Treatment of newly diagnosed acute promyelocytic leukemia (APL): a comparison of French-Belgian-Swiss and PETHEMA results.
All-trans retinoic acid (ATRA) plus anthracycline chemotherapy is the reference treatment of newly diagnosed acute promyelocytic leukemia (APL), whereas the role of cytosine arabinoside (AraC) remains disputed. We performed a joint analysis of patients younger than 65 years included in Programa para el Estudio de la Terapéutica en Hemopatía Maligna (PETHEMA) LPA 99 trial, where patients received no AraC in addition to ATRA, high cumulative dose idarubicin, and mitoxantrone, and APL 2000 trial, where patients received AraC in addition to ATRA and lower cumulative dose daunorubicin. In patients with white blood cell (WBC) count less than 10 x 10(9)/L, complete remission (CR) rates were similar, but 3-year cumulative incidence of relapse (CIR) was significantly lower in LPA 99 trial: 4.2% versus 14.3% (P = .03), although 3-year survival was similar in both trials. This suggested that AraC is not required in APL with WBC count less than 10 x 10(9)/L, at least in trials with high-dose anthracycline and maintenance treatment. In patients with WBC of 10 x 10(9)/L or more, however, the CR rate (95.1% vs 83.6% P = .018) and 3-year survival (91.5% vs 80.8%, P = .026) were significantly higher in APL 2000 trial, and there was a trend for lower 3-year CIR (9.9% vs 18.5%, P = .12), suggesting a beneficial role for AraC in those patients.
Adès
Lionel
L
Hôpital Avicenne, Université Paris 13, Paris, France.
Sanz
Miguel A
MA
Chevret
Sylvie
S
Montesinos
Pau
P
Chevallier
Patrice
P
Raffoux
Emmanuel
E
Vellenga
Edo
E
Guerci
Agnès
A
Pigneux
Arnaud
A
Huguet
Francoise
F
Rayon
Consuelo
C
Stoppa
Anne Marie
AM
de la Serna
Javier
J
Cahn
Jean-Yves
JY
Meyer-Monard
Sandrine
S
Pabst
Thomas
T
Thomas
Xavier
X
de Botton
Stéphane
S
Parody
Ricardo
R
Bergua
Juan
J
Lamy
Thierry
T
Vekhoff
Anne
A
Negri
Silvia
S
Ifrah
Norbert
N
Dombret
Hervé
H
Ferrant
Augustin
A
Bron
Dominique
D
Degos
Laurent
L
Fenaux
Pierre
P
D000328:Adult; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000175:diagnosis* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D016896:Treatment Outcome