Evidence map›Paper›PMID 30242578›Full record

Trial reportBreast cancer research and treatment2019

Validation of the 21-gene test as a predictor of clinical response to neoadjuvant hormonal therapy for ER+, HER2-negative breast cancer: the TransNEOS study.

Hiroji Iwata, Norikazu Masuda, Yutaka Yamamoto, Tomomi Fujisawa, Tatsuya Toyama, Masahiro Kashiwaba, Shoichiro Ohtani, Naruto Taira, Takehiko Sakai, Yoshie Hasegawa and 12 more

Open access · hybridAbstract readClinical Trial, Phase IIIValidation Study
In one paragraph

Trial report in Breast cancer research and treatment, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 2 pooled it
3.7field-weighted citation impact, top 6% 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

55 citing papers in PubMed, 2 syntheses or guidelines pooled it, 98 citations in OpenAlex.

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  20. Neoadjuvant systemic therapy for breast cancer.The British journal of surgery · 2023
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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

22 authors at 14 institutions in 2 countries.

Hiroji IwataAichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-0021, Japan. hiwata@aichi-cc.jp.ORCID http://orcid.org/0000-0002-0242-4718
Norikazu MasudaNHO Osaka National Hospital, 2-1-14 Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan.
Yutaka YamamotoKumamoto University, 1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.
Tomomi FujisawaGunma Prefectural Cancer Center, 617-1 Takahayashinishi-cho, Ota, Gunma, 373-8550, Japan.
Tatsuya ToyamaNagoya City University Graduate School of Medical Science, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan.
Masahiro KashiwabaSagara Hospital, 3-31 Matsubara-cho, Kagoshima, 892-0833, Japan.
Shoichiro OhtaniHiroshima City Hiroshima Citizens Hospital, 7-33 Motomachi, Naka-ku, Hiroshima, 730-8518, Japan.
Naruto TairaOkayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
Takehiko SakaiCancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
Yoshie HasegawaHirosaki Municipal Hospital, 3-8-1 Oaza Omachi, Hirosaki, Aomori, 036-8004, Japan.
Rikiya NakamuraChiba Cancer Center, 666-2, Nitona-cho, Chuo-ku, Chiba, Japan.
Hiromitsu AkabaneHokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital, 24-111 Ichijo-dori, Asahikawa, Hokkaido, 078-8211, Japan.
Yukiko ShibaharaTohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Hironobu SasanoTohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Takuhiro YamaguchiTohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Kentaro SakamakiGraduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Helen BaileyGenomic Health, Inc., 301 Penobscot Dr, Redwood City, CA, USA.
Diana B CherbavazGenomic Health, Inc., 301 Penobscot Dr, Redwood City, CA, USA.
Debbie M JakubowskiGenomic Health, Inc., 301 Penobscot Dr, Redwood City, CA, USA.
Naoko SugiyamaGenomic Health, Inc., 301 Penobscot Dr, Redwood City, CA, USA.
Calvin ChaoGenomic Health, Inc., 301 Penobscot Dr, Redwood City, CA, USA.
Yasuo OhashiChuo University, 1-13-27 Kasuga, Bunkyo-ku, Tokyo, 112-8551, Japan.
Genomic Health (United States) · USTohoku University · JPAichi Cancer Center · JPAsahikawa Kosei Hospital · JPChiba Cancer Center · JPChuo University · JPHiroshima City Asa Citizens Hospital · JPJapanese Foundation For Cancer Research · JPKumamoto University · JPNagoya City University · JPNational Sagamihara Hospital · JPOkayama University Hospital · JPOsaka National Hospital · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe Recurrence Score test is validated to predict benefit of adjuvant chemotherapy. TransNEOS, a translational study of New Primary Endocrine-therapy Origination Study (NEOS), evaluated whether Recurrence Score results can predict clinical response to neoadjuvant letrozole.

methodsNEOS is a phase 3 clinical trial of hormonal therapy ± adjuvant chemotherapy for postmenopausal patients with ER+, HER2-negative, clinically node-negative breast cancer, after six months of neoadjuvant letrozole and breast surgery. TransNEOS patients had tumors ≥ 2 cm and archived core-biopsy samples taken before neoadjuvant letrozole and subsequently sent for Recurrence Score testing. The primary endpoint was to evaluate clinical (complete or partial) response to neoadjuvant letrozole for RS < 18 versus RS ≥ 31. Secondary endpoints included evaluation of clinical response and rate of breast-conserving surgery (BCS) by continuous Recurrence Score result, ESR1 and PGR single-gene scores, and ER gene-group score.

resultsOf 295 TransNEOS patients (median age 63 years; median tumor size 25 mm; 66% grade 1), 53.2% had RS < 18, 28.5% had RS18-30, and 18.3% had RS ≥ 31. Clinical response rates were 54% (RS < 18), 42% (RS18-30), and 22% (RS ≥ 31). A higher proportion of patients with RS < 18 had clinical responses (p < 0.001 vs. RS ≥ 31). In multivariable analyses, continuous Recurrence Score result (p < 0.001), ESR1 score (p = 0.049), PGR score (p < 0.001), and ER gene-group score (p < 0.001) were associated with clinical response. Recurrence Score group was significantly associated with rate of BCS after neoadjuvant treatment (RS < 18 vs. RS ≥ 31, p = 0.010).

conclusionThe Recurrence Score test is validated to predict clinical response to neoadjuvant letrozole in postmenopausal patients with ER+, HER2-negative, clinically node-negative breast cancer.

Indexed as

AgedAntineoplastic AgentsBiomarkers, TumorBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticHumansLetrozoleMastectomyMastectomy, SegmentalMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalReceptors, EstrogenAntineoplastic AgentsBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLetrozoleReceptors, EstrogenBreast cancerHormonal therapyNeoadjuvantOncotype DXRecurrence score

Identifiers

PMID30242578
PMCPMC6394785
OpenAlexW2891728587

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.