dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Bosch Albareda, Francesc |
dc.contributor.author | Cantin, Guy |
dc.contributor.author | Cortelezzi, Agostino |
dc.contributor.author | Knauf, Wolfgang |
dc.contributor.author | Tiab, Mourad |
dc.contributor.author | Turgut, Mehmet |
dc.date.accessioned | 2021-11-04T13:59:18Z |
dc.date.available | 2021-11-04T13:59:18Z |
dc.date.copyright | 2019 |
dc.date.issued | 2020-02 |
dc.identifier.citation | Bosch F, Cantin G, Cortelezzi A, Knauf W, Tiab M, Turgut M, et al. Obinutuzumab plus fludarabine and cyclophosphamide in previously untreated, fit patients with chronic lymphocytic leukemia: a subgroup analysis of the GREEN study. Leukemia. 2020 Feb;34(2):441–50. |
dc.identifier.issn | 1476-5551 |
dc.identifier.uri | https://hdl.handle.net/11351/6499 |
dc.description | Haematological cancer; Prognosis |
dc.description.abstract | GREEN (NCT01905943) is a nonrandomized, open-label, single-arm, phase 3b study investigating the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in chronic lymphocytic leukemia (CLL). We report the preplanned subgroup analysis of 140 previously untreated, fit CLL patients who received obinutuzumab plus fludarabine and cyclophosphamide (G-FC). The primary endpoint was safety and tolerability. Efficacy was the secondary endpoint. Obinutuzumab 1000 mg was administered intravenously on Day (D)1 (dose split D1‒2), D8 and D15 of Cycle (C)1, and D1 of C2–6 (28-day cycles). Standard intravenous/oral doses of fludarabine and cyclophosphamide were administered on D1–3 of C1–6. Overall, 87.1% of patients experienced grade ≥ 3 adverse events (AEs), including neutropenia (67.1%) and thrombocytopenia (17.1%). Serious AEs were experienced by 42.1% of patients. Rates of grade ≥ 3 infusion-related reactions and infections were 19.3% and 15.7%, respectively. Overall response rate was observed in 90.0%, with 46.4% of patients achieving complete response (CR; including CR with incomplete marrow recovery). Minimal residual disease negativity rates were 64.3% in peripheral blood and 35.7% in bone marrow (intent-to-treat analysis). After a median observation time of 25.6 months, 2 year progression-free survival was 91%. Frontline G-FC represents a promising treatment option for fit patients with CLL. |
dc.language.iso | eng |
dc.publisher | Springer Nature |
dc.relation.ispartofseries | Leukemia;34(2) |
dc.rights | Attribution 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ |
dc.source | Scientia |
dc.subject | Leucèmia limfocítica crònica - Quimioteràpia |
dc.subject | Quimioteràpia combinada |
dc.subject.mesh | Leukemia, Lymphocytic, Chronic, B-Cell |
dc.subject.mesh | Antineoplastic Combined Chemotherapy Protocols |
dc.subject.mesh | /therapeutic use |
dc.title | Obinutuzumab plus fludarabine and cyclophosphamide in previously untreated, fit patients with chronic lymphocytic leukemia: a subgroup analysis of the GREEN study |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1038/s41375-019-0554-1 |
dc.subject.decs | leucemia linfocítica crónica de células B |
dc.subject.decs | protocolos de quimioterapia antineoplásica combinada |
dc.subject.decs | /uso terapéutico |
dc.relation.publishversion | https://doi.org/10.1038/s41375-019-0554-1 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [Bosch F] Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Cantin G] Hopital De L’Enfant—Jesus, Quebec City, QC, Canada. [Cortelezzi A] Hematology Unit, Policlinico Hospital and University of Milan, Milan, Italy. [Knauf W] Onkologische Gemeinschaftspraxis, Agaplesion Bethanien Krankenhaus, Frankfurt, Germany. [Tiab M] University Hospital, La Roche Sur Yon, France. [Turgut M] Ondokuz Mayis University, Samsun, Turkey |
dc.identifier.pmid | 31455851 |
dc.identifier.wos | 000523481800012 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |