Evidence map›Paper›PMID 37296463›Full record

ArticleExperimental hematology & oncology2023

Molecular correlation of response to pyrotinib in advanced NSCLC with HER2 mutation: biomarker analysis from two phase II trials.

Shiqi Mao, Shuo Yang, Xinyu Liu, Xingya Li, Qiming Wang, Yiping Zhang, Jianhua Chen, Yan Wang, Guanghui Gao, Fengying Wu and 7 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Experimental hematology & oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% 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.

NCT02535507 phase2unknown statusnot on this map

Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Pyrotinib as a Single Agent in HER2 Mutation Advanced Non-small Cell Lung Cancer Patients Who Failed to Previous at Least 2nd Line Treatments

TypeinterventionalSponsorTongji UniversityRan2015 to 2017Enrolled40ConditionsNon-small Cell Lung CancerArmsPyrotinib
NCT02834936 phase2completednot on this map

A Phase 2 Clinica Study: Efficacy and Safety of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation

TypeinterventionalSponsorJiangsu HengRui Medicine Co., Ltd.Ran2016 to 2019Enrolled60ConditionsNon Small Cell LungArmspyrotinib
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
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

17 authors at 8 institutions in 1 country.

Shiqi Mao *Department of Medical Oncology, Shanghai Pulmonary Hospital, Cancer Institute, Tongji University School of Medicine, Shanghai, 200433, China.
Shuo Yang *Department of Medical Oncology, Shanghai Pulmonary Hospital, Cancer Institute, Tongji University School of Medicine, Shanghai, 200433, China.
Xinyu Liu *Department of Medical Oncology, Shanghai Pulmonary Hospital, Cancer Institute, Tongji University School of Medicine, Shanghai, 200433, China.
Xingya LiSecond Ward of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450000, China.
Qiming WangDepartment of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, 450008, China.
Yiping ZhangDepartment of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, 310000, China.
Jianhua ChenDepartment of Medical Oncology, Cancer Hospital of Central South University, Changsha, 410006, China.
Yan WangDepartment of Medical Oncology, Shanghai Pulmonary Hospital, Cancer Institute, Tongji University School of Medicine, Shanghai, 200433, China.
Guanghui GaoDepartment of Medical Oncology, Shanghai Pulmonary Hospital, Cancer Institute, Tongji University School of Medicine, Shanghai, 200433, China.
Fengying WuDepartment of Medical Oncology, Shanghai Pulmonary Hospital, Cancer Institute, Tongji University School of Medicine, Shanghai, 200433, China.
Tao JiangDepartment of Medical Oncology, Shanghai Pulmonary Hospital, Cancer Institute, Tongji University School of Medicine, Shanghai, 200433, China.
Jiao ZhangGenecast Biotechnology Co., Ltd, Wuxi, 214104, China.
Ying YangGenecast Biotechnology Co., Ltd, Wuxi, 214104, China.
Xiang LinJiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Xiaoyu ZhuJiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Caicun ZhouDepartment of Medical Oncology, Shanghai Pulmonary Hospital, Cancer Institute, Tongji University School of Medicine, Shanghai, 200433, China. caicunzhou_dr@163.com.
Shengxiang RenDepartment of Medical Oncology, Shanghai Pulmonary Hospital, Cancer Institute, Tongji University School of Medicine, Shanghai, 200433, China. harry_ren@126.com.
Shanghai Pulmonary Hospital · CNTongji University · CNGenecast (China) · CNJiangsu Hengrui Medicine (China) · CNCentral South University · CNFirst Affiliated Hospital of Zhengzhou University · CNZhejiang Cancer Hospital · CNZhengzhou University · CN

Funding

Clinical Research foundation of Shanghai Pulmonary Hospital No. FKLY20008National Natural Science Foundation of China No. 81972167National Natural Science Foundation of China No.82002419Science and Technology Commission of Shanghai Municipality No. 21XD1423200Shanghai Innovative Collaboration Project No. 2020CXJQ02Shanghai Shenkang Hospital Development Center No. SHDC12019133
6 · The paper itself

Abstract

backgroundNon-small cell lung cancer (NSCLC) with HER2 mutation has entered into the era of targeted therapy. However, both anti-HER2 antibody-drug conjugates (ADCs) and tyrosine kinase inhibitors (TKIs) showed moderate objective response rate (ORR) and median progression-free survival (PFS). The aim of this study was to investigate the molecular features of responders to pyrotinib in advanced NSCLC with HER2 mutation.

methodsPatients from our two previous phase II trials were pooled analyzed. Their circulating tumor DNA (ctDNA) were detected by next-generation sequencing (NGS) panels, and the correlation with the efficacy of pyrotinib was investigated.

resultsThis pooled analysis included 75 patients, and 50 of them with baseline plasma samples were finally enrolled with a median age of 57 years old. The overall ORR and median PFS were 28% and 7.0 months respectively. Biomarker analysis showed that 5 patients were ctDNA nonshedding. Patients with TP53 wild type were significantly associated with higher disease control rate (97.1%vs. 68.8%, p = 0.010), PFS (median 8.4 vs. 2.8 months, p = 0.001) and overall survival (OS, median 26.7 vs. 10.4 months, p < 0.001) than those with mutations. ctDNA of nonshedding and clearance exhibited significantly longer PFS (median: 10.2 vs. 9.8 vs. 5.6 months, p = 0.036) and a trend of longer OS (median: 35.3 vs. 18.1 vs. 14.6 months, p = 0.357) than those not.

conclusionPatients with TP53 wild type, ctDNA nonshedding, or clearance showed superior efficacy of pyrotinib in patients with HER2-mutated advanced NSCLC, which might be helpful to guide the utility of pyrotinib in clinical setting.

trial registrationThe patients were from two registered clinical trials (ClinicalTrials.gov: NCT02535507, NCT02834936).

Indexed as

ctDNAHER2 mutationNon-small cell lung cancerpyrotinib

Identifiers

PMID37296463
PMCPMC10251549
OpenAlexW4380027817

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.