{"title":"Venetoclax加入CLAG方案可能改善复发/难治性急性髓性白血病患者的预后。","authors":"Yu Zhang, Zhao Yin, Zurong Yao, Dan Xu, Xuejie Jiang, Xiaqi Nie, Dandan Chen, Hongsheng Zhou, Pengcheng Shi, Hui Liu, Qifa Liu, Guopan Yu","doi":"10.1177/20406207251319603","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%, <i>p</i> = 0.048; MRD-negative CRc 18.4%, <i>p</i> = 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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":23048,"journal":{"name":"Therapeutic Advances in Hematology","volume":"16 ","pages":"20406207251319603"},"PeriodicalIF":3.4000,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11811969/pdf/","citationCount":"0","resultStr":"{\"title\":\"Venetoclax added to CLAG regimen might improve the outcome of patients with relapsed/refractory acute myeloid leukemia.\",\"authors\":\"Yu Zhang, Zhao Yin, Zurong Yao, Dan Xu, Xuejie Jiang, Xiaqi Nie, Dandan Chen, Hongsheng Zhou, Pengcheng Shi, Hui Liu, Qifa Liu, Guopan Yu\",\"doi\":\"10.1177/20406207251319603\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%, <i>p</i> = 0.048; MRD-negative CRc 18.4%, <i>p</i> = 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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":23048,\"journal\":{\"name\":\"Therapeutic Advances in Hematology\",\"volume\":\"16 \",\"pages\":\"20406207251319603\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-02-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11811969/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Hematology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/20406207251319603\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Hematology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/20406207251319603","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景：我们的目的是分析Venetoclax （Ven）在克拉多滨+阿糖胞苷+粒细胞集落刺激因子（G-CSF）±伊达柔比星或米托沙酮（CLAG±Ida/Mito）方案中添加的疗效和安全性，作为复发/难治性急性髓性白血病（r - aml）的补救性治疗。方法：采用单中心、回顾性、队列研究。回顾性研究了CLAG±Ida/Mito联合与不联合Ven治疗的RR-AML患者。本研究的终点是评估CLAG组和CLAG + Ven组的复合完全缓解率（CRc）、可测量残留疾病（MRD）、无事件生存期（EFS）、总生存期（OS）和复发率。结果：纳入69例患者，中位年龄37岁（范围18-65岁）。31例患者接受CLAG±Ida/Mito联合Ven的1周期抢救治疗，38例患者不接受Ven的抢救治疗。CLAG + Ven组24例（77.4%）患者获得缓解，其中复合完全缓解（CRc） 22例（71.0%），mrd阴性CRc 15例（48.4%），显著高于(CRc 47.4%, p = 0.048；CLAG组mrd阴性CRc 18.4%, p = 0.008)。亚组分析显示，两疗程诱导治疗后无反应的患者，或FLT3突变的患者在获得CRc方面，CLAG±Ida/Mito + Ven似乎比CLAG±Ida/Mito更有利。中位随访时间为13个月（95% CI 10.5-15.5）， CLAG + Ven组中位OS为22.9个月（95% CI 19.6-26.2）， EFS为15.7个月（95% CI 11.1-20.2）。相比之下，CLAG组的中位OS为18.6 （95% CI 14.7-22.6）个月，EFS为10.7 （95% CI 6.6-14.8）个月。虽然没有统计学意义，但与CLAG组相比，CLAG + Ven组的患者表现出潜在的生存优势。包括所有级别和3/4级的ae在两组中发生的频率相似。结论：在CLAG±Ida/Mito中添加Ven可能改善RR-AML患者的预后，耐受性良好，需要随机对照试验进行探索。
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 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.
期刊介绍：
Therapeutic Advances in Hematology delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of hematology. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in hematology, providing a forum in print and online for publishing the highest quality articles in this area.
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