In intermediate stage hepatocellular carcinoma: radioembolization with yttrium 90 or chemoembolization?

BACKGROUND & AIMS: Transarterial chemoembolization (TACE) is one of the standard treatments recommended for intermediate stage hepatocellular carcinoma (HCC). At the same time, only little is known about the use of radioembolization with Yttrium-90 microspheres (TARE Y-90) for this subset of patients. To perform comparative analysis between both locoregional therapies in intermediate HCCs. Primary endpoint was overall survival (OS), while safety, response rate and time-to-progression (TTP) were considered as secondary endpoints. METHODS: We collected data of 86 HCC patients in two university hospitals at which conventional TACE with doxorubicin or TARE Y-90 using glass microspheres were performed. The median observation period was 10 months. Patients were followed up for signs of toxicity and response. They underwent imaging analysis at baseline and follow-up at regular time intervals. RESULTS: Eighty-six HCC patients with intermediate stage B (BCLC) were treated with either TACE (n = 42) or TARE Y-90 (n = 44). Despite a higher tumour burden in the TARE Y-90 group, the median OS (TACE: 18 months vs. TARE Y-90: 16.4 months) and the median TTP (TACE: 6.8 months vs. TARE Y-90: 13.3 months) were not statistically different. The number of treatment sessions, the average rate of treatment sessions per patient, total hospitalization time and rate of adverse events were significantly higher in the TACE cohort. CONCLUSION: In intermediate HCC stage patients, both treatments resulted in similar survival probabilities despite more advanced disease in the TARE Y-90 group. Still, TARE Y-90 was better tolerated and associated with less hospitalization and treatment sessions.

Epidemiological characteristics of hepatocellular carcinoma in Egypt: a retrospective analysis of 1313 cases.

BACKGROUND & AIMS: Hepatocellular carcinoma (HCC) is one of the most common malignant tumours worldwide. Egypt has the highest prevalence of HCV in the world and the prevalence of HCC is increasing in the last years. The aim was to study epidemiological characteristics of HCC in Egypt. METHODS: Retrospective chart review of 1456 Egyptian patients with HCC was done. Records of 1313 patients (1035 males, 278 females; median age 56 years) fulfilling diagnostic criteria for HCC were analysed for clinical, aetiological, radiological and tumour characteristics. RESULTS: The majority of cases (75%) were from rural areas. The most frequent age category affected by HCC was between 51 and 60 years (45.7%); 50% of the patients reported accidental discovery of their hepatic focal lesions. The major presenting symptom was newly developed right hypochondrial pain (66.3%). HCV Ab was detected in 91.32% of the studied patients while HVB infection was reported in 2.51%. 59.3% of patients had AFP levels below 200 ng/ml (the diagnostic level). On studying tumour characteristics, the right lobe of the liver was more frequently occupied by the focal lesions (75.4%) than the left lobe (15.7%) and 12.5% of patients had bilobar affection. Five hundred and six patients (38.6%) had more than one hepatic focal lesion and 228 patients (17.4%) had tumours occupying >50% of the liver. CONCLUSION: HCC is a major health problem in Egypt and its incidence is increasing. The high prevalence of HCV infection makes screening programmes and surveillance of those patients a very important tool to early detect cases of small HCCs.

Sorafenib plus tegafur-uracil (UFT) versus sorafenib as first line systemic treatment for patients with advanced stage HCC: a Phase II trial (ESLC01 study).

BACKGROUND: Phase II trials found that tegafur-uracil (UFT) is an effective drug in hepatocellular carcinoma (HCC), while preclinical data suggested that its combination with sorafenib may have a promising activity. Our Phase II randomized trial aimed to evaluate efficacy and tolerability of sorafenib plus UFT vs sorafenib in advanced HCC. METHODS: Patients with advanced HCC, with no prior systemic therapy, were randomized to receive either UFT at 125 mg/m2 twice daily for 4 out of 5 weeks plus sorafenib at 400 mg twice daily (arm 1) or single agent sorafenib at 400 mg twice daily (arm 2). Primary end point was time to progression (TTP). RESULTS: Between March 2012 and March 2014, 76 eligible patients - out of 143 preplanned - were randomized. The study was terminated early because of futility. This is the final analysis of the study, after a median follow-up of 10.2 months and death of 86% of randomized patients (n=64). Median TTP was 7.5 months and 8.2 months in arms 1 and 2 respectively (HR: 1.07; 95% CI, 0.52-2.22; P=0.855), while the median overall survival was 8.2 months and 10.5 months respectively (HR: 1.58; 95% CI: 0.90-2.76, P=0.112). Nine patients (25%) in the combination arm discontinued treatment because of toxicity vs eight patients (21.1%) in the sorafenib monotherapy arm (P=0.899). CONCLUSION: In patients with advanced HCC, adding UFT to sorafenib is feasible, but it did not improve efficacy outcome over sorafenib monotherapy.

Annexin A2 as a biomarker for hepatocellular carcinoma in Egyptian patients.

AIM: To investigate the clinical utility of serum annexin A2 (ANXA2) as a diagnostic marker for early hepatocellular carcinoma (HCC). METHODS: This study was performed in HCC Clinic of Ain Shams University Hospitals, Cairo, Egypt and included: Group 1: Fifty patients with early stage HCC (Barcelona Clinic Liver Cancer stage A); Group 2: Twenty five patients with chronic liver disease; and Control Group: Fifteen healthy, age- and sex-matched subjects who were seronegative for viral hepatitis markers. The following laboratory investigations were done: Viral hepatitis markers [hepatitis B surface antigen and hepatitis C virus (HCV) antibodies], HCV RNA in HCV antibody-positive patients, serum alpha fetoprotein (AFP), and serum ANXA2 levels. RESULTS: In this study, 88% of HCC patients (n = 44) were HCV-positive, while HBV infection represented only 8% of all HCC patients (n = 4); and two patients were negative for both viral markers. A highly significant difference was found between patients with HCC and chronic liver disease as well as controls with regard to serum ANXA2 levels (130, IQR 15-240; 15, IQR 15-17; and 17, IQR 15-30 ng/mL, respectively). The area under the curve of ANXA2 was 0.865; the cut-off value was established to be 18 ng/mL with a diagnostic sensitivity of 74% and a specificity of 88%, while the sensitivity and specificity of AFP at the cut-off value of 200 ng/dL were 20% and 100%, respectively. CONCLUSION: Serum ANXA2 may serve as a biomarker for the early detection of HCC.