Evidence map›Paper›PMID 39516358›Full record

ArticleBJC reports2023

Fulvestrant plus vandetanib versus placebo for the treatment of patients with metastatic breast cancer resistant to aromatase inhibitor therapy (FURVA): a multicentre, Phase 2, randomised controlled trial.

Mark Beresford, Angela Casbard, Zoe Hudson, Margherita Carucci, Kate Ingarfield, Julia Gee, Joanna Smith, Terri Kitson, Fouad Alchami, Tracie-Ann Madden and 6 more

Registry-linked trialAbstract read
In one paragraph

Article in BJC reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02530411 (A Randomised Double Blind Placebo Controlled Phase II Study of Fulvestrant With or Without the Addition of Vandetanib as Treatment for Patients With Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT02530411 phase2unknown statusnot on this map

A Randomised Double Blind Placebo Controlled Phase II Study of Fulvestrant With or Without the Addition of Vandetanib as Treatment for Patients With Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy

TypeinterventionalSponsorVelindre NHS TrustRan2015 to 2020Enrolled160ConditionsNeoplasmsArmsFulvestrant, Vandetanib
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

16 authors.

Mark BeresfordRoyal United Hospitals Bath NHS Foundation Trust, Bath, UK. mark.beresford@nhs.net.
Angela CasbardCentre for Trials Research, Cardiff University, Cardiff, UK.
Zoe HudsonSchool of Pharmacy & Pharmaceutical Sciences, Cardiff University, Cardiff, UK.
Margherita CarucciCentre for Trials Research, Cardiff University, Cardiff, UK.
Kate IngarfieldCentre for Trials Research, Cardiff University, Cardiff, UK.
Julia GeeSchool of Pharmacy & Pharmaceutical Sciences, Cardiff University, Cardiff, UK.
Joanna SmithCentre for Trials Research, Cardiff University, Cardiff, UK.
Terri KitsonCentre for Trials Research, Cardiff University, Cardiff, UK.
Fouad AlchamiDepartment of Cellular Pathology, Cardiff & Vale University Health Board, Cardiff, UK.
Tracie-Ann MaddenCentre for Trials Research, Cardiff University, Cardiff, UK.
Larrie HaywardEdinburgh Cancer Centre, NHS Lothian, Edinburgh, UK.
David HwangRoyal Devon and Exeter Foundation NHS Trust, Exeter, UK.
Saiqa SpensleyMusgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, Taunton, UK.
Simon WatersVelindre Cancer Centre, Velindre University NHS Trust, Cardiff, UK.
Duncan WheatleyRoyal Cornwall Hospital, Royal Cornwall Hospitals NHS Trust, Cornwall, UK.
Robert H JonesSchool of Pharmacy & Pharmaceutical Sciences, Cardiff University, Cardiff, UK.

Funding

Cancer Research UK 17880
6 · The paper itself

Abstract

backgroundFURVA, a randomised, double-blind Phase II trial, investigated whether the addition of vandetanib to fulvestrant improved progression-free survival (PFS) in patients with an aromatase inhibitor(AI)-resistant advanced breast cancer.

methodsPostmenopausal women with oestrogen receptor-positive (ER+ve)/HER2-negative advanced breast cancer, who experienced disease progression on an AI, were randomised (1:1) to fulvestrant 500 mg (Q28) with vandetanib 300 mg od (f + v) or placebo (f + p) until disease progression or discontinuation. The primary endpoint was PFS; secondary endpoints included overall survival (OS) and the influence of REarranged during Transfection (RET) signalling on outcomes.

resultsIn total, 165 participants were randomised to f + v (n = 80) or f + p (n = 85). Median PFS was 5.5 months (m) for f + v compared to 5.5 m for f + p (hazard ratio (HR) 0.88; 95% CI: 0.62-1.23; P = 0.22). Unexpectedly, high total RET expression was associated with a PFS advantage of 8.87 m vs 3.94 with low RET (HR 0.493: 95% CI 0.32-0.77; P = 0.002) independent of the treatment arm, supported by an OS advantage 21.95 m vs 18.04 (HR 0.584; 95% CI 0.34-1.00; P = 0.051) in the high-RET group.

conclusionThe addition of vandetanib to fulvestrant does not improve PFS. However, high total RET expression was associated with improved PFS, suggesting RET may have a prognostic role in patients treated with fulvestrant. CLINICAL

trial registrationClinicalTrials.gov, NCT02530411.

Identifiers

PMID39516358
PMCPMC11523984

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