Single 4.5 mg fixed-dose of rasburicase for hyperuricemia associated with tumor lysis syndrome

Patel, Kajal S.; Lau, Jessica; Zembillas, Anthony; Gallagher, Erika M.

doi:10.1177/1078155216644975

Cited by 13 publications

(21 citation statements)

References 6 publications

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“…Similar results could be shown in smaller case series. 62 – 67 Recently, Patel et al 68 have showed the efficiency of a single fixed dose of 4.5 mg rasburicase in a retrospective study.…”

Section: Antihyperuricemic Therapymentioning

confidence: 99%

Prevention and treatment of tumor lysis syndrome, and the efficacy and role of rasburicase

Alakel¹,

Middeke²,

Schetelig³

et al. 2017

OTT

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Tumor lysis syndrome (TLS) is a potentially life-threatening condition that occurs in oncologic and hematologic patients with large tumor burden, either due to cytotoxic therapy or, less commonly, spontaneously because of massive tumor cell lysis. TLS is clinically characterized by acute renal failure, hyperuricemia, hyperkalemia, hyperphosphatemia, and hypocalcemia. While limited options are available for treating TLS, identifying patients at high risk for developing TLS and prevention in high-risk patients remain an important aspect in the treatment of cancer patients. In general, treatment of TLS consists of intensive hydration, stimulation of diuresis, and, more specifically, in the use of allopurinol and rasburicase. Rasburicase, a recombinant urate oxidase, rapidly and effectively reduces hyperuricemia, which subsequently significantly decreases the risk of acute renal failure and other clinical manifestations of TLS. For this review, a comprehensive literature search using the term “tumor lysis syndrome” and/or “rasburicase” was performed considering articles listed in MEDLINE. Incidence, prevention, and therapy of TLS with a special focus on the role of rasburicase are discussed. We evaluated 120 relevant articles including 35 case reports, 32 clinical trials, and 14 meta-analyses.

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“…Similar results could be shown in smaller case series. 62 – 67 Recently, Patel et al 68 have showed the efficiency of a single fixed dose of 4.5 mg rasburicase in a retrospective study.…”

Section: Antihyperuricemic Therapymentioning

confidence: 99%

Prevention and treatment of tumor lysis syndrome, and the efficacy and role of rasburicase

Alakel¹,

Middeke²,

Schetelig³

et al. 2017

OTT

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“…The subjects included were representative, and ascertainment of exposure was confirmed by secure record. The subjects of most studies did not have clinical TLS at baseline. Outcome assessment was based on pharmacy and medical records, and the follow‐up period was sufficient for outcomes to occur.…”

Section: Resultsmentioning

confidence: 99%

“…Analysis results for incidence of RRT are illustrated in Fig. , including pooled data from 12 studies . The treatment of 4·5 mg (0·22; 95% CI: 0·15–0·29) had statistically significantly lower RRT incidence than the treatment of 1·5 mg (0·93; 95% CI: 0·74–1·12).…”

Section: Resultsmentioning

confidence: 99%

“…To our knowledge, no studies with high methodological quality, such as randomized controlled trials (RCT), have evaluated all of the single‐dose regimens presented in clinical practice; however, numerous observational studies are available, and the recommended single dosages vary across these observational studies (including 1·5 mg, 3 mg, 4·5 mg, 6 mg, 7·5 mg and weight‐based 0·05 mg/kg, 0·15 mg/kg). There is a meta‐analysis about SDR which only revealed that the response rate was not inferior to that of daily dose rasburicase (DDR) in adults, without recommending an optimal dosage of SDR in adults or children.…”

Section: What Is Known and Objectivementioning

confidence: 99%

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The optimal single-dose regimen of rasburicase for management of tumour lysis syndrome in children and adults: a systematic review and meta-analysis

Liu

Nie

et al. 2016

J Clin Pharm Ther

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SUMMARYWhat is known and objective: To perform a meta-analysis exploring the optimal single-dose regimen for managing tumour lysis syndrome (TLS) in children and adults with haematological malignancies. Methods: We systematically searched PubMed, MEDLINE, Web of Science, the Cochrane Library and the ClinicalTrials.gov website for studies regarding single-dose rasburicase in paediatric and adult patients with TLS. Data were analysed using Open MetaAnalyst statistical software. Results: Fifteen adult studies (fourteen retrospective studies and one randomized controlled trial) and four observational studies using children were extracted, with a total of 906 and 92 subjects, respectively. Single doses of 1Á5, 3, 4Á5, 6, 7Á5 mg and weight-based single doses of 0Á05 and 0Á15 mg/kg were compared. The response rate for 6, 7Á5 mg and 0Á15 mg/kg single doses was 90% (95% CI: 0Á825-0Á974), 98Á6% (95% CI: 0Á957-1Á015) and 93Á6% (95% CI: 0Á864-1Á007), respectively, and higher than other dosing regimens tested. The single doses of 6 mg and 0Á15 mg/kg rasburicase decreased uric acid levels more than the other regimens, and the mean uric acid reduction was 8Á45 mg/dL (95% CI, 7Á51-9Á38) and 10 mg/dL (95% CI, 8Á58-11Á42), respectively. What is new and conclusion: Our meta-analysis revealed that, for adult patients, a single 6 mg rasburicase dose is sufficient to normalize and sustain lower uric acid and creatinine levels in adults with TLS. This dose, therefore, balances cost and efficacy of treatment. The 3-and 4Á5-mg single dose can be considered if the baseline uric acid level <12 mg/dL, with close monitoring of clinical and biochemical parameters, and repeat dosing if required. The 1Á5 mg and 0Á15 mg/kg single dose were sufficient to manage TLS in children. WHAT IS KNOWN AND OBJECTIVETumour lysis syndrome (TLS) is a frequently encountered and lifethreatening oncologic emergency. It is characterized by severe electrolyte and metabolite abnormalities caused by rapid and massive breakdown of cancer cells and release of intracellular content into the systemic circulation, which leads to severe complications, such as hyperuricemia, hyperkalemia, hyperphosphatemia and hypocalcaemia.1,2 TLS occurs most commonly within 12-72 h after initiation of cytoreductive chemotherapy of haematological malignancies, especially in non-Hodgkin lymphoma and acute lymphocytic leukaemia (ALL), as well as in solid tumours that are characterized by high sensitivity to cytotoxic treatment, high proliferative rate or large tumour size or burden; however, it can also occur spontaneously without chemotherapy. 2-4Numerous studies have demonstrated that rasburicase is effective and safe in reducing uric acid (UA) levels and works within 4 h post-administration. [5][6][7][8] Rasburicase was approved by the US FDA for the treatment and prophylaxis of hyperuricemia in paediatric and adult patients with leukaemia, lymphoma or solid tumours who are receiving chemotherapy or at high risk of TLS, in 2002 and 2009, respectively. The recommended dose by the FDA i...

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“…The labeled dose is 0.2 mg/kg, daily given as a 30-min IV infusion, for up to 5 days [72]; however, in patients with low-intermediate risk of TLS, the smaller doses (0.1-0.15 mg/kg) were demonstrated to be also efficient, allowing for substantial cost reduction [81]. Alternatively, for patients with the low to moderate risk, a single fixed (3, 4.5, 6, or 7.5 mg) or weightbased (0.15-0.20 mg/kg) dose regimen has been proposed, and its efficacy is demonstrated [82][83][84][85][86][87][88]. A systematic review and meta-analysis of 19 studies by Yu et al [89] revealed that single doses of rasburicase: 6 mg for adults and 1.5 and 0.15 mg/kg for children, were sufficient to normalize and sustain lower uric acid and creatinine levels in adults with TLS.…”

Section: Rasburicasementioning

confidence: 99%

Prevention and Treatment of Tumor Lysis Syndrome in the Era of Onco-Nephrology Progress

Matuszkiewicz‐Rowińska

Małyszko²

2020

Kidney Blood Press Res

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Background: Tumor lysis syndrome (TLS) is an oncologic emergency due to a rapid break down of malignant cells usually induced by cytotoxic therapy, with hyperuricemia, hyperkalemia, hyperphosphatemia, hypocalcemia, and serious clinical consequences such as acute renal injury, cardiac arrhythmia, hypotension, and death. Rapidly expanding knowledge of cancer immune evasion mechanisms and host-tumor interactions has significantly changed our therapeutic strategies in hemato-oncology what resulted in the expanding spectrum of neoplasms with a risk of TLS. Summary: Since clinical TLS is a life-threatening condition, identifying patients with risk factors for TLS development and implementation of adequate preventive measures remains the most critical component of its medical management. In general, these consist of vigilant laboratory and clinical monitoring, vigorous IV hydration, urate-lowering therapy, avoidance of exogenous potassium, use of phosphate binders, and – in high-risk cases – considering cytoreduction before the start of the aggressive agent or a gradual escalation of its dose. Key Messages: In patients with a high risk of TLS, cytotoxic chemotherapy should be given in the facility with ready access to dialysis and a treatment plan discussed with the nephrology team. In the case of hyperkalemia, severe hyperphosphatemia or acidosis, and fluid overload unresponsive to diuretic therapy, the early renal replacement therapy (RRT) should be considered. One must remember that in TLS, the threshold for RRT initiation may be lower than in other clinical situations since the process of cell breakdown is ongoing, and rapid increases in serum electrolytes cannot be predicted.

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Single 4.5 mg fixed-dose of rasburicase for hyperuricemia associated with tumor lysis syndrome

Cited by 13 publications

References 6 publications

Prevention and treatment of tumor lysis syndrome, and the efficacy and role of rasburicase

Prevention and treatment of tumor lysis syndrome, and the efficacy and role of rasburicase

The optimal single-dose regimen of rasburicase for management of tumour lysis syndrome in children and adults: a systematic review and meta-analysis

Prevention and Treatment of Tumor Lysis Syndrome in the Era of Onco-Nephrology Progress

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