Evidence map›Paper›PMID 20234364›Full record

Trial reportBritish journal of cancer2010

The effects of adding zoledronic acid to neoadjuvant chemotherapy on tumour response: exploratory evidence for direct anti-tumour activity in breast cancer.

R E Coleman, M C Winter, D Cameron, R Bell, D Dodwell, M M Keane, M Gil, D Ritchie, J L Passos-Coelho, D Wheatley and 4 more

3 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 80 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 4 pooled it
20.4field-weighted citation impact, top 1% 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.

NCT00072020 phase3unknown statusnot on this map

Does Adjuvant Zoledronic Acid Reduce Recurrence in Patients With High Risk Localized Breast Cancer?

TypeinterventionalSponsorUniversity of SheffieldRan2003ConditionsBreast Cancer, Metastatic CancerArmszoledronic acid, adjuvant therapy, neoadjuvant therapy
NCT02347163 phase2terminatednot on this mapstarted 2015, after this paper: background citation

A Multicenter, Single-arm, Phase II Study to Evaluate the Activity of Pre-operative Zoledronate in Triple Negative Breast Cancer Patients, According to p53 Level

TypeinterventionalSponsorMario Negri Institute for Pharmacological ResearchRan2015 to 2018Enrolled22ConditionsBreast CancerArmsZoledronate
NCT03358017 phase2completednot on this mapstarted 2018, after this paper: background citation

Multicenter, Randomized, Phase II Study of Neoadjuvant Chemotherapy Associated or Not With Zoledronate and Atorvastatin in Triple Negative Breast Cancers - YAPPETIZER Study

TypeinterventionalSponsorMario Negri Institute for Pharmacological ResearchRan2018 to 2023Enrolled54ConditionsTriple Negative Breast CancerArmsZoledronate, Atorvastatin 80mg, Standard neoadjuvant cht
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 4 syntheses or guidelines pooled it, 200 citations in OpenAlex.

  1. Pooled it
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  3. Bisphosphonates and other bone agents for breast cancer.The Cochrane database of systematic reviews · 2017
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  19. Recycling the Purpose of Old Drugs to Treat Ovarian Cancer.International journal of molecular sciences · 2020
    Review
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20 more citing papers are in PubMed but not listed here.

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

14 authors at 8 institutions in 4 countries.

R E ColemanAcademic Unit of Clinical Oncology, Weston Park Hospital, University of Sheffield, Sheffield, UK. r.e.coleman@sheffield.ac.uk
M C Winter
D Cameron
R Bell
D Dodwell
M M Keane
M Gil
D Ritchie
J L Passos-Coelho
D Wheatley
R Burkinshaw
S J Marshall
H Thorpe
AZURE (BIG01/04) Investigators
University of Leeds · GBLeeds Teaching Hospitals NHS Trust · GBRoyal Cornwall Hospital · GBBeatson West of Scotland Cancer Centre · GBInstituto Português de Oncologia de Coimbra Francisco Gentil · PTUniversity Hospital Galway · IEUniversity of Sheffield · GBWeston Park Cancer Centre · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPre-clinical studies have demonstrated synergistic anti-tumour effects of chemotherapy (CT) and zoledronic acid (ZOL). Within the AZURE trial, designed to determine whether the addition of ZOL to neoadjuvant therapy improves disease outcomes, a subgroup received neoadjuvant CT. We report a retrospective evaluation comparing pathological response in the primary tumour between treatment groups.

methodsIn total, 205 patients received neoadjuvant CT+/-ZOL (CT+ZOL, n=102; CT, n=103). The primary end point was pathologically assessed residual invasive tumour size (RITS) at surgery. Secondary end points were pathological complete response (pCR) rate and axillary nodal involvement. Following review of surgical pathology reports (n=195), outcome differences between groups were assessed adjusting for potential response modifiers.

resultsBaseline characteristics and CT treatments were similar. In multivariate analysis, allowing for biological and clinical factors known to influence tumour response, the adjusted mean RITS in CT and CT+ZOL groups were 27.4 and 15.5 mm, respectively, giving a difference in means of 12 mm (95% confidence interval: 3.5-20.4 mm; P=0.006). The pCR rate was 6.9% in the CT group and 11.7% in the CT+ZOL group (P=0.146). There was no difference in axillary nodal involvement (P=0.6315).

conclusionThese data suggest a possible direct anti-tumour effect of ZOL in combination with CT, warranting formal evaluation in prospective studies.

Indexed as

Neoadjuvant TherapyAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDiphosphonatesFemaleHumansImidazolesMiddle AgedMultivariate AnalysisNeoplasm, ResidualZoledronic AcidDiphosphonatesImidazolesZoledronic Acid

Identifiers

PMID20234364
PMCPMC2853093
OpenAlexW2077073060

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.