Evidence map›Paper›PMID 29739622›Full record

Trial reportGynecologic oncology2018

Phase II study of single-agent cabozantinib in patients with recurrent clear cell ovarian, primary peritoneal or fallopian tube cancer (NRG-GY001).

Panagiotis A Konstantinopoulos, William E Brady, John Farley, Amy Armstrong, Denise S Uyar, David M Gershenson

Abstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gynecologic oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

32 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  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

6 authors.

Panagiotis A KonstantinopoulosGynecologic Medical Oncology Program, Dana-Farber Cancer Institute, Boston, MA, United States. Electronic address: Panagiotis_Konstantinopoulos@DFCI.Harvard.edu.
William E BradyNRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Cancer Institute, Buffalo, NY, United States. Electronic address: bbrady@gogstats.org.
John FarleyDepartment of Obstetrics & Gynecology, Uniformed Serviced University of the Health Sciences, Bethesda, MD, United States. Electronic address: John.Farley@DignityHealth.org.
Amy ArmstrongObstetrics and Gynecology, CWRU School of Medicine, Cleveland, OH, United States. Electronic address: Amy.Armstrong@UHhospitals.org.
Denise S UyarGynecologic Oncology, Medical School of Wisconsin, Milwaukee, WI 53226, United States. Electronic address: duyar@mcw.edu.
David M GershensonDepartment of Gynecologic Oncology & Reproductive Medicine, Unit 1362, The University of Texas, MD Anderson Cancer Center, Houston, TX, United States. Electronic address: dgershen@mdanderson.org.

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868
6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and tolerability of cabozantinib in recurrent clear cell ovarian, primary peritoneal or fallopian tube cancer.

methodsPatients with recurrent ovarian, fallopian or primary peritoneal tumors with at least 50% clear cell histomorphology, measurable disease, one or two prior regimens and ECOG performance status 0-2 received cabozantinib 60 mg orally once daily continuously, in 4-week cycles until disease progression or unacceptable toxicity. Primary endpoints were progression-free survival (PFS) at six months and complete or partial tumor response (as assessed by RECIST 1.1). Secondary endpoints included toxicity, PFS, and overall survival (OS).

resultsOver 19 months, 13 patients were accrued. Fifty-four percent of patients were ≥60 years of age. Performance statuses of 0 and 1 comprised 8 and 5 patients. No objective tumor responses were seen. Three (23% [95% CI: 5%, 54%]) of 13 patients had PFS ≥6 months, including one patient who received cabozantinib for 23 cycles and was still on treatment as of the data cut-off date. Median PFS and OS were 3.6 and 8.1 months, respectively. There was one patient with a grade 5 event: a thromboembolic event considered possibly related to study therapy; patient's cause of death was determined to be due to disease and protocol treatment. Four other patients had thromboembolic events (two grade 3 and one each grade 1 and grade 2). Other grade 3 or higher events reported in two or more patients were nausea, vomiting, fatigue, dyspnea, and dehydration.

conclusionsCabozantinib demonstrated minimal activity in the second- and third-line treatments of clear cell ovarian, fallopian tube or primary peritoneal carcinoma.

Indexed as

Adenocarcinoma, Clear CellAdultAgedAnilidesFallopian Tube NeoplasmsFemaleHumansMiddle AgedOvarian NeoplasmsPeritoneal NeoplasmsPyridinesAnilidescabozantinibPyridinesAnti-angiogenic therapyCabozantinibClear cell ovarian cancerMET inhibition

Identifiers

PMID29739622
PMCPMC6365003

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.