RITUXIMAB MAINTENANCE FOR PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA IN FIRST COMPLETE REMISSION: RESULTS FROM A RANDOMIZED HOVON-NORDIC LYMPHOMA GROUP PHASE III STUDY
Author(s): ,
Pieternella Lugtenburg
Affiliations:
Hematology,Erasmus MC Cancer Institute,Rotterdam,Netherlands
,
Peter Brown
Affiliations:
Hematology,Rigshospitalet,Copenhagen,Denmark
,
Bronno van der Holt
Affiliations:
HOVON Data Center, Hematology,Erasmus MC Cancer Institute,Rotterdam,Netherlands
,
Francesco D'Amore
Affiliations:
Hematology,Aarhus University Hospital,Aarhus,Denmark
,
Harry Koene
Affiliations:
Internal Medicine,St. Antonius Hospital,Nieuwegein,Netherlands
,
Eva de Jongh
Affiliations:
Internal Medicine,Albert Schweitzer Hospital,Dordrecht,Netherlands
,
Rob Fijnheer
Affiliations:
Hematology,Meander MC,Amersfoort,Netherlands
,
Olaf Loosveld
Affiliations:
Hematology,Amphia Hospital,Breda,Netherlands
,
Lara Böhmer
Affiliations:
Hematology,Haga Teaching Hospital,The Hague,Netherlands
,
Hans Pruijt
Affiliations:
Internal Medicine,Jeroen Bosch Hospital,'s-Hertogenbosch,Netherlands
,
Gregor Verhoef
Affiliations:
Hematology,University Hospitals Leuven,Leuven,Belgium
,
Mels Hoogendoorn
Affiliations:
Internal Medicine,Medical Center Leeuwarden,Leeuwarden,Netherlands
,
Yavuz Bilgin
Affiliations:
Internal Medicine,Admiraal de Ruyter Hospital,Goes,Netherlands
,
Marcel Nijland
Affiliations:
Hematology,University Medical Center Groningen,Groningen,Netherlands
,
King Lam
Affiliations:
HOVON Pathology Facility and Biobank, Pathology,Erasmus MC,Rotterdam,Netherlands
,
Bart de Keizer
Affiliations:
Nuclear Medicine,UMC Utrecht,Utrecht,Netherlands
,
Daphne de Jong
Affiliations:
HOVON Pathology Facility and Biobank, Pathology,Amsterdam UMC, location VUmc,Amsterdam,Netherlands
Josee Zijlstra
Affiliations:
Hematology,Amsterdam UMC, Vrije Universiteit Cancer Center,Amsterdam,Netherlands
EHA Library. LUGTENBURG P. Jun 16, 2019; 267353; S1599
Dr. Pieternella LUGTENBURG
Dr. Pieternella LUGTENBURG
Contributions
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Abstract

Abstract: S1599

Type: Oral Presentation

Presentation during EHA24: On Sunday, June 16, 2019 from 08:30 - 08:45

Location: Hall 5

Background
This randomized phase III trial assessed whether intensification of rituximab (R) during the first 4 cycles of R-CHOP can improve outcome of diffuse large B-cell lymphoma (DLBCL) patients compared with standard R-CHOP.  Patients in complete remission (CR) after induction treatment were randomized between rituximab maintenance and observation. Intensification of rituximab was not more effective than standard R-CHOP, showing same CR-rates and progression free survival after induction (ASCO 2016 # 7504). Here, we report the results of the second randomization for rituximab maintenance therapy.  

Aims
To assess in a prospective, multicenter, randomized phase III study in patients with DLBCL the efficacy of maintenance treatment with rituximab in comparison to no further treatment on disease free survival.

Methods
Patients in CR after R-CHOP were randomized between 24 months of rituximab maintenance 375 mg/m2 intravenous every 8 weeks (n = 199 ) or observation (n = 199). CT scans were performed at 6, 12, 18 and 24 months in both arms. The primary endpoint was disease free survival (DFS) from maintenance randomization. Secondary endpoints were overall survival (OS) and adverse events (AEs). (www.trialregister.nl NTR1014).

Results
Median age was 65 years (range 31-80), 48% were 66 years or older and 49% were male. The majority of patients (54%) had a high-intermediate or high aa-IPI score.  After a median follow-up of 79.9 months (maximum 125.7 months), the 5-year DFS rate was 79% for rituximab maintenance versus 74% for observation. This difference was not statistically significant, with a hazard ratio of 0.83 (95% confidence interval 0.57-1.19, p=0.31, adjusted for age and aa-IPI). The secondary endpoint OS was also not significantly different (85% versus 83% at 5 years). No clinical subgroup benefited from rituximab maintenance. Toxicity was mild. Among patients who received rituximab maintenance CTCAE grade 3 and 4 AEs were reported in 17% and 6% of patients, respectively. Infection was the most frequent AE, a grade 3 infection occurred in 6% of patients. Neutropenia was seen in 1% (grade 3) and 3% (grade 4) of patients. 

Conclusion
Rituximab maintenance therapy provides no additional benefit for DLBCL patients in first CR after R-CHOP.

Session topic: 19. Aggressive Non-Hodgkin lymphoma - Clinical

Keyword(s): DLBCL, Maintenance, Phase III, Rituximab

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