Improved Outcomes With Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in Non-High-Risk Acute Promyelocytic Leukemia: A study of the AML study group (AMLSG)
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Improved Outcomes With Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in Non-High-Risk Acute Promyelocytic Leukemia: A study of the AML study group (AMLSG). / Platzbecker, Uwe; Avvisati, Giuseppe; Cicconi, Laura; Thiede, Christian; Paoloni, Francesca; Vignetti, Marco; Ferrara, Felicetto; Divona, Mariadomenica; Albano, Francesco; Efficace, Fabio; Fazi, Paola; Sborgia, Marco; Di Bona, Eros; Breccia, Massimo; Borlenghi, Erika; Cairoli, Roberto; Rambaldi, Alessandro; Melillo, Lorella; La Nasa, Giorgio; Fiedler, Walter; Brossart, Peter; Hertenstein, Bernd; Salih, Helmut R; Wattad, Mohammed; Lübbert, Michael; Brandts, Christian H; Hänel, Mathias; Röllig, Christoph; Schmitz, Norbert; Link, Hartmut; Frairia, Chiara; Pogliani, Enrico Maria; Fozza, Claudio; D'Arco, Alfonso Maria; Di Renzo, Nicola; Cortelezzi, Agostino; Fabbiano, Francesco; Döhner, Konstanze; Ganser, Arnold; Döhner, Hartmut; Amadori, Sergio; Mandelli, Franco; Ehninger, Gerhard; Schlenk, Richard F; Lo-Coco, Francesco.
in: J CLIN ONCOL, Jahrgang 35, Nr. 6, 20.02.2017, S. 605-612.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - Improved Outcomes With Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in Non-High-Risk Acute Promyelocytic Leukemia: A study of the AML study group (AMLSG)
AU - Platzbecker, Uwe
AU - Avvisati, Giuseppe
AU - Cicconi, Laura
AU - Thiede, Christian
AU - Paoloni, Francesca
AU - Vignetti, Marco
AU - Ferrara, Felicetto
AU - Divona, Mariadomenica
AU - Albano, Francesco
AU - Efficace, Fabio
AU - Fazi, Paola
AU - Sborgia, Marco
AU - Di Bona, Eros
AU - Breccia, Massimo
AU - Borlenghi, Erika
AU - Cairoli, Roberto
AU - Rambaldi, Alessandro
AU - Melillo, Lorella
AU - La Nasa, Giorgio
AU - Fiedler, Walter
AU - Brossart, Peter
AU - Hertenstein, Bernd
AU - Salih, Helmut R
AU - Wattad, Mohammed
AU - Lübbert, Michael
AU - Brandts, Christian H
AU - Hänel, Mathias
AU - Röllig, Christoph
AU - Schmitz, Norbert
AU - Link, Hartmut
AU - Frairia, Chiara
AU - Pogliani, Enrico Maria
AU - Fozza, Claudio
AU - D'Arco, Alfonso Maria
AU - Di Renzo, Nicola
AU - Cortelezzi, Agostino
AU - Fabbiano, Francesco
AU - Döhner, Konstanze
AU - Ganser, Arnold
AU - Döhner, Hartmut
AU - Amadori, Sergio
AU - Mandelli, Franco
AU - Ehninger, Gerhard
AU - Schlenk, Richard F
AU - Lo-Coco, Francesco
N1 - © 2016 by American Society of Clinical Oncology.
PY - 2017/2/20
Y1 - 2017/2/20
N2 - PURPOSE: The initial results of the APL0406 trial showed that the combination of all-trans-retinoic acid (ATRA) and arsenic trioxide (ATO) is at least not inferior to standard ATRA and chemotherapy (CHT) in first-line therapy of low- or intermediate-risk acute promyelocytic leukemia (APL). We herein report the final analysis on the complete series of patients enrolled onto this trial.PATIENTS AND METHODS: The APL0406 study was a prospective, randomized, multicenter, open-label, phase III noninferiority trial. Eligible patients were adults between 18 and 71 years of age with newly diagnosed, low- or intermediate-risk APL (WBC at diagnosis ≤ 10 × 10(9)/L). Overall, 276 patients were randomly assigned to receive ATRA-ATO or ATRA-CHT between October 2007 and January 2013.RESULTS: Of 263 patients evaluable for response to induction, 127 (100%) of 127 patients and 132 (97%) of 136 patients achieved complete remission (CR) in the ATRA-ATO and ATRA-CHT arms, respectively (P = .12). After a median follow-up of 40.6 months, the event-free survival, cumulative incidence of relapse, and overall survival at 50 months for patients in the ATRA-ATO versus ATRA-CHT arms were 97.3% v 80%, 1.9% v 13.9%, and 99.2% v 92.6%, respectively (P < .001, P = .0013, and P = .0073, respectively). Postinduction events included two relapses and one death in CR in the ATRA-ATO arm and two instances of molecular resistance after third consolidation, 15 relapses, and five deaths in CR in the ATRA-CHT arm. Two patients in the ATRA-CHT arm developed a therapy-related myeloid neoplasm.CONCLUSION: These results show that the advantages of ATRA-ATO over ATRA-CHT increase over time and that there is significantly greater and more sustained antileukemic efficacy of ATO-ATRA compared with ATRA-CHT in low- and intermediate-risk APL.
AB - PURPOSE: The initial results of the APL0406 trial showed that the combination of all-trans-retinoic acid (ATRA) and arsenic trioxide (ATO) is at least not inferior to standard ATRA and chemotherapy (CHT) in first-line therapy of low- or intermediate-risk acute promyelocytic leukemia (APL). We herein report the final analysis on the complete series of patients enrolled onto this trial.PATIENTS AND METHODS: The APL0406 study was a prospective, randomized, multicenter, open-label, phase III noninferiority trial. Eligible patients were adults between 18 and 71 years of age with newly diagnosed, low- or intermediate-risk APL (WBC at diagnosis ≤ 10 × 10(9)/L). Overall, 276 patients were randomly assigned to receive ATRA-ATO or ATRA-CHT between October 2007 and January 2013.RESULTS: Of 263 patients evaluable for response to induction, 127 (100%) of 127 patients and 132 (97%) of 136 patients achieved complete remission (CR) in the ATRA-ATO and ATRA-CHT arms, respectively (P = .12). After a median follow-up of 40.6 months, the event-free survival, cumulative incidence of relapse, and overall survival at 50 months for patients in the ATRA-ATO versus ATRA-CHT arms were 97.3% v 80%, 1.9% v 13.9%, and 99.2% v 92.6%, respectively (P < .001, P = .0013, and P = .0073, respectively). Postinduction events included two relapses and one death in CR in the ATRA-ATO arm and two instances of molecular resistance after third consolidation, 15 relapses, and five deaths in CR in the ATRA-CHT arm. Two patients in the ATRA-CHT arm developed a therapy-related myeloid neoplasm.CONCLUSION: These results show that the advantages of ATRA-ATO over ATRA-CHT increase over time and that there is significantly greater and more sustained antileukemic efficacy of ATO-ATRA compared with ATRA-CHT in low- and intermediate-risk APL.
U2 - 10.1200/JCO.2016.67.1982
DO - 10.1200/JCO.2016.67.1982
M3 - SCORING: Journal article
C2 - 27400939
VL - 35
SP - 605
EP - 612
JO - J CLIN ONCOL
JF - J CLIN ONCOL
SN - 0732-183X
IS - 6
ER -