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Abstract：
OBJECTIVE: To evaluate the effectiveness, safety, and convenience of in-class transition (iCT) from intravenous bortezomib-based induction to ixazomib-based oral regimens.
METHODS: This retrospective real-world study was conducted in 16 Chinese hospitals between October 2017 and April 2023 and analyzed newly diagnosed (NDMM) and first-line relapsed multiple myeloma (FRMM) patients who attained at least a partial response from bortezomib-based induction therapy, followed by an ixazomib-based oral regimen for 2 year or until disease progression or intolerable toxicity.
RESULTS: The study enrolled 199 patients, median age: 63 years old, male 55.4%, 53% as high risk (HR), and 47% as standard risk. Cytogenetic risk stratification by metaphase fluorescence in situ hybridization (M-FISH), based on the Mayo Clinic risk stratification system. The median duration of total PI therapy was 11 months, with ixazomib-based treatment spanning 6 months. At the 20-month median follow-up, 53% of patients remained on therapy. The 24-month PFS rate was 84.3% from the initiation of bortezomib-based induction and 83.4% from the start of ixazomib-based treatment. Overall response rate (ORR) was 100% post-bortezomib induction and 90% following 6 cycles of the ixazomib-based regimen. Based on the Sankey diagrams, 89.51% of patients maintained or improved their disease response after 2 cycles of iCT, 6 cycles (90.14%), and 12 cycles (80%). The HR level of Mayo was found to be a significant independent factor in a worse remission (hazard ratio (HR) 2.55; p = 0.033). Ixazomib\'s safety profile aligned with previous clinical trial data, with 49% of patients experiencing at least one AE of any grade. The most common AEs included peripheral neuropathy, nausea and vomiting, diarrhea, thrombocytopenia, and granulocytopenia.
CONCLUSIONS: In the real-world Chinese MM population, NDMM and FRMM patients responded favorably to PI-based continuous therapy, demonstrating substantial response rates. The ixazomib-based iCT allows for sustained PI-based treatment, offering promising efficacy and tolerable AEs.
METHODS: This retrospective real-world study was conducted in 16 Chinese hospitals between October 2017 and April 2023 and analyzed newly diagnosed (NDMM) and first-line relapsed multiple myeloma (FRMM) patients who attained at least a partial response from bortezomib-based induction therapy, followed by an ixazomib-based oral regimen for 2 year or until disease progression or intolerable toxicity.
RESULTS: The study enrolled 199 patients, median age: 63 years old, male 55.4%, 53% as high risk (HR), and 47% as standard risk. Cytogenetic risk stratification by metaphase fluorescence in situ hybridization (M-FISH), based on the Mayo Clinic risk stratification system. The median duration of total PI therapy was 11 months, with ixazomib-based treatment spanning 6 months. At the 20-month median follow-up, 53% of patients remained on therapy. The 24-month PFS rate was 84.3% from the initiation of bortezomib-based induction and 83.4% from the start of ixazomib-based treatment. Overall response rate (ORR) was 100% post-bortezomib induction and 90% following 6 cycles of the ixazomib-based regimen. Based on the Sankey diagrams, 89.51% of patients maintained or improved their disease response after 2 cycles of iCT, 6 cycles (90.14%), and 12 cycles (80%). The HR level of Mayo was found to be a significant independent factor in a worse remission (hazard ratio (HR) 2.55; p = 0.033). Ixazomib\'s safety profile aligned with previous clinical trial data, with 49% of patients experiencing at least one AE of any grade. The most common AEs included peripheral neuropathy, nausea and vomiting, diarrhea, thrombocytopenia, and granulocytopenia.
CONCLUSIONS: In the real-world Chinese MM population, NDMM and FRMM patients responded favorably to PI-based continuous therapy, demonstrating substantial response rates. The ixazomib-based iCT allows for sustained PI-based treatment, offering promising efficacy and tolerable AEs.
摘要：
目的：为了评估有效性，安全,以及从基于硼替佐米的静脉诱导到基于艾沙佐米的口服方案的课堂过渡（iCT）的便利性。
方法：这项回顾性研究于2017年10月至2023年4月在16家中国医院进行，分析了新诊断（NDMM）和一线复发多发性骨髓瘤（FRMM）患者，这些患者至少从硼替佐米诱导治疗中获得了部分反应。然后是以ixazomib为基础的口服方案2年或直到疾病进展或无法耐受的毒性。
结果：该研究招募了199名患者，中位年龄：63岁，男性55.4%,53%为高风险(HR)，47%为标准风险。通过中期荧光原位杂交（M-FISH）进行细胞遗传学风险分层，基于梅奥诊所风险分层系统。总PI治疗的中位持续时间为11个月，以艾沙佐米为基础的治疗持续6个月。在20个月的中位随访中，53%的患者仍在接受治疗。从基于硼替佐米的诱导开始，24个月的PFS率为84.3％，从基于艾沙唑米的治疗开始为83.4％。硼替佐米诱导后的总反应率（ORR）为100％，基于伊沙佐米的方案6个周期后为90％。根据桑基图,89.51％的患者在2个周期的iCT后维持或改善了他们的疾病反应，6个周期（90.14%），和12个周期（80％）。发现Mayo的HR水平是缓解不良的重要独立因素（风险比（HR）2.55；p=0.033）。Ixazomib的安全性与以前的临床试验数据一致，49%的患者经历至少一个任何级别的AE。最常见的不良事件包括周围神经病变，恶心和呕吐，腹泻,血小板减少症,和粒细胞减少症.
结论：在现实世界的中国MM人群中，NDMM和FRMM患者对基于PI的连续治疗反应良好，显示出相当大的反应率。基于ixazomib的iCT允许持续的基于PI的治疗，提供有希望的疗效和可耐受的不良事件。
方法：这项回顾性研究于2017年10月至2023年4月在16家中国医院进行，分析了新诊断（NDMM）和一线复发多发性骨髓瘤（FRMM）患者，这些患者至少从硼替佐米诱导治疗中获得了部分反应。然后是以ixazomib为基础的口服方案2年或直到疾病进展或无法耐受的毒性。
结果：该研究招募了199名患者，中位年龄：63岁，男性55.4%,53%为高风险(HR)，47%为标准风险。通过中期荧光原位杂交（M-FISH）进行细胞遗传学风险分层，基于梅奥诊所风险分层系统。总PI治疗的中位持续时间为11个月，以艾沙佐米为基础的治疗持续6个月。在20个月的中位随访中，53%的患者仍在接受治疗。从基于硼替佐米的诱导开始，24个月的PFS率为84.3％，从基于艾沙唑米的治疗开始为83.4％。硼替佐米诱导后的总反应率（ORR）为100％，基于伊沙佐米的方案6个周期后为90％。根据桑基图,89.51％的患者在2个周期的iCT后维持或改善了他们的疾病反应，6个周期（90.14%），和12个周期（80％）。发现Mayo的HR水平是缓解不良的重要独立因素（风险比（HR）2.55；p=0.033）。Ixazomib的安全性与以前的临床试验数据一致，49%的患者经历至少一个任何级别的AE。最常见的不良事件包括周围神经病变，恶心和呕吐，腹泻,血小板减少症,和粒细胞减少症.
结论：在现实世界的中国MM人群中，NDMM和FRMM患者对基于PI的连续治疗反应良好，显示出相当大的反应率。基于ixazomib的iCT允许持续的基于PI的治疗，提供有希望的疗效和可耐受的不良事件。
