A randomized phase 3 trial of auto vs. allo transplantation as part of first-line therapy in poor-risk peripheral T-NHL
Norbert Schmitz
(1)
,
Lorenz Truemper
(2)
,
Krimo Bouabdallah
(3)
,
Marita Ziepert
(4)
,
Mathieu Leclerc
(5)
,
Guillaume Cartron
(6, 7)
,
Arnaud Jaccard
(8)
,
Peter Reimer
(9)
,
Eva Maria Wagner-Drouet
(10)
,
Martin Wilhelm
(11)
,
Laurence Sanhes
(12)
,
Thierry Lamy
(13, 14)
,
Laurence de Leval
(15)
,
Andreas Rosenwald
(16)
,
Murielle Roussel
(17, 18)
,
Frank Kroschinsky
(19)
,
Walter Walter Lindemann
(20)
,
Peter Dreger
(21)
,
Andreas Viardot
(22)
,
Noel Milpied
(3)
,
Christian Gisselbrecht
(23)
,
Gerald Wulf
(2)
,
Emmanuel Gyan
(24)
,
Philippe Gaulard
(5)
,
Jacques-Olivier Bay
(25)
,
Bertram Glass
(26)
,
Viola Poeschel
(27)
,
Gandhi Damaj
(28)
,
David Sibon
(29)
,
Alain Jacques Delmer
(30)
,
Karin Bilger
(31)
,
Anne Banos
(32)
,
Mathias Haenel
(33)
,
Martin Dreyling
(34)
,
Bernd Metzner
(35)
,
Ulrich Keller
(36)
,
Friederike Braulke
(2)
,
Birte Friedrichs
(1)
,
Maike Nickelsen
(37)
,
Bettina Altmann
(4)
,
Olivier Tournilhac
(38, 39, 40)
1
UKM -
University Hospital Münster - Universitaetsklinikum Muenster [Germany]
2 Georg-August-University = Georg-August-Universität Göttingen
3 Hôpital Haut-Lévêque [CHU Bordeaux]
4 Leipzig University / Universität Leipzig
5 Hôpital Henri Mondor
6 IGMM - Institut de Génétique Moléculaire de Montpellier
7 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
8 CHU Limoges
9 Kliniken Essen-Mitte
10 University Medical Center [Mainz]
11 PMU - Paracelsus Medizinische Privatuniversität = Paracelsus Medical University
12 Centre Hospitalier Saint Jean de Perpignan
13 MICMAC - Microenvironment, Cell Differentiation, Immunology and Cancer
14 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
15 CHUV - Centre Hospitalier Universitaire Vaudois = Lausanne University Hospital [Lausanne]
16 JMU - Julius-Maximilians-Universität Würzburg = University of Würzburg
17 IUCT Oncopole - UMR 1037 - Institut Universitaire du Cancer de Toulouse - Oncopole
18 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
19 University Hospital Carl Gustav Carus [Dresden, Germany]
20 Catholic Hospital = Katholisches Krankenhaus [Hagen]
21 Universität Heidelberg [Heidelberg] = Heidelberg University
22 Universitätsklinikum Ulm - University Hospital of Ulm
23 AP-HP - Hopital Saint-Louis [AP-HP]
24 CHRU Tours - Centre Hospitalier Régional Universitaire de Tours
25 CHU Clermont-Ferrand
26 Helios-Klinikum Berlin-Buch
27 University Hospital Homburg
28 IHBN - Institut d'Hématologie de Basse-Normandie
29 Hôpital Necker - Enfants Malades [AP-HP]
30 Hôpital Robert Debré
31 ICANS - Institut de Cancérologie de Strasbourg Europe
32 CHCB - Centre Hospitalier de la Côte Basque
33 Hospital of Chemnitz
34 Klinikum der Universität [München]
35 Klinikum Oldenburg
36 Charité - UniversitätsMedizin = Berlin University Medicine
37 Onkologie Lerchenfeld [Hamburg]
38 CHU Estaing [Clermont-Ferrand]
39 CHELTER - Role of intra-Clonal Heterogeneity and Leukemic environment in ThErapy Resistance of chronic leukemias
40 CIC 1405 - Centre d'Investigation Clinique [CHU Clermont-Ferrand]
2 Georg-August-University = Georg-August-Universität Göttingen
3 Hôpital Haut-Lévêque [CHU Bordeaux]
4 Leipzig University / Universität Leipzig
5 Hôpital Henri Mondor
6 IGMM - Institut de Génétique Moléculaire de Montpellier
7 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
8 CHU Limoges
9 Kliniken Essen-Mitte
10 University Medical Center [Mainz]
11 PMU - Paracelsus Medizinische Privatuniversität = Paracelsus Medical University
12 Centre Hospitalier Saint Jean de Perpignan
13 MICMAC - Microenvironment, Cell Differentiation, Immunology and Cancer
14 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
15 CHUV - Centre Hospitalier Universitaire Vaudois = Lausanne University Hospital [Lausanne]
16 JMU - Julius-Maximilians-Universität Würzburg = University of Würzburg
17 IUCT Oncopole - UMR 1037 - Institut Universitaire du Cancer de Toulouse - Oncopole
18 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
19 University Hospital Carl Gustav Carus [Dresden, Germany]
20 Catholic Hospital = Katholisches Krankenhaus [Hagen]
21 Universität Heidelberg [Heidelberg] = Heidelberg University
22 Universitätsklinikum Ulm - University Hospital of Ulm
23 AP-HP - Hopital Saint-Louis [AP-HP]
24 CHRU Tours - Centre Hospitalier Régional Universitaire de Tours
25 CHU Clermont-Ferrand
26 Helios-Klinikum Berlin-Buch
27 University Hospital Homburg
28 IHBN - Institut d'Hématologie de Basse-Normandie
29 Hôpital Necker - Enfants Malades [AP-HP]
30 Hôpital Robert Debré
31 ICANS - Institut de Cancérologie de Strasbourg Europe
32 CHCB - Centre Hospitalier de la Côte Basque
33 Hospital of Chemnitz
34 Klinikum der Universität [München]
35 Klinikum Oldenburg
36 Charité - UniversitätsMedizin = Berlin University Medicine
37 Onkologie Lerchenfeld [Hamburg]
38 CHU Estaing [Clermont-Ferrand]
39 CHELTER - Role of intra-Clonal Heterogeneity and Leukemic environment in ThErapy Resistance of chronic leukemias
40 CIC 1405 - Centre d'Investigation Clinique [CHU Clermont-Ferrand]
Norbert Schmitz
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- PersonId : 1093131
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Guillaume Cartron
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- ORCID : 0000-0003-0659-9635
- IdRef : 075137119
Peter Dreger
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- ORCID : 0000-0002-7429-8570
Emmanuel Gyan
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- ORCID : 0000-0002-7651-9189
Résumé
First-line therapy for younger patients with peripheral T-cell non-Hodgkin lymphoma (T-NHL) consists of 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with or without etoposide (CHOEP), consolidated by high-dose therapy and autologous stem cell transplantation (auto-SCT). We hypothesized that allogeneic stem cell transplantation (allo-SCT) could improve outcomes. 104 patients with peripheral T-cell non-Hodgkin lymphoma, except ALK+ anaplastic large cell lymphoma, 18 to 60 years, all stages, and all age adjusted International Prognostic Index scores, except 0 and stage I, were randomized to 4 cycles of CHOEP and 1 cycle of dexamethasone, cytosine-arabinoside, and platinum (DHAP) followed by high-dose therapy and auto-SCT or myeloablative conditioning and allo-SCT. The primary end point was event-free survival (EFS) at 3 years. After a median follow-up of 42 months, the 3-year EFS after allo-SCT was 43%, as compared with 38% after auto-SCT. Overall survival at 3 years was 57% vs 70% after allo- or auto-SCT, without significant differences between treatment arms. None of the 21 responding patients proceeding to allo-SCT relapsed, as opposed to 13 of 36 patients (36%) proceeding to auto-SCT. Eight of 26 patients (31%) and none of 41 patients died of transplant-related toxicity after allo- and auto-SCT, respectively. The strong graft-versus-lymphoma effect after allo-SCT was counterbalanced by transplant-related mortality. This trial is registered at www.clinicaltrials.gov as #NCT00984412.
Domaines
Hématologie
Fichier principal
Schmitz et al-2021-A randomized phase 3 trial of auto vs.pdf (1.75 Mo)
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