Standardization of Patient Assessments and Administration Guidelines for Blinatumomab

Conference Correspondent  - Conference Correspondent, ONS

Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) is a rare and often fatal disease occurring in adults and children. An estimated 5940 new cases of ALL will occur in 2017, and 1440 deaths will occur in 2017.

About 20% to 45% of adults with relapsed and refractory B-cell ALL experience complete remission (CR), with a median overall survival of 3 to 9 months. Allogeneic hematopoietic stem-cell transplantation (allo-HSCT) is the only curative therapy for adult patients with relapsed and refractory B-cell ALL, and these patients must achieve CR before undergoing allo-HSCT.

Blinatumomab is a bispecific T-cell antibody approved for the treatment of relapsed and refractory B-cell ALL. This antibody binds to CD19-positive B-cells and CD3-positive cytotoxic T-cells, resulting in the upregulation of cell-adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines, and T-cell‒mediated lysis of normal and malignant B-cells. Blinatumomab has been shown to induce CR in approximately 33% of patients, and it is the only single-agent therapy with proven activity in patients with chemotherapy-resistant disease.

Blinatumomab can result in serious and sometimes life-threatening adverse events, including cytokine release syndrome (CRS) and neurologic adverse events. CRS can be effectively treated with dexamethasone, and neurologic adverse events are almost always reversible with early detection and intervention. In addition, blinatumomab presents unique administration challenges related to preventing CRS, which ultimately can lead to line occlusions and possible delay of treatment.

The Clinical Practice Council investigated current practice guidelines after 2 patients experienced adverse events. The purpose of this project was to develop nursing education for blinatumomab, with a focus on proper drug administration.

A “Fact Sheet” was developed, describing the action of blinatumomab in B-cell ALL. The Fact Sheet included dosage information, administration guidelines to minimize line occlusions, and a table outlining the drug’s toxicity profile. Nursing education was provided via mandatory in-services. The Clinical Practice Council also collaborated with clinical pharmacy specialists and hematology physicians, and used the “Terminology Criteria for Adverse Events” grading system to help guide proper assessment of patients. An “FAQ” guide was also created as the use of blinatumomab increased within the institution. Finally, a standardized neurologic patient assessment was developed to ensure the safe and effective administration of blinatumomab.

Blinatumomab assessment and administration guidelines facilitate identification of adverse neurologic events and reduce the number of therapy interruptions and line occlusions. Retrospective chart audits were performed to identify patients who had neurologic toxicities, CRS, or line occlusions while receiving blinatumomab prior to the above-described interventions. The same audits will be done postimplementation, and will be compared with preimplementation data. The postimplementation audits will also monitor adherence to the new assessment documentation guidelines.

Szoch S, et al. ONS Abstract 243.

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Last modified: May 8, 2017