Obinutuzumab vs rituximab for transplant-eligible patients with mantle cell lymphoma

Author:

Sarkozy Clémentine123,Callanan Mary4,Thieblemont Catherine5,Obéric Lucie6ORCID,Burroni Barbara7,Bouabdallah Krimo8,Damaj Gandhi9,Tessoulin Benoit10ORCID,Ribrag Vincent11,Houot Roch12,Morschhauser Franck13ORCID,Griolet Samuel14,Joubert Clémentine14,Cacheux Victoria15,Delwail Vincent16,Safar Violaine17,Gressin Remy18,Cheminant Morgane19,Delfau-Larue Marie-Hélène20ORCID,Hermine Olivier19,Macintyre Elizabeth21,Le Gouill Steven123ORCID

Affiliation:

1. 1Service d’hématologie, Institut Curie, Saint Cloud, France

2. 2Université de Versailles Saint-Quentin, Versailles, France

3. 3Laboratoire d’Imagerie Translationnelle en Oncologie, U1288 INSERM/Institut Curie Centre de Recherche, Paris, France

4. 4University of Burgundy, INSERM U1231, Unit for Innovation in Genetics and Epigenetics in Oncology, University Hospital, Dijon, France

5. 5Service d’Hématologie, Hôpital Saint Louis, Assistance Publique–Hôpitaux de Paris, Paris, France

6. 6Service d’Hématologie, Institut Universitaire du Cancer Toulouse, Oncopole, Toulouse, France

7. 7Service d’Anatomopathologie, Hôpital Cochin, Assistance Publique–Hôpitaux de Paris, Paris, France

8. 8Service d’Hématologie, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France

9. 9Service d’Hématologie, Centre Hospitalier Universitaire de Caen, Caen, France

10. 10Service d’Hématologie, Centre Hospitalier Universitaire Nantes, Nantes, France

11. 11Département d’Hématologie, Institut Gustave Roussy, Villejuif, France

12. 12Service d’Hématologie, Centre Hospitalier Universitaire Rennes, Rennes, France

13. 13Department of Hematology, Claude Huriez Hospital, University of Lille, EA 7365, Research Group on Injectable Forms and Associated Technologies, Lille, France

14. 14LYSARC, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France

15. 15Service d’Hématologie, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France

16. 16Service d’Hématologie, Hôpital Poitiers, Poitiers, France

17. 17Service d’Hématologie, Hôpital Lyon Sud, Pierre Bénite, France

18. 18Service d’Hématologie, Centre Hospitalier Universitaire Grenoble, Grenoble, France

19. 19Department of Clinical Hematology, INSERM U1163, University of Paris, Necker University Hospital, Paris, France

20. 20Department of Immunology, INSERM U955 Équipe 9, Institut Mondor de Recherche Biomédicale, Hospital Henri Mondor, Creteil, France

21. 21Laboratory of Onco-Haematology, Université Paris Descartes Sorbonne Cité, Institut Necker-Enfants Malades, INSERM U1151, Assistance Publique–Hôpitaux de Paris, Hôpital Necker Enfants-Malades, Paris, France

Abstract

Abstract Obinutuzumab (O) and rituximab (R) are 2 CD antibodies that have never been compared in a prospective randomized trial of mantle cell lymphoma (MCL). Herein, we report the long-term outcome of the LyMa-101 trial, in which newly diagnosed patients with MCL were treated with chemotherapy plus O before transplantation, followed by O maintenance (O group). We then compared these patients with those treated with the same treatment design with R instead of O (R group). A propensity score matching (PSM) was used to compare the 2 populations (O vs R groups) in terms of measurable residual disease (MRD) at the end of induction (EOI), progression-free survival (PFS), and overall survival (OS). In LyMa-101, the estimated 5-year PFS and OS after inclusion (n = 85) were 83.4% (95% confidence interval [CI], 73.5-89.8) and 86.9% (95% CI, 77.6-92.5), respectively. At EOI, patients treated in the O group had more frequent bone marrow MRD negativity than those treated in the R group (83.1% vs 63.4%; χ2, P = .007). PSM resulted in 2 sets of 82 patients with comparable characteristics at inclusion. From treatment initiation, the O group had a longer estimated 5-year PFS (P = .029; 82.8% vs 66.6%; hazard ratio [HR], 1.99; 95% confidence interval (CI), 1.05-3.76) and OS (P = .039; 86.4% vs 71.4%; HR, 2.08; 95% CI, 1.01-4.16) compared with the R group. Causes of death were comparable in the 2 groups, the most common cause being lymphoma. O before transplantation and in maintenance provides better disease control and enhances PFS and OS compared with R in transplant-eligible patients with MCL. These trials were registered at www.clinicaltrials.gov as #NCT00921414 and NCT02896582.

Publisher

American Society of Hematology

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