Evidence map›Paper›PMID 22184381›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2012

Double-blind, randomized trial of docetaxel plus vandetanib versus docetaxel plus placebo in platinum-pretreated metastatic urothelial cancer.

Toni K Choueiri, Robert W Ross, Susanna Jacobus, Ulka Vaishampayan, Evan Y Yu, David I Quinn, Noah M Hahn, Thomas E Hutson, Guru Sonpavde, Stephanie C Morrissey and 10 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00880334 (Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC), which is not on this map. Cited by 64 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 3 pooled it
17.7field-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.

NCT00880334 phase2completednot on this map

Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC

TypeinterventionalSponsorDana-Farber Cancer InstituteRan2006 to 2015Enrolled149ConditionsTransitional Cell Carcinoma, Bladder CancerArmsDocetaxel, vandetanib, Placebo
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 3 syntheses or guidelines pooled it, 181 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. A phase II trial of temsirolimus in second-line metastatic urothelial cancer.Medical oncology (Northwood, London, England) · 2012
    Trial
  14. Landscape of targeted therapies for advanced urothelial carcinoma.Exploration of targeted anti-tumor therapy · 2024
    Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Review

4 more citing papers are in PubMed but not listed here.

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

20 authors at 1 institution in 1 country.

Toni K ChoueiriDana-Farber Cancer Institute, Boston, MA 02215, USA. Toni_Choueiri@dfci.harvard.edu
Robert W Ross
Susanna Jacobus
Ulka Vaishampayan
Evan Y Yu
David I Quinn
Noah M Hahn
Thomas E Hutson
Guru Sonpavde
Stephanie C Morrissey
Geoffrey C Buckle
William Y Kim
Daniel P Petrylak
Christopher W Ryan
Mario A Eisenberger
Amir Mortazavi
Glenn J Bubley
Mary-Ellen Taplin
Jonathan E Rosenberg
Philip W Kantoff
Dana-Farber Cancer Institute · US

Funding

Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI Jennifer L Beebe-Dimmer · 1985 to 2026
$68.4M
Enhancing neoadjuvant chemotherpay responses with targeted T cellsR01CA140314 · NCI · WAYNE STATE UNIVERSITY · PI BEPLER, GEROLD · 2010 to 2015
$2.5M
NCI NIH HHS P30 CA022453NCI NIH HHS R01 CA140314
6 · The paper itself

Abstract

purposeVandetanib is an oral once-daily tyrosine kinase inhibitor with activity against vascular endothelial growth factor receptor 2 and epidermal growth factor receptor. Vandetanib in combination with docetaxel was assessed in patients with advanced urothelial cancer (UC) who progressed on prior platinum-based chemotherapy. PATIENTS AND

methodsThe primary objective was to determine whether vandetanib 100 mg plus docetaxel 75 mg/m(2) intravenously every 21 days prolonged progression-free survival (PFS) versus placebo plus docetaxel. The study was designed to detect a 60% improvement in median PFS with 80% power and one-sided α at 5%. Patients receiving docetaxel plus placebo had the option to cross over to single-agent vandetanib at progression. Overall survival (OS), overall response rate (ORR), and safety were secondary objectives.

resultsIn all, 142 patients were randomly assigned and received at least one dose of therapy. Median PFS was 2.56 months for the docetaxel plus vandetanib arm versus 1.58 months for the docetaxel plus placebo arm, and the hazard ratio for PFS was 1.02 (95% CI, 0.69 to 1.49; P = .9). ORR and OS were not different between both arms. Grade 3 or higher toxicities were more commonly seen in the docetaxel plus vandetanib arm and included rash/photosensitivity (11% v 0%) and diarrhea (7% v 0%). Among 37 patients who crossed over to single-agent vandetanib, ORR was 3% and OS was 5.2 months.

conclusionIn this platinum-pretreated population of advanced UC, the addition of vandetanib to docetaxel did not result in a significant improvement in PFS, ORR, or OS. The toxicity of vandetanib plus docetaxel was greater than that for vendetanib plus placebo. Single-agent vandetanib activity was minimal.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinomaDisease-Free SurvivalDisease ProgressionDocetaxelDouble-Blind MethodFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMultivariate AnalysisPiperidinesPlatinum CompoundsDocetaxelPiperidinesPlatinum CompoundsProtein Kinase InhibitorsProtein-Tyrosine KinasesQuinazolinesTaxoidsvandetanib

Identifiers

PMID22184381
PMCPMC4104290
OpenAlexW2152194109

What OpenQuestion holds

Textmetadata
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.