| Literature DB >> 27400939 |
Uwe Platzbecker1, Giuseppe Avvisati1, Laura Cicconi1, Christian Thiede1, Francesca Paoloni1, Marco Vignetti1, Felicetto Ferrara1, Mariadomenica Divona1, Francesco Albano1, Fabio Efficace1, Paola Fazi1, Marco Sborgia1, Eros Di Bona1, Massimo Breccia1, Erika Borlenghi1, Roberto Cairoli1, Alessandro Rambaldi1, Lorella Melillo1, Giorgio La Nasa1, Walter Fiedler1, Peter Brossart1, Bernd Hertenstein1, Helmut R Salih1, Mohammed Wattad1, Michael Lübbert1, Christian H Brandts1, Mathias Hänel1, Christoph Röllig1, Norbert Schmitz1, Hartmut Link1, Chiara Frairia1, Enrico Maria Pogliani1, Claudio Fozza1, Alfonso Maria D'Arco1, Nicola Di Renzo1, Agostino Cortelezzi1, Francesco Fabbiano1, Konstanze Döhner1, Arnold Ganser1, Hartmut Döhner1, Sergio Amadori1, Franco Mandelli1, Gerhard Ehninger1, Richard F Schlenk1, Francesco Lo-Coco1.
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 × 109/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.Entities:
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Year: 2016 PMID： 27400939 DOI： 10.1200/JCO.2016.67.1982
Source DB: PubMed Journal: J Clin Oncol ISSN： 0732-183X Impact factor: 44.544