Evidence map›Paper›PMID 33393167›Full record

Trial reportThe oncologist2021

A Phase II Study of Apatinib in Patients with Chemotherapy-Refractory Esophageal Squamous Cell Carcinoma (ESO-Shanghai 11).

Li Chu, Yun Chen, Qi Liu, Fei Liang, Shengping Wang, Quan Liu, Hui Yu, Xianghua Wu, Junhua Zhang, Jiaying Deng and 4 more

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

Trial report in The oncologist, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06281886 (Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing 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.

NCT06281886 phase2completednot on this mapstarted 2024, after this paper: background citation

Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma: a Open-label, Randomized, Controlled Phase II Clinical Trial

TypeinterventionalSponsorSun Yat-sen UniversityRan2024 to 2026Enrolled170ConditionsEsophageal Squamous Cell Carcinoma, Efficacy, ToxicityArmsInduction Immunotherapy-Toripalimab, Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin, Radiotherapy, Apatinib, Capecitabine
3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

  1. Trial
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  4. Observational
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  7. Observational
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  9. Article
  10. Review
  11. Article
  12. Approach to Localized Squamous Cell Cancer of the Esophagus.Current treatment options in oncology · 2022
    Review
  13. Article
  14. Review
  15. Review
  16. Review
  17. 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

14 authors.

Li ChuDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Yun ChenDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Qi LiuDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Fei LiangDepartment of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.
Shengping WangDepartment of Radiology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Quan LiuDepartment of Radiology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Hui YuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Xianghua WuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Junhua ZhangDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Jiaying DengDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Dashan AiDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Zhengfei ZhuDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Yongzhan NieState Key Laboratory of Cancer Biology & Xijing Hospital of Digest Diseases, Fourth Military Medical University, Xi'an, People's Republic of China.
Kuaile ZhaoDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.ORCID 0000-0001-8663-2874

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedApatinib has potential as an effective and safe second-line or higher treatment for patients with chemotherapy-refractory esophageal squamous cell carcinoma (ESCC). Clinical safety is of potential concern when administering apatinib to patients with uncontrolled esophageal lesions or severe invasion of trachea, bronchi, or major blood vessels. To the best of the authors' knowledge, this is the first prospective phase II study to investigate apatinib for patients with chemotherapy-refractory ESCC. Apatinib could provide an alternative option for ESCC after first-line or higher therapy in carefully selected patients.

backgroundThe aim of this study was to evaluate the efficacy and adverse effects of the oral vascular endothelial growth factor receptor 2 (VEGFR-2) tyrosine kinase inhibitor apatinib in patients with chemotherapy-refractory esophageal squamous cell carcinoma (ESCC).

methodsWe enrolled patients with chemotherapy-refractory ESCC. All patients received continuous apatinib 500 mg once daily.

resultsBetween July 2017 and August 2018, 40 patients were recruited, of whom 5 (12.5%) had uncontrolled primary tumors. Additionally, three patients with partial response (PR) and 23 with stable disease (SD) were observed for overall response rate (ORR) of 7.5% and disease control rate (DCR) of 65.0%. Median progression-free survival (PFS) was 3.8 months (95% confidence interval [CI], 2.2-5.4); median overall survival (OS) was 5.8 months (95% CI, 3.2-8.4). Common adverse effects were fatigue (15%), hypertension (12.5%), and palmar-plantar erythrodysesthesia syndrome (10%). Two cases of death from massive bronchopulmonary hemorrhage were observed, and esophageal fistula occurred in another two patients. Notably, both patients with esophageal fistula and one patient with massive fatal bronchopulmonary hemorrhage were individuals with uncontrolled primary tumors (3/5, 60%). Fatal bronchopulmonary hemorrhage in a second patient was associated with major blood vessel invasion.

conclusionApatinib has potential as an effective and safe treatment for patients with chemotherapy-refractory ESCC whose primary tumors are controlled and without severe invasion of trachea, bronchi, or major blood vessels.

Indexed as

Antineoplastic AgentsEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaHead and Neck NeoplasmsChinaHumansProspective StudiesPyridinesVascular Endothelial Growth Factor AAntineoplastic AgentsapatinibPyridinesVascular Endothelial Growth Factor AApatinibChemotherapyEsophageal squamous cell carcinomaPhase II

Identifiers

PMID33393167
PMCPMC8176978

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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.