Evidence map›Paper›PMID 21531816›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2011

The addition of bevacizumab to standard radiation therapy and temozolomide followed by bevacizumab, temozolomide, and irinotecan for newly diagnosed glioblastoma.

James J Vredenburgh, Annick Desjardins, David A Reardon, Katherine B Peters, James E Herndon, Jennifer Marcello, John P Kirkpatrick, John H Sampson, Leighann Bailey, Stevie Threatt and 3 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 75 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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

75 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Safety of bevacizumab in patients with malignant gliomas: a systematic review.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2014
    Pooled it
  6. Pooled it
  7. Trial
  8. Phase II study of bevacizumab, temozolomide, and hypofractionated stereotactic radiotherapy for newly diagnosed glioblastoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2014
    Trial
  9. Trial
  10. Trial
  11. Trial
  12. Review
  13. Review
  14. Neuro-ophthalmic complications of modern anti-cancer drugs.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Review
  15. Article
  16. Review
  17. Review
  18. Article
  19. Review
  20. Review

15 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

13 authors.

James J VredenburghDepartments of Surgery, Neurology, Pediatrics, Medicine, Radiation Oncology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, North Carolina. vrede001@mc.duke.edu
Annick Desjardins
David A Reardon
Katherine B Peters
James E Herndon
Jennifer Marcello
John P Kirkpatrick
John H Sampson
Leighann Bailey
Stevie Threatt
Allan H Friedman
Darell D Bigner
Henry S Friedman

Funding

TUMOR SUPPRESSOR GENES IN HUMAN MEDULLOBLASTOMAP50NS020023 · NINDS · DUKE UNIVERSITY · PI REARDON, DAVID A · 1985 to 2013
$17.3M
BRAIN TUMORS: IMMUNOLOGICAL AND BIOLOGICAL STUDIESR37CA011898 · NCI · DUKE UNIVERSITY · PI BIGNER, DARELL D · 1988 to 2012
$8.1M
Research Training in Age-Related Cognitive DisordersT32AG027668 · NIA · JOHNS HOPKINS UNIVERSITY · PI MARILYN S. ALBERT · 2007 to 2026
$6.3M
SPORE in Brain CancerP20CA096890 · NCI · DUKE UNIVERSITY · PI BIGNER, DARELL D · 2002 to 2003
$1000k
NCI NIH HHS 5 R37CA11898NCI NIH HHS P20 CA096890NCI NIH HHS R37 CA011898NCRR NIH HHS MO1 RR 30NIA NIH HHS T32 AG027668NINDS NIH HHS 5P50-NS-20023NINDS NIH HHS P50 NS020023
6 · The paper itself

Abstract

purposeTo determine if the addition of bevacizumab to radiation therapy and temozolomide, followed by bevacizumab, temozolomide, and irinotecan, for newly diagnosed glioblastoma patients is safe and effective. EXPERIMENTAL

designA total of 75 patients with newly diagnosed glioblastoma were enrolled in the phase II trial that investigated the addition of bevacizumab to standard radiation therapy and daily temozolomide followed by the addition of bevacizumab and irinotecan to adjuvant temozolomide. The bevacizumab was given at 10 mg/kg every 14 days beginning a minimum of 4 weeks postcraniotomy. Two weeks after radiation therapy, the patients began 6 to 12 cycles of 5-day temozolomide with bevacizumab and irinotecan every 14 days. The primary endpoint was the proportion of patients alive 16 months after informed consent.

resultsThe therapy had moderate toxicity. Three patients, one of whom had a grade 2 central nervous system hemorrhage, came off study during radiation therapy. Seventy patients started the postradiation therapy, and 16 (23%) terminated this adjuvant therapy early because of toxicity. The median overall survival was 21.2 months (95% CI: 17.2-25.4), and 65% of the patients were alive at 16 months (95% CI: 53.4-74.9). The median progression-free survival was 14.2 months (95% CI: 12-16).

conclusionThe addition of bevacizumab to standard radiation therapy and temozolomide, followed by bevacizumab, irinotecan, and temozolomide, for the treatment of newly diagnosed glioblastoma has moderate toxicity and may improve efficacy compared with historical controls. The results from phase III trials are required before the role of bevacizumab for newly diagnosed glioblastoma is established.

Indexed as

AdultAgedAngiogenesis InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabCamptothecinChemotherapy, AdjuvantCombined Modality TherapyDacarbazineFemaleGlioblastomaHumansIrinotecanMaleAngiogenesis InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabCamptothecinDacarbazineIrinotecanTemozolomide

Identifiers

PMID21531816
PMCPMC3117928

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.