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中华肺部疾病杂志(电子版)

中华肺部疾病杂志(电子版) ›› 2026, Vol. 19 ›› Issue (02) : 189 -196. doi: 10.3877/cma.j.issn.1674-6902.2026.02.002

论著

ALK阳性非小细胞肺癌患者靶向治疗失败后的疾病进展模式分析
沈梦熠1, 陈佳妍1, 陈玥莹1, 王振1, 许春伟1,2, 王栋1,†(), 吕镗烽1,†()   
  1. 1210002　南京，南京大学医学院附属金陵医院·东部战区总医院呼吸与危重症医学科
    2310022　杭州，中国科学院杭州医学研究所
  • 收稿日期:2026-01-24 出版日期:2026-04-25
  • 通信作者: 王栋, 吕镗烽
  • 基金资助:
    国家自然科学基金项目(82370096)

Pattern of failure analysis in ALK-positive non-small cell lung cancer patients treated with targeted therapy

Mengyi Shen1, Jiayan Chen1, Yueying Chen1, Zhen Wang1, Chunwei Xu1,2, Dong Wang1,†(), Tangfeng Lyu1,†()   

  1. 1Department of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University/General Hospital of Eastern Theater Command, Nanjing 210002, China
    2Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou 310022, China
  • Received:2026-01-24 Published:2026-04-25
  • Corresponding author: Dong Wang, Tangfeng Lyu
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引用本文：

沈梦熠, 陈佳妍, 陈玥莹, 王振, 许春伟, 王栋, 吕镗烽. ALK阳性非小细胞肺癌患者靶向治疗失败后的疾病进展模式分析[J/OL]. 中华肺部疾病杂志(电子版), 2026, 19(02): 189-196.

Mengyi Shen, Jiayan Chen, Yueying Chen, Zhen Wang, Chunwei Xu, Dong Wang, Tangfeng Lyu. Pattern of failure analysis in ALK-positive non-small cell lung cancer patients treated with targeted therapy[J/OL]. Chinese Journal of Lung Diseases(Electronic Edition), 2026, 19(02): 189-196.

目的

探讨间变性淋巴瘤激酶(anaplastic lymphoma kinase, ALK)融合基因阳性非小细胞肺癌(non-small cell lung cancer, NSCLC)患者接受第一代ALK酪氨酸激酶抑制剂(ALK-TKI)、一线及序贯二线第二代ALK-TKI治疗后，不同临床进展模式与无进展生存期(progression-free survival, PFS)的关系，进一步分析基线特征对进展模式的预测价值，并探讨第二代ALK-TKI耐药不同治疗策略的临床结局。

方法

回顾性纳入2017年1月1日至2025年9月30日期间四家中心接受ALK-TKI治疗后发生影像学进展的ALK阳性晚期NSCLC患者。根据耐药发生时所用ALK-TKI和治疗线数，分为一线第一代ALK-TKI耐药队列53例与第二代ALK-TKI耐药队列56例；其中第二代ALK-TKI耐药队列包含一线第二代ALK-TKI治疗后进展亚组和第一代ALK-TKI后序贯第二代ALK-TKI治疗(二线第二代ALK-TKI治疗)后进展亚组。依据RECIST 1.1标准进行疾病进展判定，进展模式分为寡进展与全身进展、原发部位进展与远处部位进展。采用Kaplan-Meier法分析PFS，采用Firth Logistic回归分析第二代ALK-TKI耐药后全身进展的预测因素。

结果

第二代ALK-TKI耐药队列中，30例为一线使用二代TKI后耐药，26例为一代序贯二代后耐药。两个亚组除二代TKI治疗前胸膜转移的组间分布存在统计学差异(P<0.05)，其余基线特征均无显著统计学差异(P>0.05)。第二代TKI耐药后寡进展患者的中位PFS(17.7个月；95%CI：12.5~22.8个月)显著长于全身进展患者(9.0个月；95%CI：4.5~13.5个月，P<0.001)；亚组分析显示，一线使用第二代TKI还是一代序贯二代TKI治疗，寡进展患者的PFS均显著优于全身进展患者(P<0.05)。二代TKI治疗前为寡转移的患者不易发生全身进展(OR＝0.18，95%CI：0.03~0.87，P＝0.033)。二代TKI耐药后，继续原药、换用其他二代TKI或启用三代TKI的三组患者PFS无统计学差异(P＝0.979)。

结论

第二代ALK-TKI耐药后，无论治疗线数，寡进展模式均与更长的PFS相关，治疗前转移状态可作为进展模式的预测因素。二代TKI耐药后不同后续TKI策略的疗效未见显著差异。

关键词: 非小细胞肺癌, 间变性淋巴瘤激酶, 酪氨酸激酶抑制剂
Objective

To investigate the impact of distinct clinical progression patterns on progression-free survival (PFS) in patients with anaplastic lymphoma kinase (ALK) fusion gene-positive non-small cell lung cancer (NSCLC) following treatment with first-generation, first-line and sequential second-line second-generation ALK tyrosine kinase inhibitors (ALK-TKIs), to analyze whether baseline patient characteristics can predict progression patterns, and to evaluate survival differences among various treatment strategies after second-generation ALK-TKI resistance.

Methods

A retrospective analysis was conducted on ALK-positive advanced NSCLC patients who experienced disease progression after ALK-TKI therapy between January 1, 2017, and September 30, 2025, across four centers (Eastern Theater Command General Hospital, Hunan Cancer Hospital, Shanxi Bethune Hospital, and Nanjing Chest Hospital). Patients were divided into first-generation ALK-TKI resistance cohort and second-generation ALK-TKI resistance cohort based on the targeted agent and treatment line at the time of drug resistance. The second-generation ALK-TKI resistance cohort included two subgroups: patients progressed after first-line second-generation ALK-TKI treatment, and patients progressed after sequential second-generation ALK-TKI treatment (second-line) following first-generation ALK-TKI. Progression patterns (oligoprogression vs. systemic progression; primary site progression vs. distant site progression) were assessed according to RECIST 1.1 criteria. Kaplan-Meier method was used for PFS analysis, and Firth regression was applied to identify predictive factors for systemic progression after second-generation ALK-TKI resistance.

Results

The first- and second-generation TKI resistance cohorts included 53 and 56 patients, respectively. The median PFS for patients with oligoprogression after second-generation TKI resistance (17.7 months; 95%CI: 12.5~22.8 months) was significantly longer than for those with systemic progression (9.0 months; 95%CI: 4.5~13.5 months, P<0.001). Subgroup analysis showed that patients with oligoprogression had significantly better PFS than those with systemic progression, regardless of first-line or sequential second-line second-generation TKI treatment (all P<0.05). Patients presenting with oligometastatic disease before second-generation TKI treatment were less likely to develop systemic progression (OR=0.18, 95%CI: 0.03~0.87, P=0.033). After second-generation TKI resistance, no significant difference in PFS was observed among patients who continued the original drug, switched to another second-generation TKI, or initiated a third-generation TKI (P=0.979).

Conclusions

After second generation ALK-TKI resistance, oligoprogression pattern is associated with longer PFS regardless of treatment line, and pre-treatment metastatic status may serve as an independent predictor for the progression pattern. No significant difference in efficacy was found among different subsequent TKI strategies following second-generation TKI resistance, and this result is only an exploratory analysis, which needs to be further verified by prospective studies

Key words: Non-small cell lung cancer, Anaplastic lymphoma kinase, Tyrosine kinase inhibitor
图1 NSCLC患者筛选流程图
表1 第一代与第二代ALK-TKI耐药队列患者基线特征[n(%)]
临床资料 一代耐药队列(n＝53) 二代耐药队列(n＝56)
性别    
男 25(47.17) 30(53.57)
女 28(52.83) 26(46.43)
年龄 51.89±11.81 52.29±9.44
吸烟史    
无 45(84.91) 45(80.36)
有 8(15.09) 11(19.64)
ECOG评分    
0-1 52(98.11) 48(85.71)
≥2 1(1.87) 8(14.29)
临床分期    
ⅢB、ⅢC 10(18.87) 3(5.38)
ⅣA 17(32.08) 19(33.93)
ⅣB 26(49.06) 34(60.71)
耐药时所使用的TKI    
克唑替尼 53(100.00) /
阿来替尼 / 36(64.29)
布加替尼 / 5(8.93)
恩沙替尼 / 4(7.14)
赛瑞替尼 / 11(19.64)
基线转移部位    
肺 12(22.64) 9(16.07)
中枢神经系统 10(18.87) 17(30.36)
胸膜 22(41.51) 18(32.14)
骨 19(35.85) 25(44.64)
肾上腺 2(3.73) 5(8.93)
肝 5(9.43) 10(17.86)
腹腔 3(5.66) 4(7.14)
表2 第二代ALK-TKI耐药队列两个亚组基线特征[n(%)]
临床资料 一线二代耐药(n＝30) 一代序贯二代耐药(n＝26) 统计值(F/χ2) P值
临床分期       0.828
ⅢB、ⅢC 1(3.33) 2(7.69)    
ⅣA 10(33.33) 9(34.62)    
ⅣB 19(63.34) 15(57.69)    
耐药时所使用的TKI       0.577
克唑替尼 / /    
阿来替尼 20(66.67) 16(61.54)    
布加替尼 2(6.67) 3(11.54)    
恩沙替尼 1(3.33) 3(11.54)    
赛瑞替尼 7(23.33) 4(15.38)    
基线转移部位        
肺 4(13.33) 5(19.23)   0.719
中枢神经系统 10(33.33) 7(26.92) 0.271 0.603
胸膜 6(20.00) 12(46.15) 4.368 0.037
骨 13(43.33) 12(44.15) 0.045 0.832
肾上腺 5(16.67) 0   0.055
肝 6(20.00) 4(15.38)   0.737
腹腔 3(10.00) 1(3.84)   0.615
表3 ALK-TKI耐药模式[n(%)]
NSCLC转移器官及模式 一代耐药队列(n＝53) 二代耐药队列(n＝56) 统计值(χ2值) P值
进展部位        
肺 18(33.96) 12(21.43) 2.144 0.143
中枢神经系统 25(47.17) 22(39.29) 0.690 0.406
胸膜 6(11.32) 7(12.50) 0.036 0.849
骨 4(7.55) 6(10.71)   0.743
肾上腺 1(1.89) 1(1.78)   1.000
肝 2(3.87) 4(7.14)   0.679
腹腔 1(1.89) 2(3.57)   1.000
区域淋巴结 3(5.66) 2(3.57)   0.673
进展模式     0.056 0.813
寡进展 30(56.60) 34(60.71)    
全身进展 23(43.40) 22(39.29)    
进展模式     4.243 0.039
原发部位进展 12(22.64) 23(41.07)    
远处部位进展 41(77.36) 33(58.93)    
表4 进展模式Firth回归分析[n(%)]
临床资料 寡进展(n＝34) 全身进展(n＝22) 单因素分析 Firth回归
T分期     P＝0.460  
T1、T2 6(17.65) 2(9.10)    
T3、T4 28(82.35) 20(90.90)    
N分期     P＝1.000  
N0 1(2.94) 0    
N1-3 33(97.06) 22(100.00)    
治疗前转移模式     Pearson
χ2＝9.009
P＝0.003		 OR＝0.179(95%CI：0.0329~0.8705)
P＝0.033
寡转移 20(55.82) 4(18.18)    
全身转移 14(41.18) 18(81.82)    
治疗模式     Pearsonχ2＝2.336
P＝0.126		  
一代序贯二代 13(38.24) 13(59.10)    
一线二代 21(61.76) 9(40.91)    
中枢神经系统进展     Pearson χ2＝0.100
P＝0.752		  
有 14(41.18) 10(45.45)    
无 20(58.82) 12(54.55)    
肺部进展     P＝1.000  
有 6(17.65) 3(13.64)    
无 28(82.35) 19(86.36)    
胸膜进展     Pearson
χ2＝4.861
P＝0.027		 OR＝1.0519(95%CI：0.2286~4.6920)
P＝0.946
有 10(29.41) 13(59.10)    
无 24(70.59) 9(40.91)    
骨进展     Pearson χ2＝0.204
P＝0.651		  
有 16(47.06) 9(40.91)    
无 18(52.94) 13(59.10)    
肾上腺进展     P＝1.000  
有 3(8.82) 2(9.10)    
无 31(91.18) 20(90.90)    
肝进展     P＝1.000  
有 7(20.59) 4(18.18)    
无 27(79.41) 18(81.82)    
腹腔进展     P＝1.000  
有 3(8.82) 1(4.55)    
无 31(91.18) 21(95.45)    
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