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Leukemia. 2019 Aug 28. doi: 10.1038/s41375-019-0559-9. [Epub ahead of print]

MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial.

Author information

1
University Hospital Schleswig-Holstein, Kiel, Germany. c.pott@med2.uni-kiel.de.
2
British Columbia Cancer Agency and the University of British Columbia, Vancouver, BC, Canada.
3
Department of Internal Medicine-Haematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.
4
Queen Mary University of London, London, UK.
5
Hospital of the Ludwig-Maximilians University, Munich, Germany.
6
Washington University School of Medicine, St Louis, MO, USA.
7
University Hospital Schleswig-Holstein, Kiel, Germany.
8
University of Lyon, Lyon, France.
9
F. Hoffmann-La Roche Ltd, Basel, Switzerland.
10
Roche, Welwyn Garden City, UK.
11
Georgetown University Hospital, Washington, DC, USA.

Abstract

We report assessment of minimal residual disease (MRD) status and its association with outcome in rituximab-refractory follicular lymphoma (FL) in the randomized GADOLIN trial (NCT01059630). Patients received obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone. Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement) detected at study screening were assessed for MRD at mid-induction (MI), end of induction (EOI), and every 6-24 months post-EOI/discontinuation by real-time quantitative PCR. At MI, 41/52 (79%) patients receiving G-Benda were MRD-negative vs. 17/36 (47%) patients receiving Benda alone (p = 0.0029). At EOI, 54/63 (86%) patients receiving G-Benda were MRD-negative vs. 30/55 (55%) receiving Benda alone (p = 0.0002). MRD-negative patients at EOI had improved progression-free survival (HR, 0.33, 95% CI, 0.19-0.56, p < 0.0001) and overall survival (HR, 0.39, 95% CI, 0.19-0.78, p = 0.008) vs. MRD-positive patients, and maintained their MRD-negative status for longer if they received G maintenance than if they did not. These results suggest that the addition of G to Benda-based treatment during induction can significantly contribute to the speed and depth of response, and G maintenance in MRD-negative patients potentially delays lymphoma regrowth.

PMID:
31462735
DOI:
10.1038/s41375-019-0559-9

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