking. In women, drinking 0.1–69.9 g/week (0.71 [0.52–0.96]) and drinking 70.0–139.9 g/week (0.67 [0.45–0.98]) were inversely associated with fatty liver after the adjustment. Conclusions Light to moderate alcohol consumption, or even somewhat excessive amounts especially in men, was likely to protect most individuals against fatty liver over time. [ABSTRACT FROM AUTHOR]