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Blood, 1 February 2008, Vol. 111, No. 3, pp. 1078-1084. Prepublished online as a Blood First Edition Paper on November 1, 2007; DOI 10.1182/blood-2007-07-099978.
CLINICAL TRIALS AND OBSERVATIONS Treatment of newly diagnosed acute promyelocytic leukemia (APL): a comparison of French-Belgian-Swiss and PETHEMA results1 Hôpital Avicenne, Université Paris 13, Paris, France; 2 University Hospital La Fe, Valencia, Spain; 3 Hôpital Saint Louis, Université Paris 7, Paris, France; 4 Centre Hospitalier Universitaire (CHU) Nantes, Nantes, France; 5 University Hospital Groningen, Hanzeplein, the Netherlands; 6 CHU Nancy, Nancy, France; 7 CHU de Bordeaux, Bordeaux, France; 8 CHU de Toulouse, Toulouse, France; 9 Hospital Central de Asturias, Oviedo, Spain; 10 Institut Paoli Calmettes, Marseille, France; 11 Hospital 12 de Octubre, Madrid, Spain; 12 CHU Grenoble, Grenoble, France; 13 Universitatsspital Basel, Basel, Switzerland; 14 Universitatsspital Berne, Berne, Switzerland; 15 CHU Lyon, Lyon, France; 16 Institut gustave Roussy, Villejuif, France; 17 Hospital Virgen del Rocío, Sevilla, Spain; 18 Hospital San Pedro de Alcántara, Cáceres, Spain; 19 CHU Rennes, Rennes, France; 20 Hotel Dieu, Université Paris 5, Paris, France; 21 Hospital Carlos Haya, Málaga, Spain; 22 CHU Angers, Angers, France; 23 Université Catholique de Louvain, Brussels, Belgium; and 24 Institut Jules Bordet, Brussels, Belgium
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 109/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 109/L, at least in trials with high-dose anthracycline and maintenance treatment. In patients with WBC of 10 x 109/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.
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