Evidence map›Paper›PMID 23403817›Full record

Trial reportBritish journal of cancer2013

Ridaforolimus as a single agent in advanced endometrial cancer: results of a single-arm, phase 2 trial.

N Colombo, D S McMeekin, P E Schwartz, C Sessa, P A Gehrig, R Holloway, P Braly, D Matei, A Morosky, P F Dodion and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00122343 (A Phase II Study of AP23573, an mTOR Inhibitor, in Female Adult Patients With Recurrent or Persistent Endometrial Cancer), which is not on this map. Cited by 49 papers.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed
–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.

NCT00122343 phase2completednot on this map

A Phase II Study of AP23573, an mTOR Inhibitor, in Female Adult Patients With Recurrent or Persistent Endometrial Cancer

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2005 to 2008Enrolled45ConditionsEndometrial CancerArmsridaforolimus
3 · Its place in the literature

Who cites it

49 citing papers in PubMed.

  1. Trial
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  6. Phase II study of everolimus and letrozole in patients with recurrent endometrial carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015
    Trial
  7. Trial
  8. Trial
  9. Review
  10. Review
  11. Review
  12. Transcriptomic analysis revealsOncology letters · 2024
    Article
  13. Review
  14. Management of endometrial cancer in Latin America: raising the standard of care and optimizing outcomes.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2024
    Review
  15. Review
  16. Review
  17. Review
  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

12 authors.

N ColomboDivision of Gynecology, University of Milan-Bicocca, Milano, Italy. nicoletta.colombo@ieo.it
D S McMeekin
P E Schwartz
C Sessa
P A Gehrig
R Holloway
P Braly
D Matei
A Morosky
P F Dodion
M H Einstein
F Haluska

Funding

Expanded Phase II Trial of Carraguard for Prevention of HPV InfectionR01CA148966 · NCI · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI EINSTEIN, MARK H. · 2010 to 2015
$3.2M
NCI NIH HHS R01 CA148966
6 · The paper itself

Abstract

backgroundThis open-label, multicentre, phase 2 trial evaluated the efficacy and tolerability of the mammalian target of rapamycin inhibitor ridaforolimus in women with advanced endometrial cancer.

methodsWomen with measurable recurrent or persistent endometrial cancer and documented disease progression were treated with ridaforolimus 12.5 mg intravenously once daily for 5 consecutive days every 2 weeks in a 4-week cycle. The primary end point was clinical benefit response, defined as an objective response or prolonged stable disease of 16 weeks or more.

resultsIn all, 45 patients were treated with single-agent ridaforolimus. Clinical benefit was achieved by 13 patients (29%), including 5 (11%) with confirmed partial responses and 8 (18%) with prolonged stable disease. All patients with clinical benefit response received ridaforolimus for more than 4 months. In this heavily pretreated population, the 6-month progression-free survival was 18%. Ridaforolimus was generally well tolerated: adverse events were predictable and manageable, consistent with prior studies in other malignancies. Overall, the most common adverse events were diarrhoea (58%) and mouth sores (56%); most common grade 3 or higher adverse events were anaemia (27%) and hyperglycaemia (11%).

conclusionSingle-agent ridaforolimus has antitumor activity and acceptable tolerability in advanced endometrial cancer patients. Further clinical evaluation of ridaforolimus is warranted.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, AlkylatingDisease-Free SurvivalDrug Administration ScheduleEndometrial NeoplasmsFemaleHumansMiddle AgedRetreatmentSirolimusTOR Serine-Threonine KinasesAntineoplastic Agents, AlkylatingMTOR protein, humanridaforolimusSirolimusTOR Serine-Threonine Kinases

Identifiers

PMID23403817
PMCPMC3619076

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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.