The initial management of a ruptured hepatocellular adenoma should be haemodynamic stabilization. Definitive resection is required for rebleeding or for tumours exceeding 5 cm in diameter. A conservative approach may well be justified in case of regression of an asymptomatic adenoma.
BackgroundColorectal cancer patients with unresectable liver-only metastases may be cured after downsizing of metastases by neoadjuvant systemic therapy. However, the optimal neoadjuvant induction regimen has not been defined, and the lack of consensus on criteria for (un)resectability complicates the interpretation of published results.Methods/designCAIRO5 is a multicentre, randomised, phase 3 clinical study. Colorectal cancer patients with initially unresectable liver-only metastases are eligible, and will not be selected for potential resectability. The (un)resectability status is prospectively assessed by a central panel consisting of at least one radiologist and three liver surgeons, according to predefined criteria. Tumours of included patients will be tested for RAS mutation status. Patients with RAS wild type tumours will be treated with doublet chemotherapy (FOLFOX or FOLFIRI) and randomised between the addition of either bevacizumab or panitumumab, and patients with RAS mutant tumours will be randomised between doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab or triple chemotherapy (FOLFOXIRI) plus bevacizumab. Radiological evaluation to assess conversion to resectability will be performed by the central panel, at an interval of two months.The primary study endpoint is median progression-free survival. Secondary endpoints are the R0/1 resection rate, median overall survival, response rate, toxicity, pathological response of resected lesions, postoperative morbidity, and correlation of baseline and follow-up evaluation with respect to outcomes by the central panel.DiscussionCAIRO5 is a prospective multicentre trial that investigates the optimal systemic induction therapy for patients with initially unresectable, liver-only colorectal cancer metastases.Trial registrationCAIRO 5 is registered at European Clinical Trials Database (EudraCT) (2013-005435-24).CAIRO 5 is registered at ClinicalTrials.gov: NCT02162563, June 10, 2014.
IntroductionThis study investigates the treatment and survival of young versus elderly potentially curable gastric cancer patients in the Netherlands.Patients and methodsAll noncardia gastric cancer patients with potentially curable gastric cancer according to stage (cTx–3, cNx–3, and cMx–0) diagnosed between 1989 and 2013 were selected from the Netherlands Cancer Registry. Trends in treatment and overall survival were compared between young patients (younger than 70 years) and elderly patients (70 years or older). Multivariable logistic regression analysis was used to examine the probability of patients undergoing surgery and chemotherapy in the most recent period. Multivariable Cox regression analysis was used to identify independent factors associated with survival.ResultsIn total, 8107 young and 13,814 elderly gastric cancer patients were included. There was a major increase in the proportion of patients treated with resection and chemotherapy after 2004–2008. In young patients the increase was from 2.6% in 1999–2003 to 63% in 2009–2013 (p < 0.01). Also an increase was noticed among elderly patients, from 0.1% to 16% (p < 0.01). Median survival increased from 2004 to 2008 onward particularly in young patients and to a lesser extent in elderly patients (from 28 to 41 months vs from 11 to 13 months). Multivariable Cox regression analyses confirmed that overall survival improved for young and elderly patients.DiscussionYoung patients experienced a stronger improvement in survival than elderly patients, resulting in an increasing survival gap. The literature shows this is a problem not only in the Netherlands but also throughout Europe. The dissimilarity in treatment between young and elderly patients could be the reason for this difference.
Background/Aims: Fibrocaps is a dry powder fibrin sealant containing human plasma-derived fibrinogen and thrombin. The safety, efficacy, and application methods for Fibrocaps were evaluated in an exploratory, first-in-human, noncomparative, clinical study. Methods: Patients with minor bleeding/oozing after elective partial hepatic resection had Fibrocaps applied to the bleeding site either directly from the vial or from a spray device, with manual pressure applied using a cellulose, collagen, or gelatin sponge, if needed. Safety was evaluated at screening and postoperative days 1, 2, and 5, and weeks 4 and 12. The formation of anti-thrombin antibodies was assessed at baseline, and after 4 and 12 weeks. Time to hemostasis (TTH) within 10 min was determined. Results: Twenty-nine patients were treated with Fibrocaps; 6 experienced serious adverse events that were not related to the course of treatment. Adverse events occurring in >10% of patients were nausea, constipation, hypotension, obstipation, hypokalemia, and postoperative pain. Most adverse events were mild or moderate in severity. No patient developed anti-thrombin antibodies. The percentage of patients who achieved hemostasis was 93%; the median TTH was 3.8 min (range 0.3-10.3). Manual pressure was applied with Fibrocaps in 19 patients and considered beneficial in most. Conclusion: Fibrocaps was well tolerated in patients undergoing elective hepatic resection and resulted in rapid hemostasis. These safety and efficacy results support further clinical testing of this ready-to-use fibrin sealant as an adjunct to surgical hemostasis.
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