Evidence map›Paper›PMID 37147645›Full record

Trial reportBMC medicine2023

Safety and efficacy of apatinib in patients with advanced gastric or gastroesophageal junction adenocarcinoma after the failure of two or more lines of chemotherapy (AHEAD): a prospective, single-arm, multicenter, phase IV study.

Jin Li, Shukui Qin, Lu Wen, Junsheng Wang, Wenying Deng, Weijian Guo, Tongfu Jia, Da Jiang, Guifang Zhang, Yifu He and 25 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in BMC medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02426034 (Safety and Efficacy of Apatinib in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma After Failure of Two or More Lines of Chemotherapy), which is not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
7.8field-weighted citation impact, top 2% 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.

NCT02426034 phase4completednot on this map

Safety and Efficacy of Apatinib in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma After Failure of Two or More Lines of Chemotherapy (Ahead-G201): a Prospective, Single-arm, Multicenter, Phase IV Study

TypeinterventionalSponsorJiangsu HengRui Medicine Co., Ltd.Ran2015 to 2020Enrolled2,004ConditionsAdvanced Gastric or Gastroesophageal Junction AdenocarcinomaArmsApatinibTablets
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Article
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

35 authors at 20 institutions in 1 country.

Jin LiDepartment of Oncology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
Shukui QinDepartment of Oncology, Cancer Center of Jinling Hospital, Nanjing University of Chinese Medicine, No. 34 Biao, 34 Hao, Yanggongjing Road, Qinhuai District, Nanjing, 210002, Jiangsu Province, China. qinsk@csco.org.cn.
Lu WenDepartment of Gastroenterology, Shanxi Provincial Cancer Hospital, Taiyuan, China.
Junsheng WangDepartment of Internal Medicine, Anyang Cancer Hospital, Anyang, China.
Wenying DengDepartment of Gastroenterology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.
Weijian GuoDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Tongfu JiaDepartment of Oncology, ZiBo Central Hospital, Zibo, China.
Da JiangDepartment of Oncology, The Fourth Hospital of Hebei Medical University & Hebei Cancer Hospital, Shijiazhuang, China.
Guifang ZhangDepartment of Oncology, Xinxiang Central Hospital, Xinxiang, China.
Yifu HeDepartment of Oncology, The First Affiliated Hospital of USTC West District & Anhui Provincial Cancer Hospital, Hefei, China.
Yi BaDepartment of Digestive Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.
Haijun ZhongDepartment of Medical Oncology, Zhejiang Cancer Hospital, Institute of Cancer and Basic Medicine, Chinese Academy of Sciences, Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou, China.
Lin WangDepartment of Oncology, Cancer Center of Jinling Hospital, Nanjing University of Chinese Medicine, No. 34 Biao, 34 Hao, Yanggongjing Road, Qinhuai District, Nanjing, 210002, Jiangsu Province, China.
Xiaoyan LinDepartment of Medical Oncology, Fujian Medical University Affiliated Union Hospital, Fuzhou, China.
Jianwei YangDepartment of Abdominal Oncology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Fuzhou, China.
Jun ZhaoDepartment of Oncology, Changzhi People's Hospital, Changzhi, China.
Yuxian BaiDepartment of Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
Xiangyuan WuDepartment of Oncology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Feng GaoDepartment of Oncology, Heilongjiang Agricultural Reclamation Bureau General Hospital, Harbin, China.
Guogui SunDepartment of Radiotherapy and Chemotherapy, Tangshan People's Hospital, Tangshan, China.
Yongjuan WuDepartment of Digestive Oncology, Baotou Tumor Hospital, Baotou, China.
Feng YeDepartment of Oncology, The First Affiliated Hospital of Xiamen University, Xiamen, China.
Qiong WangDepartment of Oncology, Jiangyin People's Hospital, Jiangyin, China.
Zhong XieDepartment of Oncology, The Affiliated Hospital of Guangdong Medical University, Zhanjiang, China.
Tienan YiDepartment of Oncology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, Xiangyang, China.
Yong HuangDepartment of Oncology, The Second People's Hospital of Hefei, Hefei, China.
Guohua YuDepartment of Oncology, Weifang People's Hospital, Weifang, China.
Lin LuDepartment of Oncology, 105 Hospital of People's Liberation Army, Hefei, China.
Ying YuanDepartment of Oncology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China.
Wei LiDepartment of Oncology, The First Hospital of Jilin University, Changchun, China.
Likun LiuDepartment of Oncology, Shanxi Traditional Chinese Medical Hospital, Taiyuan, China.
Yuping SunDepartment of Oncology, Central Hospital Affiliated To Shandong First Medical University, Jinan, China.
Ying SunJiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Lifeng YinJiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Zhiguo HouJiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Jiangsu Hengrui Medicine (China) · CN117th Hospital of People's Liberation Army · CNAnhui Provincial Hospital · CNAnyang Tumor Hospital · CNBaotou Medical College · CNCentral Hospital of Zibo · CNChangzhi Medical College · CNFirst Affiliated Hospital of Xiamen University · CNFirst Hospital of Jilin University · CNFudan University Shanghai Cancer Center · CNFujian Medical University · CNGuangdong Medical College · CNHarbin Medical University · CNHebei Medical University · CNHeilongjiang Academy of Land Reclamation Sciences · CNHenan Cancer Hospital · CNHubei University of Arts and Science · CNJiangyin People's Hospital · CNNanjing General Hospital of Nanjing Military Command · CNNanjing University of Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundApatinib, a highly selective VEGFR2 inhibitor, significantly improved efficacy versus placebo as a third- and later-line treatment for advanced gastric cancer in phase 2 and 3 trials. This prospective, single-arm, multicenter phase IV AHEAD study was conducted to verify the safety and efficacy of apatinib in patients with advanced or metastatic gastric or gastroesophageal adenocarcinoma after at least two lines of systematic therapy in clinical practice settings.

methodsPatients with advanced gastric cancer who had previously failed at least two lines of chemotherapy received oral apatinib until disease progression, death or unacceptable toxicity. The primary endpoint was safety. The secondary endpoints included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). Adverse events were summarized by the incidence rate. Median OS and PFS were estimated using the Kaplan-Meier method. ORR, DCR, OS at 3 and 6 months, and PFS at 3 and 6 months were calculated, and their 95% CIs were estimated according to the Clopper-Pearson method.

resultsBetween May 2015 and November 2019, a total of 2004 patients were enrolled, and 1999 patients who received at least one dose of apatinib were assessed for safety. In the safety population, 87.9% of patients experienced treatment-related adverse events (TRAEs), with the most common hypertension (45.2%), proteinuria (26.5%), and white blood cell count decreased (25.3%). Additionally, 51% of patients experienced grade ≥ 3 TRAEs. Fatal TRAEs occurred in 57 (2.9%) patients. No new safety concerns were reported. Among the 2004 patients included in the intention-to-treat population, the ORR was 4.4% (95% CI, 3.6-5.4%), and DCR was 35.8% (95% CI, 33.7-38.0%). The median PFS was 2.7 months (95% CI 2.2-2.8), and the median OS was 5.8 months (95% CI 5.4-6.1).

conclusionsThe findings in the AHEAD study confirmed the acceptable and manageable safety profile and clinical benefit of apatinib in patients with advanced gastric cancer as a third- or later-line of treatment.

trial registrationThis study was registered with ClinicalTrials.gov NCT02426034. Registration date was April 24, 2015.

Indexed as

AdenocarcinomaAntineoplastic AgentsStomach NeoplasmsEsophageal NeoplasmsEsophagogastric JunctionHumansProspective StudiesPyridinesAntineoplastic AgentsapatinibPyridinesAdvanced gastric cancerApatinibEfficacyPhase IV studySafetyThird- and later-line treatment

Identifiers

PMID37147645
PMCPMC10163723
OpenAlexW4372294516

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.