Evidence map›Paper›PMID 20646741›Full record

Trial reportUrology2010

Phase II study of Aflibercept (VEGF-Trap) in patients with recurrent or metastatic urothelial cancer, a California Cancer Consortium Trial.

Przemyslaw Twardowski, Walter M Stadler, Paul Frankel, Primo N Lara, Christopher Ruel, Gurkamal Chatta, Elisabeth Heath, David I Quinn, David R Gandara

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Urology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 5 pooled it
11.3field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 5 syntheses or guidelines pooled it, 86 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Hemorrhagic events in cancer patients treated with aflibercept: a meta-analysis.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2014
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Review
  12. Novel Tyrosine Kinase Targets in Urothelial Carcinoma.International journal of molecular sciences · 2021
    Review
  13. Incorporating VEGF-targeted therapy in advanced urothelial cancer.Therapeutic advances in medical oncology · 2017
    Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Targeted therapies in urothelial carcinoma.Current opinion in oncology · 2014
    Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Przemyslaw TwardowskiCity of Hope Cancer Ctr, Duarte, CA, USA. ptwardowski@coh.org
Walter M Stadler
Paul Frankel
Primo N Lara
Christopher Ruel
Gurkamal Chatta
Elisabeth Heath
David I Quinn
David R Gandara
City of Hope · USUniversity of California, Davis · USUniversity of Chicago · USUniversity of Southern California · USUPMC Hillman Cancer Center · USWayne State University · US

Funding

Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Gina M Dayton · 2002 to 2026
$84.9M
NCI NIH HHS P30 CA093373
6 · The paper itself

Abstract

objectivesTo determine whether aflibercept, a recombinant fusion protein that binds and neutralizes multiple vascular endothelial growth factor isoforms, is effective in the treatment of urothelial cancer. The efficacy of systemic therapies for advanced urothelial cancer after failure of front-line platinum-based chemotherapy is limited. Evidence has shown that vascular endothelial growth factor is important in the pathophysiology of urothelial cancer.

methodsPatients with measurable, metastatic, or locally advanced urothelial cancer previously treated with 1 platinum-containing regimen were enrolled. Aflibercept was administered at 4 mg/kg intravenously every 2 weeks. The response rate (RR) and progression-free survival (PFS) were assessed in a 2-stage accrual design (22 + 18). A maximum of 40 patients were to be accrued to rule out a null hypothesis RR of 4% and PFS of 3 months versus an alternative RR of 15% and PFS of 5.4 months, with α = 0.12 and β = 0.19.

resultsA total of 22 patients were accrued. One partial response (4.5% RR, 95% confidence interval 0.1%-22.8%) was seen. The median PFS was 2.79 months (95% confidence interval 1.74-3.88). Attributable Grade 3 toxicities included fatigue, hypertension, proteinuria, pulmonary hemorrhage, pain, hyponatremia, anorexia, and lymphopenia. No treatment-related Grade 4 or greater toxicities occurred.

conclusionsAflibercept was well tolerated, with toxicity similar to those seen with other vascular endothelial growth factor pathway inhibitors; however, it had limited single-agent activity in patients with urothelial carcinoma previously treated with platinum-containing chemotherapy.

Indexed as

AgedAngiogenesis InhibitorsAntineoplastic AgentsCarcinoma, Transitional CellCombined Modality TherapyDisease-Free SurvivalFatigueFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsSalvage TherapyTreatment FailureafliberceptAngiogenesis InhibitorsAntineoplastic AgentsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor A

Identifiers

PMID20646741
PMCPMC2952720
OpenAlexW2017054455

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.