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Blood, 15 February 2004, Vol. 103, No. 4, pp. 1237-1243.
Prepublished online as a Blood First Edition Paper on October 23, 2003; DOI 10.1182/blood-2003-07-2462.
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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Risk-adapted treatment of acute promyelocytic leukemia with all-trans-retinoic acid and anthracycline monochemotherapy: a multicenter study by the PETHEMA group
Miguel A. Sanz,
Guillermo Martín,
Marcos González,
Angel León,
Chelo Rayón,
Concha Rivas,
Dolors Colomer,
Elena Amutio,
Francisco J. Capote,
Gustavo A. Milone,
Javier de la Serna,
José Román,
Eva Barragán,
Juan Bergua,
Lourdes Escoda,
Ricardo Parody,
Silvia Negri,
María J. Calasanz, and
Pascual Bolufer
From the Hospital Universitario La Fe, Valencia, Spain; Hospital Universitario, Salamanca, Spain; Hospital General, Jerez de la Frontera, Spain; Hospital Central de Asturias, Oviedo, Spain; Hospital General, Alicante, Spain; Hospital Clinic, Barcelona, Spain; Hospital de Cruces, Baracaldo, Spain; Hospital Universitario Puerta del Mar, Cádiz, Spain; Fundaleu, Buenos Aires, Argentina; Hospital 12 de Octubre, Madrid, Spain; Hospital Reina Sofía, Córdoba, Spain; Hospital San Pedro de Alcántara, Cáceres, Spain; Hospital Joan XXIII, Tarragona, Spain; Hospital Universitario Virgen del Rocío, Sevilla, Spain; Hospital Carlos Haya, Málaga, Spain; and Universidad de Navarra, Spain.
All-trans-retinoic acid (ATRA) increases the efficacy of chemotherapy when used for induction and maintenance treatment of acute promyelocytic leukemia (APL), but its role in consolidation is unknown. Since November 1996, 426 patients with newly diagnosed APL have received induction therapy with ATRA and idarubicin. Before November 1999 (LPA96 study), consolidation therapy consisted of 3 courses of anthracycline monochemotherapy. After November 1999 (LPA99 study), patients with intermediate and high risks of relapse received consolidation therapy with ATRA and increased doses of anthracyclines. Of the 384 patients who achieved complete remission (90%), 382 proceeded to consolidation therapy. Seven patients died in remission (1.8%). The 3-year cumulative incidence of relapse for patients in the LPA96 and LPA99 studies was 17.2% and 7.5%, respectively (P = .008). Patients treated with ATRA in consolidation therapy showed an overall reduction in the relapse rate from 20.1% to 8.7% (P = .004). In intermediate-risk patients the rate decreased from 14.0% to 2.5% (P = .006). This improved antileukemic efficacy also translated into significantly better disease-free and overall survival. A risk-adapted strategy combining anthracycline monochemotherapy and ATRA for induction and consolidation therapy of newly diagnosed APL results in improved antileukemic efficacy and a high degree of compliance.
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