Date of Award

1-1-2022

Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department

Physician Assistant Studies

Abstract

Objective: The objective of this selective EBM review paper is to determine whether or not, “Does the use of blinatumomab improve the overall survival rate in adults with relapsed/refractory acute lymphoblastic leukemia?”

Study Design: A systematic review of two RCTs and one case-based series were utilized. All studies were published between 2014-2019.

Data Sources: The two RCTs were found through PubMed and the case-based series was obtained through CINAHL Plus. All the studies were published in peer-reviewed journals.

Outcomes Measured: The main outcome measured in all the studies was overall survival. Both RCTs defined overall survival as the time from randomization (i.e., when patients are assigned to receive blinatumomab or standard chemotherapy) to death from any cause. The case-based series by Topp et. al defined overall survival as the time from the first dose of blinatumomab to death from any cause.

Results: In the first RCT by Kantarjian et al., the median overall survival was 7.7 months in the blinatumomab group (95% CI, 5.6 to 9.6) and 4.0 months (95% CI, 2.9 to 5.3) in the chemotherapy group. The hazard ratio calculated for death was 0.71 (95% CI, 0.55 to 0.93) with a p-value of 0.01. The second RCT determined median overall survival for the first salvage group to be 11.1 months for blinatumomab (95% CI, 8.2 months-NR, not reached) and 5.5 months for chemotherapy (95% CI, 3.7–9.0 months), for a hazard ratio of 0.59 (95% CI, 0.38–0.91); p = 0.016. Median overall survival for second or later salvage was 5.1 months for blinatumomab (95% CI, 3.2–7.1 months) and 3.0 months for chemotherapy (95% CI, 2.1–4.0 months). A hazard ratio of 0.72 (95% CI, 0.52–1.01) and a p-value of 0.055 was calculated. The case-based series by Topp et al. revealed shorter overall survival (p=0.201) in patients who relapsed after previous HSCT (8.8 months) compared with those who relapsed that did not undergo a prior HSCT (14.1 months).

Conclusions: All three studies in this review indicate that blinatumomab improves overall survival in patients with relapsed/refractory B cell ALL.

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