Lenalidomide-rituximab or lenalidomide-rituximab-bendamustine for relapsed/refractory follicular lymphoma: primary and final analysis of the randomized phase II HOVON110/ReBeL study
Abstract
The R2 (lenalidomide-rituximab) and R2 with bendamustine (R2B) regimens are both feasible in relapsed/refractory follicular lymphoma (R/R FL), but prospective phase II data on R2B are lacking. In this multinational, prospective, randomised, non-comparative trial, patients with R/R FL were randomised 1:1 to R2 (arm A) or R2B (arm B). Patients achieving CT-based partial or complete remission (PR/CR) received rituximab maintenance every 3 months for 2 years. Co-primary endpoints were investigator-assessed CR rates at end-of-induction (EOI) and severe toxicity rates. Between December 2014 and July 2019, 92 patients were randomized. The trial was stopped prematurely due to slow accrual. CR rates at EOI were 11.4% (95% CI [3.8, 24.6%]) for R2 and 15.2% (CI [6.3, 28.9%]) for R2B. With a median follow-up of 74 months, predefined severe toxicities occurred in 3 (6.8%; CI [1.4, 18.7%]) and 6 pts (13.0%, CI [4.9, 26.3%]) in Arm A and Arm B respectively, with 2 pneumonia-related deaths in arm A and no treatment-related deaths in arm B; 43% and 66% experienced any grade 3-4 AE (2%/7% grade 4). At 60 months, in arms A and B event free survival (EFS) was 39.5% (CI [25.1, 53.6%]) and 56.4% (CI [40.1, 69.3%]). Overall survival (OS) was excellent at 72.1% and 86.3%, respectively. R2 and R2B are both effective treatment regimens for R/R FL. While CT-based CR rates were low, treatment with R2B resulted in numerically longer median EFS and OS, but this was associated with higher toxicity.
Authors 38
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Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam
Affiliation as printed
Department of Hematology, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam. m.j.kersten@amsterdamumc.nl
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LMU Klinikum · Ludwig-Maximilians-Universität München
Affiliation as printed
Department of Hematology, University Clinic, LMU Munich, Munich
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University of Manchester · The Christie NHS Foundation Trust
Affiliation as printed
Division of Cancer Sciences, The University of Manchester and The Christie NHS Foundation Trust, Manchester
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Affiliation as printed
HOVON Foundation, Rotterdam, Netherlands; Department of Hematology, Erasmus Medical Center, Rotterdam
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Amsterdam University Medical Centers · Cancer Center Amsterdam
Affiliation as printed
Department of Radiology and Nuclear Medicine, Amsterdam UMC, Cancer Center Amsterdam, Amsterdam
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Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam
Affiliation as printed
Department of Hematology, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam
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Affiliation as printed
HOVON Foundation, Rotterdam
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Amsterdam University Medical Centers
Affiliation as printed
Clinical trial office, Department of Hematology, Amsterdam UMC, Amsterdam
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Affiliation as printed
HOVON Foundation, Rotterdam
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Cancer Center Amsterdam · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Department of Hematology, Amsterdam UMC, location VUMC, Cancer Center Amsterdam, Amsterdam
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Affiliation as printed
Department of Hematology, Noord-West Ziekenhuis, Alkmaar
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Affiliation as printed
Department of Hematology, Albert Schweitzer Ziekenhuis, Dordrecht
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Leiden University Medical Center
Affiliation as printed
Department of Hematology, Leiden University Medical Center, Leiden
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Affiliation as printed
Department of Internal Medicine, Maasstad Ziekenhuis, Rotterdam
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Affiliation as printed
Department of Internal Medicine, Admiraal de Ruyter Ziekenhuis, Goes
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Essen University Hospital · Stiftung Universitätsmedizin Essen
Affiliation as printed
Department of Hematology, University Medicine Essen, Essen
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Beatson West of Scotland Cancer Centre
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Department of Hematology, The Beatson West of Scotland Cancer Centre, Glasgow
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Affiliation as printed
Department of Hematology, Medisch Spectrum Twente, Enschedé
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University of Liverpool · Clatterbridge Cancer Centre NHS Foundation Trust
Affiliation as printed
University of Liverpool, Liverpool, UK; and The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool
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Utrecht University · University Medical Center Utrecht
Affiliation as printed
Department of Hematology, UMC Utrecht, University Utrecht, Utrecht
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Affiliation as printed
Hematology Private Practice, Dresden
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Department of Hematology, Rijnstate Ziekenhuis, Arnhem
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Department of Hematology Haga Teaching Hospital, The Hague
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Department of Hematology, Maxima Medisch Centrum, Veldhoven
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Department of Hematology, Stadtisches Klinikum Dessau
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Department of Hematology, Ter Gooi Ziekenhuis, Hilversum
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Affiliation as printed
Department of Hematology, Meander MC, Amersfoort
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Spaarne Ziekenhuis · Spaarne Gasthuis
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Department of Hematology, Spaarne Gasthuis, Hoofddorp
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University Medical Center Utrecht
Affiliation as printed
Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Utrecht
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Maastricht University Medical Centre · Maastricht University
Affiliation as printed
Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, and GROW - Research Institute for Oncology and Reproduction, Maastricht
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Radboud University Nijmegen · Radboud University Medical Center
Affiliation as printed
Department of Medical Imaging, Radboud University Medical Center, Nijmegen
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Amsterdam University Medical Centers · Cancer Center Amsterdam
Affiliation as printed
Department of Radiology and Nuclear Medicine, Amsterdam UMC, Cancer Center Amsterdam, Amsterdam
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Amsterdam UMC Location Vrije Universiteit Amsterdam
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Department of Epidemiology and Data Science, Amsterdam UMC, location VUMC, Amsterdam
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Christian-Albrechts-Universität zu Kiel
Affiliation as printed
Department of Hematopathology, Kiel University, Kiel
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Affiliation as printed
Department of Eye and Vision Science, Institute of Life Course and Medical Sciences, University of Liverpool; Liverpool Clinical Laboratories, NHS University Hospitals of Liverpool Group; Liverpool
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The Netherlands Cancer Institute · Hovon
Affiliation as printed
Dept of Pathology, Netherlands Cancer Institute, Amsterdam, Netherlands; HOVON Pathology Facility and Biobank, Amsterdam
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Affiliation as printed
Department of Hematology, Erasmus Medical Center, Rotterdam
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Cancer Center Amsterdam · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Department of Hematology, Amsterdam UMC, location VUMC, Cancer Center Amsterdam, Amsterdam
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