Evidence map›Paper›PMID 21684583›Full record

Trial reportGynecologic oncology2011

Phase II trial of cetuximab in the treatment of persistent or recurrent squamous or non-squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study.

Alessandro D Santin, Michael W Sill, D Scott McMeekin, Mario M Leitao, Jubilee Brown, Gregory P Sutton, Linda Van Le, Patricia Griffin, Cecelia H Boardman

Registry-linked trialAbstract 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 NCT02446652 (Phase III Clinical Trial), which is not on this map. Cited by 42 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 2 pooled it
9.4field-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.

NCT02446652 phase3withdrawnnot on this mapstarted 2015, after this paper: background citation

Phase III Clinical Trial: "Evaluation of the Combination of TRANSKRIP ® Plus Carboplatin and Paclitaxel as First Line Chemotherapy on Survival of Patients With Recurrent - Persistent Cervical Cancer

TypeinterventionalSponsorNational Institute of CancerologíaRan2015 to 2018Enrolled0ConditionsCervical CancerArmsHydralazine/Magnesium, Placebo, Carboplatin, Paclitaxel
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 109 citations in OpenAlex.

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

9 authors at 9 institutions in 1 country.

Alessandro D SantinYale University School of Medicine, Department of Obstetrics, Gynecology & Reproductive Sciences, New Haven, CT 06520-8063, USA. alessandro.santin@yale.edu
Michael W Sill
D Scott McMeekin
Mario M Leitao
Jubilee Brown
Gregory P Sutton
Linda Van Le
Patricia Griffin
Cecelia H Boardman
Buffalo State University · USMemorial Sloan Kettering Cancer Center · USOklahoma City University · USSt Vincent Hospital · USThe University of Texas MD Anderson Cancer Center · USUniversity Health System · USUniversity of North Carolina at Chapel Hill · USUniversity of South Carolina Upstate · USYale 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
Treatment of Chemotherapy-Resistant Human Ovarian Cancer by Administration of CPER01CA122728 · NCI · YALE UNIVERSITY · PI SANTIN, ALESSANDRO D · 2008 to 2011
$1.4M
NCI NIH HHS CA 27469NCI NIH HHS CA 37517NCI NIH HHS R01 CA122728NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517
6 · The paper itself

Abstract

purposeThe Gynecologic Oncology Group (GOG) conducted a phase II trial to assess the efficacy and tolerability of the anti-EGFR antibody cetuximab, in persistent or recurrent carcinoma of the cervix. PATIENTS AND

methodsEligible patients had cervical cancer, measurable disease, and GOG performance status ≤2. Treatment consisted of cetuximab 400 mg/m(2) initial dose followed by 250 mg/m(2) weekly until disease progression or prohibitive toxicity. The primary endpoints were progression-free survival (PFS) at 6 months and response. The study used a 2-stage group sequential design.

resultsThirty-eight patients were entered with 3 exclusions, leaving 35 evaluable for analysis. Thirty-one patients (88.6%) received prior radiation as well as either 1 (n=25, 71.4%) or 2 (n=10) prior cytotoxic regimens. Twenty-four patients (68.6%) had a squamous cell carcinoma. Grade 3 adverse events possibly related to cetuximab included dermatologic (n=5), GI (n=4), anemia (n=2), constitutional (n=3), infection (n=2), vascular (n=2), pain (n=2), and pulmonary, neurological, vomiting and metabolic (n=1 each). No clinical responses were detected. Five patients (14.3%; two-sided 90% CI, 5.8% to 30%) survived without progression for at least 6 months. The median PFS and overall survival (OS) times were 1.97 and 6.7 months, respectively. In this study, all patients with PFS at 6 months harbored tumors with squamous cell histology.

conclusionCetuximab is well tolerated but has limited activity in this population. Cetuximab activity may be limited to patients with squamous cell histology.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsCarcinoma, Squamous CellCetuximabDisease-Free SurvivalFemaleHumansMiddle AgedNeoplasm Recurrence, LocalSurvival RateUterine Cervical NeoplasmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsCetuximab

Identifiers

PMID21684583
PMCPMC3152667
OpenAlexW1965757481

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.