Detail
Article
Online article
FT
Medvik - BMC
  • Something wrong with this record ?

Guadecitabine vs treatment choice in newly diagnosed acute myeloid leukemia: a global phase 3 randomized study

P. Fenaux, M. Gobbi, PL. Kropf, JJ. Issa, GJ. Roboz, J. Mayer, J. Krauter, T. Robak, H. Kantarjian, J. Novak, WW. Jedrzejczak, X. Thomas, M. Ojeda-Uribe, Y. Miyazaki, YH. Min, SP. Yeh, J. Brandwein, L. Gercheva-Kyuchukova, J. Demeter, E....

. 2023 ; 7 (17) : 5027-5037. [pub] 2023Sep12

Language English Country United States

Document type Clinical Trial, Phase III, Randomized Controlled Trial, Journal Article, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc23016248

This phase 3 study evaluated the efficacy and safety of the new hypomethylating agent guadecitabine (n = 408) vs a preselected treatment choice (TC; n = 407) of azacitidine, decitabine, or low-dose cytarabine in patients with acute myeloid leukemia unfit to receive intensive induction chemotherapy. Half of the patients (50%) had poor Eastern Cooperative Oncology Group Performance Status (2-3). The coprimary end points were complete remission (19% and 17% of patients for guadecitabine and TC, respectively [stratified P = .48]) and overall survival (median survival 7.1 and 8.5 months for guadecitabine and TC, respectively [hazard ratio, 0.97; 95% confidence interval, 0.83-1.14; stratified log-rank P = .73]). One- and 2-year survival estimates were 37% and 18% for guadecitabine and 36% and 14% for TC, respectively. A large proportion of patients (42%) received <4 cycles of treatment in both the arms. In a post hoc analysis of patients who received ≥4 treatment cycles, guadecitabine was associated with longer median survival vs TC (15.6 vs 13.0 months [hazard ratio, 0.78; 95% confidence interval, 0.64-0.96; log-rank P = .02]). There was no significant difference in the proportion of patients with grade ≥3 adverse events (AEs) between guadecitabine (92%) and TC (88%); however, grade ≥3 AEs of febrile neutropenia, neutropenia, and pneumonia were higher with guadecitabine. In conclusion, no significant difference was observed in the efficacy of guadecitabine and TC in the overall population. This trial was registered at www.clinicaltrials.gov as #NCT02348489.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc23016248
003      
CZ-PrNML
005      
20240516120803.0
007      
ta
008      
231013s2023 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1182/bloodadvances.2023010179 $2 doi
035    __
$a (PubMed)37276510
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Fenaux, Pierre $u Hôpital Saint-Louis, Paris, France
245    10
$a Guadecitabine vs treatment choice in newly diagnosed acute myeloid leukemia: a global phase 3 randomized study / $c P. Fenaux, M. Gobbi, PL. Kropf, JJ. Issa, GJ. Roboz, J. Mayer, J. Krauter, T. Robak, H. Kantarjian, J. Novak, WW. Jedrzejczak, X. Thomas, M. Ojeda-Uribe, Y. Miyazaki, YH. Min, SP. Yeh, J. Brandwein, L. Gercheva-Kyuchukova, J. Demeter, E. Griffiths, K. Yee, K. Döhner, Y. Hao, H. Keer, M. Azab, H. Döhner
520    9_
$a This phase 3 study evaluated the efficacy and safety of the new hypomethylating agent guadecitabine (n = 408) vs a preselected treatment choice (TC; n = 407) of azacitidine, decitabine, or low-dose cytarabine in patients with acute myeloid leukemia unfit to receive intensive induction chemotherapy. Half of the patients (50%) had poor Eastern Cooperative Oncology Group Performance Status (2-3). The coprimary end points were complete remission (19% and 17% of patients for guadecitabine and TC, respectively [stratified P = .48]) and overall survival (median survival 7.1 and 8.5 months for guadecitabine and TC, respectively [hazard ratio, 0.97; 95% confidence interval, 0.83-1.14; stratified log-rank P = .73]). One- and 2-year survival estimates were 37% and 18% for guadecitabine and 36% and 14% for TC, respectively. A large proportion of patients (42%) received <4 cycles of treatment in both the arms. In a post hoc analysis of patients who received ≥4 treatment cycles, guadecitabine was associated with longer median survival vs TC (15.6 vs 13.0 months [hazard ratio, 0.78; 95% confidence interval, 0.64-0.96; log-rank P = .02]). There was no significant difference in the proportion of patients with grade ≥3 adverse events (AEs) between guadecitabine (92%) and TC (88%); however, grade ≥3 AEs of febrile neutropenia, neutropenia, and pneumonia were higher with guadecitabine. In conclusion, no significant difference was observed in the efficacy of guadecitabine and TC in the overall population. This trial was registered at www.clinicaltrials.gov as #NCT02348489.
650    _2
$a lidé $7 D006801
650    _2
$a výsledek terapie $7 D016896
650    12
$a azacytidin $x škodlivé účinky $7 D001374
650    _2
$a cytarabin $x škodlivé účinky $7 D003561
650    12
$a akutní myeloidní leukemie $x diagnóza $x farmakoterapie $7 D015470
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a časopisecké články $7 D016428
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Gobbi, Marco $u Ospedale Policlinico San Martino, Genova, Italy
700    1_
$a Kropf, Patricia L $u Novant Health Cancer Institute - Elizabeth, Charlotte, NC
700    1_
$a Issa, Jean-Pierre J $u Coriell Institute for Medical Research, Camden, NJ
700    1_
$a Roboz, Gail J $u Weill Cornell Medicine, New York, NY $1 https://orcid.org/0000000203843658
700    1_
$a Mayer, Jiri $u Fakultní Nemocnice, Brno, Česká Republika
700    1_
$a Krauter, Jürgen $u Städtisches Klinikum Braunschweig gGmbH, Braunschweig, Germany
700    1_
$a Robak, Tadeusz $u Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland $1 https://orcid.org/0000000234116357
700    1_
$a Kantarjian, Hagop $u The University of Texas MD Anderson Cancer Center, Houston, TX
700    1_
$a Novak, Jan $u Univerzita Karlova, Praha, Česká Republika
700    1_
$a Jedrzejczak, Wieslaw W $u Samodzielny Publiczny Centralny Szpital Kliniczny, Warszawa, Poland $1 https://orcid.org/0000000268133331
700    1_
$a Thomas, Xavier $u Hôpital Lyon Sud, Pierre Bénite, France $7 xx0317364
700    1_
$a Ojeda-Uribe, Mario $u GHR Mulhouse Sud-Alsace, Mulhouse, France
700    1_
$a Miyazaki, Yasushi $u Nagasaki University Hospital, Nagasaki, Japan
700    1_
$a Min, Yoo Hong $u Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea
700    1_
$a Yeh, Su-Peng $u China Medical University Hospital, Taichung City, Taiwan
700    1_
$a Brandwein, Joseph $u University of Alberta Hospital, Edmonton, Canada $1 https://orcid.org/0000000190958789
700    1_
$a Gercheva-Kyuchukova, Liana $u Hospital "St. Marina" EAD, Varna, Bulgaria
700    1_
$a Demeter, Judit $u Semmelweis Egyetem, Budapest, Hungary $1 https://orcid.org/0000000187450757
700    1_
$a Griffiths, Elizabeth $u Roswell Park Comprehensive Cancer Institute, Buffalo, NY $1 https://orcid.org/0000000202888248
700    1_
$a Yee, Karen $u Princess Margaret Cancer Centre, Toronto, ON, Canada $1 https://orcid.org/0000000225729952
700    1_
$a Döhner, Konstanze $u Ulm University Hospital, Ulm, Germany
700    1_
$a Hao, Yong $u Astex Pharmaceuticals Inc, Pleasanton, CA
700    1_
$a Keer, Harold $u Astex Pharmaceuticals Inc, Pleasanton, CA
700    1_
$a Azab, Mohammad $u Astex Pharmaceuticals Inc, Pleasanton, CA
700    1_
$a Döhner, Hartmut $u Ulm University Hospital, Ulm, Germany $1 https://orcid.org/0000000321165536
773    0_
$w MED00194912 $t Blood advances $x 2473-9537 $g Roč. 7, č. 17 (2023), s. 5027-5037
856    41
$u https://pubmed.ncbi.nlm.nih.gov/37276510 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20231013 $b ABA008
991    __
$a 20240516120757 $b ABA008
999    __
$a ok $b bmc $g 2000018 $s 1202610
BAS    __
$a 3
BAS    __
$a PreBMC-MEDLINE
BMC    __
$a 2023 $b 7 $c 17 $d 5027-5037 $e 2023Sep12 $i 2473-9537 $m Blood advances $n Blood Adv $x MED00194912
LZP    __
$a Pubmed-20231013

Find record

Citation metrics

Archiving options