Journal of Diagnostics Concepts & Practice ›› 2024, Vol. 23 ›› Issue (03): 285-296.doi: 10.16150/j.1671-2870.2024.03.006
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MDS Professional Committee of Hematology Branch of Chinese Geriatrics Society
Received:2024-04-16
Accepted:2024-05-20
Online:2024-06-25
Published:2024-06-25
CLC Number:
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.
Table 1
Common gene mutations in MDS
| 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% | - | + |
Table 2
The minimum diagnostic criteria for MDS recommended by IWG on MDS in 2016
| 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 |
Table 3
MDS comorbidity index (MDS-CI)
| 合并症 | 积分 |
|---|---|
| 心脏疾病 | 2 |
| 中重度肝脏疾病 | 1 |
| 严重肺部疾病 | 1 |
| 肾脏疾病 | 1 |
| 实体肿瘤 | 1 |
Table 4
MDS patient vulnerability grading
| 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 |
Table 5
WHO (2022) classification of MDS
| 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% | ||
Figure 1
WHO (2022) diagnostic classification process for MDS MDS-LBRS: MDS with low blasts and ring sideroblasts。
Table 6
IPSS-M prognostic grouping
| 分组 | IPSS-M 分值 | 中位LFS （年） | 中位OS （年） | AML转化（%） | |
|---|---|---|---|---|---|
| 1年 | 4年 | ||||
| 极低危 | ≤-1.5 | 9.7 | 10.6 | 0.0 | 2.8 |
| 低危 | >-1.5~-0.5 | 5.9 | 6.0 | 1.7 | 5.1 |
| 中低危 | >-0.5~0 | 4.5 | 4.6 | 4.9 | 11.4 |
| 中高危 | >0~0.5 | 2.3 | 2.8 | 9.5 | 18.9 |
| 高危 | >0.5~1.5 | 1.5 | 1.7 | 14.3 | 29.2 |
| 极高危 | >1.5 | 0.76 | 1.0 | 28.2 | 42.8 |
Table 7
MDS response criteria
| 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 | - |
Table 8
The criteria of hematopoietic improvement for MDS patients
| 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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