Evidence map›Paper›PMID 21329967›Full record

Trial reportGynecologic oncology2011

Phase II study of cisplatin plus cetuximab in advanced, recurrent, and previously treated cancers of the cervix and evaluation of epidermal growth factor receptor immunohistochemical expression: a Gynecologic Oncology Group study.

John Farley, Michael W Sill, Michael Birrer, Joan Walker, Russell J Schilder, J Tate Thigpen, Robert L Coleman, Brigitte E Miller, Peter G Rose, Heather A Lankes

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Gynecologic oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00101192 (A Limited Access Phase II Trial of Cetuximab), which is not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
10.0field-weighted citation impact, top 2% 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.

NCT00101192 phase2completednot on this map

A Limited Access Phase II Trial of Cetuximab (C225, NSC #714692) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix

TypeinterventionalSponsorGynecologic Oncology GroupRan2004Enrolled76ConditionsCervical CancerArmscetuximab, cisplatin
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it, 95 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Review
  9. The Use of Targeted Agents in the Treatment of Gynecologic Cancers.Current treatment options in oncology · 2022
    Review
  10. Article
  11. Review
  12. Updates on systemic therapy for cervical cancer.The Indian journal of medical research · 2021
    Review
  13. Review
  14. Immunotherapy in Cervical Cancer.Current oncology reports · 2021
    Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. AnOncoTargets and therapy · 2020
    Article
  20. EGFRJournal of oncology · 2019
    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

10 authors at 9 institutions in 1 country.

John FarleyDepartment of Obstetrics and Gynecology, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA. john.farley@us.army.mil
Michael W Sill
Michael Birrer
Joan Walker
Russell J Schilder
J Tate Thigpen
Robert L Coleman
Brigitte E Miller
Peter G Rose
Heather A Lankes
Roswell Park Comprehensive Cancer Center · USCleveland Clinic · USFox Chase Cancer Center · USMassachusetts General Hospital · USThe University of Texas MD Anderson Cancer Center · USUniformed Services University of the Health Sciences · USUniversity of Mississippi · USUniversity of Oklahoma Health Sciences Center · USWake Forest University · 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
GYNECOLOGIC ONCOLOGY GROUPU10CA101165 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 2003 to 2014
$43.1M
NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA101165
6 · The paper itself

Abstract

backgroundThe purpose of this study was to evaluate the safety and efficacy of cetuximab (C225), an antibody that inhibits epidermal growth factor receptor (EGFR) activity, with cisplatin and to explore associations between EGFR protein expression with patient demographics or clinical outcome.

methodsWomen with advanced, persistent, or recurrent carcinoma of the cervix were eligible. The women received cisplatin at 30mg/m(2) on days 1 and 8 with a loading dose of cetuximab at 400mg/m(2) followed by 250mg/m(2) on days 1, 8, and 15 in a 21day cycle. Adverse events were assessed with CTCAE v 3.0. Primary measure of efficacy was tumor response by RECIST. The study was stratified by prior chemotherapy (CT). EGFR protein expression in pre-treatment tumor was analyzed by immunohistochemistry.

resultsBetween September 2004 and March 2008, 76 patients were enrolled. Of these, 69 were eligible and evaluable; 44 (64%) received prior chemotherapy. There were 4 responses in each group, prior chemotherapy and no chemotherapy, 9% and 16%, respectively. Grade 4 toxicities included anemia (1), allergy (1), metabolic (1), and vascular (1). The most common grade 3 toxicities were metabolic (15), dermatologic (8), fatigue (6), and gastrointestinal (6). EGFR protein was expressed in 47/48 (98%) of tumors analyzed with a median cellular expression of 81%. Exploratory analyses revealed a trend between the percentage of cells expressing EGFR protein and PFS (hazard ratio=1.76, 95% confidence interval=0.96-3.21).

conclusionsThe combination of cetuximab with cisplatin was adequately tolerated but did not indicate additional benefit beyond cisplatin therapy.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCetuximabCisplatinDisease-Free SurvivalErbB ReceptorsFemaleHumansImmunohistochemistryMiddle AgedNeoplasm Recurrence, LocalUterine Cervical NeoplasmsYoung AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCetuximabCisplatinEGFR protein, humanErbB Receptors

Identifiers

PMID21329967
PMCPMC3081894
OpenAlexW1986440851

What OpenQuestion holds

Textmetadata
LicenceTDM
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.