Evidence map›Paper›PMID 24367492›Full record

Trial reportPloS one2013

RSF1 and not cyclin D1 gene amplification may predict lack of benefit from adjuvant tamoxifen in high-risk pre-menopausal women in the MA.12 randomized clinical trial.

Dana Keilty, Marguerite Buchanan, Katerina Ntapolias, Olga Aleynikova, Dongsheng Tu, Xiao Li, Lois Shepherd, Vivien Bramwell, Mark Basik

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.2field-weighted citation impact, top 37% 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

7 citing papers in PubMed, 10 citations in OpenAlex.

  1. CCND1 and FGFR1 gene amplifications are associated with reduced benefit from aromatase inhibitors in metastatic breast cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
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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

9 authors at 2 institutions in 1 country.

Dana KeiltyDepartment of Oncology and Surgery, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada.
Marguerite BuchananDepartment of Oncology and Surgery, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada.
Katerina NtapoliasDepartment of Pathology, Jewish General Hospital, Montreal, Quebec, Canada.
Olga AleynikovaDepartment of Pathology, Jewish General Hospital, Montreal, Quebec, Canada.
Dongsheng TuNCIC Clinical Trials Group, Cancer Research Institute, Queen's University, Ontario, Canada.
Xiao LiNCIC Clinical Trials Group, Cancer Research Institute, Queen's University, Ontario, Canada.
Lois ShepherdNCIC Clinical Trials Group, Cancer Research Institute, Queen's University, Ontario, Canada.
Vivien BramwellDepartment of Medical Oncology, Tom Baker Cancer Centre, Calgary, Alberta, Canada.
Mark BasikDepartment of Oncology and Surgery, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada.
Jewish General Hospital · CAQueen's University · CA

Funding

Canadian Institutes of Health Research
6 · The paper itself

Abstract

Most women with estrogen receptor expressing breast cancers receiving anti-estrogens such as tamoxifen may not need or benefit from them. Besides the estrogen receptor, there are no predictive biomarkers to help select breast cancer patients for tamoxifen treatment. CCND1 (cyclin D1) gene amplification is a putative candidate tamoxifen predictive biomarker. The RSF1 (remodeling and spacing factor 1) gene is frequently co-amplified with CCND1 on chromosome 11q. We validated the predictive value of these biomarkers in the MA.12 randomized study of adjuvant tamoxifen vs. placebo in high-risk premenopausal early breast cancer. Premenopausal women with node-positive/high-risk node-negative early breast cancer received standard adjuvant chemotherapy and then were randomized to tamoxifen (20 mg/day) or placebo for 5 yrs. Overall survival (OS) and relapse-free survival (RFS) were evaluated. Fluorescent in-situ hybridization was performed on a tissue microarray of 495 breast tumors (74% of patients) to measure CCND1 and RSF1 copy number. A multivariate Cox model to obtain hazard ratios (HR) adjusting for clinico-pathologic factors was used to assess the effect of these biomarkers on Os and RFS. 672 women were followed for a median of 8.4 years. We were able to measure the DNA copy number of CCND1 in 442 patients and RSF1 in 413 patients. CCND1 gene amplification was observed in 8.7% and RSF1 in 6.8% of these patients, preferentially in estrogen receptor-positive breast cancers. No statistically significant interaction with treatment was observed for either CCND1 or RSF1 amplification, although patients with high RSF1 copy number did not show benefit from adjuvant tamoxifen (HR = 1.11, interaction p = 0.09). Unlike CCND1 amplification, RSF1 amplification may predict for outcome in high-risk premenopausal breast cancer patients treated with adjuvant tamoxifen.

Indexed as

Antineoplastic Agents, HormonalBreast NeoplasmsCyclin D1HumansIn Situ Hybridization, FluorescenceNuclear ProteinsPremenopauseTamoxifenTrans-ActivatorsTreatment OutcomeAntineoplastic Agents, HormonalCCND1 protein, humanCyclin D1Nuclear ProteinsRSF1 protein, humanTamoxifenTrans-Activators

Identifiers

PMID24367492
PMCPMC3868649
OpenAlexW2089122543

What OpenQuestion holds

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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.