Abstract

We thank the patient and her family for participating in this clinical trial and the GP28331 study site staff on the Hope Unit at the Leicester Royal Infirmary. We also thank Dr Gregory Vosganian and his colleagues at Genentech and Roche for their help and review of the case. Studies were supported by the Leicester Experimental Cancer Medicine Centre (C325/A15575 Cancer Research UK/UK Department of Health).

Highlights

  • Obinutuzumab, an afucosylated, type 2 anti-CD20 antibody, showed superior results to rituximab in a head-to-head comparison in combination with chlorambucil in the first-line treatment of chronic lymphocytic leukaemia (CLL) patients with comorbidities in the CLL11 trial (NCT01010061).[1]

  • The frequency of infusion-related reactions (IRRs) of any grade observed in the CLL11 study was 66% in the obinutuzumab and chlorambucil arm, with 20% being Grade 3–4.1 In comparison, only 3% of patients receiving rituximab developed Grade 3–4 IRR

  • Two recent reports from Freeman et al.[4,5] have characterised obinutuzumab-associated IRRs in CLL patients. They demonstrated that IRRs were associated with acute release of cytokines including interleukin 6 (IL6), tumour necrosis factor alpha (TNFA) and interleukin 8 (IL8).[4]

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Summary

Introduction

Obinutuzumab, an afucosylated, type 2 anti-CD20 antibody, showed superior results to rituximab in a head-to-head comparison in combination with chlorambucil in the first-line treatment of chronic lymphocytic leukaemia (CLL) patients with comorbidities in the CLL11 trial (NCT01010061).[1]. Obinutuzumab is associated with increased toxicities, mainly infusion-related reactions (IRRs), which occur predominantly during the first antibody infusion, often after only small amounts of antibody.[4] The frequency of IRR of any grade observed in the CLL11 study was 66% in the obinutuzumab and chlorambucil arm, with 20% being Grade 3–4.1 In comparison, only 3% of patients receiving rituximab developed Grade 3–4 IRR. Two recent reports from Freeman et al.[4,5] have characterised obinutuzumab-associated IRRs in CLL patients.

Results
Conclusion
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