Evidence map›Paper›PMID 24637999›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014

Risk factors for GI adverse events in a phase III randomized trial of bevacizumab in first-line therapy of advanced ovarian cancer: A Gynecologic Oncology Group Study.

Robert A Burger, Mark F Brady, Michael A Bookman, Bradley J Monk, Joan L Walker, Howard D Homesley, Jeffrey Fowler, Benjamin E Greer, Matthew Boente, Gini F Fleming and 4 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 1 pooled it
13.5field-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

42 citing papers in PubMed, 1 synthesis or guideline pooled it, 80 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Angiogenesis in Inflammatory Bowel Disease.Pharmaceuticals (Basel, Switzerland) · 2026
    Review
  4. Article
  5. Review
  6. Article
  7. Surgery for Recurrent Epithelial Ovarian Cancer.Current oncology reports · 2024
    Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Article
  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

14 authors at 1 institution in 1 country.

Robert A BurgerRobert A. Burger, Fox Chase Cancer Center, Philadelphia, PA; Mark F. Brady, GOG Statistical and Data Center, Buffalo, NY; Michael A. Bookman, Arizona Cancer Center, Tucson, AZ; Bradley J. Monk, University of California at Irvine, Orange, CA; Joan L. Walker, University of Oklahoma, Oklahoma City, OK; Howard D. Homesley, Wake Forest University Medical Center, Winston-Salem, NC; Jeffrey Fowler, Ohio State University, Columbus, OH; Benjamin E. Greer, University of Washington Medical Center, Seattle, WA; Matthew Boente, Minnesota Oncology Hematology, Minneapolis, MN; Gini F. Fleming, University of Chicago, Chicago, IL; Peter C. Lim, Center of Hope at Renown Regional Medical Center, Reno, NV; Stephen C. Rubin, University of Pennsylvania Cancer Center, Philadelphia, PA; Noriyuki Katsumata, Saitama Medical University/International Medical Center-GOG Japan, Saitama, Japan; and Sharon X. Liang, North Shore University Hospital, Manhasset, NY.
Mark F Brady
Michael A Bookman
Bradley J Monk
Joan L Walker
Howard D Homesley
Jeffrey Fowler
Benjamin E Greer
Matthew Boente
Gini F Fleming
Peter C Lim
Stephen C Rubin
Noriyuki Katsumata
Sharon X Liang
Fox Chase Cancer Center · US

Funding

GYNECOLOGIC ONCOLOGY GROUP HEADQUARTERSU10CA027469 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 1985 to 2013
$132.6M
GYNECOLOGIC ONCOLOGY GROUP STATISTICAL OFFICEU10CA037517 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI BLESSING, JOHN A · 1985 to 2013
$67.4M
Re-Engineering Translational Research at the University of ChicagoUL1TR000430 · NCATS · UNIVERSITY OF CHICAGO · PI SOLWAY, JULIAN · 2012 to 2016
$20.2M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareUG1CA233180 · NCI · DANA-FARBER CANCER INST · PI Harold John Burstein · 2019 to 2026
$8.6M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareU10CA180867 · NCI · DANA-FARBER CANCER INST · PI BURSTEIN, HAROLD JOHN, KIBEL, ADAM S · 2014 to 2018
$6.2M
NCATS NIH HHS UL1 TR000430NCI NIH HHS CA 27469NCI NIH HHS CA 37517NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA180867NCI NIH HHS UG1 CA233180
6 · The paper itself

Abstract

purposeTo evaluate risk factors for GI adverse events (AEs) within a phase III trial of bevacizumab in first-line ovarian cancer therapy. PATIENTS AND

methodsWomen with previously untreated advanced disease after surgery were randomly allocated to six cycles of platinum-taxane chemotherapy plus placebo cycles (C)2 to C22 (R1); chemotherapy plus bevacizumab C2 to C6 plus placebo C7 to C22 (R2); or chemotherapy plus bevacizumab C2 to C22 (R3). Patients were evaluated for history or on-study development of potential risk factors for GI AEs defined as grade ≥ 2 perforation, fistula, necrosis, or hemorrhage.

resultsOf 1,873 patients enrolled, 1,759 (94%) were evaluable, and 2.8% (50 of 1,759) experienced a GI AE: 10 of 587 (1.7%, R1), 20 of 587 (3.4%, R2), and 20 of 585 (3.4%, R3). Univariable analyses indicated that previous treatment of inflammatory bowel disease (IBD; P = .005) and small bowel resection (SBR; P = .032) or large bowel resection (LBR; P = .012) at primary surgery were significantly associated with a GI AE. The multivariable estimated relative odds of a GI AE were 13.4 (95% CI, 3.44 to 52.3; P < .001) for IBD; 2.05 (95% CI, 1.09 to 3.88; P = .026) for LBR; 1.95 (95% CI, 0.894 to 4.25; P = .093) for SBR; and 2.15 for bevacizumab exposure (aggregated 95% CI, 1.05 to 4.40; P = .036).

conclusionHistory of treatment for IBD, and bowel resection at primary surgery, increase the odds of GI AEs in patients receiving first-line platinum-taxane chemotherapy for advanced ovarian cancer. After accounting for these risk factors, concurrent bevacizumab doubles the odds of a GI AE, but is not appreciably increased by continuation beyond chemotherapy.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabDisease-Free SurvivalDouble-Blind MethodFemaleGastrointestinal DiseasesHumansLogistic ModelsMiddle AgedNeoplasm StagingOrganoplatinum CompoundsOvarian NeoplasmsAntibodies, Monoclonal, HumanizedBevacizumabOrganoplatinum CompoundsTaxoids

Identifiers

PMID24637999
PMCPMC3986384
OpenAlexW2079035144

What OpenQuestion holds

Textmetadata
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.