Front-line treatment of acute promyelocytic leukemia with AIDA induction followed by risk-adapted consolidation for adults younger than 61 years: results of the AIDA-2000 trial of the GIMEMA Group
Francesco Lo-Coco, Giuseppe Avvisati, Marco Vignetti, Massimo Breccia, Eugenio Gallo, Alessandro Rambaldi, Francesca Paoloni, Giuseppe Fioritoni, Felicetto Ferrara, Giorgina Specchia, Giuseppe Cimino, Daniela Diverio, Erika Borlenghi, Giovanni Martinelli, Francesco Di Raimondo, Eros Di Bona, Paola Fazi, Antonio Peta, Alberto Bosi, Angelo M Carella, Francesco Fabbiano, Enrico M Pogliani, Maria C Petti, Sergio Amadori, Franco Mandelli, Italian GIMEMA Cooperative Group, Francesco Lo-Coco, Giuseppe Avvisati, Marco Vignetti, Massimo Breccia, Eugenio Gallo, Alessandro Rambaldi, Francesca Paoloni, Giuseppe Fioritoni, Felicetto Ferrara, Giorgina Specchia, Giuseppe Cimino, Daniela Diverio, Erika Borlenghi, Giovanni Martinelli, Francesco Di Raimondo, Eros Di Bona, Paola Fazi, Antonio Peta, Alberto Bosi, Angelo M Carella, Francesco Fabbiano, Enrico M Pogliani, Maria C Petti, Sergio Amadori, Franco Mandelli, Italian GIMEMA Cooperative Group
Abstract
After the identification of discrete relapse-risk categories in patients with acute promyelocytic leukemia (APL) receiving all-trans retinoic and idarubicin (AIDA)-like therapies, the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) designed a protocol for newly diagnosed APL (AIDA-2000) in which postremission treatment was risk-adapted. Patients with low/intermediate risk received remission at 3 anthracycline-based consolidation courses, whereas high-risk patients received the same schedule as in the previous, non-risk-adapted AIDA-0493 trial including cytarabine. In addition, all patients in the AIDA-2000 received all-trans retinoic acid (ATRA) for 15 days during each consolidation. After induction, 600 of 636 (94.3%) and 420 of 445 (94.4%) patients achieved complete remission in the AIDA-0493 and AIDA-2000, respectively. The 6-year overall survival and cumulative incidence of relapse (CIR) rates were 78.1% versus 87.4% (P = .001) and 27.7% versus 10.7% (P < .0001). Significantly lower CIR rates for patients in the AIDA-2000 were most evident in the high-risk group (49.7% vs 9.3%, respectively, P < .0001). Our data confirm that anthracycline-based consolidation is at least equally effective as cytarabine-containing regimens for low-/intermediate-risk patients and suggest that a risk-adapted strategy including ATRA for consolidation improves outcome in newly diagnosed APL. Furthermore, our results highlight the role of cytarabine coupled to anthracyclines and ATRA during consolidation in the high-risk group.
Trial registration: ClinicalTrials.gov NCT01064570.
Source: PubMed