• Je něco špatně v tomto záznamu ?

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

M. Spina, Z. Nagy, JM. Ribera, M. Federico, I. Aurer, K. Jordan, G. Borsaru, AS. Pristupa, A. Bosi, S. Grosicki, NL. Glushko, D. Ristic, J. Jakucs, P. Montesinos, J. Mayer, EM. Rego, S. Baldini, S. Scartoni, A. Capriati, CA. Maggi, C. Simonelli, . ,

. 2015 ; 26 (10) : 2155-61. [pub] 20150727

Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc16028342

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. CLINICAL TRIAL REGISTRATION: NCT01724528.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc16028342
003      
CZ-PrNML
005      
20161018120004.0
007      
ta
008      
161005s2015 enk f 000 0|eng||
009      
AR
024    7_
$a 10.1093/annonc/mdv317 $2 doi
024    7_
$a 10.1093/annonc/mdv317 $2 doi
035    __
$a (PubMed)26216382
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a enk
100    1_
$a Spina, M $u Division of Medical Oncology A, National Cancer Institute, Aviano, Italy mspina@cro.it.
245    10
$a 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 / $c M. Spina, Z. Nagy, JM. Ribera, M. Federico, I. Aurer, K. Jordan, G. Borsaru, AS. Pristupa, A. Bosi, S. Grosicki, NL. Glushko, D. Ristic, J. Jakucs, P. Montesinos, J. Mayer, EM. Rego, S. Baldini, S. Scartoni, A. Capriati, CA. Maggi, C. Simonelli, . ,
520    9_
$a 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. CLINICAL TRIAL REGISTRATION: NCT01724528.
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a senioři nad 80 let $7 D000369
650    _2
$a alopurinol $x terapeutické užití $7 D000493
650    _2
$a dvojitá slepá metoda $7 D004311
650    _2
$a febuxostat $x terapeutické užití $7 D000069465
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a následné studie $7 D005500
650    _2
$a antiuratika $x terapeutické užití $7 D006074
650    _2
$a hematologické nádory $x farmakoterapie $x patologie $7 D019337
650    _2
$a lidé $7 D006801
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a staging nádorů $7 D009367
650    _2
$a prognóza $7 D011379
650    _2
$a rizikové faktory $7 D012307
650    _2
$a syndrom nádorového rozpadu $x krev $x prevence a kontrola $7 D015275
650    _2
$a kyselina močová $x krev $7 D014527
650    _2
$a mladý dospělý $7 D055815
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a srovnávací studie $7 D003160
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Nagy, Z $u First Department of Medicine, Semmelweis University Medical School, Budapest, Hungary.
700    1_
$a Ribera, J M $u ICO-Hospital Germans Trias i Pujol, Jose Carreras Research Institute, UAB, Badalona, Spain.
700    1_
$a Federico, M $u Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy.
700    1_
$a Aurer, I $u University Hospital Centre Zagreb and Medical School, Zagreb, Croatia. $7 gn_A_00010145
700    1_
$a Jordan, K $u Department of Hematology and Oncology, Martin Luther University Halle-Wittenberg, Halle, Germany.
700    1_
$a Borsaru, G $u Department of Hematology, "Coltea" Clinical Hospital, Bucharest, Romania.
700    1_
$a Pristupa, A S $u Department of Hematology, Ryazan Regional Clinical Hospital, Ryazan, Russia.
700    1_
$a Bosi, A $u Hematology Unit, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.
700    1_
$a Grosicki, S $u Department of Cancer Prevention, Faculty of Public Health, Silesian Medical University in Katowice, Katowice, Poland.
700    1_
$a Glushko, N L $u Department of Hematology, Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, Ukraine.
700    1_
$a Ristic, D $u Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.
700    1_
$a Jakucs, J $u First Department of Internal Medicine Endocrinology and Hematology, Pandy Kalman Megyei Korhaz, Gyula, Hungary.
700    1_
$a Montesinos, P $u Department of Hematology, Hospital Universitario La Fe, Valencia, Spain.
700    1_
$a Mayer, J $u Department of Internal Medicine, Hematology and Oncology, University Hospital Brno, Brno, Czech Republic.
700    1_
$a Rego, E M $u Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto-USP, Ribeirão Preto, Brazil.
700    1_
$a Baldini, S $u Department of Clinical Research, Menarini Ricerche, Firenze, Italy.
700    1_
$a Scartoni, S $u Department of Clinical Research, Menarini Ricerche, Firenze, Italy.
700    1_
$a Capriati, A $u Department of Clinical Research, Menarini Ricerche, Firenze, Italy.
700    1_
$a Maggi, C A $u Department of Clinical Research, Menarini Ricerche, Firenze, Italy.
700    1_
$a Simonelli, C $u Department of Clinical Research, Menarini Ricerche, Firenze, Italy.
700    1_
$a ,
773    0_
$w MED00000432 $t Annals of oncology official journal of the European Society for Medical Oncology ESMO $x 1569-8041 $g Roč. 26, č. 10 (2015), s. 2155-61
856    41
$u https://pubmed.ncbi.nlm.nih.gov/26216382 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20161005 $b ABA008
991    __
$a 20161018120408 $b ABA008
999    __
$a ok $b bmc $g 1166656 $s 952972
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2015 $b 26 $c 10 $d 2155-61 $e 20150727 $i 1569-8041 $m Annals of oncology $n Ann Oncol $x MED00000432
LZP    __
$a Pubmed-20161005

Najít záznam

Citační ukazatele

Možnosti archivace