Evidence map›Paper›PMID 29336101›Full record

Trial reportBJOG : an international journal of obstetrics and gynaecology2018

Recurrence of vulval intraepithelial neoplasia following treatment with cidofovir or imiquimod: results from a multicentre, randomised, phase II trial (RT3VIN).

C N Hurt, Sef Jones, T-A Madden, A Fiander, A J Nordin, R Naik, N Powell, M Carucci, A Tristram

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BJOG : an international journal of obstetrics and gynaecology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.9field-weighted citation impact, top 14% 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

11 citing papers in PubMed, 35 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Vulval premalignant lesions: a review article.Obstetrics & gynecology science · 2024
    Article
  5. Article
  6. Review
  7. Host-pathogen protein-nucleic acid interactions: A comprehensive review.Computational and structural biotechnology journal · 2022
    Review
  8. Article
  9. Looking past PD-L1: expression of immune checkpoint TIM-3 and its ligand galectin-9 in cervical and vulvar squamous neoplasia.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2020
    Article
  10. Article
  11. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 2 countries.

C N HurtCentre for Trials Research, Cardiff University, Cardiff, UK.
Sef JonesSchool of Medicine, Cardiff University, Cardiff, UK.
T-A MaddenCentre for Trials Research, Cardiff University, Cardiff, UK.
A FianderCentre for Women's Global Health, Royal College of Obstetricians & Gynaecologists, London, UK.
A J NordinEast Kent Gynaecological Oncology Centre, Queen Elizabeth the Queen Mother Hospital, Margate, UK.
R NaikNorthern Gynaecological Oncology Centre, Queen Elizabeth Hospital, Gateshead, UK.
N PowellSchool of Medicine, Cardiff University, Cardiff, UK.
M CarucciCentre for Trials Research, Cardiff University, Cardiff, UK.
A TristramSchool of Medicine, Cardiff University, Cardiff, UK.
Cardiff University · GBQueen Elizabeth Hospital · GBQueen Elizabeth the Queen Mother Hospital · GBRoyal College of Obstetricians and Gynaecologists · GB

Funding

Cancer Research UK 15954Cancer Research UK 25350
6 · The paper itself

Abstract

objectiveTo compare the recurrence rates after complete response to topical treatment with either cidofovir or imiquimod for vulval intraepithelial neoplasia (VIN) 3.

designA prospective, open, randomised multicentre trial.

setting32 general hospitals located in Wales and England. POPULATION OR SAMPLE: 180 patients were randomised consecutively between 21 October 2009 and 11 January 2013, 89 to cidofoovir (of whom 41 completely responded to treatment) and 91 to imiquimod (of whom 42 completely responded to treatment).

methodsAfter 24 weeks of treatment, complete responders were followed up at 6-monthly intervals for 24 months. At each visit, the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was assessed and any new lesions were biopsied for histology.

main outcome measuresTime to histologically confirmed disease recurrence (any grade of VIN).

resultsThe median length of follow up was 18.4 months. At 18 months, more participants were VIN-free in the cidofovir arm: 94% (95% CI 78.2-98.5) versus 71.6% (95% CI 52.0-84.3) [univariable hazard ratio (HR) 3.46, 95% CI 0.95-12.60, P = 0.059; multivariable HR 3.53, 95% CI 0.96-12.98, P = 0.057). The number of grade 2+ events was similar between treatment arms (imiquimod: 24/42 (57%) versus cidofovir: 27/41 (66%), χ2 = 0.665, P = 0.415), with no grade 4+.

conclusionsLong-term data indicates a trend towards response being maintained for longer following treatment with cidofovir than with imiquimod, with similar low rates of adverse events for each drug. Adverse event rates indicated acceptable safety of both drugs TWEETABLE ABSTRACT: Long-term follow up in the RT3VIN trial suggests cidofovir may maintain response for longer than imiquimod.

Indexed as

Administration, TopicalAntineoplastic AgentsCarcinoma in SituCidofovirFemaleHumansImiquimodMiddle AgedNeoplasm Recurrence, LocalProspective StudiesTreatment OutcomeVulvar NeoplasmsAntineoplastic AgentsCidofovirImiquimodCidofovirimiquimodlong-term follow uprecurrencevulval intraepithelial neoplasia

Identifiers

PMID29336101
PMCPMC6055842
OpenAlexW2783921804

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.