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

Annals of Hematology - Tập 94 - Trang 1347-1356 - 2015
Miguel A. Sanz1,2, Pau Montesinos1,2, Haesook T. Kim3, Guillermo J. Ruiz-Argüelles4, María S. Undurraga5, María R. Uriarte6, Lem Martínez6, Rafael H. Jacomo7, Homero Gutiérrez-Aguirre8, Raul A. M. Melo9, Rosane Bittencourt10, Ricardo Pasquini11, Katia Pagnano12, Evandro M. Fagundes13, Edo Vellenga14, Alexandra Holowiecka15, Ana J. González-Huerta16, Pascual Fernández17, Javier De la Serna18, Salut Brunet19, Elena De Lisa20, José González-Campos21, José M. Ribera22, Isabel Krsnik23, Arnold Ganser24, Nancy Berliner25, Raul C. Ribeiro26, Francesco Lo-Coco27,28, Bob Löwenberg, Eduardo M. Rego7
1Hematology Department, University Hospital La Fe, Valencia, Spain
2Department of Medicine, University of Valencia, Valencia, Spain
3Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, USA
4Clinica Ruiz de Puebla, Puebla, Mexico
5Department of Hematology, Hospital del Salvador, Santiago, Chile
6Asociación Española Primera de Socorros Mutuos, Montevideo, Uruguay
7Hematology/Oncology Division, Department of Internal Medicine, Medical School of Ribeirão Preto and Center for Cell Based Therapy, University of São Paulo, Ribeirão Preto, Brazil
8Hematology Division, Hospital Universitario Dr José E. González, Monterrey, Mexico
9Fundação HEMOPE, Recife, Brazil
10Hematology Division, Federal University of Rio Grande do Sul, Porto Alegre, Brazil;
11Hematology Division, Federal University of Paraná, Curitiba, Brazil
12Hematology and Hemotherapy Center, University of Campinas - UNICAMP, Campinas, Brazil
13Hematology Division, Federal University of Minas Gerais, Belo Horizonte, Brazil
14Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands
15Department of Hematology, Silesian Medical University, Katowice, Poland
16Hospital Central de Asturias, Oviedo, Spain
17Department of Hematology, Hospital General Universitario de Alicante, Alicante, Spain
18Department of Hematology Hospital 12 de Octubre, Madrid, Spain
19Hospital Sant Pau, Barcelona, Spain;
20Department of Hematology, Hospital Maciel, Montevideo, Uruguay
21Department of Hematology, Hospital Virgen del Rocio, Sevilla, Spain
22Department of Hematology, Hospital Germans Trias I Pujol, Badalona, Spain
23Department of Hematology. Hospital Puerta de Hierro, Madrid, Spain
24Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany
25Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, USA
26Department of Oncology, St Jude Children’s Research Hospital, Memphis, USA
27Department of Biopathology, University Tor Vergata, Rome, Italy
28Santa Lucia Foundation, Rome, Italy

Tóm tắt

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 www.clinicaltrials.gov as #NCT00408278 [ClinicalTrials.gov].

Tài liệu tham khảo

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Annals of Hematology

Tập 94

1347-1356

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