| 修订的国际分期系统（R-ISS）对初诊多发性骨髓瘤患者预后评估价值及局限性 |
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| 引用本文： | 樊慧守,刘佳慧,毛雪涵,杜辰星,阎禹廷,王轶,隋伟薇,邓书会,王婷玉,傅明伟,李增军,邹德慧,赵耀中,邱录贵,安刚.修订的国际分期系统（R-ISS）对初诊多发性骨髓瘤患者预后评估价值及局限性[J].中国肿瘤临床,2019,46(20):1074-1079. |
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| 作者姓名： | 樊慧守 刘佳慧 毛雪涵 杜辰星 阎禹廷 王轶 隋伟薇 邓书会 王婷玉 傅明伟 李增军 邹德慧 赵耀中 邱录贵 安刚 |
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| 作者单位： | 中国医学科学院血液病医院(中国医学科学院血液学研究所), 实验血液学国家重点实验室, 国家血液病临床医学研究中心(天津市 300020) |
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| 基金项目： | 中国医学科学院中央级公益性科研院所基本科研业务费青年医学人才奖励编号:2018RC320011 |
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| 摘 要： | 目的 探讨修订的国际分期系统（revised international staging system，R-ISS）在真实世界中对初诊多发性骨髓瘤（multiplemyeloma，MM）患者预后评估价值及局限性。 方法 回顾性分析2002年6月至2017年11月中国医学科学院血液病医院新诊断的568例MM患者临床资料。所有患者均接受基于硼替佐米或沙利度胺/来那度胺为主的方案诱导治疗≥4个疗程。以ISS分期为对照，分析R-ISS分期的预后意义。考虑到R-ISSⅡ期的MM患者之间存在较大的异质性，本研究将R-ISSⅡ期患者分成四组:第1组患者ISSⅠ期伴有乳酸脱氢酶（lactate dehydrogenase，LDH）水平升高或高危遗传学异常；第2组患者ISSⅡ期无LDH水平升高及高危遗传学异常；第3组患者ISSⅡ期伴有LDH水平升高或高危遗传学异常；第4组患者ISSⅢ期无LDH水平升高和高危遗传学异常。在此分组条件下对这部分患者进行生存分析。 结果 568例MM患者中，男性347例，女性221例，中位发病年龄56（25~83）岁，中位随访33（4~203）个月。采用R-ISS分期，Ⅰ、Ⅱ、Ⅲ期患者分别为59例（12%）、310例（62%）、130例（26%），中位总体生存（median overall survival，mOS）时间分别为142、86和40个月（χ2=29.588，P < 0.001）；采用ISS分期，Ⅰ、Ⅱ和Ⅲ期患者分别为106例（19%）、210例（37%）和252例（44%），mOS时间分别为142、71和40个月（χ2=22.099，P < 0.001）。采用Cox回归分析，ISS分期Ⅲ期对Ⅰ期HR=2.903，P < 0.001，ISS分期Ⅱ期对Ⅰ期HR=1.985，P=0.005；而R-ISS分期Ⅲ期对Ⅰ期HR=5.441，P < 0.001，R-ISS分期Ⅱ期对Ⅰ期HR=2.844，P=0.003。R-ISS分期Ⅱ期的4组患者的mOS时间分别为126、83、49（95%CI:33~65）、65（95%CI:44~86）个月（P=0.131）。总体上，四组OS无显著性差异，但是第2组和第3组OS相比呈显著性差异（χ2=4.916，P=0.027）。 结论 R-ISS分期相对于ISS分期能够更好地区分MM患者预后。对于有髓外浸润、有1q21扩增、不同年龄分组（年龄≥65岁和年龄 < 65岁）、不同治疗方案（硼替佐米治疗组及沙利度胺治疗组）、不同染色体倍数（低二倍体、非低二倍体）的患者OS均具有较高的预后判断价值。但R-ISS分期同为Ⅱ期患者的生存情况仍存在差异，需要临床上予以重视。
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| 关 键 词： | 多发性骨髓瘤 ISS分期 R-ISS分期 预后价值 局限性 |
| 收稿时间： | 2019-09-17 |
Prognostic value and limitations of the revised international staging system in newly diagnosed multiple myeloma |
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| Affiliation: | Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Tianjin 300020, China |
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| Abstract: | Objective To evaluate the prognostic value and limitations of the revised international staging system (R-ISS) in newly diagnosed multiple myeloma (MM). Methods The clinical data of 568 patients newly diagnosed with MM in Institute of Hematology & Blood Diseases Hospital from June 2002 to November 2017 were retrospectively analyzed. All patients received induction therapy with bortezomib or thalidomide/lenalidomide for at least 4 cycles. The prognostic significance of R-ISS was analyzed by comparing it to the international staging system (ISS). Considering the great heterogeneity between MM patients in R-ISS phase Ⅱ, we assigned the patients in this phase into four groups: the first group was characterized by elevated lactate dehydrogenase (LDH) levels or high-risk genetic abnormalities in ISS stage Ⅰ; the second group patients did not have elevated LDH levels and high-risk genetic abnormalities in ISS stage Ⅱ; the third group patients had elevated LDH levels or high-risk genetic abnormalities in ISS stage Ⅱ; and the fourth group patients had no LDH or high-risk genetic abnormalities in ISS stage Ⅲ. Survival analysis was performed among these groups. Results Among the 568 newly diagnosed MM patients, 347 were male and 221 were female, with a median age of 56 (25-83) years. The median follow-up period was 33 (4-203) months. Under the R-ISS, 59 (12%), 310 (62%), and 130 (26%) patients had stage Ⅰ, Ⅱ, and Ⅲ disease, respectively. The median overall survival (mOS) in the corresponding patients were 142, 86, and 48 months, respectively (χ2=29.588, P < 0.001). Under the ISS, 106 (19%), 210 (37%), and 252 (44%) patients had stage Ⅰ, Ⅱ, and Ⅲ disease, respectively. The median OS in the corresponding patients were 142, 71, and 63 months, respectively (χ2=22.099, P < 0.001). The hazard ratio (HR) of Ⅲ vs. Ⅰ, Ⅱ vs. Ⅰ of ISS system were 2.903 (P < 0.001) and 1.985 (P=0.005). The HR of Ⅲ vs. Ⅰ, Ⅱ vs. Ⅰ of R-ISS system were 5.441 (P < 0.001) and 2.844 (P=0.003). The median OS of the four groups in R-ISS Ⅱ were 126, 83, 49 (95% CI: 33-65), and 65 (95% CI: 44-86) months (P=0.131), respectively. In general, there were no significant differences in OS between the four groups; however, there were significant differences between groups 2 and 3 (χ2=4.916, P=0.027). Conclusions R-ISS is better than ISS for differentiating the prognosis of MM patients. The R-ISS has a strong prognostic value for OS in patients with extramedullary infiltration or 1q21 amplification, for those in different age groups (age ≥65 years and age < 65 years), for those with different treatment schemes (bortezomib and thalidomide treatment groups), and for those with different chromosome multiples (low diploid and non-low diploid). However, the survival differences between the R-ISS stage Ⅱ patients still need clinical concern. |
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