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中华临床医师杂志(电子版) ›› 2022, Vol. 16 ›› Issue (12) : 1248 -1255. doi: 10.3877/cma.j.issn.1674-0785.2022.12.017

临床研究

诱导阶段加/不加尼妥珠单抗序贯同步放化疗联合尼妥珠单抗治疗局部晚期鼻咽癌的单中心分析
江丹贤1, 曹金鑫1, 杨柳1, 黄静1,()   
  1. 1. 524000 广东湛江,广东医科大学附属医院肿瘤科
  • 收稿日期:2022-07-28 出版日期:2022-12-15
  • 通信作者: 黄静

Sequential concurrent chemoradiotherapy with/without nimotuzumab in induction phase combined with nimotuzumab for treatment of locally advanced nasopharyngeal carcinoma: a single-center study

Danxian Jiang1, Jinxin Cao1, Liu Yang1, Jing Huang1,()   

  1. 1. Department of Oncology, Affiliated Hospital of Guangdong Medical University, Zhanjiang 524000, China
  • Received:2022-07-28 Published:2022-12-15
  • Corresponding author: Jing Huang
引用本文:

江丹贤, 曹金鑫, 杨柳, 黄静. 诱导阶段加/不加尼妥珠单抗序贯同步放化疗联合尼妥珠单抗治疗局部晚期鼻咽癌的单中心分析[J]. 中华临床医师杂志(电子版), 2022, 16(12): 1248-1255.

Danxian Jiang, Jinxin Cao, Liu Yang, Jing Huang. Sequential concurrent chemoradiotherapy with/without nimotuzumab in induction phase combined with nimotuzumab for treatment of locally advanced nasopharyngeal carcinoma: a single-center study[J]. Chinese Journal of Clinicians(Electronic Edition), 2022, 16(12): 1248-1255.

目的

探讨诱导阶段加/不加尼妥珠单抗序贯同步放化疗联合尼妥珠单抗治疗局部晚期鼻咽癌的有效性及安全性。

方法

回顾性筛选符合入排标准的2016年5月1日至2021年6月1日广东医科大学附属医院收治的鼻咽癌患者资料,其中在诱导化疗及同步放化疗阶段均联合使用尼妥珠单抗的患者被纳入观察组,共计63例。对照组在同步放化疗阶段联合使用尼妥珠单抗,诱导化疗阶段不使用尼妥珠单抗,共纳入51例。2组患者的基线资料稳定的基础上,对2组患者的疗效进行了统计分析。

结果

观察组的完全缓解(CR)率及1年无进展生存(PFS)率明显优于对照组,2组不良反应无显著差异。

结论

诱导阶段加尼妥珠单抗序贯同步放化疗联合尼妥珠单抗治疗局部晚期鼻咽癌近期疗效好,且未增加毒副作用,安全性好,有临床获益。

Objective

To investigate the effectiveness and safety of sequential concurrent chemoradiotherapy with/without nimotuzumab in the induction phase combined with nimotuzumab in the treatment of locally advanced nasopharyngeal carcinoma.

Methods

The data of patients with nasopharyngeal carcinoma admitted to the Affiliated Hospital of Guangdong Medical University from May 1, 2016 to June 1, 2021 who met the inclusion criteria were retrospectively screened, among which patients who were treated with nimotuzumab in both induction chemotherapy and synchronous radiotherapy phases were included in an observation group(63 cases), and those who did not use nimotuzumab in the induction chemotherapy phase were included in a control group(51 cases). The efficacy in the two groups was statistically analyzed on the basis of stable baseline data of the patients.

Results

The complete remission(CR) rate and 1-year progression-free survival(PFS) rate in the observation group were significantly better than those in the control group, and there was no significant difference in adverse effects between the two groups.

Conclusion

Thenimotuzumab containing sequential concurrent chemoradiotherapy in the induction phase combined with nimotuzumab has good short-term efficacy and safety in the treatment of locally advanced nasopharyngeal carcinoma without increased toxic side effects.

表1 2组患者基线特征
对照组n(%)(n=51) 观察组n(%)(n=63) 检验统计量 P
性别 0.456(χ2 0.499
36(70.59) 48(76.19)
15(29.41) 15(23.81)
年龄 1.186(χ2 0.276
<55 35(68.63) 37(58.73)
≥55 16(31.37) 26(41.27)
T分期 6.599(双侧确切概率) 0.084
T1 1(1.96) 6(9.52)
T2 19(37.25) 13(20.63)
T3 16(34.00) 28(34.00)
T4 15(28.30%) 16(25.40%)
N 分期 2.086(双侧确切概率) 0.576
N0 4(7.84%) 5(7.94%)
N1 9(17.65%) 11(17.46%)
N2 26(50.98%) 25(39.68%)
N3 12(23.53%) 22(34.92%)
临床分期 0.052(卡方) 0.852
III 24(49.10%) 31(47.83%)
IVa 27(50.90%) 32(52.17%)
Kps评分 (双侧确切概率) 0.699
<90 4(7.84%) 3(4.35%)
≥90 47(92.16%) 60(95.65%)
BMI 0.106(卡方) 0.745
<18.5 16(31.37%) 18(28.99%)
≥18.5 35(68.63%) 49(71.01%)
诱导化疗 0.518(卡方) 0.564
TPF 29(56.86%) 40(63.77%)
TP 22(43.14%) 23(36.23%)
家族史 (双侧确切概率) 0.222
50(98.04%) 63(91.30%)
1(1.96%) 6(8.70%)
糖尿病 (双侧确切概率) 0.447
50(98.04%) 58(92.06%)
1(1.96%) 5(7.94%)
高血压 (双侧确切概率) 0.655
48(94.12%) 61(96.83%)
3(5.88%) 2(3.17%)
白细胞(/109 7.26(6.17~7.99)a 6.63(5.77~7.97)a -1.202(Z) 0.229
中性粒细胞(/109 4.27(3.55~5.54)a 3.82(3.14~4.89)a -1.681(Z) 0.093
血红蛋白(g/L) 139(126~152)a 140(130~156)a -1.152(Z) 0.249
血小板(/109 251.43±56.41 253.24±54.99 -0.172(T) 0.863
ALT(U/L) 16.8(13.6~27.8)a 18.6(13.9~27.8)a -0.610(Z) 0.542
AST(U/L) 19.8(16.0~24.0)a 18.4(16.1~26.4)a -0.473(Z) 0.636
总胆红素(mmol/L) 9.30(6.60~11.7)a 8.80(6.2~11)a -0.673(Z) 0.501
直接胆红素(mmol/L) 3.10(2.60~4.3)a 3.10(2.4~3.9)a -0.131(Z) 0.896
间接胆红素(mmol/L) 6.20(3.6~8)a 5.4(3.9~7.3)a -0.695(Z) 0.487
白蛋白(g/L) 43.22±4.26 44.71±3.97 -1.926(T) 0.057
肌酐(μmol/L) 72.61±19.15 75.21±15.55 -0.800(T) 0.426
总胆固醇(mmol/L) 4.85(4.2~5.29)a 4.87(4.23~5.63)a -0.735(Z) 0.462
表2 2组患者总体临床疗效比较
表3 2组患者原发灶的临床疗效比较
表4 2组患者颈部淋巴结的临床疗效比较
图1 PFS曲线图
图2 OS曲线图
表5 影响预后的危险因素分析
PFS OS
HR(95% Cl) Wald χ2
P
HR(95% Cl) Wald χ2
P
单因素分析
组别(同步/全程) 0.138(0.017~1.125) 3.42 0.064 0.023(0~4266.33) 0.37 0.541
性别(男/女) 1.259(0.253~6.262) 0.08 0.778 33.063(0~NA) 0.25 0.617
年龄(岁) 1.275(0.303~5.366) 0.11 0.740 0.033(0~55627.447) 0.22 0.641
KPS 21.97(0~NA) 0.21 0.647 21.482(0~NA) 0.02 0.888
BMI 0.629(0.15~2.641) 0.40 0.527 0.195(0.01~3.642) 1.20 0.274
家族史 3.397(0.414~27.88) 1.30 0.255 18.303(1.01~332.43) 3.86 0.049
高血压 0.046(0~302795.76) 0.15 0.701 0.049(0~NA) 0.01 0.936
糖尿病 0.049(0~NA) 0.04 0.838 0.049(0~NA) 0.01 0.936
T期(T1/T2/T3/T4 1.219(0.548~2.711) 0.24 0.627 0.821(0.169~3.991) 0.06 0.806
N期(N0/N1/N2/N3 0.91(0.429~1.932) 0.06 0.806 0.391(0.086~1.775) 1.48 0.224
临床分期(III/IV) 1.508(0.36~6.312) 0.32 0.574 0.413(0.023~7.563) 0.36 0.551
诱导化疗(TPF/TP) 1.818(0.366~9.024) 0.53 0.465 58.334(0~NA) 0.47 0.495
白细胞 1.202(0.922~1.568) 1.85 0.173 1.311(0.826~2.083) 1.32 0.251
中性粒细胞 1.35(1.055~1.727) 5.68 0.017 1.353(0.874~2.093) 1.84 0.175
血红蛋白 0.987(0.971~1.003) 2.74 0.098 0.973(0.943~1.005) 2.75 0.097
血小板 1.009(0.997~1.022) 2.11 0.146 1.015(0.989~1.042) 1.23 0.268
ALT 0.998(0.982~1.015) 0.06 0.809 1.001(0.979~1.022) 0.00 0.994
AST 0.987(0.924~1.054) 0.16 0.692 1.005(0.959~1.054) 0.05 0.824
总胆红素 0.867(0.704~1.066) 1.83 0.176 0.801(0.505~1.272) 0.88 0.348
直接胆红素 0.825(0.451~1.509) 0.39 0.531 0.900(0.458~1.769) 0.09 0.760
间接胆红素 0.788(0.59~1.053) 2.59 0.108 0.601(0.265~1.367) 1.47 0.225
白蛋白 0.779(0.662~0.918) 8.94 0.003 0.535(0.26~1.103) 2.87 0.090
肌酐 0.997(0.956~1.04) 0.02 0.884 1.024(0.965~1.087) 0.62 0.431
总胆固醇 0.454(0.246~0.839) 6.35 0.012 0.052(0.002~1.46) 3.02 0.082
多因素分析
家族史 2.979(0.331~26.80) 0.95 0.330 100663.987(0~NA) 0.02 0.897
中性粒细胞 1.205(0.924~1.57) 1.89 0.169 1.233(0~NA) 0.00 0.989
白蛋白 0.812(0.68~0.97) 5.27 0.022 0.253(0~178905.56) 0.04 0.842
总胆固醇 0.534(0.256~1.115) 2.79 0.095 0.07(0~5.433E+54) 0.00 0.968
表6 不良反应总结
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