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食管鳞状细胞癌患者根治术后生存预测模型的建立与验证:一项多中心真实世界队列研究

杨文蕾 刘芳芳 徐瑞平 杨伟 何煜 刘震 周福有 衡反修 侯波林 张立新 陈蕾 张凡 蔡奋 许铧文 林妙萍 刘萌飞 潘雅琪 刘英 胡喆 陈环宇 何忠虎 柯杨

杨文蕾, 刘芳芳, 徐瑞平, 杨伟, 何煜, 刘震, 周福有, 衡反修, 侯波林, 张立新, 陈蕾, 张凡, 蔡奋, 许铧文, 林妙萍, 刘萌飞, 潘雅琪, 刘英, 胡喆, 陈环宇, 何忠虎, 柯杨. 食管鳞状细胞癌患者根治术后生存预测模型的建立与验证:一项多中心真实世界队列研究[J]. 协和医学杂志, 2023, 14(1): 101-113. doi: 10.12290/xhyxzz.2022-0496
引用本文: 杨文蕾, 刘芳芳, 徐瑞平, 杨伟, 何煜, 刘震, 周福有, 衡反修, 侯波林, 张立新, 陈蕾, 张凡, 蔡奋, 许铧文, 林妙萍, 刘萌飞, 潘雅琪, 刘英, 胡喆, 陈环宇, 何忠虎, 柯杨. 食管鳞状细胞癌患者根治术后生存预测模型的建立与验证:一项多中心真实世界队列研究[J]. 协和医学杂志, 2023, 14(1): 101-113. doi: 10.12290/xhyxzz.2022-0496
YANG Wenlei, LIU Fangfang, XU Ruiping, YANG Wei, HE Yu, LIU Zhen, ZHOU Fuyou, HENG Fanxiu, HOU Bolin, ZHANG Lixin, CHEN Lei, ZHANG Fan, CAI Fen, XU Huawen, LIN Miaoping, LIU Mengfei, PAN Yaqi, LIU Ying, HU Zhe, CHEN Huanyu, HE Zhonghu, KE Yang. Development and Validation of A Prognosis Prediction Model for Esophageal Squamous Cell Carcinoma Patients Treated with Esophagectomy: A Multicenter Real-world Cohort Study[J]. Medical Journal of Peking Union Medical College Hospital, 2023, 14(1): 101-113. doi: 10.12290/xhyxzz.2022-0496
Citation: YANG Wenlei, LIU Fangfang, XU Ruiping, YANG Wei, HE Yu, LIU Zhen, ZHOU Fuyou, HENG Fanxiu, HOU Bolin, ZHANG Lixin, CHEN Lei, ZHANG Fan, CAI Fen, XU Huawen, LIN Miaoping, LIU Mengfei, PAN Yaqi, LIU Ying, HU Zhe, CHEN Huanyu, HE Zhonghu, KE Yang. Development and Validation of A Prognosis Prediction Model for Esophageal Squamous Cell Carcinoma Patients Treated with Esophagectomy: A Multicenter Real-world Cohort Study[J]. Medical Journal of Peking Union Medical College Hospital, 2023, 14(1): 101-113. doi: 10.12290/xhyxzz.2022-0496

食管鳞状细胞癌患者根治术后生存预测模型的建立与验证:一项多中心真实世界队列研究

doi: 10.12290/xhyxzz.2022-0496
基金项目: 

国家自然科学基金 82073626

国家科技基础资源调查专项 2019FY101102

详细信息
    通讯作者:

    何忠虎, E-mail:zhonghuhe@foxmail.com

    柯杨, E-mail:keyang@bjmu.edu.cn

    杨文蕾、刘芳芳、徐瑞平、杨伟、何煜、刘震、周福有对本文同等贡献

    杨文蕾、刘芳芳、徐瑞平、杨伟、何煜、刘震、周福有对本文同等贡献

    杨文蕾、刘芳芳、徐瑞平、杨伟、何煜、刘震、周福有对本文同等贡献

    杨文蕾、刘芳芳、徐瑞平、杨伟、何煜、刘震、周福有对本文同等贡献

    杨文蕾、刘芳芳、徐瑞平、杨伟、何煜、刘震、周福有对本文同等贡献

    杨文蕾、刘芳芳、徐瑞平、杨伟、何煜、刘震、周福有对本文同等贡献

    杨文蕾、刘芳芳、徐瑞平、杨伟、何煜、刘震、周福有对本文同等贡献

  • 中图分类号: R735.1; R181.2

Development and Validation of A Prognosis Prediction Model for Esophageal Squamous Cell Carcinoma Patients Treated with Esophagectomy: A Multicenter Real-world Cohort Study

Funds: 

National Natural Science Foundation of China 82073626

National Science & Technology Fundamental Resources Investigation Program of China 2019FY101102

More Information
  • 摘要:   目的  建立并验证食管鳞状细胞癌患者根治术后生存预后预测模型与风险分级标准,为术后最优辅助治疗方案的确定提供真实世界证据。  方法  分别收集2011年5月31日至2018年7月31日在河南省安阳市肿瘤医院(安阳中心)和2009年8月1日至2018年12月31日在广东省汕头大学医学院附属肿瘤医院(汕头中心)连续就诊的食管鳞状细胞癌患者的临床数据和生存随访数据。以安阳中心数据集为建模集,采用基于多因素Cox比例风险回归逐步后退法和AIC准则(Akaike information criterion)的“两步法”构建总生存预测模型。通过Bootstrap重抽样1 000次对模型进行内部统计验证,在汕头中心数据集进行外部验证。根据列线图得分构建预后风险分级标准。  结果  建模队列和验证队列分别纳入4 171例和1 895例食管鳞状细胞癌患者。模型由年龄、性别、肿瘤原发位置、T分期、N分期、淋巴结清扫数、肿瘤大小、辅助治疗方案和术前血红蛋白水平9个变量组成。其中,N分期与辅助治疗方案存在显著交互作用(P<0.001),即与单纯手术相比,N+期患者可能从辅助治疗中获益,但辅助治疗无法改善N0期患者的预后。建模队列的模型一致性指数(C-index)为0.728 (95% CI: 0.713~0.742),经Bootstrap内部验证后为0.722 (95% CI: 0.711~0.739),验证队列的模型C-index为0.679 (95% CI: 0.662~0.697)。校准图提示模型预测生存率与观测生存率一致性良好。在两个队列中模型准确性均显著高于第7版AJCC(American Joint Committee on Cancer)TNM分期系统(P<0.05)。此外,在各TNM分期内部,该模型仍可实现理想的预后风险分层效果。  结论  本研究为我国食管鳞状细胞癌患者根治术后总生存提供了个体化预测模型,并揭示N分期可能是制订食管鳞状细胞癌患者术后辅助治疗方案的重要决定因素。
    作者贡献:柯杨、何忠虎负责研究设计与论文修订;何忠虎、杨文蕾、刘芳芳、何煜、刘震负责数据整理、统计分析、论文撰写;徐瑞平、杨伟、周福有、张立新、陈蕾负责数据获取;徐瑞平、杨伟、周福有、张立新、陈蕾、侯波林、张凡、蔡奋、许铧文、林妙萍、衡反修、刘萌飞、潘雅琪、刘英、胡喆、陈环宇负责数据集建立与质量控制。
    利益冲突:所有作者均声明不存在利益冲突
  • 图  1  患者纳入及排除流程图

    A.建模队列; B.验证队列

    图  2  食管鳞状细胞癌患者根治术后总生存预后预测模型列线图

    注:女性患者血红蛋白截断值为115 g/L

    图  3  食管鳞状细胞癌患者根治术后生存预后预测模型在建模队列和验证队列的1年、3年、5年生存率预测校准图

    A.建模队列填补数据集;B.验证队列填补数据集;C.建模队列完整数据集;D.验证队列完整数据集

    图  4  建模队列和验证队列不同预后风险组患者的Kaplan-Meier生存曲线

    注:图中未展示少于10人的亚组

    表  1  建模队列与验证队列患者特征比较

    特征 建模队列(n=4171) 验证队列(n=1895) P
    例数(%)* 死亡例数(%)# 例数(%)* 死亡例数(%)#
    年龄(岁) <0.001
      <60 966(23.2) 232(24.0) 889(46.9) 373(42.0)
      60~64 1168(28.0) 294(25.2) 511(27.0) 225(44.0)
      65~69 1136(27.2) 326(28.7) 272(14.4) 120(44.1)
      70~74 626(15.0) 199(31.8) 168(8.9) 87(51.8)
      ≥75 275(6.6) 95(34.5) 55(2.9) 38(69.1)
    性别 <0.001
      女 1656(39.7) 403(24.3) 475(25.1) 185(38.9)
      男 2515(60.3) 743(29.5) 1420(74.9) 658(46.3)
    共病 <0.001
      否 2426(58.2) 627(25.8) 1437(75.8) 629(43.8)
      是 1745(41.8) 519(29.7) 458(24.2) 214(46.7)
    食管癌家族史§ <0.001
      否 3013(72.2) 847(28.1) 1643(87.5) 737(44.9)
      是 1158(27.8) 299(25.8) 235(12.5) 100(42.6)
    原发位置 0.235
      食管下段 781(18.7) 212(27.1) 373(19.7) 179(48.0)
      食管中段 2745(65.8) 708(25.8) 1259(66.4) 547(43.4)
      食管上段 645(15.5) 226(35.0) 263(13.9) 117(44.5)
    T分期 <0.001
      T0~T1 959(23.0) 87(9.1) 221(11.7) 38(17.2)
      T2 1019(24.4) 257(25.2) 296(15.6) 121(40.9)
      T3 2037(48.8) 719(35.3) 697(36.8) 311(44.6)
      T4 156(3.7) 83(53.2) 681(35.9) 373(54.8)
    N分期 <0.001
      N0 2576(61.8) 473(18.4) 969(51.1) 306(31.6)
      N1 1041(25.0) 389(37.4) 484(25.5) 233(48.1)
      N2~N3 554(13.3) 284(51.3) 442(23.3) 304(68.8)
    淋巴结清扫数(个) <0.001
      0~9 617(14.8) 205(33.2) 74(3.9) 42(56.8)
      10~19 2358(56.5) 661(28.0) 498(26.3) 226(45.4)
      20~29 963(23.1) 240(24.9) 724(38.2) 306(42.3)
      ≥30 233(5.6) 40(17.2) 599(31.6) 269(44.9)
    治疗方案 <0.001
      单纯手术 2774(66.5) 656(23.6) 1063(56.1) 424(39.9)
      手术+术后化疗 1158(27.8) 376(32.5) 272(14.4) 114(41.9)
      手术+术后放疗 107(2.6) 50(46.7) 362(19.1) 183(50.6)
      手术+术后放化疗 132(3.2) 64(48.5) 198(10.4) 122(61.6)
    手术方式 <0.001
      OE 2929(70.2) 858(29.3) 1382(72.9) 682(49.3)
      MIE 1242(29.8) 288(23.2) 513(27.1) 161(31.4)
    肿瘤大小(cm) <0.001
      M(P25, P75) 4.0(3.0,5.0) 5.0(4.0,6.0)
    红细胞(×1012/L) <0.001
      ≥4.3 2859(68.5) 739(25.8) 1594(84.1) 678(42.5)
      <4.3 1312(31.5) 407(31.0) 301(15.9) 165(54.8)
    血红蛋白(g/L) <0.001
      ≥130(男)/115(女) 3105(74.4) 833(26.8) 1567(82.7) 692(44.2)
      <130(男)/115(女) 1066(25.6) 313(29.4) 328(17.3) 151(46.0)
    嗜酸性粒细胞(×109/L) <0.001
      ≥0.02 3387(81.2) 935(27.6) 1828(96.5) 811(44.4)
      <0.02 784(18.8) 211(26.9) 67(3.5) 32(47.8)
    系统性免疫炎症指数 <0.001
      ≤650 1905(45.7) 502(26.4) 1203(63.5) 540(44.9)
      >650 2266(54.3) 644(28.4) 692(36.5) 303(43.8)
    白蛋白/球蛋白比值 <0.001
      ≥1.2 2757(66.1) 706(25.6) 1803(95.1) 802(44.5)
      <1.2 1414(33.9) 440(31.1) 92(4.9) 41(44.6)
    OE:开放食管切除术;MIE:微创食管切除术;*变量中各亚组占总人数的比例; #各亚组内死亡人数占该组人数的比例;采用χ2检验、t检验;患有高血压、糖尿病或心脏病中的任何一种疾病;§验证队列有17例患者食管癌家族史信息缺失
    下载: 导出CSV

    表  2  建模队列预后预测变量的单因素和多因素Cox回归模型分析结果

    预测变量 n(%) 单因素分析 多因素Cox回归模型分析
    HR(95% CI) P HR(95% CI) P
    年龄(岁)
      <60 966(23.2) 1.00 1.00
      60~64 1168(28.0) 1.16(0.98~1.38) 0.085 1.18(0.99~1.41) 0.061
      65~69 1136(27.2) 1.45(1.23~1.72) <0.001 1.50(1.26~1.78) <0.001
      70~74 626(15.0) 1.74(1.44~2.10) <0.001 1.62(1.33~1.96) <0.001
      ≥75 275(6.6) 1.99(1.57~2.53) <0.001 1.90(1.49~2.42) <0.001
    性别
      女 1656(39.7) 1.00 1.00
      男 2515(60.3) 1.25(1.10~1.41) <0.001 1.09(0.97~1.24) 0.157
    原发位置
      食管下段 781(18.7) 1.00 1.00
      食管中段 2745(65.8) 0.95(0.81~1.10) 0.492 1.08(0.93~1.27) 0.304
      食管上段 645(15.5) 1.28(1.06~1.54) 0.011 1.59(1.31~1.93) <0.001
    T分期
      T0~T1 959(23.0) 1.00 1.00
      T2 1019(24.4) 2.89(2.26~3.68) <0.001 2.07(1.61~2.66) <0.001
      T3 2037(48.8) 4.61(3.69~5.76) <0.001 3.00(2.37~3.80) <0.001
      T4 156(3.7) 9.64(7.13~13.02) <0.001 5.10(3.69~7.06) <0.001
    淋巴结清扫数(个)
      0~9 617(14.8) 1.00 1.00
      10~19 2358(56.5) 0.95(0.81~1.11) 0.512 0.81(0.69~0.95) 0.009
      20~29 963(23.1) 1.04(0.86~1.25) 0.687 0.73(0.61~0.89) 0.001
      ≥30 233(5.6) 0.87(0.62~1.23) 0.430 0.52(0.37~0.73) <0.001
    肿瘤大小(cm)
      M(P25, P75) 4.0(3.0,5.0) 1.17(1.14~1.21) <0.001 1.04(1.00~1.08) 0.070
    血红蛋白(g/L)
      ≥130(男)/115(女) 3105(74.4) 1.00 1.00
      <130(男)/115(女) 1066(25.6) 1.39(1.22~1.58) <0.001 1.33(1.16~1.52) <0.001
    治疗方案根据N分期分层*
      N0
        单纯手术 2040(79.2) 1.00 1.00
        手术+术后化疗 462(17.9) 1.54(1.24~1.90) <0.001 1.25(1.00~1.55) 0.047
        手术+术后放疗 37(1.4) 2.33(1.39~3.91) 0.001 1.73(1.03~2.92) 0.040
        手术+术后放化疗 37(1.4) 4.36(2.78~6.85) <0.001 2.87(1.82~4.53) <0.001
      N1
        单纯手术 506(48.6) 1.00 1.00
        手术+术后化疗 434(41.7) 0.73(0.59~0.90) 0.003 0.81(0.65~1.00) 0.053
        手术+术后放疗 48(4.6) 0.82(0.53~1.28) 0.392 0.79(0.51~1.24) 0.312
        手术+术后放化疗 53(5.1) 1.13(0.72~1.78) 0.585 1.08(0.68~1.70) 0.752
      N2~N3
        单纯手术 228(41.2) 1.00 1.00
        手术+术后化疗 262(47.3) 0.66(0.51~0.85) 0.001 0.77(0.60~0.99) 0.041
        手术+术后放疗 22(4.0) 0.98(0.55~1.73) 0.941 0.87(0.49~1.55) 0.642
        手术+术后放化疗 42(7.6) 0.83(0.53~1.29) 0.408 0.85(0.54~1.33) 0.481
    HR:风险比;*根据N分期分层估计各辅助治疗相对于单纯手术的风险比
    下载: 导出CSV

    表  3  食管鳞状细胞癌患者根治术后预后风险分级标准在建模队列和验证队列的效果评估

    风险组 截断值§ 建模队列(n=4171)
    例数(%)* 死亡例数(%)# 生存率(%,95% CI)
    1年 3年 5年
    低风险 [0,11.72978) 1390(33.3) 139(10.0) 98.4(97.7~99.0) 90.3(88.5~92.2) 82.8(79.7~86.0)
    中风险 [11.72978,16.60198) 1390(33.3) 347(25.0) 94.9(93.8~96.1) 73.5(70.9~76.3) 62.9(59.4~66.7)
    高风险 [16.60198,∞) 1391(33.3) 660(47.4) 85.3(83.4~87.2) 47.4(44.4~50.7) 31.6(28.2~35.5)
    风险组 验证队列(n=1895)
    例数(%)* 死亡例数(%)# 生存率(%,95% CI)
    1年 3年 5年
    低风险 474(25.0) 101(21.3) 97.3(95.8~98.7) 87.1(84.1~90.2) 82.0(78.5~85.6)
    中风险 517(27.3) 211(40.8) 93.2(91.1~95.4) 71.5(67.7~75.6) 62.9(58.8~67.3)
    高风险 904(47.7) 531(58.7) 81.1(78.6~83.7) 51.6(48.4~55.0) 42.9(39.7~46.4)
    §截断值依据建模队列列线图总得分的三分位数确定;*表 1#表 1
    下载: 导出CSV
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  • 收稿日期:  2022-09-02
  • 录用日期:  2022-10-13
  • 网络出版日期:  2022-11-29
  • 刊出日期:  2023-01-30

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