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.
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.
Lo-Coco
Francesco
F
Department of Biopathology, University Tor Vergata of Rome, Via Montpellier 1, Rome, Italy. francesco.lo.coco@uniroma2.it
Avvisati
Giuseppe
G
Vignetti
Marco
M
Breccia
Massimo
M
Gallo
Eugenio
E
Rambaldi
Alessandro
A
Paoloni
Francesca
F
Fioritoni
Giuseppe
G
Ferrara
Felicetto
F
Specchia
Giorgina
G
Cimino
Giuseppe
G
Diverio
Daniela
D
Borlenghi
Erika
E
Martinelli
Giovanni
G
Di Raimondo
Francesco
F
Di Bona
Eros
E
Fazi
Paola
P
Peta
Antonio
A
Bosi
Alberto
A
Carella
Angelo M
AM
Fabbiano
Francesco
F
Pogliani
Enrico M
EM
Petti
Maria C
MC
Amadori
Sergio
S
Mandelli
Franco
F
D000293:Adolescent; D000328:Adult; D018943:Anthracyclines / Q000008:administration & dosage / Q000627:therapeutic use; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage / Q000627:therapeutic use*; D015473:Leukemia, Promyelocytic, Acute / Q000175:diagnosis / Q000188:drug therapy*; D008875:Middle Aged; D012074:Remission Induction; D014212:Tretinoin / Q000008:administration & dosage / Q000627:therapeutic use*; D055815:Young Adult
D018943:Anthracyclines; D000903:Antibiotics, Antineoplastic; D000970:Antineoplastic Agents; D003561:Cytarabine; D014212:Tretinoin; D015255:Idarubicin