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

Spina, Michele; Nagy, Zsolt; Ribera, Josep‐Marǐa; Federico, Massimo; Aurer, Igor; Jordan, Karin; Borsaru, Gabriela; Pristupa, Alexander; Bosi, Alberto; Grosicki, Sebastian; Glushko, Nataliia; Ristić, Dušan; Jakucs, János; Montesinos, Pau; Mayer, Jiřı́; Rego, Eduardo Magalhães; Baldini, Simone; Scartoni, Simona; Capriati, Angela; Maggi, Carlo Alberto; Simonelli, Cecilia

doi:10.1093/annonc/mdv317

Cited by 73 publications

(51 citation statements)

References 18 publications

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“…Serum uric acid levels at days 2 and 7 were found to be significantly lower than the baseline values in patients treated with febuxostat. Compared to allopurinol, febuxostat achieved similar serum uric acid levels at day 2 in 2 studies, while significantly lower values were reported in largest RCT . Correspondingly, day 7 serum uric acid did not differ between the 2 groups in 2 studies, while another 2 observed that febuxostat leads to significantly lower values.…”

Section: Resultsmentioning

confidence: 81%

“…The most important methodological characteristics (study design, exclusion criteria, population and disease type, criteria for TLS diagnosis and response definition, timing and dosage of febuxostat and allopurinol) of the included studies are described in Table . Three studies were RCTs, while the rest 3 were observational with a cohort design . Patients with severe kidney impairment were excluded from the majority of the studies.…”

Section: Resultsmentioning

confidence: 99%

“…In addition, safe conclusions about the optimal preventive protocol cannot be safely drawn, since remarkable variation of febuxostat doses was present among studies. It should be noted that the highest fixed dose (120 mg/d) was tested in the largest included RCT, proposing that febuxostat was well‐tolerated and effectively leads to a rapid fall of serum uric acid concentration. In addition, the comparability of the included studies is limited as the majority of them did not report the implemented hydration protocol, although it represents one of the most important prophylactic measures for TLS prevention.…”

Section: Discussionmentioning

confidence: 99%

“…Six studies [22][23][24][25][26][27] were finally included in the present review, with a total of 659 patients. Among them, 331 were treated with febuxostat, while allopurinol was administered in the rest 328 patients.…”

Section: Included Studiesmentioning

confidence: 99%

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Febuxostat administration for the prevention of tumour lysis syndrome: A meta‐analysis

et al. 2019

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Summary What is known and objective Tumour lysis syndrome is an oncological emergency, characterized by rapid cytolysis leading to an abrupt rise of serum uric acid levels. The aim of the present meta‐analysis is to evaluate the efficacy and safety of febuxostat as a preventive measure in patients at risk of tumour lysis syndrome development, by comparing it with allopurinol administration. Methods MEDLINE, Scopus, Cochrane Central Register of Controlled Trials, Clinicaltrials.gov and Google Scholar databases were searched from inception to 15 December 2018. All studies evaluating the effectiveness of febuxostat in preventing tumour lysis syndrome were held eligible. Results and Discussion Six studies were included with a total of 658 patients. Compared to allopurinol, febuxostat achieved a similar response rate (OR: 1.39, 95% CI: [0.55, 3.51]) and tumour lysis syndrome incidence (OR: 1.01, 95% CI: [0.56, 1.81]). Serum uric acid levels did not differ between the investigated groups at the second (MD: −0.21 mg/dL, 95% CI: [−1.30, 0.88]) and seventh (MD: −0.43 mg/dL, 95% CI: [−1.38, 0.51]) day of treatment. Elevation of liver function tests was the most common adverse effect, although its incidence was similar among patients treated with allopurinol and febuxostat. What is new and conclusions The present meta‐analysis suggests that febuxostat may serve as an effective alternative to allopurinol in the prevention of tumour lysis syndrome. Future large‐scale studies should define the optimal febuxostat dosage, explore the most appropriate population for its administration and better define its safety profile.

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Section: Resultsmentioning

confidence: 81%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Included Studiesmentioning

confidence: 99%

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Febuxostat administration for the prevention of tumour lysis syndrome: A meta‐analysis

et al. 2019

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“…Bei wiederholten Cisplatindosen von >100 mg/m 2 ist die Gabe von Mannitol mit einem verminderten Auftreten von AKI assoziiert [55]. Eine Präventionsmaßnahme für Patienten mit einem hohen Risiko für ein Tumorlysesyndrom ist die Gabe von Xanthinoxidaseinhibitoren [74]. Die im deutschsprachigen Raum tätige iCHOPGruppe ("intensive care in hematologic-oncologic patients") stellt auch das Thema AKI in das Zentrum ihrer fortlaufenden Analysen [70].…”

Section: Patienten Mit Hämato-onkologischen Erkrankungenunclassified

Prävention der akuten Nierenschädigung beim kritisch kranken Patienten

Joannidis

Klein

John

et al. 2018

Med Klin Intensivmed Notfmed

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Die akute Nierenschädigung ("acute kidney injury", AKI) ist ein komplexes Krankheitsbild, das durchschnittlich 50 % der Patienten auf Intensivstationen weltweit betrifft und mit erhöhter Morbidität und Mortalität einhergeht [32,36]. Das Spektrum der AKI reicht von einer Schädigung der Niere ohne Funktionsverlust bis zum Versagen des Organs mit der Notwendigkeit einer Nierenersatztherapie.Über die letzten Jahre wurden Diagnosekriterien für die AKI entwickelt. Die aktuellsten stellen die KDIGO-Leitlinien (KDIGO: "Kidney Disease: Improving Global Outcomes") aus dem Jahr 2012 dar, in denen auch die Klassifikation der AKI geregelt wird.

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