Evidence map›Paper›PMID 29425304›Full record

Trial reportJournal of the National Cancer Institute2018

Associations Between Serum Bone Biomarkers in Early Breast Cancer and Development of Bone Metastasis: Results From the AZURE (BIG01/04) Trial.

Janet Brown, Emma Rathbone, Samantha Hinsley, Walter Gregory, Fatma Gossiel, Helen Marshall, Roger Burkinshaw, Helen Shulver, Hasina Thandar, Gianfilippo Bertelli and 6 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the National Cancer Institute, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 11% 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

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
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  5. Review
  6. Article
  7. Article
  8. Observational
  9. Article
  10. Review
  11. Organ-Specificity of Breast Cancer Metastasis.International journal of molecular sciences · 2023
    Review
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  13. Article
  14. Review
  15. Article
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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 at 10 institutions in 3 countries.

Janet BrownAcademic Unit of Clinical Oncology and Sheffield ECMC, University of Sheffield, Weston Park Hospital, Sheffield, UK.
Emma RathboneAcademic Unit of Clinical Oncology and Sheffield ECMC, University of Sheffield, Weston Park Hospital, Sheffield, UK.
Samantha HinsleyClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Walter GregoryClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Fatma GossielAcademic Unit of Bone Metabolism, Metabolic Bone Centre, University of Sheffield, Northern General Hospital, Sheffield, UK.
Helen MarshallClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Roger BurkinshawAcademic Unit of Clinical Oncology and Sheffield ECMC, University of Sheffield, Weston Park Hospital, Sheffield, UK.
Helen ShulverAcademic Unit of Clinical Oncology and Sheffield ECMC, University of Sheffield, Weston Park Hospital, Sheffield, UK.
Hasina ThandarRoyal Surrey County Hospital, Guildford, UK.
Gianfilippo BertelliSingleton Hospital, Swansea, UK.
Keane MacconCancer Trials Ireland, University College Hospital, Galway, Ireland.
Angela BowmanUniversity of Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, UK.
Andrew HanbyLeeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.
Richard BellDeakin University, Geelong, Australia.
David CameronUniversity of Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, UK.
Robert ColemanAcademic Unit of Clinical Oncology and Sheffield ECMC, University of Sheffield, Weston Park Hospital, Sheffield, UK.
University of Leeds · GBUniversity of Sheffield · GBWeston Park Cancer Centre · GBCalderdale and Huddersfield NHS Foundation Trust · GBDeakin University · AUEdinburgh Cancer Research · GBRoyal Surrey County Hospital · GBSingleton Hospital · GBUniversity Hospital Galway · IEWestern General Hospital · GB

Funding

Cancer Research UK 10048
6 · The paper itself

Abstract

Background: Adjuvant therapies can prevent/delay bone metastasis development in breast cancer. We investigated whether serum bone turnover markers in early disease have clinical utility in identifying patients with a high risk of developing bone metastasis. Methods: Markers of bone formation (N-terminal propeptide of type-1 collagen [P1NP]) and bone resorption (C-telopeptide of type-1 collagen [CTX], pyridinoline cross-linked carboxy-terminal telopeptide of type-1 collagen [1-CTP]) were measured in baseline (pretreatment blood samples from 872 patients from a large randomized trial of adjuvant zoledronic acid (AZURE-ISRCTN79831382) in early breast cancer. Cox proportional hazards regression and cumulative incidence functions (adjusted for factors having a statistically significant effect on outcome) were used to investigate prognostic and predictive associations between recurrence events, bone marker levels, and clinical variables. All statistical tests were two-sided. Results: When considered as continuous variables (log transformed), P1NP, CTX, and 1-CTP were each prognostic for future bone recurrence at any time (P = .006, P = .009, P = .008, respectively). Harrell's c-indices were a P1NP of 0.57 (95% confidence interval [CI] = 0.51 to 0.63), CTX of 0.57 (95% CI = 0.51 to 0.62), and 1-CTP of 0.57 (95% CI = 0.52 to 0.63). In categorical analyses based on the normal range, high baseline P1NP (>70 ng/mL) and CTX (>0.299 ng/mL), but not 1-CTP (>4.2 ng/mL), were also prognostic for future bone recurrence (P = .03, P = .03, P = .10, respectively). None of the markers were prognostic for overall distant recurrence; that is, they were bone metastasis specific, and none of the markers were predictive of treatment benefit from zoledronic acid. Conclusions: Serum P1NP, CTX, and 1-CTP are clinically useful, easily measured markers that show good prognostic ability (though low-to-moderate discrimination) for bone-specific recurrence and are worthy of further study.

Indexed as

Biomarkers, TumorBone and BonesBone DevelopmentBone NeoplasmsBone RemodelingBreast NeoplasmsChemotherapy, AdjuvantDisease ProgressionEarly Detection of CancerFemaleHumansInfusions, IntravenousMiddle AgedPrognosisStandard of CareUnited KingdomBiomarkers, TumorZoledronic Acid

Identifiers

PMID29425304
PMCPMC6093369
OpenAlexW2787163472

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.