Evidence map›Paper›PMID 35101045›Full record

Trial reportBMC medicine2022

Efficacy and safety of pyrotinib in advanced lung adenocarcinoma with HER2 mutations: a multicenter, single-arm, phase II trial.

Zhengbo Song, Yuping Li, Shiqing Chen, Shenpeng Ying, Shuguang Xu, Jianjin Huang, Dan Wu, Dongqing Lv, Ting Bei, Shuxun Liu and 11 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
8.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 60 citations in OpenAlex.

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  16. HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors WithJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 11 institutions in 1 country.

Zhengbo Song *Department of Clinical Trial, Zhejiang Cancer Hospital, Hangzhou, 310022, China.
Yuping Li *Department of Respiratory Diseases, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325000, China.
Shiqing Chen *The Medical Department, 3D Medicines Inc., Shanghai, 201114, China.
Shenpeng Ying *Department of Radiotherapy, Taizhou Central Hospital, Affiliated Hospital of Taizhou University, Taizhou, 318000, China.
Shuguang XuDepartment of Respiratory Disease, Ningbo Medical Center, Lihuili Eastern Hospital, Ningbo, 315001, China.
Jianjin HuangDepartment of Medical Oncology, the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China.
Dan WuDepartment of Thoracic Surgery, Cixi People Hospital, Ningbo, 315300, China.
Dongqing LvDepartment of Respiratory Disease, Taizhou Hospital, Taizhou, 317000, China.
Ting BeiThe Medical Department, 3D Medicines Inc., Shanghai, 201114, China.
Shuxun LiuDepartment of Medical Oncology, Taizhou Cancer Hospital, Hangzhou, 317500, China.
Xiaoping HuangDepartment of Respiratory Diseases, the Affiliated Ningbo No. 1 Hospital, School of Medicine, Ningbo University, Ningbo, 315001, China.
Congying XieDepartment of Radiation and Medical Oncology, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325000, China.
Xiaoyu WuDepartment of Respiratory Diseases, Guangfu Hospital, Jinhua, 321000, China.
Jianfei FuDepartment of Medical Oncology, Jinhua Central Hospital, Jinhua, 321000, China.
Feng HuaDepartment of Respiratory Diseases, Huzhou Central Hospital, Huzhou, 313003, China.
Wenxian WangDepartment of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou, 310022, China.
Chunwei XuDepartment of Medical Oncology, Zhejiang Cancer Hospital, 1 East Banshan Road, Hangzhou, 310022, China.
Chan GaoThe Medical Department, 3D Medicines Inc., Shanghai, 201114, China.
Shangli CaiThe Medical Department, 3D Medicines Inc., Shanghai, 201114, China.
Shun LuShanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 20030, China.
Yiping ZhangDepartment of Medical Oncology, Zhejiang Cancer Hospital, 1 East Banshan Road, Hangzhou, 310022, China. yi_ping_zhang@163.com.ORCID 0000-0001-7039-4226
Zhejiang Cancer Hospital · CNWenzhou Medical University · CNGuang Fu Hospital · CNHangzhou Cancer Hospital · CNHuzhou Central Hospital · CNJinhua Central Hospital · CNNingbo Medical Center Lihuili Hospital · CNNingbo University · CNSecond Affiliated Hospital of Zhejiang University · CNShanghai Jiao Tong University · CNTaizhou Central Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is currently a lack of effective treatments for non-small cell lung cancer (NSCLC) patients harboring HER2 mutations. We examined the efficacy and safety of, and potential resistance mechanism to, pyrotinib, a pan-HER inhibitor, in advanced NSCLC carrying HER2 mutations.

methodsIn this multicenter, single-arm, phase II trial, stage IIIB-IV NSCLC patients harboring HER2 mutations, as determined using next-generation sequencing, were enrolled and treated with pyrotinib at a dose of 400 mg/day. The primary endpoint was 6-month progression-free survival (PFS) rate, and secondary endpoints were objective response rate (ORR), PFS, overall survival (OS), disease control rate (DCR), and safety. The impact of different HER2 mutation types on sensitivity to pyrotinib and the potential of utilizing mutational profile derived from circulating tumor DNA (ctDNA) to predict disease progression were also explored.

resultsSeventy-eight patients were enrolled for efficacy and safety analysis. The 6-month PFS rate was 49.5% (95% confidence interval [CI], 39.2-60.8). Pyrotinib produced an ORR of 19.2% (95% CI, 11.2-30.0), with median PFS of 5.6 months (95% CI, 2.8-8.4), and median OS of 10.5 months (95% CI, 8.7-12.3). The median duration of response was 9.9 months (95% CI, 6.2-13.6). All treatment-related adverse events (TRAEs) were grade 1-3 (all, 91.0%; grade 3, 20.5%), and the most common TRAE was diarrhea (all, 85.9%; grade 3, 16.7%). Patients with exon 20 and non-exon 20 HER2 mutations had ORRs of 17.7% and 25.0%, respectively. Brain metastases at baseline and prior exposure to afatinib were not associated with ORR, PFS, or OS. Loss of HER2 mutations and appearance of amplification in HER2 and EGFR were detected upon disease progression.

conclusionsPyrotinib exhibited promising efficacy and acceptable safety in NSCLC patients carrying exon 20 and non-exon 20 HER2 mutations and is worth further investigation.

trial registrationChinese Clinical Trial Registry Identifier: ChiCTR1800020262.

Indexed as

Adenocarcinoma of LungCarcinoma, Non-Small-Cell LungLung NeoplasmsAcrylamidesAminoquinolinesGenes, erbB-2HumansMutationAcrylamidesAminoquinolinespyrotinibEfficacyHER2 mutationsNon-small cell lung cancerPyrotinibResistance mechanism

Identifiers

PMID35101045
PMCPMC8805254
OpenAlexW4210484120

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.