Myeloablative versus Reduced-Intensity Conditioning for Hematopoietic Cell Transplantation in Acute Myelogenous Leukemia and Myelodysplastic Syndromes-Long-Term Follow-Up of the BMT CTN 0901 Clinical Trial.
Acute myelogenous leukemia
Conditioning intensity
Hematopoietic cell transplantation
Myelodysplastic syndrome
Journal
Transplantation and cellular therapy
ISSN: 2666-6367
Titre abrégé: Transplant Cell Ther
Pays: United States
ID NLM: 101774629
Informations de publication
Date de publication:
06 2021
06 2021
Historique:
received:
07
01
2021
revised:
23
02
2021
accepted:
23
02
2021
pubmed:
30
3
2021
medline:
3
7
2021
entrez:
29
3
2021
Statut:
ppublish
Résumé
Several prospective randomized trials comparing conditioning intensity before allogeneic hematopoietic cell transplantation (HCT) have been performed, with conflicting results. Although reduced-intensity conditioning (RIC) leads to lower treatment-related mortality (TRM), this is offset by higher rates of relapse. Long-term follow-up of randomized comparative trials are limited. Here we present long-term follow-up of a randomized comparison of myeloablative conditioning (MAC) compared with RIC before HCT for acute myelogenous leukemia (AML) or myelodysplasia (MDS). Long-term comparative analyses of overall survival, relapse, and relapse-free survival were performed. Patients age 18 to 65 years with <5% marrow myeloblasts were randomized to receive MAC (n = 135) or RIC (n = 137), followed by HCT from an HLA-matched donor. The primary endpoint of the trial was an 18-month pointwise comparison of overall survival. The analyses were performed using a proportional hazards model. The median follow-up of the entire cohort was 51 months. At 4 years, the transplant-related mortality (TRM) was 25.1% for MAC, compared with 9.9% for RIC (P < .001). Patients who received RIC had a significantly higher risk of relapse compared to those who received MAC (hazard ratio [HR], 4.06; 95% CI, 2.59 to 6.35; P < 0.001). Among the patients who relapsed after HCT, postrelapse survival was similar at 3 years (24% for MAC and 26% for RIC). Overall survival was superior for patients who received MAC compared to those who received RIC (HR, 1.54; 95% CI, 1.07 to 2.2; P = .03). Our data show that patients who received MAC were at higher risk of late TRM compared with those who received RIC; however, because of the exceedingly high rates of relapse in the RIC arm, overall survival remained significantly better for patients who received MAC. Among patients with MDS or AML eligible for either MAC or RIC regimens, long-term follow up demonstrates a survival advantage for patients who received MAC.
Identifiants
pubmed: 33775615
pii: S2666-6367(21)00718-1
doi: 10.1016/j.jtct.2021.02.031
pmc: PMC8217373
mid: NIHMS1697953
pii:
doi:
Substances chimiques
Diterpenes
0
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
483.e1-483.e6Subventions
Organisme : NHLBI NIH HHS
ID : U10 HL069294
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL069290
Pays : United States
Organisme : NHLBI NIH HHS
ID : U01 HL069274
Pays : United States
Organisme : NHLBI NIH HHS
ID : U10 HL069274
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL108987
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL069246
Pays : United States
Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL069274
Pays : United States
Organisme : NCI NIH HHS
ID : U24 CA076518
Pays : United States
Organisme : NHLBI NIH HHS
ID : U24 HL138660
Pays : United States
Informations de copyright
Copyright © 2021. Published by Elsevier Inc.
Références
Biol Blood Marrow Transplant. 2020 Aug;26(8):e177-e182
pubmed: 32438042
Lancet Haematol. 2018 Apr;5(4):e161-e169
pubmed: 29550384
Biol Blood Marrow Transplant. 2016 Jul;22(7):1227-1233
pubmed: 27064057
Am J Hematol. 2007 Oct;82(10):867-72
pubmed: 17616969
J Clin Oncol. 2017 Jul 1;35(19):2157-2164
pubmed: 28463633
Biol Blood Marrow Transplant. 2007 Dec;13(12):1469-76
pubmed: 18022577
Lancet Oncol. 2012 Oct;13(10):1035-44
pubmed: 22959335
J Clin Oncol. 2009 Sep 20;27(27):4570-7
pubmed: 19652066
Leukemia. 2015 Jan;29(1):137-44
pubmed: 24888275
Leukemia. 2006 Jan;20(1):128-35
pubmed: 16270037
Blood. 2006 Jul 15;108(2):419-25
pubmed: 16609072
J Clin Oncol. 2020 Apr 20;38(12):1273-1283
pubmed: 31860405
Blood Adv. 2018 Aug 28;2(16):2095-2103
pubmed: 30135184
Bone Marrow Transplant. 2008 Jan;41(1):33-8
pubmed: 17982504
Leukemia. 2006 Feb;20(2):322-8
pubmed: 16307018
Blood. 2006 Aug 1;108(3):836-46
pubmed: 16597592
Biol Blood Marrow Transplant. 2006 Oct;12(10):1047-55
pubmed: 17067911
J Clin Oncol. 2017 Apr 10;35(11):1154-1161
pubmed: 28380315
Blood. 2009 Jul 30;114(5):937-51
pubmed: 19357394
Leukemia. 2005 Dec;19(12):2304-12
pubmed: 16193083
Blood. 2007 Dec 15;110(13):4606-13
pubmed: 17873123
Bone Marrow Transplant. 2012 Feb;47(2):203-11
pubmed: 21441963