Venetoclax added to CLAG regimen might improve the outcome of patients with relapsed/refractory acute myeloid leukemia
Background: We aim to analyze the efficacy and safety of Venetoclax (Ven) added to cladribine + cytarabine + granulocyte colony-stimulating factor (G-CSF) ± idarubicin or mitoxantrone (CLAG ± Ida/Mito) regimen as a salvage treatment of relapsed/refractory acute myeloid leukemia (RR-AML). Methods: A...
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SAGE Publishing
2025-02-01
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| Series: | Therapeutic Advances in Hematology |
| Online Access: | https://doi.org/10.1177/20406207251319603 |
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| author | Yu Zhang Zhao Yin Zurong Yao Dan Xu Xuejie Jiang Xiaqi Nie Dandan Chen Hongsheng Zhou Pengcheng Shi Hui Liu Qifa Liu Guopan Yu |
| author_facet | Yu Zhang Zhao Yin Zurong Yao Dan Xu Xuejie Jiang Xiaqi Nie Dandan Chen Hongsheng Zhou Pengcheng Shi Hui Liu Qifa Liu Guopan Yu |
| author_sort | Yu Zhang |
| collection | DOAJ |
| description | Background: We aim to analyze the efficacy and safety of Venetoclax (Ven) added to cladribine + cytarabine + granulocyte colony-stimulating factor (G-CSF) ± idarubicin or mitoxantrone (CLAG ± Ida/Mito) regimen as a salvage treatment of relapsed/refractory acute myeloid leukemia (RR-AML). Methods: A single-center, retrospective, cohort study was performed. Patients with RR-AML, being treated with CLAG ± Ida/Mito with versus without Ven, were retrospectively studied. The endpoints of this study were to evaluate the rate of composite complete remission (CRc), measurable residual disease (MRD), event-free survival (EFS), overall survival (OS), and relapse between CLAG and CLAG + Ven groups. Results: Sixty-nine patients were included, with a median age of 37 (range, 18–65) years. Thirty-one patients underwent one cycle of salvage treatment of CLAG ± Ida/Mito with Ven and 38 without. In the CLAG + Ven group, 24 (77.4%) patients acquired response, including 22 (71.0%) with composite complete remission (CRc) and 15 (48.4%) MRD-negative CRc, which was significantly higher than those (CRc 47.4%, p = 0.048; MRD-negative CRc 18.4%, p = 0.008) in the CLAG group. Subgroup analysis showed that patients without response after two courses of induction therapy, or patients with FLT3 mutations seemed to benefit more from CLAG ± Ida/Mito + Ven than CLAG ± Ida/Mito in acquiring CRc. With a median follow-up of 13 (95% CI 10.5–15.5) months, the CLAG + Ven group had a median OS of 22.9 (95% CI 19.6–26.2) months and EFS of 15.7 (95% CI 11.1–20.2) months. In contrast, the CLAG group had a median OS of 18.6 (95% CI 14.7–22.6) months and EFS of 10.7 (95% CI 6.6–14.8) months. Although not statistically significant, patients in the CLAG + Ven group showed a potential survival advantage compared to the CLAG group. AEs including all grade and grade 3/4 occurred at similar frequencies in the two groups. Conclusions: Ven added to CLAG ± Ida/Mito might improve the outcome of the patients with RR-AML, with well toleration, and a randomized controlled trial is needed to explored. |
| format | Article |
| id | doaj-art-f19df96cb841417fb48ef1a60e2bd07c |
| institution | Kabale University |
| issn | 2040-6215 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | SAGE Publishing |
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| series | Therapeutic Advances in Hematology |
| spelling | doaj-art-f19df96cb841417fb48ef1a60e2bd07c2025-02-11T08:03:26ZengSAGE PublishingTherapeutic Advances in Hematology2040-62152025-02-011610.1177/20406207251319603Venetoclax added to CLAG regimen might improve the outcome of patients with relapsed/refractory acute myeloid leukemiaYu ZhangZhao YinZurong YaoDan XuXuejie JiangXiaqi NieDandan ChenHongsheng ZhouPengcheng ShiHui LiuQifa LiuGuopan YuBackground: We aim to analyze the efficacy and safety of Venetoclax (Ven) added to cladribine + cytarabine + granulocyte colony-stimulating factor (G-CSF) ± idarubicin or mitoxantrone (CLAG ± Ida/Mito) regimen as a salvage treatment of relapsed/refractory acute myeloid leukemia (RR-AML). Methods: A single-center, retrospective, cohort study was performed. Patients with RR-AML, being treated with CLAG ± Ida/Mito with versus without Ven, were retrospectively studied. The endpoints of this study were to evaluate the rate of composite complete remission (CRc), measurable residual disease (MRD), event-free survival (EFS), overall survival (OS), and relapse between CLAG and CLAG + Ven groups. Results: Sixty-nine patients were included, with a median age of 37 (range, 18–65) years. Thirty-one patients underwent one cycle of salvage treatment of CLAG ± Ida/Mito with Ven and 38 without. In the CLAG + Ven group, 24 (77.4%) patients acquired response, including 22 (71.0%) with composite complete remission (CRc) and 15 (48.4%) MRD-negative CRc, which was significantly higher than those (CRc 47.4%, p = 0.048; MRD-negative CRc 18.4%, p = 0.008) in the CLAG group. Subgroup analysis showed that patients without response after two courses of induction therapy, or patients with FLT3 mutations seemed to benefit more from CLAG ± Ida/Mito + Ven than CLAG ± Ida/Mito in acquiring CRc. With a median follow-up of 13 (95% CI 10.5–15.5) months, the CLAG + Ven group had a median OS of 22.9 (95% CI 19.6–26.2) months and EFS of 15.7 (95% CI 11.1–20.2) months. In contrast, the CLAG group had a median OS of 18.6 (95% CI 14.7–22.6) months and EFS of 10.7 (95% CI 6.6–14.8) months. Although not statistically significant, patients in the CLAG + Ven group showed a potential survival advantage compared to the CLAG group. AEs including all grade and grade 3/4 occurred at similar frequencies in the two groups. Conclusions: Ven added to CLAG ± Ida/Mito might improve the outcome of the patients with RR-AML, with well toleration, and a randomized controlled trial is needed to explored.https://doi.org/10.1177/20406207251319603 |
| spellingShingle | Yu Zhang Zhao Yin Zurong Yao Dan Xu Xuejie Jiang Xiaqi Nie Dandan Chen Hongsheng Zhou Pengcheng Shi Hui Liu Qifa Liu Guopan Yu Venetoclax added to CLAG regimen might improve the outcome of patients with relapsed/refractory acute myeloid leukemia Therapeutic Advances in Hematology |
| title | Venetoclax added to CLAG regimen might improve the outcome of patients with relapsed/refractory acute myeloid leukemia |
| title_full | Venetoclax added to CLAG regimen might improve the outcome of patients with relapsed/refractory acute myeloid leukemia |
| title_fullStr | Venetoclax added to CLAG regimen might improve the outcome of patients with relapsed/refractory acute myeloid leukemia |
| title_full_unstemmed | Venetoclax added to CLAG regimen might improve the outcome of patients with relapsed/refractory acute myeloid leukemia |
| title_short | Venetoclax added to CLAG regimen might improve the outcome of patients with relapsed/refractory acute myeloid leukemia |
| title_sort | venetoclax added to clag regimen might improve the outcome of patients with relapsed refractory acute myeloid leukemia |
| url | https://doi.org/10.1177/20406207251319603 |
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