TY - JOUR
T1 - Front-line treatment of acute promyelocytic leukemia with AIDA induction followed by risk-adapted consolidation for adults younger than 61 years
T2 - Results of the AIDA-2000 trial of the GIMEMA Group
AU - Lo-Coco, Francesco
AU - Avvisati, Giuseppe
AU - Vignetti, Marco
AU - Breccia, Massimo
AU - Gallo, Eugenio
AU - Rambaldi, Alessandro
AU - Paoloni, Francesca
AU - Fioritoni, Giuseppe
AU - Ferrara, Felicetto
AU - Specchia, Giorgina
AU - Cimino, Giuseppe
AU - Diverio, Daniela
AU - Borlenghi, Erika
AU - Martinelli, Giovanni
AU - Di Raimondo, Francesco
AU - Di Bona, Eros
AU - Fazi, Paola
AU - Peta, Antonio
AU - Bosi, Alberto
AU - Carella, Angelo M.
AU - Fabbiano, Francesco
AU - Pogliani, Enrico M.
AU - Petti, Maria C.
AU - Amadori, Sergio
AU - Mandelli, Franco
PY - 2010/10/28
Y1 - 2010/10/28
N2 - After the identification of discrete relapse-risk categories in patients with acute promyelocytic leukemia (APL) receiving alltrans 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. This trial was registered at www.clinicaltrials.gov as #NCT 001064570.
AB - After the identification of discrete relapse-risk categories in patients with acute promyelocytic leukemia (APL) receiving alltrans 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. This trial was registered at www.clinicaltrials.gov as #NCT 001064570.
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U2 - 10.1182/blood-2010-03-276196
DO - 10.1182/blood-2010-03-276196
M3 - Article
C2 - 20644121
AN - SCOPUS:77958499078
VL - 116
SP - 3171
EP - 3179
JO - Blood
JF - Blood
SN - 0006-4971
IS - 17
ER -