Evidence map›Paper›PMID 12890841›Full record

Trial reportThe New England journal of medicine2003

A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer.

James C Yang, Leah Haworth, Richard M Sherry, Patrick Hwu, Douglas J Schwartzentruber, Suzanne L Topalian, Seth M Steinberg, Helen X Chen, Steven A Rosenberg

3 registry-linked trialsOpen access · bronzeAbstract readClinical TrialClinical Trial, Phase IIComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 783 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
783citing papers in PubMed, 6 pooled it
153.4field-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.

NCT00318513 phase1unknown statusnot on this map

Phase I Study Evaluating the Safety of Bevacizumab in Women With a History of Breast Cancer Suffering From Moderate to Severe Upper Extremity Lymphedema

TypeinterventionalSponsorPremiere Oncology of ArizonaEnrolled35ConditionsLymphedemaArmsBevacizumab
NCT00868192 phase2completednot on this mapstarted 2008, after this paper: background citation

Phase II Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian and Primary Peritoneal Carcinoma

TypeinterventionalSponsorWashington University School of MedicineRan2008 to 2012Enrolled38ConditionsOvarian Carcinoma, Primary Peritoneal CarcinomaArmsPemetrexed, Bevacizumab
NCT04520048 narecruitingnot on this mapstarted 2023, after this paper: background citation

Exploratory Study. Endothelial Function and Vascular-tropic Biomarkers: Predictive Indicators of the Progression of Hypertensive Disorders in Pregnancy to Pre-eclampsia?

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2023 to 2026Enrolled110ConditionsHypertension Disorders in Pregnancy, Gestational Hypertension, Pre-EclampsiaArmsDetermination of the UEMP levels, Aortic central pressure and the carotid-femoral pulse wave velocity, Vascular biomarker assay, Measurement of the uterine artery diameter
3 · Its place in the literature

Who cites it

783 citing papers in PubMed, 6 syntheses or guidelines pooled it, 2,702 citations in OpenAlex.

  1. Pooled it
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  4. Kidney Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2022
    Guideline
  5. Targeted therapy for metastatic renal cell carcinoma.The Cochrane database of systematic reviews · 2020
    Pooled it
  6. Pooled it
  7. Trial
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  9. Phase Ib/II Clinical Trial of Pembrolizumab With Bevacizumab for Metastatic Renal Cell Carcinoma: BTCRC-GU14-003.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Trial
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  11. Trial
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  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

James C YangSurgery Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md 20892, USA. james_yang@nih.gov
Leah Haworth
Richard M Sherry
Patrick Hwu
Douglas J Schwartzentruber
Suzanne L Topalian
Seth M Steinberg
Helen X Chen
Steven A Rosenberg
National Institutes of Health · US

Funding

THE IMMUNOTHERAPY OF ANIMAL AND HUMAN CANCERZ01SC003811 · SC · CLINICAL SCIENCES · PI ROSENBERG, STEVEN A · 1996 to 2007
$3.2M
Intramural NIH HHS Z01 SC003811
6 · The paper itself

Abstract

backgroundMutations in the tumor-suppressor gene VHL cause oversecretion of vascular endothelial growth factor by clear-cell renal carcinomas. We conducted a clinical trial to evaluate bevacizumab, a neutralizing antibody against vascular endothelial growth factor, in patients with metastatic renal-cell carcinoma.

methodsA randomized, double-blind, phase 2 trial was conducted comparing placebo with bevacizumab at doses of 3 and 10 mg per kilogram of body weight, given every two weeks; the time to progression of disease and the response rate were primary end points. Crossover from placebo to antibody treatment was allowed, and survival was a secondary end point.

resultsMinimal toxic effects were seen, with hypertension and asymptomatic proteinuria predominating. The trial was stopped after the interim analysis met the criteria for early stopping. With 116 patients randomly assigned to treatment groups (40 to placebo, 37 to low-dose antibody, and 39 to high-dose antibody), there was a significant prolongation of the time to progression of disease in the high-dose--antibody group as compared with the placebo group (hazard ratio, 2.55; P<0.001). There was a small difference, of borderline significance, between the time to progression of disease in the low-dose--antibody group and that in the placebo group (hazard ratio, 1.26; P=0.053). The probability of being progression-free for patients given high-dose antibody, low-dose--antibody, and placebo was 64 percent, 39 percent, and 20 percent, respectively, at four months and 30 percent, 14 percent, and 5 percent at eight months. At the last analysis, there were no significant differences in overall survival between groups (P>0.20 for all comparisons).

conclusionsBevacizumab can significantly prolong the time to progression of disease in patients with metastatic renal-cell cancer.

Indexed as

Tumor Suppressor ProteinsUbiquitin-Protein LigasesAdenocarcinoma, Clear CellAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBevacizumabCarcinoma, Renal CellDisease ProgressionDouble-Blind MethodEndothelial Growth FactorsFemaleGenes, Tumor SuppressorHumansIntercellular Signaling Peptides and ProteinsKidney NeoplasmsLigasesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBevacizumabEndothelial Growth FactorsIntercellular Signaling Peptides and ProteinsLigasesLymphokinesTumor Suppressor ProteinsUbiquitin-Protein LigasesVascular Endothelial Growth Factor AVascular Endothelial Growth FactorsVHL protein, humanVon Hippel-Lindau Tumor Suppressor Protein

Identifiers

PMID12890841
PMCPMC2275324
OpenAlexW2046507292

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.