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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorStilgenbauer, Stephan
dc.contributor.authorBosch Albareda, Francesc
dc.contributor.authorIlhan, Osman
dc.contributor.authorKisro, Jens
dc.contributor.authorMahé, Béatrice
dc.contributor.authorMikuskova, Eva
dc.date.accessioned2021-06-23T11:14:36Z
dc.date.available2021-06-23T11:14:36Z
dc.date.issued2021-04
dc.identifier.citationStilgenbauer S, Bosch F, Ilhan O, Kisro J, Mahé B, Mikuskova E, et al. 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. Br J Haematol. 2021 Apr;193(2):325-338.
dc.identifier.issn1365-2141
dc.identifier.urihttp://hdl.handle.net/11351/6091
dc.descriptionObinutuzumab; Chronic lymphocytic leukaemia; Minimal residual disease
dc.description.abstractThe 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.
dc.language.isoeng
dc.publisherWiley
dc.relation.ispartofseriesBritish Journal of Haematology;193(2)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectLeucèmia limfocítica crònica
dc.subjectQuimioteràpia combinada
dc.subjectPrognosi
dc.subject.meshLeukemia, Lymphocytic, Chronic, B-Cell
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.meshTreatment Outcome
dc.titleSafety 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
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1111/bjh.17326
dc.subject.decsleucemia linfocítica crónica de células B
dc.subject.decsprotocolos de quimioterapia antineoplásica combinada
dc.subject.decsresultado del tratamiento
dc.relation.publishversionhttps://onlinelibrary.wiley.com/doi/10.1111/bjh.17326
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Stilgenbauer S] Department of Internal Medicine III, Ulm University, Ulm and Innere Medizin I, Universitätsklinikum des Saarlandes, Homburg, Germany. [Bosch F] Servei d’Hematologia, Vall d'Hebron Hospital Universitari, 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
dc.identifier.pmid33605445
dc.identifier.wos000619541700001
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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