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N Engl J Med. 2017 Sep 28;377(13):1250-1260. doi: 10.1056/NEJMoa1701769.

Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma.

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1
From Service d'Hématologie Clinique (S.L.G., T.G.), Service d'Anatomopathologie (A.M.), and Service d'Hématologie Biologique (M.C.B.), Hôtel-Dieu Centre Hospitalier Universitaire (CHU) de Nantes, and Centre de Recherche en Cancérologie et Immunologie (S.L.G., M.C.B.) and Faculté de Médecine (S.L.G.), Université de Nantes, Nantes, Hemato-Oncologie, Assistance Publique-Hôpitaux de Paris (APHP), Hôpital Saint-Louis, Université Diderot Sorbonne Paris-Cité (C.T.), Université Descartes (C.T.), Département d'Hématologie, Faculté de Médecine, Université Paris-Sud (V.R.), Département d'Anatomopathologie (D.C.) and Département d'Hématologie (O.H.), Necker Hospital, APHP, Sorbonne Paris-Cité, and INSERM Unité 1163 et Centre National de la Recherche Scientifique (CNRS) Équipe de Recherche Labellisée 8654, Imagine Institute (O.H.), Paris, Département d'Hématologie, Institut Universitaire du Cancer-Oncopole de Toulouse, Toulouse (L.O.), Service d'Hématologie Clinique et Thérapie Cellulaire, CHU de Bordeaux, Bordeaux (K.B.), Service d'Hématologie et Thérapie Cellulaire, CHU de Tours, Tours (C.D.), Service d'Hématologie, CHU d'Amiens, Amiens (G.D.), INSERM, Gustave Roussy Cancer Campus, Université Paris-Saclay, Villejuif (V.R.), Département d'Hématologie, CHU de Nancy, Nancy (P.F.), INSERM Unité 954, Vandoeuvre (P.F.), Service d'Hématologie Clinique, CHU de Dijon, and INSERM Unité Mixte de Recherche 1231, Dijon (O.C.), Service d'Hématologie, Centre Hospitalier d'Avignon, Avignon (H.Z.), Lymphoid Malignancies Unit, Hôpital Henri Mondor, APHP, Créteil (C.H.), Service d'Hématologie du Centre Hospitalier de Vendée, La Roche-sur-Yon (H.M.), Service Hématologie Clinique (R.H.) and Département d'Hématologie (T.L.), CHU de Rennes, INSERM Unité 917 (R.H.), and INSERM Unité 1236 (T.L.), Rennes, Département d'Hematology, Centre Henri-Becquerel et Université de Normandie Unité 1245, Rouen (F.J., H.T.), Service d'Hématologie Clinique Adulte et de Thérapie Cellulaire, CHU de Clermont-Ferrand et Université Clermont Auvergne, Clermont-Ferrand (O.T.), Service d'Hématologie, Clinique Victor Hugo, Le Mans (K.L.D.), Department of Hematology, Université de Lille, Groupe de Recherche sur les Formes Injectables et les Technologies Associées, and CHU de Lille, Lille (F.M.), Département d'Hématologie Clinique, CHU de Montpellier, CNRS UMR 5235, Montpellier (G.C.), Service d'Oncologie et d'Hématologie, Hôpitaux Universitaires de Strasbourg, Strasbourg (L.-M.F.), INSERM 1209, CNRS UMR 5309, Faculté de Médecine, Université Grenoble Alpes (M.C., R.G.), Institute for Advanced Biosciences (M.C.), and Laboratoire de Génétique Onco-hématologie (M.C.) and Faculté de Médecine (R.G.), CHU de Grenoble Alpes, Grenoble, Service d'Hématologie, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre-Bénite (G.S.), and Université Claude Bernard Lyon 1 and Cancer Research Center of Lyon, INSERM 1052 CNRS 5286 Lyon, Lyon (G.S.) - all in France; and Département d'Hématologie, Cliniques Universitaires Saint-Luc-Université Catholique de Louvain, Brussels (E.V.D.N.).

Abstract

BACKGROUND:

Mantle-cell lymphoma is generally incurable. Despite high rates of complete response after initial immunochemotherapy followed by autologous stem-cell transplantation, patients have relapses. We investigated whether rituximab maintenance therapy at a dose of 375 mg per square meter of body-surface area administered every 2 months for 3 years after transplantation would prolong the duration of response.

METHODS:

In a phase 3 trial involving 299 patients who were younger than 66 years of age at diagnosis, we randomly assigned 240 patients to receive rituximab maintenance therapy or to undergo observation after autologous stem-cell transplantation (120 patients per group); 59 patients did not undergo randomization. The primary end point was event-free survival (with an event defined as disease progression, relapse, death, allergy to rituximab, or severe infection) after transplantation among patients who underwent randomization.

RESULTS:

After four courses of immunochemotherapy induction (rituximab, dexamethasone, cytarabine, and a platinum derivative [R-DHAP]), the overall response rate was 89%, and the complete response rate 77%. Transplantation was performed in 257 patients. The median follow-up from randomization after transplantation was 50.2 months (range, 46.4 to 54.2). Starting from randomization, the rate of event-free survival at 4 years was 79% (95% confidence interval [CI], 70 to 86) in the rituximab group versus 61% (95% CI, 51 to 70) in the observation group (P=0.001). The rate of progression-free survival at 4 years was 83% (95% CI, 73 to 88) in the rituximab group versus 64% (95% CI, 55 to 73) in the observation group (P<0.001). The rate of overall survival was 89% (95% CI, 81 to 94) in the rituximab group versus 80% (95% CI, 72 to 88) in the observation group (P=0.04). According to a Cox regression unadjusted analysis, the rate of overall survival at 4 years was higher in the rituximab group than in the observation group (hazard ratio for death, 0.50; 95% CI, 0.26 to 0.99; P=0.04).

CONCLUSIONS:

Rituximab maintenance therapy after transplantation prolonged event-free survival, progression-free survival, and overall survival among patients with mantle-cell lymphoma who were younger than 66 years of age at diagnosis. (Funded by Roche and Amgen; LyMa ClinicalTrials.gov number, NCT00921414 .).

PMID:
28953447
DOI:
10.1056/NEJMoa1701769
[Indexed for MEDLINE]
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