Clofarabine/busulfan-based reduced intensity conditioning regimens provides very good survivals in acute myeloid leukemia patients in complete remission at transplant: a retrospective study on behalf of the SFGM-TC
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Amandine Le Bourgeois1, Myriam Labopin2, Mathieu Leclerc3, Régis Peffault de Latour4, Jean-Henri Bourhis5, Patrice Ceballos6, Corentin Orvain7, Hélène Labussière Wallet8, Karin Bilger9, Didier Blaise10, Marie-Thérese Rubio11, Thierry Guillaume1, Mohamad Mohty2, Patrice Chevallier1 and on behalf of Société Francophone de Greffe de Moelle et de Thérapie Cellulaire
1Department of Hematology, CHU Hôtel Dieu, Nantes, France
2Department of Hematology, Hôpital Saint Antoine, Paris, France
3Department of Hematology, Hôpital Henri Mondor, Créteil, France
4Department of Hematology, Hôpital Saint Louis, Université Paris 7, Denis Diderot, Paris, France
5Department of Hematology, Hôpital Gustave Roussy, Paris, France
6Department of Hematology, CHU de Montpellier, Montpellier, France
7Department of Hematology, CHU d’Angers, Angers, France
8Department of Hematology, Centre Hospitalier Lyon Sud, Lyon, France
9Department of Hematology, CHU Strasbourg, Strasbourg, France
10Department of Hematology, Centre de Recherche en Cancérologie de Marseille, Institut Paoli Calmettes, Marseille, France
11Department of Hematology, CHU Nancy, Nancy, France
Amandine Le Bourgeois, email: email@example.com
Patrice Chevallier, email: firstname.lastname@example.org
Keywords: allogeneic stem cell transplantation; clofarabine; busulfan; reduced intensity conditioning regimen; acute myeloid leukemia
Received: August 24, 2018 Accepted: November 01, 2018 Published: November 27, 2018
Background: Clofarabine has been proved to have higher anti-leukemic myeloid activity compared to fludarabine, a drug extensively used as part of reduced intensity conditioning (RIC) for allogeneic stem cell transplantation (allo-SCT).
Results: Eighty-four patients were included. The majority of patients had acute myeloid leukemia (AML, n = 63). Sixty-one patients were in complete remission (AML n = 55). With a median follow up of 31 months (range: 5.7–74.1), 2-year overall (OS) and disease-free (DFS) survivals, relapse incidence (RI), non-relapse mortality (NRM) and graft-versus-host disease (GVHD)/relapse free survival (GRFS) were 64.5% (53.8–75.2); 57.2% (46.2–68.2); 27.7% (18.2–37.9); 15.1% (8.2–23.9) and 43.6% (32.5–54.7), respectively. Considering AML in remission, 2-year OS, DFS, RI, NRM and GRFS were 74.2% (62–86.5); 66.8% (53.6–79.9); 23.4% (12.7–36); 9.8% (3.5–19.9) and 50.9% (36.9–64.9), respectively. Two-year outcomes were similar between CloB2A1 and CloB2A2 sub-groups. In multivariate analysis, active disease at transplant was the only factor adversely impacting 2 years outcomes.
Conclusions: CloB2A2/A1 RIC regimen provides very good results for AML patients allografted in CR and could be retained as a new RIC platform for these patients.
Materials and Methods: This was a retrospective study including all patients who received a clofarabine/busulfan based RIC allo-SCT for myeloid malignancies and reported within the SFGM-TC registry. RIC regimen consisted of clofarabine 30 mg/m²/day 4 to 5 days (Clo), busulfan 3.2 mg/kg/day 2 days (B2) and 2.5 mg/kg/day of rabbit anti-thymocyte globulin 1 or 2 days (A1 or A2). The primary objective of the study was to report the main outcomes of the whole cohort at 2 years.
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