Safety and efficacy of obinutuzumab alone or with chemotherapy in previously untreated or relapsed/refractory chronic lymphocytic leukaemia patients: Final analysis of the Phase IIIb GREEN study.

Autor: Stilgenbauer S; Department of Internal Medicine III, Ulm University, Ulm and Innere Medizin I, Universitätsklinikum des Saarlandes, Homburg, Germany., Bosch F; Department of Hematology, University Hospital Vall d'Hebron, Barcelona, Spain., Ilhan O; Internal Medical Sciences Departments, Ankara University School of Medicine, Ankara, Turkey., Kisro J; Onkologische Schwerpunktpraxis Lübeck, Lübeck, Germany., Mahé B; Clinical Hematology, CHU Nantes Hôtel-Dieu, Nantes, France., Mikuskova E; Department of Hemato-oncology II, National Cancer Institute, Bratislava, Slovakia Blokhin., Osmanov D; Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russian Federation., Reda G; UOC Ematologia - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy., Robinson S; QEII Health Sciences Centre, Halifax, NS, Canada., Tausch E; Department of Internal Medicine III, Ulm University, Ulm, Germany., Turgut M; Department of Internal Medical Sciences, Ondokuz Mayis University, Samsun, Turkey., Wójtowicz M; Clinical Department of Hematology, Hematological Oncology and Internal Diseases, Szpital Wojewodski, Opole, Poland., Böttcher S; Department III of Internal Medicine, Rostock University Medical Center, Rostock (current affiliation) and University Hospital Schleswig-Holstein, Kiel, Germany., Perretti T; PDB Biostatistics -Medical Affairs, F. Hoffmann-La Roche Ltd, Basel, Switzerland., Trask P; Patient Centered Outcomes Research, Genentech Inc, South San Francisco, CA, USA., Van Hoef M; Global Product Development - Medical Affairs, F. Hoffmann-La Roche Ltd, Basel, Switzerland., Leblond V; Clinical Hematology, Sorbonne Université, AP-HP Hôpital Pitié Salpêtrière, Paris, France., Foà R; Division of Hematology, Sapienza University, Rome, Italy.
Jazyk: angličtina
Zdroj: British journal of haematology [Br J Haematol] 2021 Apr; Vol. 193 (2), pp. 325-338. Date of Electronic Publication: 2021 Feb 19.
DOI: 10.1111/bjh.17326
Abstrakt: The manageable toxicity profile of obinutuzumab (GA101; G) alone or with chemotherapy in first-line (1L; fit and non-fit) and relapsed/refractory (R/R) patients with chronic lymphocytic leukaemia (CLL) was established in the primary analysis of the Phase IIIb GREEN trial (Clinicaltrials.gov: NCT01905943). The final analysis (cut-off, 31 January 2019) is reported here. Patients received G (1000 mg) alone (G-mono; fit and non-fit patients) or with chemotherapy [fludarabine and cyclophosphamide (FC; fit patients); chlorambucil (non-fit patients); bendamustine (any patient)]. Study endpoints were safety (primary) and efficacy (secondary). Subgroup analyses were performed on prognostic biomarkers in 1L CLL. Overall, 630 patients received 1L and 341 received R/R CLL treatment. At the final analysis, no new safety signals were observed [Grade ≥ 3 adverse events (AEs): 1L 82·7%, R/R 84·5%; serious AEs: 1L 58·1%, R/R 62·5%]. Neutropenia (1L 50·5%, R/R 53·4%) and thrombocytopenia (1L 14·6%, R/R 19·1%) were the most common Grade 3-5 AEs. G-mono-, G-bendamustine and G-FC-treated patients with unmutated immunoglobulin heavy chain trended towards shorter progression-free survival. Achievement of minimal residual disease negativity was greatest in 1L patients treated with G-FC. In this final analysis of the GREEN trial, the safety profile of G was consistent with current risk management strategies. Biomarker analyses supported efficacy in the specific subgroups.
(© 2021 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.)
Databáze: MEDLINE
Externí odkaz: