作者
Uwe Platzbecker, Giuseppe Avvisati, Laura Cicconi, Christian Thiede, Francesca Paoloni, Marco Vignetti, Felicetto Ferrara, Mariadomenica Divona, Francesco Albano, Fabio Efficace, Paola Fazi, Marco Sborgia, Eros Di Bona, Massimo Breccia, Erika Borlenghi, Roberto Cairoli, Alessandro Rambaldi, Lorella Melillo, Giorgio La Nasa, Walter Fiedler, Peter Brossart, Bernd Hertenstein, Helmut R Salih, Mohammed Wattad, Michael Lübbert, Christian H Brandts, Mathias Hänel, Christoph Röllig, Norbert Schmitz, Hartmut Link, Chiara Frairia, Enrico Maria Pogliani, Claudio Fozza, Alfonso Maria D’Arco, Nicola Di Renzo, Agostino Cortelezzi, Francesco Fabbiano, Konstanze Döhner, Arnold Ganser, Hartmut Döhner, Sergio Amadori, Franco Mandelli, Gerhard Ehninger, Richard F Schlenk, Francesco Lo-Coco
发表日期
2017/2/20
期刊
Journal of Clinical Oncology
卷号
35
期号
6
页码范围
605-612
出版商
American Society of Clinical Oncology
简介
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 …
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U Platzbecker, G Avvisati, L Cicconi, C Thiede… - Journal of Clinical Oncology, 2017