Originally published as JCO Early Release 10.1200/JCO.2006.08.1596 on November 20 2006

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Is Cytarabine Useful in the Treatment of Acute Promyelocytic Leukemia? Results of a Randomized Trial From the European Acute Promyelocytic Leukemia Group

Lionel Adès, Sylvie Chevret, Emmanuel Raffoux, Stephane de Botton, Agnes Guerci, Arnaud Pigneux, Anne Marie Stoppa, Thierry Lamy, Francoise Rigal-Huguet, Anne Vekhoff, Sandrine Meyer-Monard, Frederic Maloisel, Eric Deconinck, Augustin Ferrant, Xavier Thomas, Nathalie Fegueux, Christine Chomienne, Herve Dombret, Laurent Degos, Pierre Fenaux

From the Assistance Publique-Hôpitaux de Paris, Hôpital Avicenne, Service d'Hématologie Clinique, Paris 13 University, Bobigny; Hospital Saint Louis; Hotel Dieu, Paris; Centre Hospitalier Universitaire (CHU), Lille; CHU Nancy; CHU Bordeaux; Institut Paoli-Calmettes, Marseille; CHU Rennes; CHU Toulouse; CHU Strasbourg; CHU Besancon; CHU Lyon; CHU Montpellier, France; Universitatsspital Basel, Basel, Switzerland; and the Université Catholique de Louvain, Brussels, Belgium

Address reprint requests to Pierre Fenaux, MD, PhD, Assistance Publique-Hôpitaux de Paris, Hôpital Avicenne, Service d'Hématologie Clinique, Paris 13 University, 125 rue de Stalingrad, 93009 Bobigny, France; e-mail: pierre.fenaux{at}avc.aphp.fr

PURPOSE: Several phase II studies have suggested that cytarabine (AraC) was not required in the treatment of newly diagnosed acute promyelocytic leukemia (APL) patients receiving all-trans-retinoic acid (ATRA), an anthracycline, and maintenance therapy, and we aimed at confirming this finding in a randomized trial.

PATIENTS AND METHODS: Newly diagnosed APL patients younger than age 60 years with a WBC count of less than 10,000/µL were randomly assigned to receive either ATRA combined with and followed by three daunorubicin (DNR) plus AraC courses and a 2-year maintenance regimen (AraC group) or the same treatment but without AraC (no AraC group). Patients older than age 60 years and patients with initial WBC count of more than 10,000/µL were not randomly assigned but received risk-adapted treatment, with higher dose of AraC and CNS prophylaxis in patients with WBC counts more than 10,000/µL.

RESULTS: Overall, 328 (96.5%) of 340 patients achieved complete remission (CR). In the AraC and the no AraC groups, the CR rates were 99% and 94% (P = .12), the 2-year cumulative incidence of relapse (CIR) rates were 4.7% and 15.9% (P = .011), the event-free survival (EFS) rates were 93.3% and 77.2% (P = .0021), and survival rates were 97.9% and 89.6% (P = .0066), respectively. In patients younger than age 60 years with WBC counts more than 10,000/µL, the CR, 2-year CIR, EFS, and survival rates were 97.3%, 2.9%, 89%, and 91.9%, respectively.

CONCLUSION: These results support a role for AraC in addition to ATRA and anthracyclines in the treatment of newly diagnosed APL, at least using DNR at the cumulative dose we used and with the consolidation and maintenance regimens we used.

published online ahead of print at www.jco.org on November 20, 2006.

Supported by the Programme Hospitalier de Recherche Clinique and the Centre Hospitalier Universitaire of Lille-France, the Association pour la Recherche sur le Cancer, and the Ligue Contre le Cancer (Comité du Nord).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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