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Cancer Med. 2016 Nov;5(11):3068-3076. doi: 10.1002/cam4.880. Epub 2016 Oct 17.

Clofarabine versus fludarabine-based reduced-intensity conditioning regimen prior to allogeneic transplantation in adults with AML/MDS.

Author information

1
Hematology Department, CHU Hotel-Dieu, Nantes, France.
2
Université Pierre & Marie Curie, Paris, France.
3
INSERM, UMRs 938, Paris, France.
4
Hôpital Saint-Antoine, AP-HP, Paris, France.
5
Hematology Department, Hôpital Saint-Louis, Paris, France.
6
Hematology Department, CHRU Hautepierre, Strasbourg, France.
7
Hematology Department, CHU, Grenoble, France.
8
Hematology Department, Centre Anti-cancéreux, Toulouse, France.
9
Hematology Department, Institut Paoli-Calmette, Marseille, France.
10
Hematology Department, CHU, Limoges, France.
11
Hematology Department, CHU, Besançon, France.
12
Hematology Department, CHU, Poitiers, France.
13
CHU de Lille, LIRIC INSERM U995, Université Lille2, Lille, France.
14
Hematology Department, CHU, Brest, France.
15
Hematology Department, CHU, Montpellier, France.
16
Hematology Department, CHU, Rouen, France.
17
Hematology Department, CHU, Clermont-Ferrand, France.
18
Hematology Department, CHU Henri Mondor, Creteil, France.
19
Hematology Department, IGR, Villejuif, France.
20
Hematology Department, CHU, Lyon, France.
21
Hematology Department, CHU, Bordeaux, France.
22
Hematology Department, CHU, Angers, France.
23
Hematology Department, CHU, Nice, France.

Abstract

We have retrospectively compared survivals between acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) patients who received either a clofarabine/busulfan (CloB2A2) or a fludarabine/busulfan (FB2A2) RIC regimen for allogeneic stem cell transplantation. Between 2009 and 2014, 355 allotransplanted cases were identified from the SFGM-TC registry as having received either the FB2A2 (n = 316, 56% males, median age: 59.2 years, AML 78.5%, first complete remission [CR1] 72%, median follow-up: 20 months) or the CloB2A2 (n = 39, 62% males, median age: 60.8 years, AML 62%, CR1 69%, median follow-up: 22.4 months) RIC regimen. In multivariate analysis, FB2A2 was associated with significant lower overall survival (OS, HR: 2.14; 95%CI: 1.05-4.35, P = 0.04) and higher relapse incidence (RI, HR: 2.17; 95%CI: 1.02-4.61, P = 0.04) and a trend for lower leukemia-free survival (LFS, HR: 1.75; 95%CI: 0.94-3.26, P = 0.08). These results were confirmed using a propensity score-matching strategy. However, when considering AML and MDS patients separately, the benefit of the CLOB2A2 regimen was restricted to AML patients (2-year OS FB2A2: 38% [14.5-61.6] vs. CloB2A2: 79.2% [62.9-95.4], P = 0.01; 2-year LFS FB2A2: 38% [16-59.9] vs. CloB2A2: 70.8% [52.6-89], P = 0.03). The better survivals were due to the lower risk of relapse in this CloB2A2 AML subgroup (2-year RI FB2A2: 41.2% [19-62.4] vs. CloB2A2: 16.7% [5-34.2], P = 0.05). This retrospective comparison suggests that the CloB2A2 RIC regimen can likely provide longer survival than that awarded by a FB2A2 RIC regimen and may become a new standard of care RIC regimen for allotransplanted AML patients. A prospective phase 3 randomized study is warranted.

KEYWORDS:

Acute myeloid leukemia; allogeneic stem cell transplantation; clofarabine; fludarabine; myelodysplastic syndrome; reduced-toxicity conditioning regimen

PMID:
27748046
PMCID:
PMC5119961
DOI:
10.1002/cam4.880
[Indexed for MEDLINE]
Free PMC Article

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