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Real-world evidence on treatment pattern, effectiveness, and safety of blinatumomab in Chinese patients with B-cell acute lymphoblastic leukemia.
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- Author(s): Zhou, Huifen; Wu, Xiaoxia; Yang, Zhen; Lu, Shenqi; Zhang, Xinhui; Yang, Xiaofei; Chen, Suning; Wu, Depei; Miao, Miao
- Source:
Investigational New Drugs; Jun2024, Vol. 42 Issue 3, p299-308, 10p- Subject Terms:
THERAPEUTIC use of antineoplastic agents; THERAPEUTIC use of monoclonal antibodies; PATIENT safety; ANTINEOPLASTIC agents; SCIENTIFIC observation; TREATMENT effectiveness; RETROSPECTIVE studies; TREATMENT duration; DESCRIPTIVE statistics; MONOCLONAL antibodies; REMISSION induction; BLOOD cells; LYMPHOBLASTIC leukemia; CARCINOGENESIS; PROGRESSION-free survival; CONFIDENCE intervals; B cells; INDUCTION chemotherapy - Source:
- Additional Information
- Subject Terms:
- Abstract: Summary: Blinatumomab is efficacious in patients with B-cell acute lymphoblastic leukemia (B-ALL), yet limited real-world data exists in this context. This retrospective study provided real-world data on the treatment pattern, effectiveness, and safety of blinatumomab in Chinese patients with newly diagnosed (ND) and relapsed/refractory (R/R) B-ALL. Patients with B-ALL who received at least one dose of blinatumomab in frontline or R/R settings between August 2021 and June 2023 were included. The primary outcome was the treatment pattern of blinatumomab. Key secondary outcomes included complete remission (CR)/CR with incomplete blood cell recovery (CRi) rate, minimal residual disease (MRD) negativity, median event-free survival (EFS), and safety. The study included 96 patients with B-ALL; 53 (55.2%) patients were in the ND group and 43 (44.8%) patients were in the R/R group. The median treatment duration was one cycle (range: 1–5). Most patients underwent chemotherapies, allo-HSCT, or experimental CAR-T following blinatumomab. The ND patients using blinatumomab induction therapy achieved 100% CR/CRi rate; 87.2% achieved MRD negativity within two cycles of blinatumomab. In R/R re-induction patients, the CR/CRi rate was 50%; MRD negativity rate was 64.2%. In R/R patients using blinatumomab for consolidation, MRD negativity rate was 90.9%. The median EFS was not reached in both ND and R/R patients; 1-year EFS rate was 90.8% (95% CI: 67%, 97%) and 55.1% (95% CI: 30%, 74%), respectively. Grade ≥ 3 adverse events were observed in 12.5% patients. Blinatumomab was found to be effective with a tolerable safety profile in real world setting. [ABSTRACT FROM AUTHOR]
- Abstract: Copyright of Investigational New Drugs is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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