Evidence map›Paper›PMID 19162309›Full record

Trial reportGynecologic oncology2009

Phase II trial of single agent cetuximab in patients with persistent or recurrent epithelial ovarian or primary peritoneal carcinoma with the potential for dose escalation to rash.

Russell J Schilder, Harsh B Pathak, Anna E Lokshin, Robert W Holloway, Ronald D Alvarez, Carol Aghajanian, Hua Min, Karthik Devarajan, Eric Ross, Charles W Drescher and 1 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Gynecologic oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
14.4field-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.

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

44 citing papers in PubMed, 1 synthesis or guideline pooled it, 99 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Review
  9. Review
  10. Options for the Treatment of Mucinous Ovarian Carcinoma.Current treatment options in oncology · 2021
    Review
  11. Article
  12. Mucinous Cancer of the Ovary: Overview and Current Status.Diagnostics (Basel, Switzerland) · 2020
    Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. The rise of genomic profiling in ovarian cancer.Expert review of molecular diagnostics · 2016
    Review
  20. Targeted therapy in ovarian cancer.Women's health (London, England) · 2016
    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

11 authors at 6 institutions in 1 country.

Russell J SchilderDepartment of Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA 19111, USA. russell.schilder@fccc.edu
Harsh B Pathak
Anna E Lokshin
Robert W Holloway
Ronald D Alvarez
Carol Aghajanian
Hua Min
Karthik Devarajan
Eric Ross
Charles W Drescher
Andrew K Godwin
Fox Chase Cancer Center · USFlorida Hospital Cancer Institute · USFred Hutch Cancer Center · USMemorial Sloan Kettering Cancer Center · USUniversity of Alabama at Birmingham · USUniversity of Pittsburgh · US

Funding

Vaccinating against IGFBP-2 to prevent ovarian cancer relapseP50CA083636 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI DRESCHER, CHARLES, URBAN, NICOLE DENISE · 1999 to 2015
$35.1M
Therapeutic Micro RNA Strategies for Ovarian CancerP50CA083638 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI GODWIN, ANDREW K., GOLEMIS, ERICA A. · 1999 to 2013
$33.6M
NCI NIH HHS P50 CA083636NCI NIH HHS P50 CA083638
6 · The paper itself

Abstract

objectivesDetermine if cetuximab dose escalation to induce grade 2 rash correlates with anti-tumor activity and if sera-based markers could predict likelihood of response.

methodsPatients with persistent/recurrent ovarian or primary peritoneal carcinoma received an initial dose of cetuximab 400 mg/m(2), then 250 mg/m(2) weekly for two 3-week cycles. Patients who had stable disease (SD) and <grade 2 rash were dose escalated in 75 mg/m(2) increments every 3 weeks until grade 2 rash or to a maximum weekly dose of 400 mg/m(2). Pre- and post-treatment serum samples were evaluated for potential predictive markers of response.

resultsOne of 25 patients achieved partial remission (PR) and 9 patients had SD. The median progression free survival was 2.1 months; the 1-year survival rate was 54.8%. Rash (96%) was the most common drug-related adverse event. At first response assessment, 4 patients remained at 250 mg/m(2); 8 patients were dose-escalated to 325 mg/m(2); of these, 4 ultimately were increased to 400 mg/m(2). Patients with progressive disease (PD) were removed from the study. Ninety-two serologic markers were analyzed from 20 patients to identify markers associated with clinical activity and/or predictive of outcome. Pretreatment levels of twelve markers were significantly elevated in patients exhibiting PD versus SD or PR; however, changes in marker levels during the course of treatment were not significant indicators of response.

conclusionsSingle-agent cetuximab showed minimal activity in patients with recurrent ovarian cancer. Patients with elevated levels of 12 serologic markers at baseline were more likely to have earlier disease progression.

Indexed as

Acneiform EruptionsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBiomarkers, TumorCetuximabDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansInfusions, IntravenousMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBiomarkers, TumorCetuximab

Identifiers

PMID19162309
PMCPMC2741166
OpenAlexW2085739259

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.