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Spina M.,Italian National Cancer Institute | Nagy Z.,Semmelweis University | Ribera J.M.,Jose Carreras Research Institute | Federico M.,University of Modena and Reggio Emilia | And 17 more authors.
Annals of Oncology | Year: 2015

Background: Serum uric acid (sUA) control is of key relevance in tumor lysis syndrome (TLS) prevention as it correlates with both TLS and renal event risk. We sought to determine whether febuxostat fixed dose achieves a better sUA control than allopurinol while preserving renal function in TLS prevention. Patients and methods: Patients with hematologic malignancies at intermediate to high TLS risk grade were randomized to receive febuxostat or allopurinol, starting 2 days before induction chemotherapy, for 7-9 days. Study treatment was blinded, whereas daily dose (low/standard/high containing allopurinol 200/300/600 mg, respectively, or fixed febuxostat 120 mg) depended on the investigator's choice. The co-primary end points, sUA area under curve (AUC sUA1-8) and serum creatinine change, were assessed from baseline to day 8 and analyzed through analysis of covariance with two-sided overall significance level of 5%. Secondary end points included treatment responder rate, laboratory and clinical TLS incidence and safety. Results: A total of 346 patients (82.1% intermediate TLS risk; 82.7% assigned to standard dose) were randomized. Mean AUC sUA1-8 was 514.0 ± 225.71 versus 708.0 ± 234.42 mgxh/dl (P < 0.0001) in favor of febuxostat. Mean serum creatinine change was -0.83 ± 26.98% and -4.92 ± 16.70% for febuxostat and allopurinol, respectively (P = 0.0903). No differences among secondary efficacy end points were detected. Drug-related adverse events occurred in 6.4% of patients in both arms. Conclusion: In the largest adult trial carried out in TLS prevention, febuxostat achieved a significant superior sUA control with one fixed dose in comparison to allopurinol with comparable renal function preservation and safety profile. Clinical trial registration: NCT01724528. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

Nagy K.H.,Pandy Kalman Megyei Korhaz | Pomucz J.,Pandy Kalman Megyei Korhaz | Varga R.,Pandy Kalman Megyei Korhaz | Szabo E.,Pandy Kalman Megyei Korhaz | Soltesz G.,University of Pecs
Orvosi Hetilap | Year: 2013

Introduction: Disturbances in carbohydrate metabolism during pregnancy may result in harmful fetal and neonatal consequences. Objectives: To assess the fetal and neonatal complications of pregnancy in mothers with gestational and pregestational diabetes during a 10-year period in a county hospital in Hungary. Methods: Retrospective analysis of infants of diabetic mothers admitted to the neonatal unit between 2001 and 2010. Results: 32% of the infants were transferred to the neonatal unit. Neonatal macrosomia (birth weight >90 centile) was observed in one quarter of the infants. 39% of the infants developed hypoglycemia (blood glucose <2.6 mmol/l), in the majority of the cases within the first 8 hours. Hypoglycaemia was symptomatic in 55% of the infants. Hypocalcemia was observed in 17%, hyperviscosity in 23%, hyperbilirubinaemia in 32%, respiratory distress syndrome and/or transient tachypnoe in 22% and cardiac complications in 13% of the infants. 10% of the inafnts were affected with birth injuries. Congenital anomalies were seen in 17% of the cases, and severe malformations were present in 4% of the infants. Conclusions: Despite modern diabetes management, there is still a higher incidence of fetal macrosomia, adverse neonatal outcomes and a higher rate of severe congenital malformations in neonates of diabetic mothers. Orv. Hetil., 2013, 154, 172-177.

Glioblastoma is a brain tumor with poor prognosis in the therapy of which operation, postoperative temozolomide sensitized radiochemotherapy followed by temozolomide monotherapy offer the best chances. Administration of temozolomide is also recommended in relapse if the patient is naïve to this treatment. In recurrent or progressive glioblastoma following the above therapy, several biological therapeutic agents were tested, out of which the angiogenesis inhibitor bevacizumab has been approved by FDA (and similar authority of several other countries). Bevacizumab monotherapy resulted in objective tumor response in 28.2%, the median of progression-free survival was 4.2 (2.9-5.8) months, the median of overall survival was 9.2 (8.2-10.7) months. When combined with irinotecan, these results were 37.8%, 5.6 (4.4-6.2) and 8.7 (7.8-10.9) months, respectively. Adverse events were known from the use of bevacizumab in other indications, symptoms affecting the central nervous system were mild, i.e. the therapy proved to be not only effective but safe as well. Reduction of edema provided further advantage. In Hungary the product is available for "off-label" use only through a fairness request process. © 2012 Professional Publishing Hungary.

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