Zhongguo shi yan xue ye xue za zhi · 2025
[Efficacy and Safety of Blinatumomab in Adult Patients with B-Cell Acute Lymphoblastic Leukemia].
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Hu Ya-Lei, Su Yong-Feng, Li Yang, Zheng Xuan, Wang An, Wang Yi-Zhi, Xu Lei, Gao Chun-Ji, Hu Liang-Ding, Liu Dai-Hong, Gao Xiao-Ning
Аннотация
OBJECTIVE: To evaluate the efficacy and safety of blinatumomab in adult patients with relapsed/refractory (R/R) or measurable residual disease (MRD) positive B-cell acute lymphoblastic leukemia (B-ALL) in the real world.
METHODS: The clinical data of 30 B-ALL patients received at least 1 course of blinatumomab therapy in the Chinese PLA General Hospital from January 1st, 2021 to December 31st, 2023 were retrospectively analyzed, including pre-treatment baseline clinical feature, post-treatment complete response (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), complete MRD response rate, MRD response rate (MRD< 10-4), overall survival (OS), and disease-free survival (DFS), as well as drug-related adverse reactions.
RESULTS: Among 5 patients who were not assessed 4 were MRD negative and 1 did not receive bone marrow biopsy. In the R/R B-ALL group (13 cases), 11 patients achieved CR/CRh/CRi and 10 patients achieved complete MRD response. In MRD+ group (12 cases), 9 patients achieved overall MRD response and 7 patients achieved complete MRD response. The median follow-up time was 8.4(95%CI : 6.3-10.4) months. The median OS was 15.5(95%CI : 0.7-30.3) months in the R/R group, while not reached in the MRD+ group. The median DFS of the two groups were not reached. Drug-related adverse reactions occurred in 22 patients, and pyrexia was the most common (13 cases). Grade ≥3 adverse reactions occurred in 15 patients, and neutropenia was the most common (9 cases). Cytokine release syndrome occurred in 6 patients, including 5 cases with grade 1 and 1 case with grade 3. No patients interrupted therapy or died due to drug-related adverse reactions.
CONCLUSION: Blinatumomab is effective in the treatment of R/R or continuous MRD+ B-ALL with acceptable adverse reactions.
METHODS: The clinical data of 30 B-ALL patients received at least 1 course of blinatumomab therapy in the Chinese PLA General Hospital from January 1st, 2021 to December 31st, 2023 were retrospectively analyzed, including pre-treatment baseline clinical feature, post-treatment complete response (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), complete MRD response rate, MRD response rate (MRD< 10-4), overall survival (OS), and disease-free survival (DFS), as well as drug-related adverse reactions.
RESULTS: Among 5 patients who were not assessed 4 were MRD negative and 1 did not receive bone marrow biopsy. In the R/R B-ALL group (13 cases), 11 patients achieved CR/CRh/CRi and 10 patients achieved complete MRD response. In MRD+ group (12 cases), 9 patients achieved overall MRD response and 7 patients achieved complete MRD response. The median follow-up time was 8.4(95%CI : 6.3-10.4) months. The median OS was 15.5(95%CI : 0.7-30.3) months in the R/R group, while not reached in the MRD+ group. The median DFS of the two groups were not reached. Drug-related adverse reactions occurred in 22 patients, and pyrexia was the most common (13 cases). Grade ≥3 adverse reactions occurred in 15 patients, and neutropenia was the most common (9 cases). Cytokine release syndrome occurred in 6 patients, including 5 cases with grade 1 and 1 case with grade 3. No patients interrupted therapy or died due to drug-related adverse reactions.
CONCLUSION: Blinatumomab is effective in the treatment of R/R or continuous MRD+ B-ALL with acceptable adverse reactions.