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Haematologica. 2015 Jul;100(7):955-63. doi: 10.3324/haematol.2015.125344. Epub 2015 Apr 24.

Rituximab maintenance for patients with aggressive B-cell lymphoma in first remission: results of the randomized NHL13 trial.

Author information

1
Medical University of Vienna, Dept. of Medicine I, Division of Hematology and Hemostaseology, Comprehensive Cancer Center, Vienna, Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie, AGMT, Salzburg, Austria ulrich.jaeger@meduniwien.ac.at.
2
Institute of Hematology and Blood Transfusion, 1st Dept. of Medicine, 1st Faculty of Medicine, Charles University, General Hospital, Czech Lymphoma Study Group, Praha, Czech Republic.
3
Medical University of Vienna, Dept. of Medicine I, Division of Hematology and Hemostaseology, Comprehensive Cancer Center, Vienna, Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie, AGMT, Salzburg, Austria.
4
Assign Data Management and Biostatistics GmbH Assign Group, Innsbruck, Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie, AGMT, Salzburg, Austria.
5
Dept. of Internal Medicine, Faculty of Medicine, Chiang Mai University, Thailand.
6
Dept. of Hematology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
7
Australasian Leukaemia & Lymphoma Group, East Melbourne, Australia.
8
Clinic for Hematology, Clinical Center Serbia, Belgrade, Serbia.
9
Ankara University School of Medicine, Dept. of Hematology, Ankara, Turkey.
10
NOU, Klenova Bratislava, Slovakia.
11
Dept. of Internal Medicine, Sundsvall Hospital, Sweden.
12
Division of Hematology and Oncology, Dept. of Medicine, Taipei Veterans General Hospital, and National Yang-Ming University, Taipei, Taiwan.
13
University Medical Unit, Queen Mary Hospital, Hong Kong, China.
14
Dept. of Internal Medicine IV, Wels-Grieskirchen Hospital, Wels, Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie, AGMT, Salzburg, Austria.
15
1st Medical Dept., Landesklinikum Wiener Neustadt, Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie, AGMT, Salzburg, Austria.
16
3rd Medical Dept., Hanusch Hospital, Vienna, Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie, AGMT, Salzburg, Austria.
17
LBI-ACR & ACR-ITR Vienna, Kaiser Franz Josef-Spital, Vienna, Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie, AGMT, Salzburg, Austria.
18
Institute of Pathology and Microbiology, Wilhelminenspital, Vienna, Austria.
19
3rd Dept. of Medicine, AKH-Linz, Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie, AGMT, Salzburg, Austria.
20
Dept. of Internal Medicine III, Private Medical University of Salzburg, Austria Arbeitsgemeinschaft Medikamentöse Tumortherapie, AGMT, Salzburg, Austria.

Abstract

We investigated rituximab maintenance therapy in patients with diffuse large B-cell lymphoma (n=662) or follicular lymphoma grade 3b (n=21) in first complete remission. Patients were randomized to rituximab maintenance (n=338) or observation (n=345). At a median follow-up of 45 months, the event-free survival rate (the primary endpoint) at 3 years was 80.1% for rituximab maintenance versus 76.5% for observation. This difference was not statistically significant for the intent-to-treat population (likelihood ratio P=0.0670). The hazard ratio by treatment arm was 0.79 (95% confidence interval 0.57-1.08; P=0.1433). The secondary endpoint, progression-free survival was also not met for the whole statistical model (likelihood ratio P=0.3646). Of note, rituximab maintenance was superior to observation when treatment arms only were compared (hazard ratio: 0.62; 95% confidence interval 0.43-0.90; P=0.0120). Overall survival remained unchanged (92.0 versus 90.3%). In subgroup analysis male patients benefited from rituximab maintenance with regards to both event-free survival (84.1% versus 74.4%) (hazard ratio: 0.58; 95% confidence interval 0.36-0.94; P=0.0267) and progression-free survival (89.0% versus 77.6%) (hazard ratio: 0.45; 95% confidence interval 0.25-0.79; P=0.0058). Women had more grade 3/4 adverse events (P=0.0297) and infections (P=0.0341). Men with a low International Prognostic Index treated with rituximab had the best outcome. In summary, rituximab maintenance in first remission after R-CHOP-like treatment did not prolong event-free, progression-free or overall survival of patients with aggressive B-non-Hodgkin lymphoma. The significantly better outcome of men warrants further studies prior to the routine use of rituximab maintenance in men with low International Prognostic Index. This trial is registered under EUDRACT #2005-005187-90 and www.clinicaltrials.gov as #NCT00400478.

PMID:
25911553
PMCID:
PMC4486230
DOI:
10.3324/haematol.2015.125344
[Indexed for MEDLINE]
Free PMC Article

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