Evidence map›Paper›PMID 19811811›Full record

Trial reportGynecologic oncology2009

Sunitinib malate in the treatment of recurrent or persistent uterine leiomyosarcoma: a Gynecologic Oncology Group phase II study.

Martee L Hensley, Michael W Sill, Dennis R Scribner, Jubilee Brown, Robert L Debernardo, Ellen M Hartenbach, Carolyn K McCourt, James R Bosscher, Paola A Gehrig

Abstract readClinical Trial, Phase IIMulticenter Study
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 38 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 3 pooled it
6.0field-weighted citation impact, top 4% 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

38 citing papers in PubMed, 3 syntheses or guidelines pooled it, 89 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Regorafenib for the Treatment of Sarcoma.Current treatment options in oncology · 2022
    Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Uterine sarcoma - current perspectives.International journal of women's health · 2017
    Review
  17. Review
  18. Article
  19. Article
  20. The role of adjuvant therapy in uterine leiomyosarcoma.Expert review of anticancer therapy · 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

9 authors at 9 institutions in 1 country.

Martee L HensleyMemorial Sloan-Kettering Cancer Center, Department of Medical Oncology, 1275 York Avenue, New York, NY 10065, USA. hensleym@mskcc.org
Michael W Sill
Dennis R Scribner
Jubilee Brown
Robert L Debernardo
Ellen M Hartenbach
Carolyn K McCourt
James R Bosscher
Paola A Gehrig
Buffalo State University · USCarilion Clinic · USMemorial Sloan Kettering Cancer Center · USSt. John's Hospital · USThe University of Texas MD Anderson Cancer Center · USUniversity Hospitals Case Medical Center · USUniversity of North Carolina at Chapel Hill · USUW Health University Hospital · USWomen & Infants Hospital of Rhode Island · 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
NCI NIH HHS CA 27469NCI NIH HHS CA 37517NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517
6 · The paper itself

Abstract

purposeNew agents are needed for patients with metastatic uterine leiomyosarcoma who progress after treatment with doxorubicin or gemcitabine-docetaxel. Agents targeting tumor vasculature have potential for activity in leiomyosarcoma. We aimed to assess the activity of sunitinib in patients with recurrent uterine leiomyosarcoma who had received one or two prior therapies by determining the frequency of patients who survived progression-free for at least 6 months or who achieved objective tumor response. We also aimed to characterize the toxicity of sunitinib and to estimate time-to-progression. PATIENTS AND

methodsEligible patients with uterine leiomyosarcoma were treated with sunitinib 50 mg by mouth daily for 4 weeks, with 2 weeks rest. Tumor response and progression-free status were assessed every 6 weeks.

resultsTwenty-three of 25 patients enrolled were evaluable for efficacy (two wrong histologies). The median number of cycles was one. Two of 23 patients achieved a partial response (8.7%, 90% two-sided, binomial confidence interval (CI) 1.6-24.9%). Four patients remained progression-free at 6 months (17.4%, 90% two-sided, binomial confidence interval 6.2-35.5%). Toxicities included: grade 3 neutropenia (17.4%); grade 3 thrombocytopenia (13%); grade 3 anemia (17.4%); grades 3-4 lymphopenia (8.7%); grades 3-4 fatigue (30%); grade 3 vomiting/diarrhea (21.7%); skin rash/hand-foot syndrome, grade 2 (13%), grade 3 (4.3%); hypertension, grade 2 (39%), grade 3 (4.3%); grade 2 decrease in cardiac ejection fraction (4.3%), and grade 3 thrombosis (4.3%) Median progression-free survival (PFS) was 1.5 months.

conclusionSunitinib fails to achieve sufficient objective response or sustained disease stabilization as second- or third-line treatment for uterine leiomyosarcoma.

Indexed as

AdultAgedAngiogenesis InhibitorsAntineoplastic AgentsDisease-Free SurvivalFemaleHumansIndolesLeiomyosarcomaMiddle AgedNeoplasm Recurrence, LocalPyrrolesSunitinibUterine NeoplasmsAngiogenesis InhibitorsAntineoplastic AgentsIndolesPyrrolesSunitinib

Identifiers

PMID19811811
PMCPMC2783261
OpenAlexW2030541266

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.