Febuxostat achieved a significant serum uric acid control with one fixed dose compared with allopurinol with comparable renal function preservation and safety profile in patients with hematologic malignancies at intermediate to high tumor lysis syndrome risk, a new study published online ahead of print in the journal Annals of Oncology has shown.
Serum uric acid level correlated with both tumor lysis syndrome and risk for renal events. Allopurinol is typically given to patients at risk for developing tumor lysis syndrome in order to prevent complications like acute kidney failure.
In this double-blind, phase 3 trial, researchers enrolled 346 patients with hematologic malignancies at intermediate-to-high tumor lysis syndrome risk and randomly assigned them to receive febuxostat 120 mg or allopurinol 200-600 mg. Uric acid-lowering drugs were initiated 2 days prior to induction chemotherapy, for 7 to 9 days.
Results showed that febuxostat significantly reduced serum uric acid levels compared with allopurinol (P<0.0001).
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In addition, both drugs achieved similar renal function preservation (P=0.0903). No differences in treatment responder rate tumor lysis syndrome incidence and safety were observed.
In regard to drug safety, drug-related adverse events were reported in 6.4% of patients in both treatment arms.
- Spina M, Nagy Z, Ribera JM, et al. FLORENCE: a randomized, double-blind, phase III pivotal study of febuxostat versus allopurinol for the prevention of tumor lysis syndrome (TLS) in patients with hematologic malignancies at intermediate to high TLS risk. Ann Oncol. 2015. [epub ahead of print]. doi: 10.1093/annonc/mdv317.