Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies

Summary

The purpose of this study is to determine whether febuxostat is superior to allopurinol in the prevention of tumor lysis syndrome (TLS) in patients with hematological malignancies at intermediate or high risk of TLS (according to Cairo-Bishop classification) who undergo chemotherapy

Timeline

Start

2012-10

Primary completion

2013-10

Completion

2013-10

Outcome

Mixed primary results

paper Mean AUC sUA1-8 was 514.0 ± 225.71 versus 708.0 ± 234.42 mgxh/dl (P < 0.0001) in favor of febuxostat. PMID 26216382 ↗

paper Mean serum creatinine change was -0.83 ± 26.98% and -4.92 ± 16.70% for febuxostat and allopurinol, respectively (P = 0.0903). PMID 26216382 ↗

Publications

• Spina M, Nagy Z, Ribera JM, Federico M, Aurer I, Jordan K, Borsaru G, Pristupa AS, Bosi A, Grosicki S, Glushko NL, Ristic D, Jakucs J, Montesinos P, Mayer J, Rego EM, Baldini S, Scartoni S, Capriati A, Maggi CA, Simonelli C; FLORENCE Study Group. 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 Oct;26(10):2155-61. doi: 10.1093/annonc/mdv317. Epub 2015 Jul 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Allopurinol	Small molecule	200 mg	—
Comparator	Allopurinol	Small molecule	300 mg	—
Comparator	Allopurinol	Small molecule	600 mg	—
Subject	Febuxostat	Small molecule	120 mg	Oral

Indications