1. A randomized phase 3 trial of auto vs. allo transplantation as part of first-line therapy in poor-risk peripheral T-NHL
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Martin Wilhelm, Bettina Altmann, Mathieu Leclerc, Laurence de Leval, Ulrich Keller, Arnaud Jaccard, Emmanuel Gyan, Olivier Tournilhac, Peter Reimer, Maike Nickelsen, Martin Dreyling, Jacques-Olivier Bay, Karin Bilger, Bernd Metzner, Andreas Viardot, Laurence Sanhes, Murielle Roussel, Philippe Gaulard, Marita Ziepert, Noel Milpied, Gandhi Damaj, Norbert Schmitz, Friederike Braulke, Walter Lindemann, Eva Maria Wagner-Drouet, Alain Delmer, Bertram Glass, Guillaume Cartron, Thierry Lamy, Krimo Bouabdallah, Viola Poeschel, Frank Kroschinsky, Birte Friedrichs, Lorenz Truemper, David Sibon, Peter Dreger, Andreas Rosenwald, Christian Gisselbrecht, Mathias Haenel, Anne Banos, Gerald Wulf, University Hospital Münster - Universitaetsklinikum Muenster [Germany] (UKM), Georg-August-University [Göttingen], Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Universität Leipzig [Leipzig], Hôpital Henri Mondor, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Limoges, Kliniken Essen-Mitte, University Medical Center [Mainz], Paracelsus Medizinische Privatuniversität = Paracelsus Medical University (PMU), Centre Hospitalier Saint Jean de Perpignan, Microenvironment, Cell Differentiation, Immunology and Cancer (MICMAC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), CHU Pontchaillou [Rennes], Centre Hospitalier Universitaire Vaudois [Lausanne] (CHUV), Julius-Maximilians-Universität Würzburg [Wurtzbourg, Allemagne] (JMU), Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse], University Hospital Carl Gustav Carus [Dresden, Germany], Technische Universität Dresden = Dresden University of Technology (TU Dresden), Catholic Hospital = Katholisches Krankenhaus [Hagen], Universität Heidelberg [Heidelberg], Universitätsklinikum Ulm - University Hospital of Ulm, Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), CHU Clermont-Ferrand, Helios-Klinikum Berlin-Buch, University Hospital Homburg, Institut d'Hématologie de Basse-Normandie (IHBN), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN)-Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-UNICANCER, CHU Necker - Enfants Malades [AP-HP], Hôpital Robert Debré, Hôpital Robert Debré-Centre Hospitalier Universitaire de Reims (CHU Reims), Institut de Cancérologie de Strasbourg Europe (ICANS), Le CHCB, Centre Hospitalier de la Côte Basque, Hospital of Chemnitz, Klinikum der Universität [München], Klinikum Oldenburg, Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Onkologie Lerchenfeld [Hamburg], CHU Estaing [Clermont-Ferrand], Role of intra-Clonal Heterogeneity and Leukemic environment in ThErapy Resistance of chronic leukemias (CHELTER), Université Clermont Auvergne (UCA), CIC Clermont Ferrand, Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-Centre de Pharmacologie Clinique, Georg-August-University = Georg-August-Universität Göttingen, Universität Leipzig, Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Julius-Maximilians-Universität Würzburg (JMU), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Universität Heidelberg [Heidelberg] = Heidelberg University, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier de la Côte Basque (CHCB), Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-UNICANCER, Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Herrada, Anthony
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0301 basic medicine ,[SDV.MHEP.HEM] Life Sciences [q-bio]/Human health and pathology/Hematology ,Vincristine ,medicine.medical_specialty ,Allogeneic transplantation ,Immunology ,CHOP ,Biochemistry ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,International Prognostic Index ,Autologous stem-cell transplantation ,immune system diseases ,Internal medicine ,hemic and lymphatic diseases ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Anaplastic large-cell lymphoma ,Etoposide ,Lymphoid Neoplasia ,business.industry ,Lymphoma, T-Cell, Peripheral ,[SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology ,Cell Biology ,Hematology ,medicine.disease ,3. Good health ,Transplantation ,030104 developmental biology ,surgical procedures, operative ,business ,human activities ,030215 immunology ,medicine.drug - Abstract
Standard first-line therapy for younger patients with peripheral T-cell lymphoma consists of six courses of CHOP or CHOEP consolidated by high-dose therapy and autologous stem cell transplantation (AutoSCT). We hypothesized that consolidative allogeneic transplantation (AlloSCT) could improve outcome. 104 patients with nodal peripheral T-cell lymphoma except ALK+ ALCL, 18 to 60 years of age, all stages and IPI scores except stage 1 and aaIPI 0, were randomized to receive 4 x CHOEP and 1 x DHAP followed by high-dose therapy and AutoSCT or myeloablative conditioning and AlloSCT. The primary endpoint was event-free survival (EFS) at three years. After a median follow-up of 42 months, 3-year EFS of patients undergoing AlloSCT was 43% (95% confidence interval [CI]: 29%; 57%) as compared to 38% (95% CI: 25%; 52%) after AutoSCT. Overall survival at 3 years was 57% (95% CI: 43%; 71%) versus 70% (95% CI: 57%; 82%) after AlloSCT or AutoSCT, without significant differences between treatment arms. None of 21 responding patients proceeding to AlloSCT as opposed to 13 of 36 patients (36%) proceeding to AutoSCT relapsed. Eight of 26 patients (31%) and none of 41 patients died due to transplant-related toxicity after allogeneic and autologous transplantation, respectively. In younger patients with T-cell lymphoma standard chemotherapy consolidated by autologous or allogeneic transplantation results in comparable survival. The strong graft-versus-lymphoma effect after AlloSCT was counterbalanced by transplant-related mortality. CHO(E)P followed by AutoSCT remains the preferred treatment option for transplant-eligible patients. AlloSCT is the treatment of choice for relapsing patients also after AutoSCT.
- Published
- 2021
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