Table 4.

Studies on rasburicase

Authors	Year	Treatment plan	Patients	Effects on uric acid levels	Other effects	Toxicity
Pui et al. (dose-validation phase and accrual phase) Phase II trial 13	2001	Rasburicase for 5-7 days. Effective dose founded is 0.20 mg/kg	131 children, adolescent and young adults with leukaemia or lymphoma, high tumor burden, high acid uric and creatinine levels.	After 4 hours, uric acid decreased (from 9.7 to 1 mg/dl in 65 patients; from 4.3 to 0.5 mg/dl in 66 patients). After chemotherapy, uricemia remained low.	After 1 day, creatinine levels decreased and, after 6 days, returned into normal range	Negligible toxicity, only a single case of nausea and vomiting. The case of bronchospasm and hypoxemia might be related to hypereosinophily, induced by chemotherapy. None of the patients needed dialysis
Jeha et al. (North American study – a compassionate – use trial) 18	2005	Rasburicase at a dose of 0.20 mg/kg for 1-7 days. 71 patients received additional courses.	1069 patients (682 children and 387 adults) with haematologic malignancies or solid tumours at risk of TLS or with TLS	Uric acid levels remained low, also after chemotherapy, preventing effectively TLS. The efficacy of rasburicase in the treatment has been demonstrated in all hyperuricemic adults and in 98.5% of hyperuricemic children.		The adverse reactions in single course were: headache (0.7%), rash (0.4%), fever (0.3%), vomiting (0.3%). Only some cases of haemolityc anemia (4), albunimuria (1), allergic reaction (1) and dyspnea (1), methemoglobinemia (2), hypoxia(2), anaphylactic shock (1), rigor (1), convulsion (1), electrolyte abnormalities. 30 patients developed acute renal failure, that required haemodialysis. It was caused by sepsis or complications of chemotherapy, only 10 cases by TLS or hyperphosphatemia
Bosly et al. (international compassionate-use study) 53	2003	Rasburicase at 0.20 mg/kg once a day, for 1 to 7 days	219 children and adults at risk to TLS	In hyperuricemic patients, rasburicase lowered uric acid levels (in adults from 13.1 mg/dl to 0.3 mg/dl after treatment; in children from 11.3 mg/dl to 0.2 mg/dl)		5 patients need dialysis. Adverse effects were: headache (1.8%), fever (1.4%), rigors (1.1%), allergic reactions (0.7%)
Trifilio et al. (retrospective study) 24	2006	Single dose of rasburicase at 3 mg and allopurinol, hydration and other supportive therapy in 36 patients; additional dose of 1.5 or 3 mg in 6 patient with not controlled hyperuricemia	43 adults patients with cancer	Both in single dose and in double dose, rasburicase lowered uric acid levels, slower than higher dose	After 24 hours, creatinine levels declined in 39 patients and raised in 4 ones.	No patients required dialysis.
Associazione Italiana Ematologia Oncologia Pediatrica (AIEOP) Experience in Bologna 41	2005	Rasburicase at 0.15-0.20 mg/dl for 1-11 days	26 paediatric patients at risk for TLS	Highly significant decline of uric acid levels within 24 hours in hyperuricemic and in non-hyperuricemic patients. These values were maintained during the course of treatment	Creatinine levels normalized within 5 days after the start of rasburicase	Well tolerated in all patients