Evidence map›Paper›PMID 29527009›Full record

Trial reportBritish journal of cancer2018

Phase II study of everolimus (RAD001) monotherapy as first-line treatment in advanced biliary tract cancer with biomarker exploration: the RADiChol Study.

David K Lau, Rebecca Y Tay, Yvonne H Yeung, Fiona Chionh, Jennifer Mooi, Carmel Murone, Effie Skrinos, Timothy J Price, John M Mariadason, Niall C Tebbutt

Open access · bronzeAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
5.4field-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

30 citing papers in PubMed, 43 citations in OpenAlex.

  1. Review
  2. Review
  3. Hepatocellular carcinoma: signaling pathways and therapeutic advances.Signal transduction and targeted therapy · 2025
    Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Combination Therapies for Advanced Biliary Tract Cancer.Journal of clinical and translational hepatology · 2023
    Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Evaluation of a Dual PI3K/mTOR Inhibitor PF-04691502 against Bladder Cancer Cells.Evidence-based complementary and alternative medicine : eCAM · 2022
    Article
  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

10 authors at 3 institutions in 1 country.

David K LauOlivia Newton-John Cancer Research Institute, Melbourne, VIC, Australia.
Rebecca Y TayDept of Medical Oncology, Olivia Newton-John Cancer Wellness and Research Centre, Austin Health, Melbourne, VIC, Australia.
Yvonne H YeungOlivia Newton-John Cancer Research Institute, Melbourne, VIC, Australia.
Fiona ChionhOlivia Newton-John Cancer Research Institute, Melbourne, VIC, Australia.
Jennifer MooiOlivia Newton-John Cancer Research Institute, Melbourne, VIC, Australia.
Carmel MuroneOlivia Newton-John Cancer Research Institute, Melbourne, VIC, Australia.
Effie SkrinosDept of Medical Oncology, Olivia Newton-John Cancer Wellness and Research Centre, Austin Health, Melbourne, VIC, Australia.
Timothy J PriceThe Queen Elizabeth Hospital and University of Adelaide, Woodville, SA, Australia.
John M MariadasonOlivia Newton-John Cancer Research Institute, Melbourne, VIC, Australia. john.mariadason@onjcri.org.au.
Niall C TebbuttOlivia Newton-John Cancer Research Institute, Melbourne, VIC, Australia. niall.tebbutt@onjcri.org.au.
Olivia Newton-John Cancer Wellness & Research Centre · AULa Trobe University · AUQueen Elizabeth Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdvanced biliary tract cancers (BTCs) have a poor prognosis and limited treatment options. This exploratory phase II study aimed to evaluate the activity of the mTOR inhibitor everolimus in advanced BTC and explore prognostic biomarkers.

methodsPatients with advanced BTCs, who had not received chemotherapy for advanced disease, were enroled to receive everolimus (10 mg daily). The primary endpoint was disease control rate (DCR) at 12 weeks. Secondary endpoints included overall response rate, progression-free survival (PFS), overall survival (OS) and adverse events. Activation status of the RAS and phosphatidylinositol 3-kinase (PI3K)/AKT/mTOR pathways was assessed by DNA sequencing and immunohistochemistry on archival tumour tissue.

resultsThe study enroled 27 patients and the DCR at 12 weeks was 48%. Median PFS was 5.5 months (95% confidence interval (CI): 2.1-10.0 months) and median OS was 9.5 months (95% CI: 5.5-16.6 months). DCR at 12 weeks was significantly worse for gall bladder carcinoma compared to other anatomical sites, and there was a trend towards a worsened PFS and OS. Treatment was well tolerated. KRAS (12%) and PIK3CA mutations (12%) were uncommon. Immunohistochemical staining for PI3K/AKT/mTOR pathways did not significantly correlate with outcome.

conclusionIn unselected patients, everolimus demonstrated clinical activity as first-line monotherapy in advanced BTC.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overBiliary Tract NeoplasmsBiomarkers, TumorDisease ProgressionEverolimusFemaleHumansMaleMiddle AgedNeoadjuvant TherapySurvival AnalysisBiomarkers, TumorEverolimus

Identifiers

PMID29527009
PMCPMC5931084
OpenAlexW2789293879

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.