硼替佐米同类转换为伊沙佐米治疗新诊断多发性骨髓瘤疗效和安全性分析OA北大核心CSTPCD
Efficacy and safety analysis of newly diagnosed multiple myeloma by in-class transition from Bortezomib to Ixazomib
目的 真实世界研究中,评估从蛋白酶体抑制剂(PI)硼替佐米同类药物转换(iCT)为伊沙佐米治疗新诊断多发性骨髓瘤(NDMM)的有效性和安全性.方法 回顾性分析2018年12月至2021年7月在安徽省立医院收治的在诱导巩固阶段,早期由硼替佐米iCT为伊沙佐米的50例NDMM患者,进行疗效和安全性评估.结果 所有患者中,伊沙佐米和PI治疗的中位周期数分别为10.5(1.0~39.0)和14.5(3.0~45.0)个.转换后总体反应率(ORR)从90%(45/50)提升至98%(49/50),完全缓解(CR)率从46%(23/50)提升至72%(36/50).所有患者中位随访时间39.0(6.0~56.0)个月,中位无进展生存期(PFS)为49个月,中位总生存期(OS)未达到,2年PFS率和OS率分别为78%和94%.亚组分析中,1q21扩增阳性患者iCT后2年PFS率和OS率分别为75%和88.9%.使用伊沙佐米≥12周期的患者较<12周期者OS显著改善(2年OS率100%比89.3%,4年OS率88.8%比52.3%,P=0.0337).伊沙佐米治疗期间总体不良事件(AEs)发生率为90%,主要为1~2级AEs,3级AEs的发生率为8%,无4级AEs发生.非血液学AEs最常见为周围神经病变(56%)和腹泻(36%).结论 通过早期iCT伊沙佐米可以改善NDMM患者的缓解情况,减少不良反应,从而实现持续治疗,并获得长期生存获益.
Objective To evaluate the real-world effectiveness and safety of the in-class transition(iCT)from the protease inhibitors(PI)Bortezomib to Ixazomib for the treatment of patients with newly diagnosed multiple myeloma(NDMM).Methods In this retrospective study,fifty patients with NDMM who had early iCT from Bortezomib to Ixazomib during the induction or consolidation phase were included at Anhui Cancer Hospital from December 2018 to July 2021.The effectiveness and safety of Ixazomib-based treatment were assessed.Results The median treatment cycles was 10.5(1.0-39.0)and 14.5(3.0-45.0)for Ixazomib and PI,respectively.The overall response rate(ORR)improved from 90%(45/50)to 98%(49/50)and the complete response(CR)rate from 46%(23/50)to 72%(36/50)after iCT.With a median follow-up duration of 39.0(6.0-56.0)months,the median progression-free survival(PFS)of 49 months and the median overall survival(OS)was not reached.The 2-year PFS and OS rate was 78%and 94%,respectively.In the subgroup analysis,the 2-year PFS and OS rates after iCT in patients with 1 q21 amplification were 75%and 88.9%,respectively.Patients received Ixazomib for ≥12 cycles had significantly improved OS than those did not(2-year OS 100%vs.89.3%,4-year OS 88.8%vs.52.3%,P=0.0337).The incidence of adverse events(AEs)of any grade was 90%during Ixazomib-based treatment,with predominantly grade 1-2 AEs.Grade 3 AEs occurred in 8%of the patients and no grade 4 AE occurred.The most common non-hematological AEs were peripheral neuropathy(56%)and diarrhea(36%).Conclusion Early iCT from Bortezomib to Ixazomib for NDMM might deepen the response and reduce the risk of adverse events,which might enable the continuous anti-tumor treatment and improve the long-term survival.
周晨阳;丁凯阳;宋浩;吴国林;胡茂贵;徐强
中国科学技术大学附属第一医院西区(安徽省立医院西区)血液内科,安徽合肥 230000
临床医学
伊沙佐米同类药物转换新诊断多发性骨髓瘤硼替佐米
Ixazomibin-class transitionnewly diagnosed multiple myelomaBortezomib
《中国实用内科杂志》 2024 (004)
286-290,306 / 6
安徽省卫生健康科研重点项目(AHWJ2023A10056)
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