dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Stilgenbauer, Stephan |
dc.contributor.author | Bosch Albareda, Francesc |
dc.contributor.author | Ilhan, Osman |
dc.contributor.author | Kisro, Jens |
dc.contributor.author | Mahé, Béatrice |
dc.contributor.author | Mikuskova, Eva |
dc.date.accessioned | 2021-06-23T11:14:36Z |
dc.date.available | 2021-06-23T11:14:36Z |
dc.date.issued | 2021-04 |
dc.identifier.citation | Stilgenbauer 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.issn | 1365-2141 |
dc.identifier.uri | https://hdl.handle.net/11351/6091 |
dc.description | Obinutuzumab; Chronic lymphocytic leukaemia; Minimal residual disease |
dc.description.abstract | 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. |
dc.language.iso | eng |
dc.publisher | Wiley |
dc.relation.ispartofseries | British Journal of Haematology;193(2) |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
dc.source | Scientia |
dc.subject | Leucèmia limfocítica crònica |
dc.subject | Quimioteràpia combinada |
dc.subject | Prognosi |
dc.subject.mesh | Leukemia, Lymphocytic, Chronic, B-Cell |
dc.subject.mesh | Antineoplastic Combined Chemotherapy Protocols |
dc.subject.mesh | Treatment Outcome |
dc.title | 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 |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1111/bjh.17326 |
dc.subject.decs | leucemia linfocítica crónica de células B |
dc.subject.decs | protocolos de quimioterapia antineoplásica combinada |
dc.subject.decs | resultado del tratamiento |
dc.relation.publishversion | https://onlinelibrary.wiley.com/doi/10.1111/bjh.17326 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut 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.pmid | 33605445 |
dc.identifier.wos | 000619541700001 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |