Long-term efficacy of reduced-intensity versus myeloablative conditioning before allogeneic haemopoietic cell transplantation in patients with acute myeloid leukaemia in first complete remission: retrospective follow-up of an open-label, randomised phase 3 trial

The Lancet Haematology - Tập 5 - Trang e161-e169 - 2018
Frederick Fasslrinner1,2, Johannes Schetelig1, Andreas Burchert3, Michael Kramer1, Rudolf Trenschel4, Ute Hegenbart5, Michael Stadler6, Kerstin Schäfer-Eckart7, Michael Bätzel8, Hans Eich9, Martin Stuschke10, Rita Engenhart-Cabillic11, Mechthild Krause12,13,14, Peter Dreger5, Andreas Neubauer3, Gerhard Ehninger1, Dietrich Beelen4, Wolfgang E Berdel15, Timo Siepmann16,2, Matthias Stelljes15
1Department of Internal Medicine, University Hospital Carl Gustav Carus, Dresden, Germany
2Division of Health Care Sciences, Center for Clinical Research and Management Education, Dresden International University, Dresden, Germany
3Department of Hematology, Oncology and Immunology, University Hospital Marburg, Marburg, Germany
4Department of Bone Marrow Transplantation, University Hospital, University of Duisburg-Essen, Essen, Germany
5Department of Medicine V, University of Heidelberg, Heidelberg, Germany
6Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany
7Medical Center, Nürnberg Nord Hospital, Nürnberg, Germany
8Center for Hematopoietic Cell Transplantation, DKD Helios Klinik, Wiesbaden, Germany
9Department of Radiation Oncology, University Hospital Münster, Münster, Germany
10Department for Radiation Oncology, University Hospital, University of Duisburg-Essen, Essen, Germany
11Department of Radiotherapy, University Hospital Marburg, Marburg, Germany
12Department of Radiation Oncology, University Hospital Carl Gustav Carus, Dresden, Germany
13German Cancer Consortium (DKTK), partner site Dresden, Dresden, Germany
14National Center for Tumor Diseases (NCT), partner site Dresden, Dresden, Germany
15Department of Medicine A, University Hospital Münster, Münster, Germany
16Department of Neurology, University Hospital Carl Gustav Carus, Dresden, Germany

Tài liệu tham khảo

Stelljes, 2014, Allogeneic transplantation versus chemotherapy as postremission therapy for acute myeloid leukemia: a prospective matched pairs analysis, J Clin Oncol, 32, 288, 10.1200/JCO.2013.50.5768 Thomas, 1982, Marrow transplantation for acute nonlymphoblastic leukemia in first remission using fractionated or single-dose irradiation, Int J Radiat Oncol Biol Phys, 8, 817, 10.1016/0360-3016(82)90083-9 Sorror, 2011, Long-term outcomes among older patients following nonmyeloablative conditioning and allogeneic hematopoietic cell transplantation for advanced hematologic malignancies, JAMA, 306, 1874, 10.1001/jama.2011.1558 Bacigalupo, 2009, Defining the intensity of conditioning regimens: working definitions, Biol Blood Marrow Transplant, 15, 1628, 10.1016/j.bbmt.2009.07.004 Bornhäuser, 2012, Reduced-intensity conditioning versus standard conditioning before allogeneic haemopoietic cell transplantation in patients with acute myeloid leukaemia in first complete remission: a prospective, open-label randomised phase 3 trial, Lancet Oncol, 13, 1035, 10.1016/S1470-2045(12)70349-2 Lee, 2013, Randomized trial of myeloablative conditioning regimens: busulfan plus cyclophosphamide versus busulfan plus fludarabine, J Clin Oncol, 31, 701, 10.1200/JCO.2011.40.2362 Rambaldi, 2015, Busulfan plus cyclophosphamide versus busulfan plus fludarabine as a preparative regimen for allogeneic haemopoietic stem-cell transplantation in patients with acute myeloid leukaemia: an open-label, multicentre, randomised, phase 3 trial, Lancet Oncol, 16, 1525, 10.1016/S1470-2045(15)00200-4 Kröger, 2017, Dose-reduced versus standard conditioning followed by allogeneic stem-cell transplantation for patients with myelodysplastic syndrome: a prospective randomized phase III study of the EBMT (RICMAC trial), J Clin Oncol, 35, 2157, 10.1200/JCO.2016.70.7349 Scott, 2017, Myeloablative versus reduced-intensity hematopoietic cell transplantation for acute myeloid leukemia and myelodysplastic syndromes, J Clin Oncol, 35, 1154, 10.1200/JCO.2016.70.7091 Clark, 2002, Quantification of the completeness of follow-up, Lancet, 359, 1309, 10.1016/S0140-6736(02)08272-7 Döhner, 2017, Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel, Blood, 129, 424, 10.1182/blood-2016-08-733196 Jagasia, 2015, National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report, Biol Blood Marrow Transplant, 21, 389, 10.1016/j.bbmt.2014.12.001 Rizzo, 2009, Solid cancers after allogeneic hematopoietic cell transplantation, Blood, 113, 1175, 10.1182/blood-2008-05-158782 Panoskaltsis-Mortari, 2011, An official American Thoracic Society research statement: noninfectious lung injury after hematopoietic stem cell transplantation: idiopathic pneumonia syndrome, Am J Respir Crit Care Med, 183, 1262, 10.1164/rccm.2007-413ST Wingard, 2011, Long-term survival and late deaths after allogeneic hematopoietic cell transplantation, J Clin Oncol, 29, 2230, 10.1200/JCO.2010.33.7212 Socié, 1999, Long-term survival and late deaths after allogeneic bone marrow transplantation. Late Effects Working Committee of the International Bone Marrow Transplant Registry, N Engl J Med, 341, 14, 10.1056/NEJM199907013410103 Sorror, 2011, Long-term outcomes among older patients following nonmyeloablative conditioning and allogeneic hematopoietic cell transplantation for advanced hematologic malignancies, JAMA, 306, 1874, 10.1001/jama.2011.1558 Socié, 2001, Busulfan plus cyclophosphamide compared with total-body irradiation plus cyclophosphamide before marrow transplantation for myeloid leukemia: long-term follow-up of 4 randomized studies, Blood, 98, 3569, 10.1182/blood.V98.13.3569 Ringdén, 1999, Blood, 93, 2196, 10.1182/blood.V93.7.2196 Abdul Wahid, 2014, Comparison of reduced-intensity and myeloablative conditioning regimens for allogeneic hematopoietic stem cell transplantation in patients with acute myeloid leukemia and acute lymphoblastic leukemia: a meta-analysis, Stem Cells Dev, 23, 2535, 10.1089/scd.2014.0123 Passweg, 2015, Conditioning intensity in middle-aged patients with AML in first CR: no advantage for myeloablative regimens irrespective of the risk group—an observational analysis by the Acute Leukemia Working Party of the EBMT, Bone Marrow Transplant, 50, 1063, 10.1038/bmt.2015.121 Shimoni, 2016, J Hematol Oncol, 9, 118, 10.1186/s13045-016-0347-1 Stelljes, 2005, Conditioning with 8-Gy total body irradiation and fludarabine for allogeneic hematopoietic stem cell transplantation in acute myeloid leukemia, Blood, 106, 3314, 10.1182/blood-2005-04-1377 Storb, 2013, Graft-versus-host disease and graft-versus-tumor effects after allogeneic hematopoietic cell transplantation, J Clin Oncol, 31, 1530, 10.1200/JCO.2012.45.0247 Mielcarek, 2003, Graft-versus-host disease after nonmyeloablative versus conventional hematopoietic stem cell transplantation, Blood, 102, 756, 10.1182/blood-2002-08-2628 Shimoni, 2013, Secondary malignancies after allogeneic stem-cell transplantation in the era of reduced-intensity conditioning; the incidence is not reduced, Leukemia, 27, 829, 10.1038/leu.2012.299 Clift, 1998, Long-term follow-up of a randomized trial of two irradiation regimens for patients receiving allogeneic marrow transplants during first remission of acute myeloid leukemia, Blood, 92, 1455, 10.1182/blood.V92.4.1455 Mielcarek, 2007, Comparable outcomes after nonmyeloablative hematopoietic cell transplantation with unrelated and related donors, Biol Blood Marrow Transplant, 13, 1499, 10.1016/j.bbmt.2007.09.004 Blaise, 2013, Randomized study of 2 reduced-intensity conditioning strategies for human leukocyte antigen-matched, related allogeneic peripheral blood stem cell transplantation: prospective clinical and socioeconomic evaluation, Cancer, 119, 602, 10.1002/cncr.27786