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Blood, 15 October 2008, Vol. 112, No. 8, pp. 3130-3134.
Prepublished online as a Blood First Edition Paper on July 29, 2008; DOI 10.1182/blood-2008-05-159632.


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CLINICAL TRIALS AND OBSERVATIONS

Brief Report

Risk-adapted treatment of acute promyelocytic leukemia with all-trans retinoic acid and anthracycline monochemotherapy: long-term outcome of the LPA 99 multicenter study by the PETHEMA Group

Miguel A. Sanz1, Pau Montesinos1,2, Edo Vellenga3, Consuelo Rayón4, Javier de la Serna5, Ricardo Parody6, Juan M. Bergua7, Angel León8, Silvia Negri9, Marcos González10, Concha Rivas11, Jordi Esteve12, Gustavo Milone13, José D. González14, Elena Amutio15, Salut Brunet16, J. García-Laraña17, Dolors Colomer12, María J. Calasanz18, Carmen Chillón10, Eva Barragán1, Pascual Bolufer1, and Bob Lowenberg19

1 Hospital Universitario La Fe, Valencia, Spain; 2 Department of Medicine of Universitat Autònoma de Barcelona, Barcelona, Spain; 3 University Hospital, Groningen, The Netherlands; 4 Hospital Central de Asturias, Oviedo, Spain; 5 Hospital 12 de Octubre, Madrid, Spain; 6 Hospital Universitario Virgen del Rocío, Sevilla, Spain; 7 Hospital San Pedro de Alcántara, Cáceres, Spain; 8 Hospital General, Jerez de la Frontera, Spain; 9 Hospital Carlos Haya, Málaga, Spain; 10 Hospital Universitario, Salamanca, Spain; 11 Hospital General, Alicante, Spain; 12 Hospital Clinic, Barcelona, Spain; 13 Fundaleu, Buenos Aires, Argentina; 14 Hospital Insular, Las Palmas, Spain; 15 Hospital de Cruces, Baracaldo, Spain; 16 Hospital Sant Pau, Barcelona, Spain; 17 Hospital Ramón y Cajal, Madrid, Spain; 18 Universidad de Navarra, Pamplona, Spain; and 19 Erasmus University Medical Center, Rotterdam, The Netherlands

A previous report of the Programa de Estudio y Tratamiento de las Hemopatías Malignas (PETHEMA) Group showed that a risk-adapted strategy combining all-trans retinoic acid (ATRA) and anthracycline monochemotherapy for induction and consolidation in newly diagnosed acute promyelocytic leukemia results in an improved outcome. Here we analyze treatment outcome of an enlarged series of patients who have been followed up for a median of 65 months. From November 1999 through July 2005 (LPA99 trial), 560 patients received induction therapy with ATRA plus idarubicin. Patients achieving complete remission received 3 courses of consolidation followed by maintenance with ATRA and low-dose chemotherapy. The 5-year cumulative incidence of relapse and disease-free survival were 11% and 84%, respectively. These results compare favorably with those obtained in the previous LPA96 study (P = .019 and P = .04, respectively). This updated analysis confirms the high antileukemic efficacy, low toxicity, and high degree of compliance of a risk-adapted strategy combining ATRA and anthracycline monochemotherapy for consolidation therapy.


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