Single- vs double-unit cord blood transplantation for children and young ă adults with acute leukemia or myelodysplastic syndrome

Gerard Michel, Claire Galambrun, Anne Sirvent, Cécile Pochon (), Bénédicte Bruno, Charlotte Jubert, Anderson Loundou, Ibrahim Yakoub-Agha (), Noël Milpied, Patrick Lutz, Aude Marie-Cardine, Virginie Gandemer, Didier Blaise (), Mauricette Michallet (), Fanny Rialland, Cecile Renard, Claire Oudin, Sophie Esmiol, Mylène Seux, Karine Baumstarck, Mohamad Mohty (), Vanderson Rocha and Jean-Hugues Dalle ()
Additional contact information
Gerard Michel: Pédiatrie et oncologie pédiatrique [Hôpital de la Timone - APHM] - AMU - Aix Marseille Université - APHM - Assistance Publique - Hôpitaux de Marseille - TIMONE - Hôpital de la Timone [CHU - APHM]
Claire Galambrun: Service de pédiatrie spécialisée et médecine infantile (neurologie, pneumologie, maladies héréditaires du métabolisme) [Hôpital de la Timone - APHM] - TIMONE - Hôpital de la Timone [CHU - APHM]
Cécile Pochon: IGR - Institut Gustave Roussy
Anderson Loundou: Unité d'Aide Méthodologique - APHM - Assistance Publique - Hôpitaux de Marseille - CHU Marseille
Ibrahim Yakoub-Agha: LIRIC - Lille Inflammation Research International Center - U 995 - Institut Pasteur de Lille - Pasteur Network (Réseau International des Instituts Pasteur) - INSERM - Institut National de la Santé et de la Recherche Médicale - Université de Lille - CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
Noël Milpied: Hôpital Haut-Lévêque [CHU Bordeaux] - CHU Bordeaux - Centre Hospitalier Universitaire de Bordeaux
Patrick Lutz: Service de pédiatrie - CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
Virginie Gandemer: IGDR - Institut de Génétique et Développement de Rennes - UR - Université de Rennes - CNRS - Centre National de la Recherche Scientifique - Biosit : Biologie - Santé - Innovation Technologique - Structure Fédérative de Recherche en Biologie et Santé de Rennes, Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Didier Blaise: IPC - Institut Paoli-Calmettes - Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)
Mauricette Michallet: Service d’Hématologie [Centre Hospitalier Lyon Sud - HCL] - CHLS - Centre Hospitalier Lyon Sud [CHU - HCL] - HCL - Hospices Civils de Lyon
Fanny Rialland: Service d'Hématologie Clinique [Nantes] - Hôpital Hôtel Dieu - CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
Claire Oudin: Service d'hématologie pédiatrique - Université de la Méditerranée - Aix-Marseille 2 - APHM - Assistance Publique - Hôpitaux de Marseille - TIMONE - Hôpital de la Timone [CHU - APHM]
Sophie Esmiol: Service d'hématologie pédiatrique - Université de la Méditerranée - Aix-Marseille 2 - APHM - Assistance Publique - Hôpitaux de Marseille - TIMONE - Hôpital de la Timone [CHU - APHM]
Mylène Seux: Stress Cellulaire - Université de la Méditerranée - Aix-Marseille 2 - INSERM - Institut National de la Santé et de la Recherche Médicale, LCP - Laboratoire Chimie Provence - Université de Provence - Aix-Marseille 1 - INC-CNRS - Institut de Chimie - CNRS Chimie - CNRS - Centre National de la Recherche Scientifique
Karine Baumstarck: AMU - Aix Marseille Université
Mohamad Mohty: Service d'Hématologie [Nantes] - CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital, CI2C - Centre d'investigation clinique en cancérologie - CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital, UMRS893 - Centre de Recherche Saint-Antoine - UPMC - Université Pierre et Marie Curie - Paris 6 - INSERM - Institut National de la Santé et de la Recherche Médicale, UPMC - Université Pierre et Marie Curie - Paris 6, CHU Saint-Antoine [AP-HP] - AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP) - SU - Sorbonne Université
Vanderson Rocha: Churchill Hospital - Churchill Hospital Oxford Centre for Haematology, Eurocord - AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP) - IUH - Institut Universitaire d'Hématologie - UPD7 - Université Paris Diderot - Paris 7, France Monacord - CSM - Centre Scientifique de Monaco
Jean-Hugues Dalle: Hôpital Robert Debré Paris - Hôpital Robert Debré - AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)

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Abstract: Transplantation of 2 unrelated cord blood (UCB) units instead of 1 has been proposed to increase the cell dose. We report a prospective randomized study, designed to compare single- vs double-UCB transplantation in children and young adults with acute leukemia in remission or myelodysplasia. Eligible patients had at least two 4-6 HLA-identical UCBs with >3 × 10(7) nucleated cells/kg for the first and >1.5 × 10(7) for the second. The primary end point was the 2-year cumulative incidence of transplantation strategy failure, a composite end point including transplant-related mortality (TRM), engraftment failure, and autologous recovery. Randomized patients who did not proceed to transplantation due to refractory disease were considered transplantation failures. A total of 151 patients were randomized and included in the intent-to-treat analysis; 137 were transplanted. Double-UCB transplantation did not decrease transplantation strategy failure (23.4% ± 4.9% vs 14.9% ± 4.2%). Two-year posttransplant survival, disease-free survival, and TRM were 68.8% ± 6.0%, 67.6% ± 6.0%, and 5.9% ± 2.9% after single-unit transplantation compared with 74.8% ± 5.5%, 68.1% ± 6.0%, and 11.6% ± 3.9% after double-unit transplantation. The final relapse risk did not significantly differ, but relapses were delayed after double-unit transplantation. Overall incidences of graft-versus-host disease (GVHD) were similar, but chronic GVHD was more frequently extensive after double-UCB transplantation (31.9% ± 5.7% vs 14.7% ± 4.3%, P = .02). In an exploratory subgroup analysis, we found a significantly lower relapse risk after double-unit transplantation in patients receiving total body irradiation without antithymocyte globulin (ATG), whereas the relapse risk was similar in the group treated with busulfan, cyclophosphamide, and ATG. Single-UCB transplantation with adequate cell dose remains the standard of care and leads to low TRM. Double-unit transplantation should be reserved for patients who lack such units. This trial was registered at www.clinicaltrials.gov as #NCT01067300.

Keywords: Quality (search for similar items in EconPapers)
Date: 2016-06
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Published in Blood, 2016, 127 (26), pp.3450-3457. ⟨10.1182/blood-2016-01-694349⟩

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Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:hal-01482531

DOI: 10.1182/blood-2016-01-694349

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