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Haematologica. 2019 Jan;104(1):138-146. doi: 10.3324/haematol.2018.191429. Epub 2018 Aug 31.

A phase 2 study of rituximab, bendamustine, bortezomib and dexamethasone for first-line treatment of older patients with mantle cell lymphoma.

Author information

1
Onco-Hematology Department, Grenoble University Hospital rgressin@chu-grenoble.fr mary.callanan@chu-dijon.fr.
2
INSERM 1209, CNRS UMR 5309, Faculté de Médecine, Université Grenoble-Alpes, Institute for Advanced Biosciences, Grenoble.
3
Hematology Department, Annecy Hospital.
4
Hematology Department, Brest University Hospital.
5
Pathology Department, Nantes University Hospital.
6
Onco-Hematology Department, Grenoble University Hospital.
7
Hematology Department, Montpellier University Hospital.
8
Hematology Department, Cancer Institute Bergonie Bordeaux.
9
Hematology Department, Rennes University Hospital.
10
Hematology Department, Tours University Hospital.
11
Hematology Department, Dunkerque Hospital.
12
Hematology Department, Chambery Hospital.
13
Hematology Department, Bayonne Hospital.
14
Hematology Department, Loire Cancer Institute, Saint Etienne.
15
Lymphoid Malignancies Unit, Henri Mondor University Hospital, Assistance Publique-Hôpitaux de Paris, Créteil.
16
IHBN - Hematology Department, Caen University Hospital.
17
Hematology Department, Clermont-Ferrand Cancer Institute.
18
Hematology Department, Rouen University Hospital.
19
Hematology Department, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud. INSERM 1052.
20
Hematology Department, Amiens University Hospital.
21
Hematology Department, Nancy University Hospital.
22
Hematology Department, University Hospital Strasbourg.
23
Hematology Department, University Clermont-Ferrand Hospital.
24
Hematology Department, Metz University Hospital.
25
Hematology Department, Bordeaux University Hospital.
26
Hematology Department, University Hospital Paris Saint-Louis.
27
Hematology Department, Saint Quentin Hospital.
28
Hematology Department, Chalon Hospital.
29
Hematology Department, Corbeil Hospital.
30
Hematology Department, Victor Hugo Clinic, Le Mans.
31
Hematology Department, Catherine de Sienne Clinic, Nantes.
32
Hematology Department, Angers University Hospital.
33
Hematology Department, Avignon Hospital.
34
Hematology Department, Besançon University Hospital.
35
Hematology Department, Mulhouse Hospital.
36
Hematology Department, Orleans Hospital.
37
Onco-Hematology Department, University Hospital Poitiers and INSERM, CIC 1402, Poitiers University.
38
Hematology Department, Baclesse Caen Cancer Center.
39
Hematology Department, Toulouse University Hospital.
40
Hematology Department, Nantes University Hospital.
41
INSERM 1209, CNRS UMR 5309, Faculté de Médecine, Université Grenoble-Alpes, Institute for Advanced Biosciences, Grenoble rgressin@chu-grenoble.fr mary.callanan@chu-dijon.fr.
42
Unit for Innovation in Genetics and Epigenetics in Oncology, Dijon University Hospital, France.

Abstract

We present results of a prospective, multicenter, phase II study evaluating rituximab, bendamustine, bortezomib and dexamethasone as first-line treatment for patients with mantle cell lymphoma aged 65 years or older. A total of 74 patients were enrolled (median age, 73 years). Patients received a maximum of six cycles of treatment at 28-day intervals. The primary objective was to achieve an 18-month progression-free survival rate of 65% or higher. Secondary objectives were to evaluate toxicity and the prognostic impact of mantle cell lymphoma prognostic index, Ki67 expression, [18F]fluorodeoxyglucose-positron emission tomography and molecular minimal residual disease, in peripheral blood or bone marrow. With a median follow-up of 52 months, the 24-month progression-free survival rate was 70%, hence the primary objective was reached. After six cycles of treatment, 91% (54/59) of responding patients were analyzed for peripheral blood residual disease and 87% of these (47/54) were negative. Four-year overall survival rates of the patients who did not have or had detectable molecular residual disease in the blood at completion of treatment were 86.6% and 28.6%, respectively (P<0.0001). Neither the mantle cell lymphoma index, nor fluorodeoxyglucose-positron emission tomography nor Ki67 positivity (cut off of ≥30%) showed a prognostic impact for survival. Hematologic grade 3-4 toxicities were mainly neutropenia (51%), thrombocytopenia (35%) and lymphopenia (65%). Grade 3-4 non-hematologic toxicities were mainly fatigue (18.5%), neuropathy (15%) and infections. In conclusion, the tested treatment regimen is active as frontline therapy in older patients with mantle cell lymphoma, with manageable toxicity. Minimal residual disease status after induction could serve as an early predictor of survival in mantle cell lymphoma. ClinicalTrials.gov: NCT 01457144.

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