Purpose Selective internal radiation therapy or radioembolization (RE) shows efficacy in unresectable hepatocellular carcinoma (HCC) limited to the liver. This study compared the safety and efficacy of RE and sorafenib in patients with locally advanced HCC. Patients and Methods SIRveNIB (selective internal radiation therapy v sorafenib), an open-label, investigator-initiated, phase III trial, compared yttrium-90 (Y) resin microspheres RE with sorafenib 800 mg/d in patients with locally advanced HCC in a two-tailed study designed for superiority/detriment. Patients were randomly assigned 1:1 and stratified by center and presence of portal vein thrombosis. Primary end point was overall survival (OS). Efficacy analyses were performed in the intention-to-treat population and safety analyses in the treated population. Results A total of 360 patients were randomly assigned (RE, 182; sorafenib, 178) from 11 countries in the Asia-Pacific region. In the RE and sorafenib groups, 28.6% and 9.0%, respectively, failed to receive assigned therapy without significant cross-over to either group. Median OS was 8.8 and 10.0 months with RE and sorafenib, respectively (hazard ratio, 1.1; 95% CI, 0.9 to 1.4; P = .36). A total of 1,468 treatment-emergent adverse events (AEs) were reported (RE, 437; sorafenib, 1,031). Significantly fewer patients in the RE than sorafenib group had grade ≥ 3 AEs (36 of 130 [27.7%]) v 82 of 162 [50.6%]; P < .001). The most common grade ≥ 3 AEs were ascites (five of 130 [3.8%] v four of 162 [2.5%] patients), abdominal pain (three [2.3%] v two [1.2%] patients), anemia (zero v four [2.5%] patients), and radiation hepatitis (two [1.5%] v zero [0%] patients). Fewer patients in the RE group (27 of 130 [20.8%]) than in the sorafenib group (57 of 162 [35.2%]) had serious AEs. Conclusion In patients with locally advanced HCC, OS did not differ significantly between RE and sorafenib. The improved toxicity profile of RE may inform treatment choice in selected patients.
Although radio-frequency (RF) ablation has been accepted as a promising and safe technique for treatment of unresectable hepatic tumors, investigation of its complications has been limited. According to the multicenter (1,139 patients in 11 institutions) survey data of the Korean Study Group of Radiofrequency Ablation, a spectrum of complications occurred after RF ablation of hepatic tumors. The prevalence of major complications was 2.43%. The most common complications were hepatic abscess (0.66%), peritoneal hemorrhage (0.46%), biloma (0.20%), ground pad burn (0.20%), pneumothorax (0.20%), and vasovagal reflex (0.13%). Other complications were biliary stricture, diaphragmatic injury, gastric ulcer, hemothorax, hepatic failure, hepatic infarction, renal infarction, sepsis, and transient ischemic attack. One procedure-related death (0.09%) occurred (due to peritoneal hemorrhage). Three important strategies for decreasing the rate of complications are prevention, early detection, and proper management. A physician who performs RF ablation of hepatic malignancies should be aware of the broad spectrum of major complications so that these strategies can be used.
Management of hepatocellular carcinoma (HCC) with portal vein thrombosis (PVT) is complex and requires an understanding of multiple therapeutic options. PVT is present in 10%-40% of HCC at the time of diagnosis, and is an adverse prognostic factor. Management options are limited, as transplantation is generally contraindicated, and surgical resection is only rarely performed in select centers. Systemic medical therapy with sorafenib has been shown to modestly prolong survival. Transarterial chemoembolization has been performed in select cases but has shown a high incidence of complications. Emerging data on treatment of PVT with Y-90 radioembolization suggest that this modality is well-tolerated and associated with favorable overall survival. Current society guidelines do not yet specifically recommend radioembolization for patients with PVT, but this may change with the development of newer staging systems and treatment algorithms. In this comprehensive literature review, we present current and available management options with the relative advantages, disadvantages and contraindications of these treatment options with summarized data on overall survival.
ObjectiveMuch controversy still exists about maternal-to-infant transmission of human papillomavirus (HPV) infection, specifically about the magnitude of the risk and the route and timing of such vertical transmission. This prospective cohort study examines the risk of vertical transmission of maternal HPV in each trimester of pregnancy.Study designOne hundred fifty three healthy pregnant women were followed longitudinally throughout pregnancy and cervical swabs obtained in each trimester and postpartum for HPV detection. Cord blood, neonatal nasopharyngeal aspirates, and placental biopsies were collected at delivery. DNA isolation, polymerase chain reaction, and hybridization were performed using the GG HPV Genotyping Chip Kit (Goodgene Inc., Seoul, Korea). Detection of HPV in neonates was defined as the presence of HPV DNA in either cord blood or neonatal nasopharyngeal aspirate.ResultsHPV DNA was detected in 14%(22/153) of healthy women in the first trimester, 18%(22/124) in the second trimester, and 10%(15/153) in the third trimester; 24%(37/153) were positive for HPV DNA on at least one occasion in pregnancy. At birth, 5.2%(8/153) of neonates were HPV DNA positive. Seven of these eight infants were born to HPV-positive mothers. Placental HPV DNA was positive in 3.3%(5/152) of cases, and all five cases were from mothers with at least one HPV-positive test. Detection of HPV DNA in neonates was associated with detection of HPV in mothers during any of the three trimesters of pregnancy.ConclusionHPV DNA was detected at birth in 5.2%(8/153) of neonates born to healthy women, and was associated with the detection of HPV in mothers during any of the three trimesters of pregnancy.
Background: The aim of this study was to compare the efficacy, safety and achievement of the target hemoglobin level (Hb ≥10 g/dl) in patients with preoperative anemia due to menorrhagia who received intravenous iron sucrose compared with oral iron protein succinylate for anemia management. Methods: Seventy-six patients with Hb levels <9.0 g/dl who were scheduled to undergo surgical treatment were randomized to receive either intravenous iron sucrose (based on the calculated total iron deficit divided into 2 ampoule infusions intravenously 3 times a week, beginning 3 weeks before surgery) or oral iron (80 mg/day of oral iron protein succinylate daily). Results: The intravenous iron group had higher increases in Hb (3.0 vs. 0.8 g/dl; p < 0.0001) and ferritin levels (170.1 vs. 4.1 μg/l; p < 0.0001) than the oral iron group. Achieving the target Hb was also higher in the intravenous iron group than in the oral iron group (76.7 vs. 11.5%; p < 0.0001). There were tolerable adverse events in both groups. Conclusion: Preoperative intravenous iron sucrose administration is more effective than oral iron and is as safe as oral iron therapy in the correction of preoperative anemia due to menorrhagia.
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