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

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Sanz, Miguel A. ^{[1, 2]} ; Montesinos, Pau ^{[1, 2]} ; Kim, Haesook T. ^[3] ; Ruiz-Argueelles, Guillermo J. ^[4] ; Undurraga, Maria S. ^[5] ; Uriarte, Maria R. ^[6] ; Martinez, Lem ^[6] ; Jacomo, Rafael H. ^{[7, 8]} ; Gutierrez-Aguirre, Homero ^[9] ; Melo, Raul A. M. ^[10] ; Bittencourt, Rosane ^[11] ; Pasquini, Ricardo ^[12] ; Pagnano, Katia ^[13] ; Fagundes, Evandro M. ^[14] ; Vellenga, Edo ^[15] ; Holowiecka, Alexandra ^[16] ; Gonzalez-Huerta, Ana J. ^[17] ; Fernandez, Pascual ^[18] ; De la Serna, Javier ^[19] ; Brunet, Salut ^[20] ; De Lisa, Elena ^[21] ; Gonzalez-Campos, Jose ^[22] ; Ribera, Jose M. ^[23] ; Krsnik, Isabel ^[24] ; Ganser, Arnold ^[25] ; Berliner, Nancy ^[26] ; Ribeiro, Raul C. ^[27] ; Lo-Coco, Francesco ^{[28, 29]} ; Lowenberg, Bob ^[30] ; Rego, Eduardo M. ^{[7, 8]} ; Grp, IC-APL ; Grp, PETHEMA ; Grp, HOVON

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^[1] Univ Hosp La Fe, Dept Hematol, Valencia 46026 - Spain

^[2] Univ Valencia, Dept Med, Valencia - Spain

^[3] Dana Farber Canc Inst, Dept Biostat & Computat Biol, Boston, MA 02115 - USA

^[4] Clin Ruiz Puebla, Puebla - Mexico

^[5] Hosp Salvador, Dept Hematol, Santiago - Chile

^[6] Asociac Espanola Primera Socorros Mutuos, Montevideo - Uruguay

^[7] Univ Sao Paulo, Med Sch Ribeirao Preto, Dept Internal Med, Hematol Oncol Div, BR-14049 Ribeirao Preto - Brazil

^[8] Univ Sao Paulo, Ctr Cell Based Therapy, BR-14049 Ribeirao Preto - Brazil

^[9] Hosp Univ Dr Jose E Gonzalez, Div Hematol, Monterrey - Mexico

^[10] Fundacao HEMOPE, Recife, PE - Brazil

^[11] Univ Fed Rio Grande do Sul, Div Hematol, Porto Alegre, RS - Brazil

^[12] Univ Fed Parana, Div Hematol, BR-80060000 Curitiba, Parana - Brazil

^[13] Univ Campinas UNICAMP, Hematol & Hemotherapy Ctr, Campinas, SP - Brazil

^[14] Univ Fed Minas Gerais, Div Hematol, Belo Horizonte, MG - Brazil

^[15] Univ Groningen, Univ Med Ctr Groningen, Dept Hematol, NL-9713 AV Groningen - Netherlands

^[16] Silesian Med Univ, Dept Hematol, Katowice - Poland

^[17] Univ Oviedo, Hosp Cent Asturias, E-33080 Oviedo - Spain

^[18] Hosp Gen Univ Alicante, Dept Hematol, Alicante - Spain

^[19] Hosp 12 Octubre, Dept Hematol, E-28041 Madrid - Spain

^[20] Hosp Santa Creu & Sant Pau, Barcelona - Spain

^[21] Hosp Maciel, Dept Hematol, Montevideo - Uruguay

^[22] Hosp Virgen del Rocio, Dept Hematol, Seville - Spain

^[23] Hosp Badalona Germans Trias & Pujol, Dept Hematol, Badalona - Spain

^[24] Hosp Puerta de Hierro, Dept Hematol, Madrid - Spain

^[25] Hannover Med Sch, Dept Hematol Hemostasis Oncol & Stem Cell Transpl, Hannover - Germany

^[26] Harvard Univ, Brigham & Womens Hosp, Sch Med, Dept Med, Boston, MA 02115 - USA

^[27] St Jude Childrens Res Hosp, Dept Oncol, Memphis, TN 38105 - USA

^[28] Univ Roma Tor Vergata, Dept Biopathol, Rome - Italy

^[29] Santa Lucia Fdn, Rome - Italy

^[30] Erasmus Univ, Med Ctr, Dept Hematol, Rotterdam - Netherlands

• Tipo de documento: Artigo Científico
• Fonte: ANNALS OF HEMATOLOGY; v. 94, n. 8, p. 1347-1356, AUG 2015.
• Citações Web of Science: 8

Resumo

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]. (AU)

• Processo FAPESP: 98/14247-6 - Center for Research on Cell-Based Therapy
• Beneficiário: Marco Antonio Zago
• Modalidade de apoio: Auxílio à Pesquisa - Centros de Pesquisa, Inovação e Difusão - CEPIDs