表皮生长因子受体非热点突变型非小细胞肺癌一线应用表皮生长因子受体酪氨酸激酶抑制剂及化疗的疗效对比研究

doi:10.12114/j.issn.1007-9572.2024.0256

中国全科医学 ›› 2024, Vol. 27 ›› Issue (35): 4426-4434.DOI: 10.12114/j.issn.1007-9572.2024.0256

表皮生长因子受体非热点突变型非小细胞肺癌一线应用表皮生长因子受体酪氨酸激酶抑制剂及化疗的疗效对比研究

檀紫瑞¹, 申青², 刘俊英¹, 陈砚凝¹, 姚继方¹^,^*()

1．050011　河北省石家庄市，河北医科大学第四医院
2．071000　河北省保定市第一中心医院

收稿日期:2024-05-10 修回日期:2024-08-06 出版日期:2024-12-15 发布日期:2024-09-13
通讯作者: 姚继方
檀紫瑞和申青为共同第一作者

作者贡献：
檀紫瑞和申青负责论文的构思与设计、资料收集与整理、统计分析、初稿撰写、论文修改；刘俊英负责论文设计与修订；陈砚凝负责论文设计与指导；姚继方负责论文设计与修订，质量控制及审校，对文章整体负责。
基金资助:
河北省2022年度医学科学研究课题(20221224)

Research on the First-line Efficacy of EGFR-TKIs and Chemotherapy in EGFR Non-hotspot Mutated Non-small Cell Lung Cancer

TAN Zirui¹, SHEN Qing², LIU Junying¹, CHEN Yanning¹, YAO Jifang¹^,^*()

1. The Fourth Hospital of Hebei Medical University, Shijiazhuang 050011, China
2. Bao Ding NO.1 Central Hospital, Baoding 071000, China

Received:2024-05-10 Revised:2024-08-06 Published:2024-12-15 Online:2024-09-13
Contact: YAO Jifang
About author:
TAN Zirui and SHEN Qing are co-first authors

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摘要/Abstract

摘要： 背景表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs）是晚期表皮生长因子受体（EGFR）突变型非小细胞肺癌（NSCLC）患者个体化靶向治疗方案之一，可显著改善患者的预后。然而不同类型EGFR的突变对EGFR-TKIs治疗的反应不同。目的比较EGFR非热点突变型NSCLC一线应用EGFR-TKIs及化疗的疗效。方法选取2012年4月—2019年6月在河北医科大学第四医院接受治疗的术后复发或晚期NSCLC患者，并确认为EGFR非热点突变型患者共90例。以患者一线治疗方案将患者分为一线EGFR-TKIs治疗组和一线化疗组。收集患者的一般资料及EGFR基因突变情况。所有患者通过电话进行随访或复查住院及门诊病例获得患者预后情况，随访截止时间为2024-03-31。观察并比较患者疗效及无进展生存期（PFS）和总生存期（OS）。结果 90例患者中一线EGFR-TKIs治疗组52例，一线化疗组38例。术后复发转移患者16例，初诊分期为ⅢB~Ⅳ期患者74例。EGFR非热点突变患者中，单基因突变51例，复合突变39例。一线EGFR-TKIs治疗进展后二线EGFR-TKIs治疗患者8例，二线化疗患者9例。一线化疗进展后二线EGFR-TKIs治疗患者8例，二线化疗患者16例，免疫治疗患者1例。EGFR非热点突变不同亚型接受一线EGFR-TKIs治疗的患者PFS比较，差异有统计学意义（χ2=24.26，P<0.001）。一线EGFR-TKIs治疗组与一线化疗组的PFS、OS比较，差异有统计学意义（P<0.05）。在单突变亚型患者中，一线EGFR-TKIs治疗组与一线化疗组的PFS、OS比较，差异有统计学意义（P<0.05）。在复合位点突变患者中，一线EGFR-TKIs治疗组与一线化疗组的PFS比较，差异有统计学意义（P<0.05）；一线EGFR-TKIs治疗组与一线化疗组的OS比较，差异无统计学意义（P>0.05）。在一线化疗进展后的患者中，二线EGFR-TKIs治疗（8例）与化疗（16例）的中位PFS分别为11.3个月和5.6个月，二线EGFR-TKIs治疗与化疗患者PFS比较，差异有统计学意义（χ2=7.487，P=0.006）。结论在EGFR非热点突变型术后复发或晚期NSCLC中，EGFR ex20ins和E20 S768I突变患者与其他突变类型患者接受一线EGFR-TKIs治疗后的生存期存在差异。而在各突变亚型中，与一线化疗相比，一线EGFR-TKIs治疗均明显延长了患者的生存时间。

关键词: 非小细胞肺癌, EGFR非热点突变, 表皮生长因子受体酪氨酸激酶抑制剂, 疗效比较研究

Abstract:

Background

Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) are one of the individualized targeted therapeutic options for patients with advanced EGFR mutated non-small cell lung cancer (NSCLC), which can significantly improve the prognosis. However, the response to TKIs changed variously depends on different type of EGFR mutations.

Objective

To explore the efficacy of EGFR-TKIs versus chemotherapy in EGFR non-hotspot mutated non-small cell lung cancer patients.

Methods

Ninety patients with postoperative recurrent or advanced NSCLC during April 2012 to June 2019 were collected from the Fourth Hospital of Hebei Medical University, of whom were confirmed with EGFR non-hotspot mutations. Patients were divided into first-line EGFR-TKIs treatment group and first-line chemotherapy group depended on first-line treatments. All patients were followed up by telephone or by reviewing in-patient and out-patient cases to obtain their prognosis information. The deadline for follow-up was March 31, 2024. The curative effect, progression-free survival (PFS) and overall survival (OS) were observed.

Results

Among 90 patients, there were 52 cases in EGFR-TKIs treatment group and 38 cases in first-line chemotherapy group. There were 16 patients with postoperative recurrence and metastasis, and 74 patients with initial stage ⅢB-Ⅳ diagnosis. Among the patients with EGFR non-hotspot mutations, there were 51 cases of single gene mutation and 39 cases of compound mutations. After progression of first-line EGFR-TKIs treatment, there were 8 patients treated with EGFR-TKIs and 9 patients treated with chemotherapy. After progression of first-line chemotherapy, 8 patients were treated with EGFR-TKIs, 16 patients with chemotherapy and 1 patient with immunotherapy. The PFS of patients with different subtypes of EGFR non-hotspot mutations who received first-line EGFR-TKIs treatment was statistically significant (χ²=24.26, P<0.001). Compared with the first-line chemotherapy group, PFS and OS in the first-line EGFR-TKIs treatment group were significantly different (P<0.05). Among the patients with single mutation, there was significant difference in PFS and OS between the first-line EGFR-TKIs treatment group and the first-line chemotherapy group (P<0.05). Among the patients with compound mutation, there was significant difference in PFS between the irst-line EGFR-TKIs treatment group and the first-line chemotherapy group (P<0.05). There was no significant difference in OS between the first-line EGFR-TKIs treatment group and the first-line chemotherapy group (P>0.05). Among the patients after progression of first-line chemotherapy, the median PFS of second-line EGFR-TKIs treatment (8 cases) and chemotherapy (16 cases) was 11.3 months and 5.6 months, respectively. There was a significant difference of PFS between second-line EGFR-TKIs treatment group and chemotherapy group (χ²=7.487, P=0.006) .

Conclusion

In postoperative recurrent or advanced NSCLC with non-hotspot EGFR mutations, there was a difference in survival between patients with EGFR ex20ins and E20 S768I mutations and patients with other mutation types treated with first-line EGFR-TKIs treatment. However, in all mutation, treatment with first-line EGFR-TKIs significantly prolonged patient survival compared with first-line chemotherapy.

Key words: Non-small cell lung cancer, EGFR non-hotspot mutations, EGFR-TKIs, Comparative effectiveness research

檀紫瑞,申青,刘俊英,等. 表皮生长因子受体非热点突变型非小细胞肺癌一线应用表皮生长因子受体酪氨酸激酶抑制剂及化疗的疗效对比研究[J]. 中国全科医学, 2024, 27(35): 4426-4434. DOI: 10.12114/j.issn.1007-9572.2024.0256.
TAN Zirui,SHEN Qing,LIU Junying, et al. Research on the First-line Efficacy of EGFR-TKIs and Chemotherapy in EGFR Non-hotspot Mutated Non-small Cell Lung Cancer[J]. Chinese General Practice, 2024, 27(35): 4426-4434. DOI: 10.12114/j.issn.1007-9572.2024.0256.

图/表 11

参考文献 33

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单突变	年龄（岁）	性别	吸烟史	治疗方案	疗效	PFS（月）
E18 G719X	52	女	无	Gefitinib	SD	6.0
E18 G719X	71	男	有	Gefitinib	PR	28.0
E18 G719X	69	女	无	Icotinib	PR	15.6
E18 G719X	70	男	有	Afatinib	PR	8.0
E18 G719X	63	女	无	Gefitinib	SD	11.5
E18 G719X	54	男	有	Afatinib	PR	25.4
E18 G719X	66	女	无	Gefitinib	SD	11.7
E18 G719X	56	女	无	Icotinib	PR	24.0
E18 G719X	68	男	无	Icotinib	SD	9.6
E21 L861Q	75	女	有	Erlotinib	SD	13.5
E21 L861Q	81	女	有	Erlotinib	PD	2.5
E21 L861Q	73	男	有	Afatinib	SD	18.6
E21 L861Q	57	女	无	Icotinib	SD	20.5
E21 L861Q	53	女	无	Gefitinib	PR	16.0
E21 L861Q	64	女	有	Gefitinib	PR	3.5
E20 S768I	61	男	无	Gefitinib	PD	3.0
E20 S768I	67	男	有	Icotinib	SD	4.0
EGFR ex²0ins	59	女	无	Afatinib	PD	3.3
EGFR ex²0ins	71	男	无	Afatinib	SD	8.0

单突变	年龄（岁）	性别	吸烟史	治疗方案	疗效	PFS（月）
E18 G719X	52	女	无	Gefitinib	SD	6.0
E18 G719X	71	男	有	Gefitinib	PR	28.0
E18 G719X	69	女	无	Icotinib	PR	15.6
E18 G719X	70	男	有	Afatinib	PR	8.0
E18 G719X	63	女	无	Gefitinib	SD	11.5
E18 G719X	54	男	有	Afatinib	PR	25.4
E18 G719X	66	女	无	Gefitinib	SD	11.7
E18 G719X	56	女	无	Icotinib	PR	24.0
E18 G719X	68	男	无	Icotinib	SD	9.6
E21 L861Q	75	女	有	Erlotinib	SD	13.5
E21 L861Q	81	女	有	Erlotinib	PD	2.5
E21 L861Q	73	男	有	Afatinib	SD	18.6
E21 L861Q	57	女	无	Icotinib	SD	20.5
E21 L861Q	53	女	无	Gefitinib	PR	16.0
E21 L861Q	64	女	有	Gefitinib	PR	3.5
E20 S768I	61	男	无	Gefitinib	PD	3.0
E20 S768I	67	男	有	Icotinib	SD	4.0
EGFR ex²0ins	59	女	无	Afatinib	PD	3.3
EGFR ex²0ins	71	男	无	Afatinib	SD	8.0

复合突变	年龄（岁）	性别	吸烟史	治疗方案	疗效	PFS（月）
E18 G719X+E20 S768I	60	女	无	Icotinib	PR	40.0
E18 G719X+E20 S768I	52	男	有	Icotinib	SD	17.0
E18 G719X+E20 S768I	49	女	无	Gefitinib	PR	10.0
E18 G719X+E20 S768I	64	女	无	Afatinib	SD	14.3
E18 G719X+E20 S768I	75	女	无	Afatinib	PR	17.6
E18 G719X+E20 S768I	53	女	无	Afatinib	PR	19.8
E18 G719X+E20 S768I	53	男	有	Icotinib	PR	16.2
E18 G719X+E20 S768I	64	女	无	Icotinib	SD	11.5
E18 G719X+E20 S768I	61	男	有	Erlotinib	SD	5.0
E18 G719X+E20 S768I	59	男	有	Icotinib	PR	30.5
E18 G719X+E20 S768I	68	男	有	Afatinib	SD	8.2
E20 S768I+E21 L858R	56	女	无	Afatinib	PR	20.5
E20 S768I+E21 L858R	63	女	无	Icotinib	PR	22.0
E20 S768I+E21 L858R	70	女	无	Icotinib	PR	14.0
E18 G719X+E19 del	51	女	无	Gefitinib	PR	6.5
E18 G719X+E21 L861Q	48	男	有	Icotinib	PR	12.0
EGFR ex²0ins+E19 del	58	男	无	Gefitinib	SD	22.4
E21 L844V+E21 L858R	62	女	无	Icotinib	SD	19.3
E21 L861Q+E21 L833F	61	女	无	Afatinib	SD	12.2
E21 L861Q+E19 del	72	女	无	Gefitinib	PD	2.5
E21 L861Q+E21 L858Q	68	男	有	Gefitinib	SD	14.0
E21 L861Q+E21 R832H	55	女	无	Gefitinib	SD	9.5
E21 L703V+E21 L858R+E20 G796A	55	女	无	Afatinib	SD	20.2

复合突变	年龄（岁）	性别	吸烟史	治疗方案	疗效	PFS（月）
E18 G719X+E20 S768I	60	女	无	Icotinib	PR	40.0
E18 G719X+E20 S768I	52	男	有	Icotinib	SD	17.0
E18 G719X+E20 S768I	49	女	无	Gefitinib	PR	10.0
E18 G719X+E20 S768I	64	女	无	Afatinib	SD	14.3
E18 G719X+E20 S768I	75	女	无	Afatinib	PR	17.6
E18 G719X+E20 S768I	53	女	无	Afatinib	PR	19.8
E18 G719X+E20 S768I	53	男	有	Icotinib	PR	16.2
E18 G719X+E20 S768I	64	女	无	Icotinib	SD	11.5
E18 G719X+E20 S768I	61	男	有	Erlotinib	SD	5.0
E18 G719X+E20 S768I	59	男	有	Icotinib	PR	30.5
E18 G719X+E20 S768I	68	男	有	Afatinib	SD	8.2
E20 S768I+E21 L858R	56	女	无	Afatinib	PR	20.5
E20 S768I+E21 L858R	63	女	无	Icotinib	PR	22.0
E20 S768I+E21 L858R	70	女	无	Icotinib	PR	14.0
E18 G719X+E19 del	51	女	无	Gefitinib	PR	6.5
E18 G719X+E21 L861Q	48	男	有	Icotinib	PR	12.0
EGFR ex²0ins+E19 del	58	男	无	Gefitinib	SD	22.4
E21 L844V+E21 L858R	62	女	无	Icotinib	SD	19.3
E21 L861Q+E21 L833F	61	女	无	Afatinib	SD	12.2
E21 L861Q+E19 del	72	女	无	Gefitinib	PD	2.5
E21 L861Q+E21 L858Q	68	男	有	Gefitinib	SD	14.0
E21 L861Q+E21 R832H	55	女	无	Gefitinib	SD	9.5
E21 L703V+E21 L858R+E20 G796A	55	女	无	Afatinib	SD	20.2

原发T790M	年龄（岁）	性别	吸烟史	治疗方案	疗效	PFS（月）
E20 T790M+E19 del	46	女	无	Osimertinib	PR	23.3
E20 T790M+E21 L858R	67	男	有	Icotinib	SD	2.5
E20 T790M+E21 L858R	64	男	有	Osimertinib	SD	23.5
E20 T790M+E21 L858R	45	男	有	Osimertinib	PR	17.4
E20 T790M+E21 L858R	64	女	无	Osimertinib	PR	11.0
E20 T790M+E21 L858R	63	女	无	Osimertinib	SD	11.5
E20 T790M+E21 L858R	40	女	无	Osimertinib	SD	7.7
E20 T790M+E21 L858R	72	女	无	Osimertinib	PR	8.8
E20 T790M+E21 L858R	51	男	有	Osimertinib	SD	17.5
E20 T790M	53	女	无	Osimertinib	SD	15.0

表皮生长因子受体非热点突变型非小细胞肺癌一线应用表皮生长因子受体酪氨酸激酶抑制剂及化疗的疗效对比研究

Research on the First-line Efficacy of EGFR-TKIs and Chemotherapy in EGFR Non-hotspot Mutated Non-small Cell Lung Cancer

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项目	例数（n=90）	一线EGFR-TKIs治疗组（n=52）	一线化疗组（n=38）
年龄（岁）
≥60	54	31	23
<60	36	21	15
性别
女	49	32	17
男	41	20	21
吸烟史
无	62	38	24
有	28	14	14
诊断时临床分期（期）
Ⅰ	2	1	1
Ⅱ	5	4	1
ⅢA	9	6	3
ⅢB~ⅢC	7	1	6
Ⅳ	67	40	27
疾病程度
复发或转移	16	11	5
晚期	74	41	33
远处转移
是	70	41	29
否	20	11	9
病理分型
腺癌	87	50	37
鳞状细胞癌	2	1	1
腺鳞癌	1	1	0
突变类型
单突变	51	20	31
Exon 18 G719X	18	9	9
Exon 21 L861Q	10	6	4
Exon 20 S768I	4	2	2
Exon 20 insertion	18	2	16
Exon 20 T790M	1	1	0
复合突变	39	32	7
E18 G719X+E20 S768I	15	11	4
E18 G719X+E19 del	1	1	0
E21 L703V+E21 L858R+E20 G796A	1	1	0
E18 G719X+E21 L861Q	2	1	1
EGFR ex20ins+E19 del	1	1	0
E20 S768I+E21 L858R	3	3	0
E20 T790M+E19 del	1	1	0
E20 T790M+E21 L858R	9	8	1
E21 L861Q+E19 del	1	1	0
E21 L844V+E21 L858R	1	1	0
E21 L861Q+E21 L833F	1	1	0
E21 L861Q+E21 R832H	1	1	0
E21 L833V+E21 H835L	1	0	1
E21 L861Q+E21 L858Q	1	1	0
治疗方式
一线治疗方式	90	52	38
Gefitinib	13	13
Erlotinib	3	3
Icotinib	15	15
Afatinib	12	12
Osimertinib	9	9
化疗	38		38
二线治疗方式	42	17	25
Gefitinib	3	1	2
Erlotinib	4		4
Icotinib	2		2
Afatinib	2	2
Osimertinib	5	5
化疗	25	9	16
免疫治疗	1		1

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