Authors:	Hess, Georg Hüttmann, Andreas Witzens-Harig, Mathias Dreyling, Martin H. Keller, Ulrich Marks, Reinhard Ernst, Thomas Pott, Christiane Viardot, Andreas Frontzek, Fabian Trautmann, Marcel Ruckes, Christian Deuster, Oliver Rosenwald, Andreas Theobald, Matthias Lenz, Goerg
Title:	A phase II trial to evaluate the combination of pixantrone and obinutuzumab for patients with relapsed aggressive lymphoma : final results of the prospective, multicentre GOAL trial
Online publication date:	19-Jan-2023
Year of first publication:	2022
Language:	english
Abstract:	The prognosis of patients with relapsed diffuse large B-cell lymphoma (DLBCL) remains poor with current options. Here we prospectively evaluated the combination of pixantrone with obinutuzumab for up to six cycles for patients with relapsed or refractory DLBCL. Overall response rate (ORR) was the primary end-point. Sixty-eight patients were evaluated, median age was 75 years, median number of prior lines was three (range 1–10), 52 patients (76.5%) were diagnosed with DLBCL and 16 (23.5%) patients had transformed indolent lymphoma or follicular lymphoma (FL) IIIB. ORR was 35.3% for all and 40% for evaluable patients (16.6% complete response), median progression-free survival (PFS) and overall survival (OS) were 2.8 months and 8 months, respectively. Analysis of the cell of origin revealed a superior course for patients with non-GCB (germinal centre B-cell-like) phenotype [median OS not reached (n.r.) vs 5.2 months]. Patients with one prior line had an improved outcome over patients treated in later lines (PFS n.r. vs 2.5 months). Disease progression was the main reason for premature termination. Adverse events were mainly haematologic. The combination treatment revealed no unexpected adverse events. Most relevant non-haematologic toxicity was infection in 28% of patients. In summary, pixantrone–obinutuzumab showed clinical activity with sometimes long-term remission; however, the trial failed to meet its primary end-point.
DDC:	610 Medizin 610 Medical sciences
Institution:	Johannes Gutenberg-Universität Mainz
Department:	FB 04 Medizin
Place:	Mainz
ROR:	https://ror.org/023b0x485
DOI:	http://doi.org/10.25358/openscience-8604
Version:	Published version
Publication type:	Zeitschriftenaufsatz
License:	CC BY-NC-ND
Information on rights of use:	https://creativecommons.org/licenses/by-nc-nd/4.0/
Journal:	European journal of heart failure 198 3
Pages or article number:	482 491
Publisher:	Wiley
Publisher place:	Oxford
Issue date:	2022
ISSN:	1365-2141
Publisher DOI:	10.1111/bjh.18161
Appears in collections:	DFG-491381577-H