---
title: "Clinicopathological and Molecular Features of NSCLC with HER-2 Variations and Prognostic Impact"
id: "pubmed-42764221"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42764221"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42764221/"
doi: "10.3760/cma.j.cn112152-20251218-00621"
published_at: "2026-09-23T00:00:00.000Z"
evidence_level: "English Abstract"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Clinicopathological and Molecular Features of NSCLC with HER-2 Variations and Prognostic Impact
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42764221
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42764221/)
- **DOI:** [10.3760/cma.j.cn112152-20251218-00621](https://doi.org/10.3760%2Fcma.j.cn112152-20251218-00621)
- **Published At:** 2026-09-23T00:00:00.000Z
- **Evidence Rating:** English Abstract
## Executive GIST (TL;DR)
- This retrospective study analyzed clinicopathological and molecular characteristics of non-small cell lung cancer (**NSCLC**) patients with **HER-2** genetic variations identified by targeted next-generation sequencing at a single center between September 2022 and June 2024. - Among 2,795 NSCLC patients, **148 (5.3%)** had HER-2 variations: 128 had HER-2 mutations (86.5%), 16 had HER-2 amplifications (10.8%), and 4 had both mutation and amplification (2.7%). - Of the 128 HER-2 mutations, **63 were Exon 20 (Exon20) mutations**. Exon20 mutations were more common in females and associated with smaller tumors and lower risk of lymph node and distant metastasis compared with other HER-2 alteration types. - Patients with **HER-2 amplification** had larger tumors, more frequent lymph node and distant metastases, and higher TNM stage than those with HER-2 mutations (all P < 0.05). - Univariate Cox regression found that **HER-2 amplification**, larger tumor size, lymph node metastasis, distant metastasis and higher TNM stage were associated with poorer prognosis (P < 0.05). - Molecular co-occurrence patterns differed by mutation site: **Exon20 mutations** rarely co-occurred with other gene alterations, while **non-Exon20 mutations** often co-occurred, most commonly with **EGFR** mutations (55.4%, 36/65). - The study identified **16 cases** with the HER-2 **p.A270S** mutation; 11 of these were advanced TNM stage (68.8%) and 5 patients died, suggesting this variant may be associated with more malignant phenotypes. - Authors conclude different **HER-2** alteration types (mutation vs amplification) show distinct clinicopathological and molecular profiles; integrating these features may inform individualized treatment. All authors declared no conflicts of interest.
## Clinical Analysis & Structured Key Points
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Affiliations Expand ### Affiliation * 1 Ningbo Clinical Pathology Diagnosis Center, Ningbo 315000, China. * PMID: **42764221** * DOI: [ 10.3760/cma.j.cn112152-20251218-00621 ](https://doi.org/10.3760/cma.j.cn112152-20251218-00621) Item in Clipboard # [Clinicopathological, molecular characteristics and prognostic analysis of non-small cell lung cancer with HER-2 genetic variations] [Article in Chinese] Y J Wang et al. Zhonghua Zhong Liu Za Zhi. 2026. Show details Display options Display options Format Abstract PubMed PMID Zhonghua Zhong Liu Za Zhi Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Zhonghua+Zhong+Liu+Za+Zhi%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Zhonghua+Zhong+Liu+Za+Zhi%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42764221/) . 2026 Sep 23;48(9):1157-1165. doi: 10.3760/cma.j.cn112152-20251218-00621. ### Authors [Y J Wang](https://pubmed.ncbi.nlm.nih.gov/?term=Wang+YJ&cauthor_id=42764221)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42764221/#short-view-affiliation-1 "Ningbo Clinical Pathology Diagnosis Center, Ningbo 315000, China."), [J Y Xu](https://pubmed.ncbi.nlm.nih.gov/?term=Xu+JY&cauthor_id=42764221)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42764221/#short-view-affiliation-1 "Ningbo Clinical Pathology Diagnosis Center, Ningbo 315000, China."), [H Z Zhang](https://pubmed.ncbi.nlm.nih.gov/?term=Zhang+HZ&cauthor_id=42764221)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42764221/#short-view-affiliation-1 "Ningbo Clinical Pathology Diagnosis Center, Ningbo 315000, China."), [M Zhao](https://pubmed.ncbi.nlm.nih.gov/?term=Zhao+M&cauthor_id=42764221)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42764221/#short-view-affiliation-1 "Ningbo Clinical Pathology Diagnosis Center, Ningbo 315000, China.") ### Affiliation * 1 Ningbo Clinical Pathology Diagnosis Center, Ningbo 315000, China. * PMID: **42764221** * DOI: [ 10.3760/cma.j.cn112152-20251218-00621 ](https://doi.org/10.3760/cma.j.cn112152-20251218-00621) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID ## Abstract in [ English, ](https://pubmed.ncbi.nlm.nih.gov/42764221/#eng-abstract) [ Chinese ](https://pubmed.ncbi.nlm.nih.gov/42764221/#zho-abstract) **Objective:** To analyze the clinicopathological and molecular characteristics of non-small cell lung cancer (NSCLC) with human epidermal growth factor receptor 2 (HER-2) variations (including mutations and amplifications) and their correlation with prognosis.​ **Methods:** Clinicopathological data of NSCLC patients with HER-2 variations who underwent targeted next-generation sequencing (NGS) at Ningbo Clinical Pathology Diagnostic Center from September 2022 to June 2024 were collected. The clinicopathological and molecular features were retrospectively analyzed, and a literature review was conducted. **Results:** Among 2 795 NSCLC patients, HER-2 variations were identified in 148 cases (5.3%, 148/2 795). Of these, 128 cases had HER-2 mutations [86.5%, 128/148, including 63 exon 20 (Exon20) mutations], 16 cases had HER-2 amplifications (10.8%, 16/148), and 4 cases had concurrent HER-2 mutation and amplification (2.7%, 4/148). Compared with the HER-2 mutation group, patients with HER-2 amplification were more likely to have larger tumor size, lymph node metastasis, distant metastasis and higher TNM stage (all _P_ ＜0.05). Among HER-2 mutations, Exon 20 mutations were more common in females and associated with lower risks of larger tumor size, lymph node metastasis and distant metastasis (all _P_ ＜0.05). Cox regression analysis indicated that HER-2 amplification, larger tumor size, lymph node metastasis, distant metastasis and higher TNM stage were associated with poor prognosis (_P_ ＜0.05). Molecular analysis revealed that Exon20 mutations rarely co-occurred with other gene variations, whereas non-Exon20 mutations were frequently accompanied by other genetic alternations, most commonly epidermal growth factor receptor (EGFR) mutations (55.4%, 36/65). In addition, 16 cases of HER-2 p.A270S mutation were identified, of which 11 were at advanced TNM stage (68.8%, 11/16), and 5 patient died.​ **Conclusions:** Different types of HER-2 variations (mutations/amplifications) exhibit distinct clinicopathological and molecular characteristics. Patients with HER-2 amplification have a poor prognosis, and the HER-2 p.A270S mutation may be associated with malignant phenotypes of NSCLC. It is necessary to integrate the characteristics of HER-2 variations to provide references for individualized treatment.​. **目的：** 分析人表皮生长因子受体2（HER-2）变异（包括突变和扩增）相关非小细胞肺癌（NSCLC）的临床病理、分子特征及与预后的相关性。 **方法：** 收集2022年9月至2024年6月宁波市临床病理诊断中心行靶向二代测序的伴有HER-2基因变异的NSCLC患者的临床病理资料，回顾性分析其临床病理特征及分子特征。 **结果：** NSCLC患者共2 795例，发现HER-2基因变异148例（5.3%，148/2 795），其中128例为HER-2突变［86.5%，128/148，包括63例20号外显子（Exon20）突变］，16例为HER-2扩增（10.8%，16/148），4例同时存在HER-2突变和扩增（2.7%，4/148）。与HER-2突变相比，HER-2扩增患者更易出现肿瘤增大、淋巴结转移、远处转移和TNM分期较高（ _P_ ＜0.05）；HER-2突变中，Exon-20突变常见于女性，且肿瘤较小、淋巴结转移和远处转移风险更低（ _P_ ＜0.05）。单因素Cox回归分析提示，HER-2扩增、肿瘤增大、淋巴结转移、远处转移和高TNM分期与患者预后不良相关（ _P_ ＜0.05）。分子特征显示，Exon20突变几乎不与其他基因共变异，而非Exon20突变常伴随其他基因变异，常见表皮生长因子受体突变（55.4%，36/65）。此外，检出16例HER-2 p.A270S突变，其中11例为TNM晚期（68.8%，11/16），5例患者死亡。 **结论：** HER-2不同变异类型（突变/扩增）呈现独特的临床病理与分子特征，其中HER-2扩增患者预后较差，p.A270S位点突变可能与肿瘤恶性表型相关。. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement 所有作者声明无利益冲突 ## Similar articles * [ [Relationship of epidermal growth factor receptor gene mutations, clinicopathologic features and prognosis in patients with non-small cell lung cancer]. ](https://pubmed.ncbi.nlm.nih.gov/22321547/) Fan MJ, Li HG, Lü ZQ, Zhang HZ, Shen XM.Fan MJ, et al.Zhonghua Bing Li Xue Za Zhi. 2011 Oct;40(10):679-82.Zhonghua Bing Li Xue Za Zhi. 2011.PMID: 22321547Chinese. * [ [The expression of programmed death receptor 1 in non-small cell lung cancer and its clinicopathological features and prognosis showed a connection with epidermal growth factor receptor gene mutations]. ](https://pubmed.ncbi.nlm.nih.gov/28635230/) Yin H, Liao CG, Wang YQ, Li Z, Fan LL, Qian ML, Lu N.Yin H, et al.Zhonghua Zhong Liu Za Zhi. 2017 Jun 23;39(6):419-423. doi: 10.3760/cma.j.issn.0253-3766.2017.06.004.Zhonghua Zhong Liu Za Zhi. 2017.PMID: 28635230Chinese. * [ [Mutation status of epidermal growth factor receptor and KRAS gene in non-small cell lung cancers at Xuanwei regions of Yunnan Province]. ](https://pubmed.ncbi.nlm.nih.gov/27033384/) Yang CS, Pan XY, Feng Q, Wang YY, Xu WM, Jiang T, Wang L, Yang JL, Wang L.Yang CS, et al.Zhonghua Bing Li Xue Za Zhi. 2016 Apr 8;45(4):226-30. doi: 10.3760/cma.j.issn.0529-5807.2016.04.003.Zhonghua Bing Li Xue Za Zhi. 2016.PMID: 27033384Chinese. * [ [Expert consensus on diagnosis and treatment of advanced non-small cell lung cancer with HER-2 alterations (2025 edition)]. ](https://pubmed.ncbi.nlm.nih.gov/40967873/) Expert Consensus Formulation Panel on Diagnosis and Treatment of Advanced Non-Small Cell Lung Cancer with HER-2 Alterations; China Anti-Cancer Association, Integrated Lung Cancer Professional Committee; China Anti-Cancer Association, Non-Small Cell Lung Cancer Professional Committee.Expert Consensus Formulation Panel on Diagnosis and Treatment of Advanced Non-Small Cell Lung Cancer with HER-2 Alterations, et al.Zhonghua Zhong Liu Za Zhi. 2025 Sep 23;47(9):830-839. doi: 10.3760/cma.j.cn112152-20250414-00163.Zhonghua Zhong Liu Za Zhi. 2025.PMID: 40967873Chinese. * [ Decoding KRAS mutation in non-small cell lung cancer patients receiving immunotherapy: A retrospective institutional comparison and literature review. ](https://pubmed.ncbi.nlm.nih.gov/39740426/) Urtecho SB, Provenzano L, Spagnoletti A, Bottiglieri A, Pircher C, Massa G, Sposetti C, Proto C, Brambilla M, Occhipinti M, Mazzeo L, Beninato T, Leporati R, Giani C, Cavalli C, Serino R, Prina MM, Bassetti A, Nasca V, di Mauro RM, Abate A, Manglaviti S, Dumitrascu AD, Liberti GD, Cassano TS, Ganzinelli M, Wu S, Garassino MC, de Braud FGM, Russo GL, Prelaj A.Urtecho SB, et al.Lung Cancer. 2025 Jan;199:108051. doi: 10.1016/j.lungcan.2024.108051. Epub 2024 Dec 9.Lung Cancer. 2025.PMID: 39740426Review. 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