诊断学理论与实践 ›› 2024, Vol. 23 ›› Issue (03): 285-296.doi: 10.16150/j.1671-2870.2024.03.006
中国老年医学学会血液学分会MDS专委会
收稿日期:
2024-04-16
接受日期:
2024-05-20
出版日期:
2024-06-25
发布日期:
2024-06-25
通讯作者:
常春康 E-mail:changchunkang@sjtu.edu.cn;MDS Professional Committee of Hematology Branch of Chinese Geriatrics Society
Received:
2024-04-16
Accepted:
2024-05-20
Published:
2024-06-25
Online:
2024-06-25
摘要:
骨髓增生异常性肿瘤(myelodysplastic neoplasms, MDS)是起源于造血干经细胞和(或)祖细胞的一组异质性髓系肿瘤。欧美流行病学调查揭示,MDS发病率为(4~5)/10万,且随年龄增长而增加,中位诊断年龄为73~76岁。根据世界卫生组织(World Health Organization, WHO)2001年诊断标准,在2004年至2007年对中国上海地区约390万人的调查中发现,MDS平均发病率为1.51/10万,中位发病年龄为62岁,其中约1/3的患者会转化为急性髓系白血病(acute myeloid leukemia,AML);53%的患者因血细胞减少引发的感染、出血或合并症而死亡。老年MDS患者由于合并症较多、体质较弱,无论是治疗选择、疾病转归都有其特点。老年MDS患者的白细胞计数、血红蛋白水平和骨髓原始细胞比例均稍高于年轻患者,而其中性粒细胞计数和血小板计数较年轻患者明显增高。此外,老年MDS患者发生基因突变的数量更多,平均每例患者可发生1.8个基因突变,其中以ASXL1、TET2、SF3B1、STAG2、SRSF2和TP53突变更多见;而年轻患者的突变数量为平均每例患者发生1.2个基因突变,且以U2AF1、ASXL1和RUNX1突变较常见。异基因造血干细胞移植(allogeneic hematopoietic stem cell transplantation, allo-HSCT)是MDS唯一的根治疗法,年轻患者可行清髓性移植,但老年患者只能行减低剂量预处理(reduced-intensity conditioning, RIC)的allo-HSCT治疗。老年MDS患者的自然病程和预后差异很大,由年龄(>70岁)、脆弱指数、分子国际预后评分系统(international prognosis scoring system, IPSS)分组等组成的MDS综合预后评分,能更好地预测MDS患者化疗的耐受性和治疗不良反应。本共识根据国内外老年MDS研究的最新循证证据,经学组专家共同讨论后制定,旨在规范中国老年MDS患者的诊断和治疗的全程管理。
中图分类号:
中国老年医学学会血液学分会MDS专委会. 中国老年骨髓增生异常性肿瘤诊断和治疗专家共识(2024版)[J]. 诊断学理论与实践, 2024, 23(03): 285-296.
MDS Professional Committee of Hematology Branch of Chinese Geriatrics Society. The consensus on the diagnosis and treatment of elderly myelodysplastic neoplasm in China (2024)[J]. Journal of Diagnostics Concepts & Practice, 2024, 23(03): 285-296.
表1
MDS中常见基因突变
突变基因 | 总体发生率 | 分型作用 | 预后意义* |
---|---|---|---|
TET2 | 20%~25% | - | - |
DNMT3A | 12%~18% | - | + |
ASXL1 | 15%~25% | - | + |
EZH2 | 5%~10% | - | + |
SF3B1 | 20%~30% | + | + |
SRSF2 | 10%~15% | - | + |
U2AF1 | 8%~12% | - | + |
ZRSR2 | 5%~10% | - | - |
RUNX1 | 10%~15% | - | + |
TP53 | 8%~12% | + | + |
STAG2 | 5%~10% | - | + |
NRAS | 5%~10% | - | + |
CBL | <5% | - | + |
NF1 | <5% | - | + |
ETV6 | <5% | - | + |
IDH1 | <5% | - | + |
IDH2 | <5% | - | + |
PHF6 | <5% | - | + |
BCOR | <5% | - | + |
KMT2A | <5% | - | + |
FLT3 | <5% | - | + |
NPM1 | <5% | - | + |
KRAS | <5% | - | + |
BCORL1 | <5% | - | + |
CEBPA | <5% | - | + |
ETNK1 | <5% | - | + |
GATA2 | <5% | - | + |
GNB1 | <5% | - | + |
PPM1D | <5% | - | + |
PRPF8 | <5% | - | + |
PTPN11 | <5% | - | + |
SETBP1 | <5% | - | + |
WT1 | <5% | - | + |
表2
2016年MDS国际工作组建议的MDS最低诊断标准
最低诊断标准 |
---|
A必要标准(2条均满足): |
持续(≥4个月)血细胞减少,但如有原始细胞增多或MDS相关细胞遗传学异常即可诊断 |
除外其他原因所致的血细胞减少/发育异常 |
B确定标准(至少满足1条): |
骨髓涂片中红系、粒系、巨核系中任一系发育异常≥10% |
有核红细胞中环状铁粒幼红细胞≥15%或者存在SF3B1突变时环铁细胞≥5% |
原始细胞:外周血2%~19%或骨髓5%~19% |
MDS典型染色体异常 |
C辅助标准:符合2~3条 |
骨髓活检和免疫组化存在支持MDS的证据,如ALIP、CD34+原始细胞簇、微巨核细胞等≥10% |
多参数流式细胞术发现髓系细胞异常,提示存在克隆性红系和(或)髓系细胞 |
测序发现MDS相关基因突变,提示存在克隆性髓系细胞 |
表4
MDS患者脆弱分级
分级 | 特征 | 治疗目标 | 治疗策略 |
---|---|---|---|
脆弱(Frail) | 存在下列之一: | 改善血细胞减少及症状 提高生活质量 | 最佳支持治疗;姑息治疗(部分患者可应用AZA) |
ECOG评分≥3分 | |||
TUGT>10 s | |||
ADL≥1个 受限 | |||
IADL≥3个 受限 | |||
HSCT-CI、CCI≥3分或MDS-CI≥1分 | |||
存在≥1项老年综合征表现(痴呆、谵妄、抑郁、跌倒和尿失禁) | |||
营养状况重度损害(BMI<16 kg/m2、近期体重减轻1~3 kg、食欲明显减退或MNA<17分) | |||
脆弱前期 (Pre-frail) | ECOG 0~2,ADL无受限,无老年综合征,存在下列之一: | 延长OS和PFS | LR: 纠正血细胞减少及相关症状,监测肝肾功能和合并症、调整药物剂量 HR: 至少6个疗程HMA,如转为“适合”分级可桥接HSCT |
IADL 1~2个 受限 | |||
HSCT-CI、CCI:1~2分 | |||
营养状况中度损害(MNA评分17~24分) | |||
SPPB<9分 | |||
MMSE<27分或3MS<77分 | |||
适合(Fit) | 缺乏上述危险因素 | 治愈疾病,延长OS和PFS | LR: 纠正血细胞减少及相关症状 HR: HMA、IC、HSCT |
表5
WHO(2022) MDS分型
分型 | 原始细胞 | 细胞遗传学 | 突变 |
---|---|---|---|
遗传学异常定义的MDS | |||
MDS伴低原始细胞和单纯5q缺失 (MDS-5q) | BM<5% BM 且PB<2% | 仅del(5q),或伴1个其他异常、除外-7/del(7q) | |
MDS伴低原始细胞和SF3B1突变a (MDS-SF3B1) | 无del(5q)、-7或复杂核型 | SF3B1 | |
MDS伴TP53双等位失活 (MDS-biTP53) | BM和PB <20% | 常为复杂核型 | ≥2个TP53突变,或1个突变同时伴TP53拷贝数丢失或cnLOH |
形态学定义的MDS | |||
MDS伴低原始细胞 (MDS-LB) | BM <5% BM 且PB<2% | ||
MDS低增生性b (MDS-h) | |||
MDS伴原始细胞增加(MDS-IB) | |||
MDS-IB1 | BM 5%~9% 或PB 2~4% | ||
MDS-IB2 | BM 10%~19%或PB 5%~19%或Auer小体 | ||
MDS伴纤维化 (MDS-f) | BM 5%~19%;PB 2%~19% |
表7
MDS疗效标准
反应 | IWG 2006(全部患者) | IWG 2023(HR-MDS患者) |
---|---|---|
完全缓解(CR) | BM:原始细胞≤5%且所有细胞系成熟正常a;持续存在的发育异常应注明a PB:Hb ≥ 110 g/L;ANC ≥ 1.0×109/L;PLT ≥ 100×109/L;原始细胞为0 | BM:原始细胞≤5%*,发育异常可存在 PB:Hb ≥ 100 g/L;ANC ≥ 1.0×109/L;PLT ≥ 100×109/L;原始细胞为0† |
等同CR* | - | 基线原始细胞<5%时 •BM:原始细胞≤5%*,发育异常可存在 •PB:Hb ≥100 g/L;ANC ≥ 1.0×109/L;PLT ≥ 100×109/L;原始细胞为0† •完全细胞遗传学反应 |
骨髓完全缓解 (mCR) | BM:原始细胞≤ 5%且较治疗前减少≥50% PB:不要求反应 | 取消 |
部分缓解(PR) | 符合CR标准,除外: BM原始细胞较治疗前减少≥50%、但仍>5%; 不考虑细胞增生程度和形态 | 符合CR标准,除外: •BM原始细胞较治疗前减少≥50%、但仍>5%; •不考虑细胞增生程度和形态 |
疾病稳定(SD) | 未能获得至少PR但无进展证据>8周 | 取消 |
CRL(CRuni和CRbi) | - | •BM:原始细胞≤5%*,发育异常可存在 •PB:原始细胞为0† •CRuni: PB不符合CR但仅下列1项:Hb ≥ 100 g/L,ANC ≥ 1.0×109/L,PLT ≥ 100×109/L; •CRbi: PB不符合CR但仅下列2项:Hb ≥ 100 g/L,ANC ≥ 1.0×109/L,PLT ≥ 100×109/L; |
CRh | - | •BM:原始细胞≤5%*,发育异常可存在 •PB:不符合CR或CRL,不需Hb,ANC ≥ 0.5×109/L,PLT ≥ 50×109/L,原始细胞为0 |
血液学改善(HI) | 见 | 同IWG 2018: •不符合CR(或等同CR)、CRuni或CRL标准 •HI-E •HI-P •HI-N |
细胞遗传学反应 | ||
疾病进展(PD) | 原始细胞<5%者:原始细胞增加≥50%至>5%; 原始细胞5%~10%者:原始细胞增加≥50%至>10%; 原始细胞10%~20%者:原始细胞增加≥50%至>20%; 原始细胞20%~30%者:原始细胞增加≥50%至>30%; 下列任何一项: ANC或PLT较最佳缓解/疗效时下降≥50%; Hb下降≥20 g/L; 依赖输血 | 符合以下任何标准#**: •由原始细胞引起的疾病进展:原始细胞较当前治疗前增加≥50%、且绝对比例增加至少5%。 •细胞减少恶化导致的疾病进展:8周内新的、重复的(>1次、间隔≥7 d)需要输注红细胞或血小板,与急性并发疾病(如败血症、胃肠道出血)或治疗效果无关,且至少一系其他细胞缺乏上述定义的HI。 •AML进展:原始细胞较基线加≥50%至比例≥20%。 |
疾病复发 (disease relapse) | 至少有下列1项: (1)BM原始细胞回升至治疗前水平; (2)ANC或PLT较达最佳反应时下降≥50%; (3)Hb下降≥15 g/L或依赖输血 | 符合以下任何标准: •原始细胞引起的疾病复发:原始细胞较当前治疗前增加≥50%、且绝对比例增加至少5%;或PB原始细胞再现,或出现髓外肉瘤。 •细胞减少恶化引起的疾病复发:PLT和/或ANC计数较最佳反应时减少≥50%,或Hb减少≥15 g/L,同时伴以下绝对减少:Hb<100 g/L、PLT<100×109/L,或ANC<1.0×109/L或与急性并发疾病(如败血症、胃肠道出血)或治疗效果无关的反复(>1次且间隔≥7天)需要RBC或PLT输注;缺乏如上定义的至少一系其他细胞HI。 |
治疗失败 | 治疗期间死亡,或病情进展表现为血细胞减少加重、骨髓原始细胞增高或较治疗前发展为更晚期的FAB亚型 | - |
HI后进展或复发a | 至少有下列1项: ANC或PLT较最佳疗效时下降≥50% Hb下降≥15 g/L 依赖输血 | - |
表8
MDS患者HI标准
反应 | IWG 2006(全部患者) | IWG 2018(LR-MDS患者) |
---|---|---|
红系反应(HI-E) | Hb升高≥15 g/L 与治疗前8周相比,RBC输注减少至少4 U/ 8周。仅治疗前Hb≤90 g/L患者才纳入RBC 输注反应评估 | NTD:与治疗开始前16周内2次Hb测量(除任何输血外)的最低平均值比较,在16-24周的观察期内至少连续2次Hb测量≥15 g/L、持续8周† LTB:非输血依赖,与治疗前16周相比,在16~24周的观察期内在相同的输血政策下,至少8周没有任何输血 HTB:主要反应:对应于非输血依赖,与治疗前16周相比,至少8周内没有任何输血;轻微反应:指与治疗前16周相比,至少16周内RBCs减少至少50% |
血小板反应(HI-P) | 治疗前PLT>20×109/L,净增值≥30×109/L; 治疗前<20×109/L,增高至>20×109/L且至少 增高100% | 治疗前PLT>20×109/L:净增值≥30×109/L; 治疗前<20×109/L:增高至>20×109/L且至少增高100% 此外,应考虑出血症状变化;治疗前>100×109/L者增量应报告 |
中性粒细胞反应(HI-N) | 治疗前ANC<1.0×109/L,增高≥100%且净增 值>0.5×109/L | 治疗前ANC<1.0×109/L:增高≥100%且净增值>0.5×109/L 治疗前ANC>1.0×109/L:ANC增量应报告 |
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