Evidence map›Paper›PMID 20117828›Full record

Trial reportGynecologic oncology2010

A phase II study of sorafenib in advanced uterine carcinoma/carcinosarcoma: a trial of the Chicago, PMH, and California Phase II Consortia.

Halla S Nimeiri, Amit M Oza, Robert J Morgan, Dezheng Huo, Laurie Elit, James A Knost, James L Wade, Edem Agamah, Everett E Vokes, Gini F Fleming

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Gynecologic oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 4 pooled it
7.5field-weighted citation impact, top 3% 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

33 citing papers in PubMed, 4 syntheses or guidelines pooled it, 96 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Review
  11. Uterine carcinosarcoma: Unraveling the role of epithelial-to-mesenchymal transition in progression and therapeutic potential.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2024
    Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Article
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 6 institutions in 2 countries.

Halla S NimeiriUniversity of Chicago Hospitals, Chicago, IL 60637, USA.
Amit M Oza
Robert J Morgan
Dezheng Huo
Laurie Elit
James A Knost
James L Wade
Edem Agamah
Everett E Vokes
Gini F Fleming
University of Chicago · USCity of Hope · USDecatur Memorial Hospital · USIllinois CancerCare · USJuravinski Cancer Centre · CAPrincess Margaret Cancer Centre · CA

Funding

VIRAL ONCOLOGY CORE FACILITYP30CA014599 · NCI · UNIVERSITY OF CHICAGO · PI MARK W. LINGEN · 1985 to 2026
$122.1M
Univ.of Calif., Irvine Cancer Center Support GrantP30CA062203 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Christine Hui · 1994 to 2026
$57.9M
REGULATION OF RADIATION-INDUCED APOPTOTIC CELL DEATHR29CA062209 · NCI · UNIVERSITY OF TEXAS MD ANDERSON CAN CTR · PI STORY, MICHAEL D · 1994 to 1998
–
NCI NIH HHS N01 CM062201NCI NIH HHS N01 CM062203NCI NIH HHS N01 CM062209NCI NIH HHS P30 CA014599
6 · The paper itself

Abstract

objectivesTo determine the efficacy and safety of single agent sorafenib, an oral multi-targeted tyrosine kinase inhibitor, in patients with advanced uterine carcinoma and carcinosarcoma.

methodsThis multi-institutional non-randomized phase II trial enrolled two cohorts: patients with uterine carcinoma (cohort A) and uterine carcinosarcoma (cohort B). Eligibility criteria included measurable disease, 0-1 prior chemotherapy regimens, and ECOG performance status <or=2. Sorafenib at a dose of 400 mg was administered orally twice daily. A cycle was defined as 28 days. Objective tumor response was the primary endpoint and was assessed following every two cycles.

resultsFifty-six patients (40 with carcinoma, 16 with carcinosarcoma) were enrolled between March 2005 and August 2007. Two (5%) patients with uterine carcinoma had a partial response (PR) and 17 (42.5%) achieved stable disease (SD). Five had SD lasting at least 4 months. The 6-month progression-free survival rate for patients with carcinoma was 29%, and the median overall survival was 11.4 months. No patients with carcinosarcoma had an objective response. Four (25%) had SD, and one had SD lasting 18 months. The 6-month progression-free survival rate was 13%, and the median overall survival was 5.0 months. Grade 3/4 drug related toxicities included: hypertension (13%), hand-foot syndrome (13%), hypophosphatemia (7%), anemia (5%), rash (5%), diarrhea (5%), thrombosis (5%), fatigue (5%) and bleeding (5%).

conclusionSorafenib had minimal activity in patients with uterine carcinoma. Predictive factors for potential benefit are needed.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsBenzenesulfonatesCarcinomaCarcinosarcomaDisease-Free SurvivalFemaleHumansMiddle AgedNeoplasm Recurrence, LocalNiacinamidePhenylurea CompoundsPyridinesSorafenibAntineoplastic AgentsBenzenesulfonatesNiacinamidePhenylurea CompoundsPyridinesSorafenib

Identifiers

PMID20117828
PMCPMC2842466
OpenAlexW1988262237

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.