Evidence map›Paper›PMID 31231785›Full record

Trial reportInvestigational new drugs2019

Phase II trial of continuous treatment with sunitinib in patients with high-risk (BCG-refractory) non-muscle invasive bladder cancer.

Haris Zahoor, Maria C Mir, Pedro C Barata, Andrew J Stephenson, Steven C Campbell, Amr Fergany, Robert Dreicer, Jorge A Garcia

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01118351 (Phase II Single Arm, Open Label, Single Institution Study of Continuous Sunitinib), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
3.3field-weighted citation impact, top 8% 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.

NCT01118351 phase2terminatednot on this map

Phase II Single Arm, Open Label, Single Institution Study of Continuous Sunitinib (Sutent) in Patients With High-Risk (BCG-Refractory) Superficial Transitional Cell Carcinoma (TCC) of the Bladder

TypeinterventionalSponsorCase Comprehensive Cancer CenterRan2008 to 2015Enrolled19ConditionsRecurrent Bladder Cancer, Transitional Cell Carcinoma of the BladderArmssunitinib malate, immunohistochemistry staining method, TdT-mediated dUTP nick end labeling assay, light microscopy, laboratory biomarker analysis
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 38 citations in OpenAlex.

  1. Article
  2. Review
  3. Harnessing myeloid cells in cancer.Molecular cancer · 2025
    Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Targeted Therapy in Non-Muscle Invasive Bladder Cancer-Clinical Updates.Archives of pharmacology and therapeutics · 2024
    Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Biomarker-Oriented Therapy in Bladder and Renal Cancer.International journal of molecular sciences · 2021
    Review
  19. Review
  20. 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

8 authors at 4 institutions in 1 country.

Haris ZahoorDivision of Medical Oncology, USC Norris Comprehensive Cancer Center, Keck School of Medicine, Los Angeles, CA, USA.
Maria C MirUrology Department, IMED Valencia Hospital, Valencia, Spain.
Pedro C BarataDepartment of Internal Medicine, Section of Hematology and Medical Oncology, Tulane Medical School, New Orleans, Louisiana, USA.
Andrew J StephensonCleveland Clinic, Glickman Urological and Kidney Institute, 9500 Euclid Avenue/R35, Cleveland, OH, 44195, USA.
Steven C CampbellCleveland Clinic, Glickman Urological and Kidney Institute, 9500 Euclid Avenue/R35, Cleveland, OH, 44195, USA.
Amr FerganyCleveland Clinic, Glickman Urological and Kidney Institute, 9500 Euclid Avenue/R35, Cleveland, OH, 44195, USA.
Robert DreicerDivision Hematology/Oncology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
Jorge A GarciaCleveland Clinic, Glickman Urological and Kidney Institute, 9500 Euclid Avenue/R35, Cleveland, OH, 44195, USA. garciaj4@ccf.org.
Cleveland Clinic · USTulane Medical Center · USUniversity of Virginia · USUSC Norris Comprehensive Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose Sunitinib is a vascular endothelial growth factor receptor (VEGFR) inhibitor with antitumor activity against bladder cancer. We hypothesized that treatment with sunitinib may decrease progression or recurrence in non-muscle invasive bladder cancer (NMIBC) refractory to intra-vesical BCG. Patients and Methods This is a single-arm phase II study of sunitinib in patients (pts) with NMIBC who progressed after BCG. Treatment included sunitinib 37.5 g daily for 12 weeks followed by 12± 2-week cystoscopy and surveillance for one year. The primary endpoint was the complete response rate at 12 months. Secondary endpoints included recurrence free survival (RFS), progression free survival (PFS), overall survival (OS), and safety of sunitinib. Correlative studies on effects of sunitinib on myeloid derived suppressor cells (MDSC) and humoral immune responses were also performed. This trial was registered on ClinicalTrials.gov, number NCT01118351. Results Between June 2011 and September 2011, 15/19 pts. completed 12 weeks of therapy. The remaining 4 pts. had treatment related adverse events leading to discontinuation of sunitinib with one patient withdrawing consent. On the 12-week cystoscopy, 44% (8/18) of the pts. showed remission, 50% (9/18) progression and 1/18 recurrence. Overall, 22% (4/18) of pts. remained free of progression for >12 months. Grade (G) 4 toxicities were noted in 2 pts. (anemia and thrombocytopenia) while G3 were noted in 58%. Sunitinib resulted in reversal of MDSC mediated immunosuppression. Conclusions In NMIBC refractory to BCG, treatment with sunitinib was safe but not associated with improved clinical outcomes. The immune effects of sunitinib deserve further investigation.

Indexed as

Adjuvants, ImmunologicAgedAged, 80 and overAntineoplastic AgentsBCG VaccineFemaleHumansMaleMiddle AgedProtein Kinase InhibitorsReceptors, Vascular Endothelial Growth FactorSunitinibSurvival AnalysisUrinary Bladder NeoplasmsAdjuvants, ImmunologicAntineoplastic AgentsBCG VaccineProtein Kinase InhibitorsReceptors, Vascular Endothelial Growth FactorSunitinibAngiogenesisBCG-refractoryMDSCNon-muscle invasive bladder cancerSunitinib

Identifiers

PMID31231785
OpenAlexW2952552564

What OpenQuestion holds

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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.