中国真实世界经验-不耐受强化疗的老年AML患者,去甲基化药物联合低剂量化疗预后佳

2022-08-09 聊聊血液 聊聊血液

本研究数据表明,HMA联合低剂量化疗可改善不适合强化疗的老年AML患者的预后,且耐受性良好。

几十年来,新诊断急性髓系白血病 (AML)患者的一线治疗选择一直是强化疗 (intensive chemotherapy,IC),其最佳完全缓解 (CR) 率为70%,长期生存率约为40%。然而事实上,因体能状态、合并症、治疗耐受性原因,只有30-60%的老年AML患者而适合强化疗,因此与年轻患者相比,老年AML患者的生存率较差。

近年出现的新型、有效和毒性较小的药物,为老年 AML 患者提供了更多的治疗选择。既往研究表明,与接受常规治疗方案 (conventional care regimens,CCRs) 的患者相比,接受去甲基化药物 (HMA) 低强度治疗(包括地西他滨和阿扎胞苷)的老年患者的总生存期 (OS) 得以延长。目前HMA已被推荐用于不适合标准诱导化疗的老年AML患者,且在中国医疗中心探索了联合治疗方案。

此外BCL-2抑制剂维奈托克(venetoclax) 是一种有前景的 AML 治疗药物,然而,大多数关于HMA或维奈托克治疗老年AML患者的数据是基于临床试验,实际的疗效和预后因素需要在实际临床实践中进一步明确。

基于此,胡建达教授牵头了一项真实世界研究,旨在评估基于HMA方案治疗不适合标准诱导化疗的老年AML患者的疗效和安全性,并比较HMA单药治疗与HMA联合治疗的缓解率和生存期,结果表明HMA联合低剂量化疗可改善不适合强化疗的老年AML患者预后,且耐受性良好。

研究设计

本研究为真实世界临床实践,纳入2012年11月至2021年10月期间140例>60岁的不适合强化诱导化疗AML患者,并在福建协和医院接受基于HMA的治疗。不适合接受强化诱导化疗的标准:患者年龄为75岁或60-74岁且满足至少1项不适合强化诱导化疗的标准(包括ECOG体能状态2-3,有充血性心力衰竭或心肌梗死或慢性稳定型心绞痛、中度肺功能受损和中度肝损害或肾损害心脏病史)。

 

30例患者接受HMA单药治疗作为初始治疗,包括19例接受地西他滨治疗的患者和11例接受阿扎胞苷治疗的患者。87例采用HMA联合小剂量化疗,其中接受HMA、阿柔比星、阿糖胞苷、粒细胞集落刺激因子(CAG方案)治疗51例,36例接受HMA、高三尖杉酯碱、阿糖胞苷、粒细胞集落刺激因子(HAG方案)治疗。23例患者接受阿扎胞苷联合维奈托克治疗。治疗方案的详细信息总结见表1。对于接受基于HMA治疗后达到CR的患者,缓解后治疗是重复初始治疗,而未达到CR的患者接受姑息治疗或其他低强度挽救治疗。

研究结果

患者

基线特征见表2。所有患者的中位年龄为70岁。根据 NCCN AML临床实践指南(1.2020版),通过治疗前诊断时的细胞遗传学异常确定风险分层,低危、中危和高危组分别占所有患者的17.6%、36.8%和45.6%。3个治疗组之间的年龄、性别、疾病分类、风险状态、血红蛋白和 PLT 计数以及诊断时乳酸脱氢酶 (LDH) 特征相似;阿扎胞苷/维奈托克组的WBC计数和骨髓原始细胞百分比高于阿扎胞苷单药治疗组和HMA+低剂量化疗组。

临床结局

老年AML患者的临床结局总结见表3。所有患者中位随访13.9个月,140例患者中共有49例 (40.1%) 达到CR或CR/CRi,19例患者 (13.6%) 达到PR。与HMA单药治疗相比,HMA+低剂量化疗可显著改善患者CR率:在HMA单药治疗组中,5/30例患者 (16.7%) 达到CR/CRi,4例患者 (13.3%) 达到PR,而HMA+低剂量化疗组分别为35/87例患者 (40.2%) 和13例患者 (14.9%)(分别为P= 0.0249和P> 0.9999)。接受HMA+低剂量化疗的患者的缓解率与阿扎胞苷+维奈托克组相似 (55.2% vs. 47.8%,P= 0.6397),且CAG和 HAG 方案之间未观察到差异(CR率:39.2% vs. 41.7%,P= 0.8282;ORR:56.9% vs. 52.8%,P= 0.8272)。

所有患者的中位 OS 为10.4个月(图1A),其中HMA单药组和HMA+低剂量化疗组分别为8.6个月和13.7个月(p= 0.0085,图1B)。所有患者的1年和2年OS率分别为42.6%和19.9%,其中HMA单药组分别为17.8%和0.0%,HMA+低剂量化疗组分别为52.8%和24.4%(P= 0.0085);且在HMA+低剂量化疗组中,接受CAG或HAG方案的患者生存率相当。接受阿扎胞苷+维奈托克治疗的患者的中位生存期为6.7个月,1年和2年 OS 率分别为16.3%和16.3%,与接受HMA+低剂量化疗的患者相比无显著差异。

所有患者中4.3%早期死亡,诱导治疗期间所有患者中87.1%存在感染,3组之间的不良事件相似。

预后因素

为了确定接受HMA治疗的老年AML患者的潜在预后因素,作者对OS进行了单变量分析。如表4和图2所列,年龄>75岁、WBC计数≥10 X 109个细胞/L和LDH升高是OS的不良预后因素,而性别、血红蛋白浓度、血小板计数、低危细胞遗传学、BM原始细胞百分比和s-AML/t-AML对OS无影响。

将上述所有预后因素纳入多变量分析后,作者确定年龄>75岁和 WBC计数≥10 X 109个细胞/L仍是影响OS的显著独立因素(风险比(HR)分别为1.781,P= 0.046;HR=2.119,P= 0.003)。此外,接受基于阿扎胞苷的方案或基于地西他滨的方案治疗的患者OS无差异。

结论

越来越多的证据证实,基于HMA的治疗方案治疗不适合标准强化疗的老年AML患者具有生存获益。

临床上,阿扎胞苷和地西他滨均推荐用于不适合标准诱导化疗的老年患者。但是,大多数研究是基于临床试验环境,关于HMA在实际临床实践中的疗效和安全性的可用数据有限,且也无比较这两种药物治疗老年AML患者的直接试验。本真实世界研究显示,48.6%的老年unfit患者对基于HMA的治疗方案有反应,40.1%可达到CR/CRi,并且地西他滨和阿扎胞苷联合低剂量化疗治疗不适合强化疗的老年 AML 患者时具有相似的效果,ORR和OS无差异。

本研究证实,HMA联合低剂量化疗较单用 HMA可显著改善CR率和预后,且与阿扎胞苷联合维奈托克方案的缓解率相当。

总的来说,本研究数据表明,HMA联合低剂量化疗可改善不适合强化疗的老年AML患者的预后,且耐受性良好。此外在中国人群中未观察到地西他滨和阿扎胞苷之间的差异。年龄>75岁和 WBC计数≥10 X 109个/L是接受基于HMA方案治疗的患者OS的独立不良预后因素。

参考文献

Yi Chen, Jing Cao, Yaozhen Ye,et al. Hypomethylating agents combined with lowdose chemotherapy for elderly patients with acute myeloid leukaemia unfit for intensive chemotherapy: a real-world clinical experience.J Chemother . 2022 Jul 26;1-8. doi: 10.1080/1120009X.2022.2097433.

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    2022-08-10 ms2428646620762205

    学习学习

    0

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    2022-08-09 134f060bm99暂无昵称

    👍

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