Leukemia Burden Impacts the Efficacy and Toxicity of Blinatumomab in Pediatric B‐Cell Acute Lymphoblastic Leukemia
ABSTRACT Background Blinatumomab has been approved for the treatment of pediatric B‐cell acute lymphoblastic leukemia (B‐ALL). This study aimed to investigate the association between leukemia burden and the efficacy of blinatumomab in real‐world applications. Methods A real‐world study was conducted...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2025-08-01
|
| Series: | Cancer Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/cam4.71159 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Summary: | ABSTRACT Background Blinatumomab has been approved for the treatment of pediatric B‐cell acute lymphoblastic leukemia (B‐ALL). This study aimed to investigate the association between leukemia burden and the efficacy of blinatumomab in real‐world applications. Methods A real‐world study was conducted by enrolling patients aged 0–18 years who were diagnosed with CD19‐positive B‐ALL and treated with blinatumomab between January 2021 and May 2023 from 14 centers in China. Results A total of 304 patients were enrolled in this analysis. In the patients with > 5% blasts before blinatumomab (non‐complete remission, NCR group), 75.9% achieved complete remission (CR) and 69.0% of the NCR patients achieved minimal residual disease (MRD) negativity. Among the patients with ≤ 5% blasts but multiparametric flow cytometry MRD (MFC MRD) positive (MRD+ group), 98.9% achieved MRD negativity. Of the MFC MRD negative patients (MRD− group), the quantitative polymerase chain reaction MRD (qPCR MRD) and next‐generation sequencing MRD (NGS MRD) clearance rate was 60.0% (12/20) and 65.5% (19/29), respectively. Additionally, patients in the MRD− and MRD+ groups had significantly better outcomes than those in the NCR group, with 30‐month overall survival (OS) rates of 95.3% (95% CI: 91.4%–99.3%), 91.2% (95% CI: 85.0%–97.8%), and 77.6% (95% CI: 67.4%–89.4%), respectively (p < 0.001), and 30‐month event‐free survival (EFS) rates of 93.9% (95% CI: 89.6%–98.3%), 90.8% (95% CI: 85.0%–97.1%), and 56.7% (95% CI: 41.0%–78.6%), respectively (p < 0.001). In this study, 41.4% of patients experienced grade ≥ 3 adverse events (AEs), with hematological toxicity being the most common (33.2%). The severe adverse events, such as cytokine release syndrome (CRS) and neurotoxicity, occurred at a low rate, particularly grade ≥ 3, at 3.6% and 2.6%, respectively. Conclusions Overall, these results indicate that blinatumomab is effective and well tolerated. Patients with a lower leukemia burden before blinatumomab administration tend to have better OS and EFS with fewer AEs. |
|---|---|
| ISSN: | 2045-7634 |