Characterization of Fever, Infection, and Cytokine Release Syndrome (CRS) in Adult Patients with Relapsed or Refractory ALL Treated with Blinatumomab
Blinatumomab is a novel bispecific T-cell engaging immunomodulatory antibody that is approved for relapsed/refractory Philadelphia chromosome–negative acute lymphoblastic leukemia (ALL).1 Blinatumomab therapy is associated with infections and cytokine release syndrome (CRS); fever is a clinical indicator for both. This single-center retrospective cohort analysis sought to characterize the incidence of fever, infection, and CRS related to blinatumomab treatment and correlate them to clinical outcomes; the results of which were reported by Patel and colleagues.2
A total of 40 patients treated at MD Anderson Cancer Center completed 72 cycles of blinatumomab during the study period; the median age was 29 years (range, 19-76 years). Fever occurred in 68% of patients during the first cycle, and occurred in 54% (n = 39) of all cycles. CRS occurred in 52% during cycle 1 and in 51% of overall cycles; but were of grade 2 severity. Both fever and CRS were significantly associated with response to blinatumomab therapy, with 20 (50%) patients with fever achieving a response, and 86% of patients with CRS achieving a response. Culture-positive infections were reported in 31% (n = 22) of cycles, but after adjustment for confounding factors such as infection at baseline, the culture-positive rate decreased to 18% (n = 13). Neutropenia occurred in 60% (n = 43) of cycles, febrile neutropenia (FN) in 42% (n = 30), and nonneutropenic fever in 13% (n = 9) of the cycles. The rate of culture-positive FN was 50% (n = 15), which decreased to 33% (n = 10) after adjustment for confounding factors. FN plus CRS occurred in 25% of cycles (n = 18), of which the culture-positive rate was 17% (n = 3). Based on these results, the authors concluded that fever and FN occur frequently with blinatumomab treatment, but the rate of culture-positive FN was comparable to other hematologic therapies when adjusted for confounding factors.
- Blincyto (blinatumomab) [Prescribing information]; 2015.
- Patel YB, et al. ASH 2015. Abstract 2530