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
Por:
Sanz, MA, Montesinos, P, Kim, HT, Ruiz-Arguelles, GJ, Undurraga, MS, Uriarte, MR, Martinez, L, Jacomo, RH, Gutierrez-Aguirre, H, Melo, RAM, Bittencourt, R, Pasquini, R, Pagnano, K, Fagundes, EM, Vellenga, E, Holowiecka, A, Gonzalez-Huerta, AJ, Fernandez, P, De la Serna, J, Brunet, S, De Lisa, E, Gonzalez-Campos, J, Ribera, JM, Krsnik, I, Ganser, A, Berliner, N, Ribeiro, RC, Lo-Coco, F, Lowenberg, B, Rego, EM
Publicada:
1 ago 2015
Resumen:
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].
Filiaciones:
Sanz, MA:
Univ Hosp La Fe, Dept Hematol, Valencia 46026, Spain
Univ Valencia, Dept Med, Valencia, Spain
Montesinos, P:
Univ Hosp La Fe, Dept Hematol, Valencia 46026, Spain
Univ Valencia, Dept Med, Valencia, Spain
Kim, HT:
Dana Farber Canc Inst, Dept Biostat & Computat Biol, Boston, MA 02115 USA
Ruiz-Arguelles, GJ:
Clin Ruiz Puebla, Puebla, Mexico
Undurraga, MS:
Hosp Salvador, Dept Hematol, Santiago, Chile
Uriarte, MR:
Asociac Espanola Primera Socorros Mutuos, Montevideo, Uruguay
Martinez, L:
Asociac Espanola Primera Socorros Mutuos, Montevideo, Uruguay
Jacomo, RH:
Univ Sao Paulo, Med Sch Ribeirao Preto, Dept Internal Med, Hematol Oncol Div, BR-14049 Ribeirao Preto, Brazil
Univ Sao Paulo, Ctr Cell Based Therapy, BR-14049 Ribeirao Preto, Brazil
Gutierrez-Aguirre, H:
Hosp Univ Dr Jose E Gonzalez, Div Hematol, Monterrey, Mexico
Melo, RAM:
Fundacao HEMOPE, Recife, PE, Brazil
Bittencourt, R:
Univ Fed Rio Grande do Sul, Div Hematol, Porto Alegre, RS, Brazil
Pasquini, R:
Univ Fed Parana, Div Hematol, BR-80060000 Curitiba, Parana, Brazil
Pagnano, K:
Univ Campinas UNICAMP, Hematol & Hemotherapy Ctr, Campinas, SP, Brazil
Fagundes, EM:
Univ Fed Minas Gerais, Div Hematol, Belo Horizonte, MG, Brazil
Vellenga, E:
Univ Groningen, Univ Med Ctr Groningen, Dept Hematol, NL-9713 AV Groningen, Netherlands
Holowiecka, A:
Silesian Med Univ, Dept Hematol, Katowice, Poland
Gonzalez-Huerta, AJ:
Univ Oviedo, Hosp Cent Asturias, E-33080 Oviedo, Spain
Fernandez, P:
Hosp Gen Univ Alicante, Dept Hematol, Alicante, Spain
De la Serna, J:
Hosp 12 Octubre, Dept Hematol, E-28041 Madrid, Spain
Brunet, S:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
De Lisa, E:
Hosp Maciel, Dept Hematol, Montevideo, Uruguay
Gonzalez-Campos, J:
Hosp Virgen del Rocio, Dept Hematol, Seville, Spain
Ribera, JM:
Hosp Badalona Germans Trias & Pujol, Dept Hematol, Badalona, Spain
Krsnik, I:
Hosp Puerta de Hierro, Dept Hematol, Madrid, Spain
Ganser, A:
Hannover Med Sch, Dept Hematol Hemostasis Oncol & Stem Cell Transpl, Hannover, Germany
Berliner, N:
Harvard Univ, Brigham & Womens Hosp, Sch Med, Dept Med, Boston, MA 02115 USA
Ribeiro, RC:
St Jude Childrens Res Hosp, Dept Oncol, Memphis, TN 38105 USA
Lo-Coco, F:
Univ Roma Tor Vergata, Dept Biopathol, Rome, Italy
Santa Lucia Fdn, Rome, Italy
Lowenberg, B:
Erasmus Univ, Med Ctr, Dept Hematol, Rotterdam, Netherlands
Rego, EM:
Univ Sao Paulo, Med Sch Ribeirao Preto, Dept Internal Med, Hematol Oncol Div, BR-14049 Ribeirao Preto, Brazil
Univ Sao Paulo, Ctr Cell Based Therapy, BR-14049 Ribeirao Preto, Brazil
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