Shortened Obinutuzumab Infusion Is Safe and Reduces Chair Time in Frontline Treatment of Chronic Lymphocytic Leukemia: A Real‐World Study
Dominika Écsiová, Eva Vejražková, Pavel Vodárek, Petra Rozsívalová, Lukáš Smolej, Pavel Žák, Martin ŠimkovičABSTRACT
Background
Obinutuzumab‐based regimens are established frontline treatments for chronic lymphocytic leukemia (CLL), but infusion‐related reactions (IRRs) and prolonged administration increase patient burden and outpatient chair occupancy. Evidence on shortened obinutuzumab infusion in CLL remains limited.
Aims
To evaluate the safety, feasibility, and clinical outcomes of a 2‐h obinutuzumab infusion protocol in treatment‐naïve CLL.
Methods
This retrospective single‐center cohort study included 112 treatment‐naïve patients receiving venetoclax–obinutuzumab ( n = 72) or obinutuzumab–chlorambucil ( n = 40). From cycle 1 day 8 onward, patients were managed according to either a shortened‐infusion strategy (Short; n = 64) or a standard‐duration strategy (Long; n = 48). The primary outcome was IRR incidence and severity; secondary outcomes included chair time, response rate, and progression‐free survival.
Results
IRR rates did not differ significantly between the Short and Long groups (71.9% vs. 83.3%; odds ratio, 0.51; 95% confidence interval, 0.17–1.41; p = 0.18). Most IRRs occurred during the first infusion (87.4%), before implementation of the shortened protocol. Because cycle 1 day 1 and day 2 were administered using the same standard protocol in both groups, the safety comparison relevant to the shortened‐infusion strategy begins at cycle 1 day 8; IRRs were infrequent from cycle 1 day 8 onward, and none occurred from cycle 1 day 15 onward, when eligible patients in the Short group were receiving the 2‐h infusion. Grade 2 reactions predominated (91.6%); no Grade 4 IRRs occurred among the 112 patients included in the analysis. The shortened protocol saved 1.8 h per visit and 11.2 h per patient (42%). No apparent adverse signal in response or progression‐free survival was observed.
Conclusions
In frontline CLL care, a 2‐h obinutuzumab infusion from cycle 1 day 8 was feasible, safe, and substantially reduced chair time, supporting its use to improve outpatient treatment efficiency.