BACKGROUND: In patients with previously untreated chronic lymphocytic leukemia (CLL) and comorbidities, treatment with the glycoengineered, type II anti-CD20 monoclonal antibody obinutuzumab (Gazyva®) (GA101) plus chlorambucil (Leukeran®) was associated with superior outcomes to rituximab (Rituxan®) plus chlorambucil, with a similar safety profile. However, a higher occurrence of infusion-related reactions (IRRs) was reported with obinutuzumab. These reactions typically require additional management. OBJECTIVES: The focus of this article is to provide oncology nurses and physicians with advice for obinutuzumab IRR management based on clinical trial data and nursing experience. METHODS: The authors reviewed the published management strategies for IRRs with obinutuzumab that were identified during the phase III CLL11 trial and an expanded access phase IIb study (ML28979). Practical advice for obinutuzumab IRR management was developed based on available clinical trial information and nursing experience. FINDINGS: IRRs with obinutuzumab are generally manageable. Most IRRs (all grades), and all grade 3-4 IRRs, occurred during the first infusion. Therefore, IRR management could be improved substantially with extra vigilance at this early stage.
BACKGROUND: In patients with previously untreated chronic lymphocytic leukemia (CLL) and comorbidities, treatment with the glycoengineered, type II anti-CD20 monoclonal antibody obinutuzumab (Gazyva®) (GA101) plus chlorambucil (Leukeran®) was associated with superior outcomes to rituximab (Rituxan®) plus chlorambucil, with a similar safety profile. However, a higher occurrence of infusion-related reactions (IRRs) was reported with obinutuzumab. These reactions typically require additional management. OBJECTIVES: The focus of this article is to provide oncology nurses and physicians with advice for obinutuzumabIRR management based on clinical trial data and nursing experience. METHODS: The authors reviewed the published management strategies for IRRs with obinutuzumab that were identified during the phase III CLL11 trial and an expanded access phase IIb study (ML28979). Practical advice for obinutuzumabIRR management was developed based on available clinical trial information and nursing experience. FINDINGS: IRRs with obinutuzumab are generally manageable. Most IRRs (all grades), and all grade 3-4 IRRs, occurred during the first infusion. Therefore, IRR management could be improved substantially with extra vigilance at this early stage.
Authors: Arnon P Kater; Sabina Kersting; Yvette van Norden; Julie Dubois; Johan A Dobber; Clemens H Mellink; Ludo M Evers; Fransien Croon-de Boer; John Schreurs; Ellen van der Spek; Hein Visser; Cecile Idink; Shulamiet Wittebol; Mels Hoogendoorn; Sanne H Tonino; Mehrdad Mobasher; Mark-David Levin Journal: Blood Adv Date: 2018-12-26
Authors: Nicole Bourrier; Ivan Landego; Oliver Bucher; Mandy Squires; Erin Streu; Irena Hibbert; Theresa Whiteside; Spencer B Gibson; Marc Geirnaert; James B Johnston; David E Dawe; Versha Banerji Journal: BMC Cancer Date: 2022-02-06 Impact factor: 4.430