Evidence map›Paper›PMID 24351403›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2014

Association of molecular subtypes with Ki-67 changes in untreated breast cancer patients undergoing pre-surgical trials.

S Gandini, A Guerrieri-Gonzaga, G Pruneri, D Serrano, M Cazzaniga, M Lazzeroni, P Veronesi, H Johansson, B Bonanni, G Viale and 1 more

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.3field-weighted citation impact, top 20% 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

16 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
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  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Biomarkers Associated With Tumor Ki67 andFrontiers in oncology · 2020
    Article
  11. Review
  12. Article
  13. Correlation Factors Analysis of Breast Cancer Tumor Volume Doubling Time Measured by 3D-Ultrasound.Medical science monitor : international medical journal of experimental and clinical research · 2017
    Article
  14. Article
  15. Article
  16. 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

11 authors at 3 institutions in 2 countries.

S GandiniDivisions of Epidemiology and Biostatistics.
A Guerrieri-GonzagaCancer Prevention and Genetics.
G PruneriPathology; School of Medicine, University of Milan, Milan.
D SerranoCancer Prevention and Genetics.
M CazzanigaCancer Prevention and Genetics.
M LazzeroniCancer Prevention and Genetics.
P VeronesiBreast Surgery, European Institute of Oncology, Milan; School of Medicine, University of Milan, Milan.
H JohanssonCancer Prevention and Genetics.
B BonanniCancer Prevention and Genetics.
G VialePathology; School of Medicine, University of Milan, Milan.
A DeCensiCancer Prevention and Genetics; Division of Medical Oncology, Department of Medicine, Galliera Hospital, Genoa, Italy. Electronic address: andrea.decensi@galliera.it.
University of Milan · ITCancer Research And Biostatistics · USEnte Ospedaliero Ospedali Galliera · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundKi-67 is increasingly being used as a response biomarker in window of opportunity, pre-surgical trials for breast cancer patients. Since Ki-67 is often higher at surgery than at baseline core biopsy in subjects allocated to placebo, we investigated which factors affected this change. PATIENTS AND

methodsWe retrieved data from 274 patients who received no active treatment in three consecutive pre-surgical trials from a single institution. We assessed the association between changes in Ki-67 from diagnostic biopsy to surgical specimen and the following factors: age, body mass index, tumor prognostic and predictive factors, including immunohistochemical molecular subtype, number and size of biopsy specimens, time from biopsy to surgery, circulating insulin-like growth factor-I, sex hormone-binding globulin and hsCRP.

resultsA total of 269 patients with paired measures of Ki-67 at biopsy and surgery were analyzed. Overall, the mean (±SD) change was 2.2 ± 9.2% after a median interval of 41 days (inter-quartile range 33-48). Molecular subtype was the only factor associated with a significant change of Ki-67 (P = 0.004), with a mean absolute increase of 5.3% [95% confidence interval (CI): 2.3-8.3, P = 0.0005] in estrogen receptor-negative HER2-positive tumors (n = 36) and 5.4% (95% CI: 2.9-7.9, P < 0.0001) in triple-negative tumors (n = 78). No significant change in luminal-A (n = 46), luminal-B (n = 85) and luminal-B HER2-positive (n = 24) tumors was observed.

conclusionsA significant increase in Ki-67 from baseline biopsy to end point surgery in untreated subjects was ascertained in HER2-positive and triple-negative tumors. This biological association suggests a real increase in cancer proliferation, possibly as a result of a biopsy-driven wound healing effect, and should be considered in the design and interpretation of pre-surgical studies. REGISTERED CLINICAL TRIAL NUMBERS: ISRCTN86894592; ISRCTN16493703.

Indexed as

Molecular TypingBiomarkers, TumorBiopsyBody Mass IndexCell ProliferationErb-b2 Receptor Tyrosine KinasesFemaleHumansInsulin-Like Growth Factor IKi-67 AntigenNeoadjuvant TherapyPlacebosPrognosisReceptors, EstrogenReceptors, ProgesteroneSex Hormone-Binding GlobulinBiomarkers, TumorErb-b2 Receptor Tyrosine KinasesInsulin-Like Growth Factor IKi-67 AntigenPlacebosReceptors, EstrogenReceptors, ProgesteroneSex Hormone-Binding GlobulinKi 67 antigenmolecular subtype breast cancerneoadjuvant treatment breast cancertriple-negative breast cancerwindow of opportunity

Identifiers

PMID24351403
PMCPMC4433505
OpenAlexW2162755162

What OpenQuestion holds

Textmetadata
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.