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

Patrice Chevallier 1 Marie Labopin 2, 3 Régis Peffault de La Tour 4 Bruno Lioure 5 Claude-Eric Bulabois 6 Anne Huynh 7 Didier Blaise 8 Pascal Turlure 9 Etienne Daguindau 10 Natacha Maillard 11 Ibrahim Yakoub-Agha 12 Gaelle Guillerm 13 Jeremy Delage 14 Nathalie Contentin 15 Jacques-Olivier Bay 16 Florence Beckerich 17 Jean-Henri Bourhis 18 Marie Detrait 19 Stéphane Vigouroux 20 Sylvie Francois 21 Faézeh Legrand 22 Thierry Guillaume 1 Mohamad Mohty 2, 3 Sfgm Tc 
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.
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https://hal.archives-ouvertes.fr/hal-01818593
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Submitted on : Tuesday, June 19, 2018 - 12:01:13 PM
Last modification on : Friday, September 9, 2022 - 10:20:08 AM

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Patrice Chevallier, Marie Labopin, Régis Peffault de La Tour, Bruno Lioure, Claude-Eric Bulabois, et al.. Clofarabine versus fludarabine-based reduced-intensity conditioning regimen prior to allogeneic transplantation in adults with AML/MDS. Cancer Medicine, Wiley, 2016, 5 (11), pp.3068 - 3076. ⟨10.1002/cam4.880⟩. ⟨hal-01818593⟩

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