Evidence map›Paper›PMID 34688250›Full record

ArticleBMC gastroenterology2021

Larotinib in patients with advanced and previously treated esophageal squamous cell carcinoma with epidermal growth factor receptor overexpression or amplification: an open-label, multicenter phase 1b study.

Rongrui Liu, Lianke Liu, Chuanhua Zhao, Yuxian Bai, Yulong Zheng, Shu Zhang, Ning Li, Jianwei Yang, Qingxia Fan, Xiuwen Wang and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03888092 (A Phase Ib, Multi-center, Open-label Study of Z650 in Advanced Esophageal Squamous Cell Carcinoma), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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.

NCT03888092 phase1 / phase2completednot on this map

A Phase Ib, Multi-center, Open-label Study of Z650 in Advanced Esophageal Squamous Cell Carcinoma (ECSS) With Epidermal Growth Factor Receptor (EGFR) Over Expression or Gene Amplification

TypeinterventionalSponsorSunshine Lake Pharma Co., Ltd.Ran2017 to 2022Enrolled81ConditionsEsophageal Squamous Cell CarcinomaArmsZ650
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Article
  5. Case report:Frontiers in oncology · 2024
    Article
  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

18 authors.

Rongrui LiuDepartment of Oncology, The Fifth Medical Center of Chinese PLA General Hospital, No. 8 Dongda Avenue, Fengtai District, Beijing, 100071, China.
Lianke LiuDepartment of Oncology, Jiangsu Province Hospital, Nanjing, China.
Chuanhua ZhaoDepartment of Oncology, The Fifth Medical Center of Chinese PLA General Hospital, No. 8 Dongda Avenue, Fengtai District, Beijing, 100071, China.
Yuxian BaiDepartment of Internal Medicine, Harbin Medical University Cancer Hospital, Harbin, China.
Yulong ZhengDepartment of Medical Oncology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Shu ZhangDepartment of Gastroenterology, Shandong Cancer Hospital, Jinan, China.
Ning LiDepartment of Medical Oncology, Henan Cancer Hospital, Zhengzhou, China.
Jianwei YangDepartment of Medical Oncology, Fujian Provincial Cancer Hospital, Fuzhou, China.
Qingxia FanDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Xiuwen WangDepartment of Chemotherapy, Qilu Hospital of Shandong University, Jinan, China.
Shan ZengDepartment of Oncology, Xiangya Hospital Central South University, Changsha, China.
Yingjun ZhangSunshine Lake Pharma Co., Ltd, Dongguan, China.
Weihong ZhangSunshine Lake Pharma Co., Ltd, Dongguan, China.
Yulei ZhuangSunshine Lake Pharma Co., Ltd, Dongguan, China.
Ning KangSunshine Lake Pharma Co., Ltd, Dongguan, China.
Yingzhi JiangSunshine Lake Pharma Co., Ltd, Dongguan, China.
Hongmei SunDepartment of Oncology and Hematology, Jiamusi Tumor Tuberculosis Hospital, Jiamusi, China.
Jianming XuDepartment of Oncology, The Fifth Medical Center of Chinese PLA General Hospital, No. 8 Dongda Avenue, Fengtai District, Beijing, 100071, China. jmxu2003@yahoo.com.ORCID http://orcid.org/0000-0003-4467-6021

Funding

National Major Science and Technology Projects of China 2016X09106001-006 & 2018ZX09301020004
6 · The paper itself

Abstract

backgroundLarotinib is a new first-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. This open-label, phase 1b study is aimed to evaluate the efficacy, safety of larotinib in patients with advanced esophageal squamous cell carcinoma (ESCC) with EGFR overexpression or amplification pretreated with one or more system regimens, and to recommend an appropriate dose for its further study.

methodsPatients received larotinib orally at 3 doses (250, 300, 350 mg), once daily. Clinical response was evaluated every 8 weeks according to RECIST v1.1 criteria by both investigators and independent radiology review (IRC).

results81 patients were enrolled. The investigator-assessed overall response rate (ORR) was 13.7% (10/73), all responses were observed in the 350 mg group of which ORR up to 20.0% (10/50), with 10 of them having EGFR overexpression and 4 having EGFR amplification. Per IRC assessment, ORR for all patients and 350 mg group were 13.9% (10/72) and 16.3% (8/50). In the 350 mg group, median overall survival (OS) and progression-free survival (PFS) were 8.0 (95% CI 4.9-10.2) months and 3.4 (95% CI 2.4-3.7) months, respectively. The most common treatment-related adverse events (TRAEs) were diarrhea, rash, and palmar-plantar erythrodysesthesia syndrome, elevated AST/ALT, vomiting, similarly with other EGFR TKIs.

conclusionsLarotinib demonstrated promising antitumor activity and manageable safety profiles in patients with pre-treated advanced ESCC with EGFR overexpression or amplification, especially at the dose of 350 mg, which showed better efficacy and acceptable safety. A phase 3 study is underway on 350 mg larotinib in ESCC patients with EGFR overexpression.

trial registrationThis trial was retrospectively registered on 25/03/2019, NCT03888092. https://clinicaltrials.gov/ct2/show/NCT03888092 .

Indexed as

Antineoplastic AgentsCarcinoma, Non-Small-Cell LungEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaLung NeoplasmsErbB ReceptorsHumansMutationProtein Kinase InhibitorsAntineoplastic AgentsErbB ReceptorsProtein Kinase InhibitorsEGFR amplificationEGFR overexpressionEGFR TKIEsophageal squamous cell carcinomaLarotinib

Identifiers

PMID34688250
PMCPMC8540164

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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.