All-trans retinoic acid with daunorubicin or idarubicin for risk-adapted treatment of acute promyelocytic leukaemia: a matched-pair analysis of the PETHEMA LPA-2005 and IC-APL studies

Fecha de publicación: 01/08/2015

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

Kim HT
Ruiz-Argüelles GJ
Undurraga MS
Uriarte MR
Jacomo RH
Gutiérrez-Aguirre H
Melo RA
Bittencourt R
Pasquini R
Pagnano K
Fagundes EM
Vellenga E
Holowiecka A
González-Huerta AJ
Fernández P
De la Serna J
Brunet S
De Lisa E
González-Campos J
Ribera JM
Krsnik I
Ganser A
Berliner N
Ribeiro RC
Lo-Coco F
Löwenberg B
Rego EM
IC-APL and PETHEMA and HOVON Groups

Grupos

Grupo de Investigación Clínica y Traslacional en Cardiología

Investigador Principal

Esther Roselló Lletí
Hematología y Hemoterapia

Investigador Principal

Javier De La Rubia Comos

Abstract

Front-line treatment of acute promyelocytic leukaemia (APL) consists of all-trans retinoic acid (ATRA) and anthracycline-based chemotherapy. In this setting, a comparison of idarubicin and daunorubicin has never been carried out. Two similar clinical trials using ATRA and chemotherapy for newly diagnosed APL were compared using matched-pair analysis. One was conducted by the PETHEMA/HOVON group with idarubicin and the other by the International Consortium on APL (IC-APL) using daunorubicin. Three hundred and fifty patients from the PETHEMA/HOVON cohort were matched with 175 patients in the IC-APL cohort, adjusting for the significantly unbalanced presenting features of the two entire cohorts. Complete remission (CR) rate was significantly higher in the PETHEMA/HOVON (94 %) than in the IC-APL cohort (85 %) (P = 0.002). The distribution of causes of induction failure and the time to achieve CR were similar in both cohorts. Patients who achieved CR had comparable cumulative incidence of relapse and disease-free survival rates, but lower overall and event-free survivals were observed in the IC-APL cohort, which was mainly due to a higher death rate during induction therapy. A higher death rate during consolidation therapy was also observed in the IC-APL. These results show that daunorubicin and idarubicin have similar antileukaemic efficacy in terms of primary resistance, molecular persistence, as well as molecular and haematological relapse rates when combined with ATRA in treatment of APL. However, a higher toxic death rate during induction and consolidation therapy was observed in the IC-APL cohort. This trial was registered at as #NCT00408278 [ClinicalTrials.gov].

Datos de la publicación

ISSN/ISSNe:: 0939-5555, 1432-0584
Tipo:: Article
Páginas:: 1347-1356
DOI:: 10.1007/s00277-015-2393-0
Factor de Impacto:: 1,093 SCImago ℠
Cuartil:: Q1 SCImago ℠

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Keywords

Acute promyelocytic leukaemia; Risk-adapted therapy; All-trans retinoic acid; Anthracyclines; Cytarabine; Prognostic factors; Matched-pair analysis

Campos de estudio

Proyectos asociados

RED DE INVESTIGACION COOPERATIVA DE CANCER

RD06/0020/0031 . INSTITUTO DE SALUD CARLOS III; FUNDACIÓN PARA LA INVESTIGACIÓN DEL HOSPITAL UNIVERSITARIO LA FE DE LA COMUNIDAD VALENCIANA . 2006

REDINSCOR

RD06/0003/1001 . INSTITUTO DE SALUD CARLOS III; FUNDACIÓN PARA LA INVESTIGACIÓN DEL HOSPITAL UNIVERSITARIO LA FE DE LA COMUNIDAD VALENCIANA . 2008

PROYECTO CAIBER

CAI08/01/0061 . INSTITUTO DE SALUD CARLOS III; FUNDACIÓN PARA LA INVESTIGACIÓN DEL HOSPITAL UNIVERSITARIO LA FE DE LA COMUNIDAD VALENCIANA . 2009

CREACION Y MEJORA DE INFRAESTRUCTURAS EN MEDICINA REGENERATIVA

Investigador Principal: FUNDACIÓN PARA LA INVESTIGACIÓN DEL HOSPITAL UNIVERSITARIO LA FE DE LA COMUNIDAD VALENCIANA

PLE2009-0141 ACI-PLAN E . MINISTERIO DE CIENCIA E INNOVACION; FUNDACIÓN PARA LA INVESTIGACIÓN DEL HOSPITAL UNIVERSITARIO LA FE DE LA COMUNIDAD VALENCIANA . 2009