Obinutuzumab plus fludarabine and cyclophosphamide in previously untreated, fit patients with chronic lymphocytic leukemia: a subgroup analysis of the GREEN study

Autor: Andrey Zaritskey, Jean Louis Merot, Ekaterina Gresko, Stephan Stilgenbauer, Francesc Bosch, Mehmet Turgut, Kerstin Trunzer, Veronique Leblond, Agostino Cortelezzi, Eugen Tausch, Sebastian Böttcher, Mourad Tiab, Susan Robson, Wolfgang Knauf, Robin Foà, Guy Cantin
Přispěvatelé: OMÜ, Institut Català de la Salut, [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, Vall d'Hebron Barcelona Hospital Campus, Gestionnaire, Hal Sorbonne Université, Vall d'Hebron University Hospital [Barcelona], Università degli Studi di Milano = University of Milan (UNIMI), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), IQVIA, Universität des Saarlandes [Saarbrücken], Universität Ulm - Ulm University [Ulm, Allemagne], F. Hoffmann-La Roche [Basel], University of Rostock, University Medical Center of Schleswig–Holstein = Universitätsklinikum Schleswig-Holstein (UKSH), Kiel University, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome] (UNIROMA), Sorbonne Université (SU), Centre d'investigation clinique Biothérapie [CHU Pitié-Salpêtrière] (CIC-BTi), Centre d'investigation clinique pluridisciplinaire [CHU Pitié Salpêtrière] (CIC-P 1421), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Università degli Studi di Milano [Milano] (UNIMI), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome], CIC Pitié BT, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)
Jazyk: angličtina
Rok vydání: 2020
Předmět:
[SDV.MHEP.HEM] Life Sciences [q-bio]/Human health and pathology/Hematology
0301 basic medicine
Male
Cancer Research
Chronic lymphocytic leukemia
medicine.medical_treatment
Gastroenterology
chemistry.chemical_compound
0302 clinical medicine
Obinutuzumab
Antineoplastic Combined Chemotherapy Protocols
Medicine
Other subheadings::/therapeutic use [Other subheadings]
Leucèmia limfocítica crònica - Quimioteràpia
Remission Induction
terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS
DIAGNÓSTICOS Y TERAPÉUTICOS]
[SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology
Hematology
Middle Aged
Prognosis
Progression-Free Survival
3. Good health
Fludarabine
Leukemia
Oncology
Tolerability
[SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology
030220 oncology & carcinogenesis
Female
[SDV.IMM.IMM] Life Sciences [q-bio]/Immunology/Immunotherapy
Vidarabine
medicine.drug
neoplasias::neoplasias por tipo histológico::leucemia::leucemia linfoide::leucemia de células B::leucemia linfocítica crónica de células B [ENFERMEDADES]
Adult
medicine.medical_specialty
Cyclophosphamide
[SDV.CAN]Life Sciences [q-bio]/Cancer
Neutropenia
Antibodies
Monoclonal
Humanized
Article
Quimioteràpia combinada
03 medical and health sciences
[SDV.CAN] Life Sciences [q-bio]/Cancer
Internal medicine
Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL
DIAGNOSTIC AND THERAPEUTIC TECHNIQUES
AND EQUIPMENT]
Humans
Aged
Chemotherapy
Haematological cancer
business.industry
Otros calificadores::/uso terapéutico [Otros calificadores]
[SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy
medicine.disease
Leukemia
Lymphocytic
Chronic
B-Cell
030104 developmental biology
Neoplasms::Neoplasms by Histologic Type::Leukemia::Leukemia
Lymphoid::Leukemia
B-Cell::Leukemia
Lymphocytic
Chronic
B-Cell [DISEASES]
chemistry
[SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology
business
Zdroj: Scientia
Leukemia
Leukemia, 2020, 34 (2), pp.441-450. ⟨10.1038/s41375-019-0554-1⟩
Leukemia, Nature Publishing Group: Open Access Hybrid Model Option B, 2020, 34 (2), pp.441-450. ⟨10.1038/s41375-019-0554-1⟩
ISSN: 0887-6924
1476-5551
Popis: Bosch, Francesc/0000-0001-9241-2886 WOS: 000523481800012 PubMed: 31455851 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. F. Hoffmann-La Roche Ltd.Hoffmann-La Roche This study was sponsored by F. Hoffmann-La Roche Ltd.
Databáze: OpenAIRE
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