| SPINA, M., Z. NAGY, J.M. RIBERA, M. FEDERICO, I. AURER, K. JORDAN, G. BORSARU, A.S. PRISTUPA, A. BOSI, S. GROSICKI, N.L. GLUSHKO, D. RISTIC, J. JAKUCS, P. MONTESINOS, Jiří MAYER, E.M. REGO, S. BALDINI, S. SCARTONI, A. CAPRIATI, CA MAGGI a C. SIMONELLI. 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. Annals of Oncology. Oxford: Oxford University Press, 2015, roč. 26, č. 10, s. 2155-2161. ISSN 0923-7534. Dostupné z: https://dx.doi.org/10.1093/annonc/mdv317. |
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@article{1310462,
author = {Spina, M. and Nagy, Z. and Ribera, J.M. and Federico, M. and Aurer, I. and Jordan, K. and Borsaru, G. and Pristupa, A.S. and Bosi, A. and Grosicki, S. and Glushko, N.L. and Ristic, D. and Jakucs, J. and Montesinos, P. and Mayer, Jiří and Rego, E.M. and Baldini, S. and Scartoni, S. and Capriati, A. and Maggi, CA and Simonelli, C.},
article_location = {Oxford},
article_number = {10},
doi = {http://dx.doi.org/10.1093/annonc/mdv317},
keywords = {allopurinol; febuxostat; hematologic malignancy; kidney injury; tumor lysis},
language = {eng},
issn = {0923-7534},
journal = {Annals of Oncology},
title = {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},
volume = {26},
year = {2015}
}
TY - JOUR
ID - 1310462
AU - Spina, M. - Nagy, Z. - Ribera, J.M. - Federico, M. - Aurer, I. - Jordan, K. - Borsaru, G. - Pristupa, A.S. - Bosi, A. - Grosicki, S. - Glushko, N.L. - Ristic, D. - Jakucs, J. - Montesinos, P. - Mayer, Jiří - Rego, E.M. - Baldini, S. - Scartoni, S. - Capriati, A. - Maggi, CA - Simonelli, C.
PY - 2015
TI - 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
JF - Annals of Oncology
VL - 26
IS - 10
SP - 2155-2161
EP - 2155-2161
PB - Oxford University Press
SN - 09237534
KW - allopurinol
KW - febuxostat
KW - hematologic malignancy
KW - kidney injury
KW - tumor lysis
N2 - BACKGROUND:Serum uric acid (sUA) control is of key relevance in tumor lysis syndrome (TLS) prevention as it correlates with both TLS and renal event risk. We sought to determine whether febuxostat fixed dose achieves a better sUA control than allopurinol while preserving renal function in TLS prevention. PATIENTS AND METHODS: Patients with hematologic malignancies at intermediate to high TLS risk grade were randomized to receive febuxostat or allopurinol, starting 2 days before induction chemotherapy, for 7-9 days. Study treatment was blinded, whereas daily dose (low/standard/high containing allopurinol 200/300/600 mg, respectively, or fixed febuxostat 120 mg) depended on the investigator's choice. The co-primary end points, sUA area under curve (AUC sUA1-8) and serum creatinine change, were assessed from baseline to day 8 and analyzed through analysis of covariance with two-sided overall significance level of 5%. Secondary end points included treatment responder rate, laboratory and clinical TLS incidence and safety. RESULTS: A total of 346 patients (82.1% intermediate TLS risk; 82.7% assigned to standard dose) were randomized. Mean AUC sUA1-8 was 514.0 ± 225.71 versus 708.0 ± 234.42 mgxh/dl (P < 0.0001) in favor of febuxostat. Mean serum creatinine change was -0.83 ± 26.98% and -4.92 ± 16.70% for febuxostat and allopurinol, respectively (P = 0.0903). No differences among secondary efficacy end points were detected. Drug-related adverse events occurred in 6.4% of patients in both arms. CONCLUSION: In the largest adult trial carried out in TLS prevention, febuxostat achieved a significant superior sUA control with one fixed dose in comparison to allopurinol with comparable renal function preservation and safety profile.
ER -
SPINA, M., Z. NAGY, J.M. RIBERA, M. FEDERICO, I. AURER, K. JORDAN, G. BORSARU, A.S. PRISTUPA, A. BOSI, S. GROSICKI, N.L. GLUSHKO, D. RISTIC, J. JAKUCS, P. MONTESINOS, Jiří MAYER, E.M. REGO, S. BALDINI, S. SCARTONI, A. CAPRIATI, CA MAGGI a C. SIMONELLI. 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. \textit{Annals of Oncology}. Oxford: Oxford University Press, 2015, roč.~26, č.~10, s.~2155-2161. ISSN~0923-7534. Dostupné z: https://dx.doi.org/10.1093/annonc/mdv317.
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