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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)

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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, Vol. 35, No. 6, 20.02.2017, p. 605-612.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Platzbecker, U, Avvisati, G, Cicconi, L, Thiede, C, Paoloni, F, Vignetti, M, Ferrara, F, Divona, M, Albano, F, Efficace, F, Fazi, P, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, HR, Wattad, M, Lübbert, M, Brandts, CH, Hänel, M, Röllig, C, Schmitz, N, Link, H, Frairia, C, Pogliani, EM, Fozza, C, D'Arco, AM, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Döhner, K, Ganser, A, Döhner, H, Amadori, S, Mandelli, F, Ehninger, G, Schlenk, RF & Lo-Coco, F 2017, '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)', J CLIN ONCOL, vol. 35, no. 6, pp. 605-612. https://doi.org/10.1200/JCO.2016.67.1982

APA

Platzbecker, U., Avvisati, G., Cicconi, L., Thiede, C., Paoloni, F., Vignetti, M., Ferrara, F., Divona, M., Albano, F., Efficace, F., Fazi, P., Sborgia, M., Di Bona, E., Breccia, M., Borlenghi, E., Cairoli, R., Rambaldi, A., Melillo, L., La Nasa, G., ... Lo-Coco, F. (2017). 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). J CLIN ONCOL, 35(6), 605-612. https://doi.org/10.1200/JCO.2016.67.1982

Vancouver

Platzbecker U, Avvisati G, Cicconi L, Thiede C, Paoloni F, Vignetti M et al. 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). J CLIN ONCOL. 2017 Feb 20;35(6):605-612. https://doi.org/10.1200/JCO.2016.67.1982

Bibtex

@article{4a48d173f12945c28e6ac6a375d7aa76,
title = "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)",
abstract = "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.",
author = "Uwe Platzbecker and Giuseppe Avvisati and Laura Cicconi and Christian Thiede and Francesca Paoloni and Marco Vignetti and Felicetto Ferrara and Mariadomenica Divona and Francesco Albano and Fabio Efficace and Paola Fazi and Marco Sborgia and {Di Bona}, Eros and Massimo Breccia and Erika Borlenghi and Roberto Cairoli and Alessandro Rambaldi and Lorella Melillo and {La Nasa}, Giorgio and Walter Fiedler and Peter Brossart and Bernd Hertenstein and Salih, {Helmut R} and Mohammed Wattad and Michael L{\"u}bbert and Brandts, {Christian H} and Mathias H{\"a}nel and Christoph R{\"o}llig and Norbert Schmitz and Hartmut Link and Chiara Frairia and Pogliani, {Enrico Maria} and Claudio Fozza and D'Arco, {Alfonso Maria} and {Di Renzo}, Nicola and Agostino Cortelezzi and Francesco Fabbiano and Konstanze D{\"o}hner and Arnold Ganser and Hartmut D{\"o}hner and Sergio Amadori and Franco Mandelli and Gerhard Ehninger and Schlenk, {Richard F} and Francesco Lo-Coco",
note = "{\textcopyright} 2016 by American Society of Clinical Oncology.",
year = "2017",
month = feb,
day = "20",
doi = "10.1200/JCO.2016.67.1982",
language = "English",
volume = "35",
pages = "605--612",
journal = "J CLIN ONCOL",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "6",

}

RIS

TY - JOUR

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 -