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Molecular Remission in PML/RAR -Positive Acute Promyelocytic Leukemia by Combined All-trans Retinoic Acid and Idarubicin (AIDA) Therapy
Franco Mandelli,
Daniela Diverio,
Giuseppe Avvisati,
Anna Luciano,
Tiziano Barbui,
Carlo Bernasconi,
Giorgio Broccia,
Raffaella Cerri,
Michele Falda,
Giuseppe Fioritoni,
Franco Leoni,
Vincenzo Liso,
Maria Concetta Petti,
Francesco Rodeghiero,
Giuseppe Saglio,
Maria Luce Vegna,
Giuseppe Visani,
Ulrich Jehn,
Roel Willemze,
Petra Muus,
Pier Giuseppe Pelicci,
Andrea Biondi, and
Francesco Lo Coco for the Gruppo Italiano Malattie Ematologiche Maligne dell' Adulto and Associazione Italiana di Ematologia ed Oncologia Pediatrica Cooperative Groups
From Ematologia, Dipartimento di Biotecnologie Cellulari ed Ematologia, University "La Sapienza," Rome; Clinica Pediatrica, Ospedale S. Gerardo, University of Milano-Monza; Divisione di Ematologia, Ospedali Riuniti di Bergamo; Divisione di Ematologia, Policlinico S. Matteo, University of Pavia; Divisione di Ematologia, Ospedale A. Businco, Cagliari; Divisione di Ematologia, Ospedale S.Martino, Genova; Divisione di Ematologia, Ospedale S. Giovanni Battista, Torino; Divisione di Ematologia, Ospedale di Pescara; Divisione di Ematologia, Policlinico Careggi, Firenze; Servizio di Ematologia, University of Bari; Divisione di Ematologia, Ospedale S. Bortolo, Vicenza; Patologia Medica, Ospedale S. Luigi Gonzaga, Orbassano, Torino; Istituto di Ematologia L. e A. Seragnoli, University of Bologna; Clinica Medica I, University of Perugia, Italy; Medizinische Klinik III, University of Munich, Munich, Germany; Department of Hematology, University Hospital, Nijmegen; Department of Hematology, University of Leiden, The Netherlands.
Two hundred fifty-three patients with newly diagnosed acute promyelocytic leukemia (APL) were eligible to enter the multicentric GIMEMA-AIEOP "AIDA" trial during the period July 1993 to February 1996. As a mandatory prerequisite for eligibility, all patients had genetic evidence of the specific t(15; 17) lesion in their leukemic cells confirmed by karyotyping or by reverse transcription-polymerase chain reaction (RT-PCR) of the PML/RAR fusion gene (the latter available in 247 cases). Median age was 37.8 years (range, 2.2 to 73.9). Induction treatment consisted of oral all-trans retinoic acid (ATRA), 45 mg/m2/d until complete remission (CR), given with intravenous Idarubicin, 12 mg/m2/d on days 2, 4, 6, and 8. Three polychemotherapy cycles were given as consolidation. Hematologic and molecular response by RT-PCR was assessed after induction and after consolidation. At the time of analysis, 240 of the 253 eligible patients were evaluable for induction. Of these, 11 (5%) died of early complications and 229 (95%) achieved hematologic remission. No cases of resistant leukemia were observed. Of 139 cases studied by RT-PCR after induction, 84 (60.5%) were PCR-negative and 55 (39.5%) PCR-positive. One hundred sixty-two patients were evaluable by RT-PCR at the end of consolidation. Of these, 159 (98%) tested PCR-negative and 3 (2%), PCR-positive. After a median follow up of 12 months (range, 0 to 33), the estimated actuarial event-free survival for the whole series of 253 eligible patients was 83% ± 2.6% and 79% ± 3.2% at 1 and 2 years, respectively. This study indicates that the AIDA protocol is a well-tolerated regimen that induces molecular remission in almost all patients with PML/RAR-positive APL. Preliminary survival data suggest that a remarkable cure rate can be obtained with this treatment.
Blood, Vol. 90 No. 3 (August 1), 1997:
pp. 1014-1021
© 1997 by The American Society of Hematology.
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