Economic comparison of rasburicase and allopurinol for treatment of tumor lysis syndrome in pediatric patients

2010 ◽  
Vol 67 (24) ◽  
pp. 2110-2114 ◽  
Author(s):  
Michael Eaddy ◽  
Brian Seal ◽  
Muralikrishna Tangirala ◽  
Elizabeth Hackney Davies ◽  
Ken O’Day
Keyword(s):  
Pediatric Patients ◽  
Tumor Lysis Syndrome ◽  
Tumor Lysis ◽  
Economic Comparison

Outcome of tumor lysis syndrome in pediatric patients with hematologic malignancies – a single-center experience from Pakistan

2016 ◽  
Vol 14 (11) ◽  
pp. 457-465
Author(s):  
Armaghan-e-Rehman Mansoor ◽  
Mohammad Faizan Zahid ◽  
Mujtaba Mubashir ◽  
Zehra Fadoo ◽  
Anwar ul Haq ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Tumor Lysis Syndrome ◽  
Hematologic Malignancies ◽  
Single Center ◽  
Tumor Lysis ◽  
Single Center Experience

Prophylaxis and therapy of tumor lysis syndrome in 115 pediatric patients diagnosed with hematological neoplasms

2017 ◽  
Vol 72 ◽  
pp. S147
Author(s):  
I. Astigarraga ◽  
S. Garcia-Obregon ◽  
S. Capape ◽  
J. Ortiz-Calahorro ◽  
M. Fernandez-Bernal ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Tumor Lysis Syndrome ◽  
Tumor Lysis ◽  
Hematological Neoplasms

Randomized Clinical Trial of Rasburicase Administered as a Standard Fixed Five Days Dosing Vs a Single Dose Followed by as Needed Dosing in Adult Patients with Hematologic Malignancies at Risk for Developing Tumor Lysis Syndrome.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 105-105 ◽  
Author(s):  
Saroj Vadhan-Raj ◽  
Luis Fayad ◽  
Michelle Fanale ◽  
Barbara Pro ◽  
Alma Rodriguez ◽  
...  
Keyword(s):  
Uric Acid ◽  
Single Dose ◽  
High Risk ◽  
Serum Creatinine ◽  
Plasma Levels ◽  
Pediatric Patients ◽  
Tumor Lysis Syndrome ◽  
Hematologic Malignancies ◽  
Tumor Lysis ◽  
Tnf Α

Abstract Abstract 105 Tumor lysis syndrome (TLS) is a potentially life threatening complication resulting from massive lysis of malignant cells and most frequently observed in patients with rapidly proliferating, bulky, and chemo-sensitive malignancies. The prevention and management of TLS includes hydration and reduction in the levels of serum uric acid by drugs that decrease production or increase excretion of uric acid. Rasburicase is a recombinant urate oxidase that rapidly reduces the levels of uric acid by enhancing the conversion of existing uric acid into allantoin which is more soluble in urine than uric acid. Rasburicase is approved in the USA for the treatment of pediatric patients at high risk for developing TLS, to be administered at a dose of 0.15 to 0.2 mg/kg once daily for 5 days. Although, activity has been seen with lower doses and shorter duration of treatment, the optimal dosing of rasburicase has not been established for adults. The purpose of this study was to evaluate the efficacy of rasburicase (0.15 mg/kg) administered as a single dose followed by as needed (max 5 doses over 5 days) as compared to standard fixed 5-days dosing in patients with hematologic malignancies at risk for TLS. The patients were stratified based on their risk for TLS and randomized 1:1 to rasburicase administered as a single dose followed by as needed (Arm A) or fixed daily dose x 5 days (Arm B). Sixty six patients were enrolled; 20 had > 2-fold LDH levels and 9 had above-normal serum creatinine. 64 patients received at least one dose of rasburicase and were evaluable for response [24 high risk with mean baseline uric acid levels, 9.8 (7.6–16.1 mg/dL) and 40 potential risk with uric acid, 5.3 (2.4-7.4 mg/dL)]. All patients normalized their uric acid levels at 4 hours after the first dose; 83% to an undetectable level (<0.7 mg/dL). On Arm B (fixed 5-days dosing), all patients (n=34, 100%) had a sustained response, as defined by the normalization of uric acid levels in 48 hours and its maintenance within normal range for 6 days. On Arm A, all except for 4 patients (all 4 high risk for TLS) had a sustained response (26 of 30, 87%) to a single dose of rasburicase. Four of 11 patients from the high risk group required a second dose around day 4 for uric acid levels >7.5 mg/dL. Serum creatinine normalized in all patients by day 5. The treatment was well tolerated, except for one incident of methemoglobinema and hemolytic anemia in a patient found to have G6PD deficiency. Since high uric acid levels have been associated with elevated cytokine levels, we examined the effects of treatment on plasma cytokines. At baseline, high risk patients showed increased TNF-α and IL-6 plasma levels. There was a marked decrease in the plasma levels of TNF-α (from mean 14.2 to 6.4 pg/ml, p<0.0001), and IL-6 (from 11.2 to 8 pg/mL, p=0.05) during treatment. Conclusion: Rasburicase is a highly effective uricolytic agent for prevention and management of TLS. This study demonstrates that it is feasible to decrease the duration of administration of rasburicase at the approved dose of 0.15 mg/kg. The majority of patients responded to a single dose of the agent, and only a small subset at high risk for TLS required a second dose. Disclosures: Vadhan-Raj: Sanofi Aventis: Honoraria, Research Funding. Off Label Use: Rasburicase is indicated for the initial management of plasma uric acid levels in pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of uric acid. The approved administration dose, route, and schedule are 0.15-0.20 mg/kg IV infusion for 5 days, respectively.

The economic implications of rasburicase treatment in pediatric tumor lysis syndrome patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 10050-10050
Author(s):  
K. O'Day ◽  
M. Eaddy ◽  
B. Seal ◽  
K. M. Tangirala
Keyword(s):  
Critical Care ◽  
Length Of Stay ◽  
Pediatric Patients ◽  
Tumor Lysis Syndrome ◽  
Urate Oxidase ◽  
Provider Type ◽  
Current Standard ◽  
Economic Implications ◽  
Pediatric Tumor ◽  
Tumor Lysis

10050 Background: Rasburicase is a recombinant urate-oxidase enzyme used to reduce high levels of plasma uric acid (UA) resulting from tumor lysis syndrome (TLS) in pediatric patients. Rasburicase reduces UA levels within 4 hours of administration, minimizing risk of serious complications from TLS. Although the efficacy of rasburicase has been demonstrated in clinical trials, there are few studies that have evaluated the economic implications of using rasburicase rather than allopurinol, the current standard of care. Methods: Pediatric patients administered rasburicase or allopurinol within 2 days of hospital admission were eligible for study inclusion. Patients were excluded if they were ≥ 18 years of age or received hemodialysis on admission. Patients receiving allopurinol or combination therapy were then propensity score matched to rasburicase patients based on gender, race, hospital type, provider type, payer type, admission source, use of electrolyte modification therapy, critical care admission, and comorbid diagnoses. Differences in healthcare costs, length of stay, and duration of subsequent critical care were assessed using gamma distributed generalized linear models with a log link function. Results: There were 63 allopurinol and 63 rasburicase patients matched in the analysis. The mean age of the sample was 7.4 years, with 27% being female. There were no statistical differences in matched covariates across the cohorts. Rasburicase patients incurred an average of $30,470 per hospitalization compared to $35,165 for allopurinol patients (p = 0.427). Mean length of stay was not statistically different across the cohorts, averaging 14 days. Duration of critical care was significantly lower for rasburicase (1.4 days) when compared to allopurinol (2.5 days, p = 0.0001). Conclusions: Treatment with rasburicase is associated with similar costs and a lower duration of critical care when compared to allopurinol therapy. [Table: see text]

scholarly journals Febuxostat Pharmacokinetic/Pharmacodynamic Bridging from Adults to Pediatrics for Effective Prophylaxis of Tumor Lysis Syndrome: From Florence to Floret Study

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4868-4868
Author(s):  
Michele Spina ◽  
Paolo Mazzei ◽  
Simone Baldini ◽  
Marta Pedretti ◽  
Enrica Mezzalana ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Pediatric Population ◽  
Tumor Lysis Syndrome ◽  
Drug Formulation ◽  
Phase Iii ◽  
Mixed Effect ◽  
Xanthine Oxidase Inhibitor ◽  
Tumor Lysis ◽  
Medical Need ◽  
Age Appropriate

Abstract Background Febuxostat, a potent and selective xanthine oxidase inhibitor, showed a significantly superior serum uric acid (sUA) control during chemotherapy (CT) in comparison to Allopurinol (Spina M. et al, ASCO 2014 and Annals of Oncology in press) when given as 120 mg oral fixed daily dosed and has been recently approved in the European Union (EU) for the prevention and treatment of hyperuricemia in adult patients undergoing CT for hematologic malignancies (HM) at intermediate- high Tumor Lysis Syndrome (TLS) risk, with recognition of the high relevance of its clinical benefit. Some pediatric HM are highly prone to develop TLS; an age-appropriate drug formulation for TLS prophylaxis is lacking in this population, resulting in an unmet medical need that Febuxostat is going to address. The similarities between adult and pediatric patients in terms of TLS pathogenesis, clinical manifestations and current management allow using pharmacokinetic (PK) information to extrapolate clinical efficacy and safety from adult to pediatric patients, as well as within the different pediatric ages (EMEA/CHMP/EWP/147013/2004). Methods A phase I/II study (Floret) has been designed to explore the PK/pharmacodynamic (PK/PD) profile of Febuxostat in the pediatric population in comparison to adults. Febuxostat daily dose will be 120 mg for adolescents and adults with a lower 80 mg dose to be administered to adolescents only, to obtain confirmatory data on the optimal exposure in terms of safety and effectiveness compared to adults. Considering the difference in body size and organ maturation, the selected daily doses of Febuxostat to be tested in children aged 6 to 11 years are 40 and 60 mg. As the only approved strengths of Febuxostat in the EU are 80 and 120 mg, an age-appropriate 20 mg tablet formulation of Febuxostat is developed to ensure the adequate dosing in children. In accordance to the European Medicines Agency Guidelines CHMP/EWP/147013/2004 and CHMP/EWP/18599/2006, the choice of population PK analysis, using non-linear mixed effect models, is considered appropriate to obtain the necessary precision of PK parameters estimates for the comparability assessment between the groups of patients. The PD/efficacy measurement, namely the sUA area under curve from baseline to the evaluation visit, corresponding to the primary efficacy measure explored during the Florence study, a Phase III comparative trial in adults vs Allopurinol (Spina M et al, ASCO 2014), together with the exposure data will abridge the efficacy results from the Florence to the Floret study and will confirm that potential PK deviation, if any, is of no clinical relevance. Conclusion: The present PK/PD approach allows reducing the number of blood samples from each patient, in particular the lowest aged pediatric patients, while replacing a conventionally designed PK study and a robust sized Phase III study in pediatrics. By bridging PK/PD data, the Floret study not only will allow Febuxostat to rapidly address an unmet medical need in a vulnerable population, but it offers a model - whenever applicable - to be adopted to accelerate new drugs availability to the pediatric population while fully complying with regulatory requirements and minimize the number of patients in clinical trials. Disclosures Spina: Menarini Ricerche SpA: Consultancy. Off Label Use: Febuxostat in pediatric Tumor lysis syndrome. Mazzei:Menarini Ricerche SpA: Employment. Baldini:Menarini Ricerche SpA: Employment. Pedretti:Menarini Ricerche SpA: Employment. Mezzalana:Menarini Ricerche SpA: Employment. Matera:Menarini Ricerche SpA: Employment. Manunta:Menarini Ricerche SpA: Employment. Calamai:Menarini Ricerche SpA: Employment. Scordari:Menarini Ricerche SpA: Employment. Scartoni:Menarini Ricerche SpA: Employment. Capriati:Menarini Ricerche SpA: Employment. Simonelli:Menarini Ricerche SpA: Employment.

Pediatric Hematologic And Oncologic Emergencies

2018 ◽  
Author(s):  
Rebecca Milligan ◽  
Jenny Mendelson
Keyword(s):  
Emergency Medicine ◽  
Immune Thrombocytopenia ◽  
Pediatric Patients ◽  
Tumor Lysis Syndrome ◽  
Von Willebrand Disease ◽  
Emergency Physicians ◽  
Tumor Lysis ◽  
Oncologic Emergencies ◽  
Life Threatening ◽  
Von Willebrand

Hematologic and oncologic emergencies that afflict children and adolescents are important for emergency medicine physicians to recognize. Pediatric patients can present with a previous formal diagnosis and have a complication related to their disease or with new symptoms that suggest a hematologic or oncologic process. Oncologic treatments can also lead to life-threatening complications. Recognizing these emergencies is very important for emergency physicians to prevent further morbidity. This review covers common patient presentations, diagnosis, and treatments for hematologic and oncologic emergencies.  This review contains 6 figures, 7 tables and 48 references Key words: hematology, hemophilia, immune thrombocytopenia, neutropenic fever, oncology, pediatric, sickle cell anemia, tumor lysis syndrome, von Willebrand disease

Impaired renal function and tumor lysis syndrome in pediatric patients with Non-Hodgkin's Lymphoma and B-ALL

1998 ◽  
Vol 210 (04) ◽  
pp. 279-284 ◽  
Author(s):  
Kathrin Seidemann ◽  
Ulrike Meyer ◽  
Petra Jansen ◽  
Elif Yakisan ◽  
Karin Rieske ◽  
...  
Keyword(s):  
Renal Function ◽  
Impaired Renal Function ◽  
Hodgkin’S Lymphoma ◽  
Pediatric Patients ◽  
Tumor Lysis Syndrome ◽  
Hodgkin's Lymphoma ◽  
Tumor Lysis ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma

Pediatric Hematologic And Oncologic Emergencies

2018 ◽  
Author(s):  
Rebecca Milligan ◽  
Jenny Mendelson
Keyword(s):  
Emergency Medicine ◽  
Immune Thrombocytopenia ◽  
Pediatric Patients ◽  
Tumor Lysis Syndrome ◽  
Von Willebrand Disease ◽  
Emergency Physicians ◽  
Tumor Lysis ◽  
Oncologic Emergencies ◽  
Life Threatening ◽  
Von Willebrand

Hematologic and oncologic emergencies that afflict children and adolescents are important for emergency medicine physicians to recognize. Pediatric patients can present with a previous formal diagnosis and have a complication related to their disease or with new symptoms that suggest a hematologic or oncologic process. Oncologic treatments can also lead to life-threatening complications. Recognizing these emergencies is very important for emergency physicians to prevent further morbidity. This review covers common patient presentations, diagnosis, and treatments for hematologic and oncologic emergencies.  This review contains 6 figures, 7 tables and 48 references Key words: hematology, hemophilia, immune thrombocytopenia, neutropenic fever, oncology, pediatric, sickle cell anemia, tumor lysis syndrome, von Willebrand disease

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