Evidence map›Paper›PMID 26151457›Full record

Trial reportBritish journal of cancer2015

A phase II and pharmacodynamic study of sunitinib in relapsed/refractory oesophageal and gastro-oesophageal cancers.

C Wu, S Mikhail, L Wei, C Timmers, S Tahiri, A Neal, J Walker, S El-Dika, M Blazer, J Rock and 6 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in British journal of cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00702884 (A Mechanistic Radiographic and Biologic Phase 2 Single Agent Study of Sunitinib Malate in Relapsed/Refractory Esophageal and Gastroesophageal Cancers), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 23% 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.

NCT00702884 phase2completednot on this map

A Mechanistic Radiographic and Biologic Phase 2 Single Agent Study of Sunitinib Malate in Relapsed/Refractory Esophageal and Gastroesophageal Cancers

TypeinterventionalSponsorTony Bekaii-SaabRan2008 to 2013Enrolled25ConditionsEsophageal CancerArmssunitinib malate
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Targeting the Microenvironment in Esophageal Cancer.Frontiers in cell and developmental biology · 2021
    Review
  7. Review
  8. 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

16 authors at 3 institutions in 1 country.

C WuDivision of Medical Oncology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research Institute, Columbus, OH 43210, USA.
S MikhailDivision of Medical Oncology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research Institute, Columbus, OH 43210, USA.
L WeiCenter for Biostatistics, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA.
C TimmersThe Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research Institute, Columbus, OH 43210, USA.
S TahiriThe Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research Institute, Columbus, OH 43210, USA.
A NealThe Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research Institute, Columbus, OH 43210, USA.
J WalkerDivision of Gastroenterology, Hepatology and Nutrition, Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, OH 43210, USA.
S El-DikaDivision of Gastroenterology, Hepatology and Nutrition, Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, OH 43210, USA.
M BlazerDepartment of Pharmacy, The Ohio State University Wexner Medical Center, Columbus, OH 43210, USA.
J RockAnatomic Pathology Laboratory, Mercy Anderson Hospital, Cincinnati, OH 43210, USA.
D J ClarkDepartment of Radiology, The Ohio State University Wexner Medical Center, Columbus, OH 43210, USA.
X YangDepartment of Radiology, The Ohio State University Wexner Medical Center, Columbus, OH 43210, USA.
J L ChenDivision of Medical Oncology, Departments of Biomedical Informatics and Internal Medicine, The Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research Institute, Columbus, OH 43210, USA.
J LiuDepartment of Pathology, Beaumont Medical Center, Grosse Pointe, MI, USA.
M V KnoppDepartment of Radiology, The Ohio State University Wexner Medical Center, Columbus, OH 43210, USA.
T Bekaii-SaabDivision of Medical Oncology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research Institute, Columbus, OH 43210, USA.
The Ohio State University Wexner Medical Center · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USGrosse Pointe Public Library · US

Funding

Translational Training Grant in Experimental TherapeuticsK12CA133250 · NCI · OHIO STATE UNIVERSITY · PI WILLIAM E. CARSON, Rosa Lapalombella · 2008 to 2026
$15.0M
NCI NIH HHS K12 CA133250
6 · The paper itself

Abstract

backgroundBlockade of the vascular endothelial growth factor (VEGF) pathway shows evidence of activity in gastro-oesophageal (GE) and oesophageal cancer. We investigated the efficacy of sunitinib, a multikinase VEGF inhibitor, in patients with relapsed/refractory GE/oesophageal cancer.

methodsThis was a single-stage Fleming phase II study. The primary end point was progression-free survival (PFS) at 24 weeks. If five or more patients out of a total of 25 were free of progressive disease at 24 weeks, sunitinib would be recommended for further study. Patients received sunitinib 37.5 mg orally daily and imaged every 6 weeks. Exploratory correlative analysis included serum growth factors, tumour gene expression and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).

resultsTwenty-five evaluable patients participated in the study. Progression-free survival at 24 weeks was 8% (n=2 patients; confidence interval (CI): 95% 1.4-22.5%), and the duration of best response for the patients was 23 and 72 weeks. Ten patients (42%) had stable disease (SD) for >10 weeks. Overall response rate is 13%. Median PFS is 7 weeks (95% CI: 5.6-11.4 weeks) and the median overall survival is 17 weeks (95% CI: 8.9-25.3 weeks). Most common grade 3/4 toxicities included fatigue (24%), anaemia (20%) thrombocytopenia (16%), and leucopenia (16%). No patients discontinued therapy due to toxicity. Serum VEGF-A and -C levels, tumour complement factor B (CFB) gene expression, and DCE-MRI correlated with clinical benefit, defined as SD or better as best response.

conclusionSunitinib is well tolerated but only a select subgroup of patients benefited. Serum VEGF-A and -C may be early predictors of benefit. On this study, patients with clinical benefit from sunitinib had higher tumour CFB expression, and thus has identified CFB as a potential predictor for efficacy of anti-angiogenic therapy. These findings need validation from future prospective trials.

Indexed as

Esophagogastric JunctionAdultAgedAngiogenesis InhibitorsComplement Factor BEsophageal NeoplasmsFemaleHumansIndolesMaleMiddle AgedPyrrolesRecurrenceSunitinibTranscriptomeVascular Endothelial Growth Factor AAngiogenesis InhibitorsComplement Factor BIndolesPyrrolesSunitinibVascular Endothelial Growth Factor AVascular Endothelial Growth Factor C

Identifiers

PMID26151457
PMCPMC4506385
OpenAlexW1484797496

What OpenQuestion holds

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LicenceCC BY-NC-SA
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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.