Evidence map›Paper›PMID 37486454›Full record

ArticleBreast cancer (Tokyo, Japan)2023

Detection of high-risk patients resistant to CDK4/6 inhibitors with hormone receptor-positive HER2-negative advanced and metastatic breast cancer in Japan (KBCSG-TR-1316).

Manabu Futamura, Takahiro Nakayama, Tetsuhiro Yoshinami, Chiya Oshiro, Mikiya Ishihara, Midori Morita, Akira Watanabe, Azusa Tanigichi, Masami Tsukabe, Masafumi Shimoda and 6 more

Open access · hybridAbstract read
In one paragraph

Article in Breast cancer (Tokyo, Japan), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 21% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
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  3. Article
  4. 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

16 authors at 11 institutions in 1 country.

Manabu FutamuraDepartment of Breast Surgery, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan. futamura.manabu.m3@f.gifu-u.ac.jp.ORCID http://orcid.org/0000-0001-5622-8352
Takahiro NakayamaDepartment of Breast and Endocrine Surgery, Osaka International Cancer Institute, Osaka, Japan.ORCID http://orcid.org/0000-0002-3713-1624
Tetsuhiro YoshinamiDepartment of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Chiya OshiroDepartment of Breast Surgery, Kaizuka City Hospital, Kaizuka, Japan.
Mikiya IshiharaMie University Hospital Cancer Center, Tsu, Japan.ORCID http://orcid.org/0000-0002-7581-2615
Midori MoritaDivision of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.ORCID http://orcid.org/0000-0003-4083-4432
Akira WatanabeDivision of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Azusa TanigichiDepartment of Breast and Endocrine Surgery, Osaka International Cancer Institute, Osaka, Japan.
Masami TsukabeDepartment of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Masafumi ShimodaDepartment of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Kanae NittaBreast and Endocrine Surgery, Otemae Hospital, Osaka, Japan.
Yoko ChiharaDepartment of Breast Surgery, Itami City Hospital, Itami, Japan.
Hiroyuki YasojimaDepartment of Surgery Breast Oncology, NHO Osaka National Hospital, Osaka, Japan.
Yoshimi OuchiDepartment of Breast Surgery, Saiseikai Shiga Hospital, Ritto, Japan.
Yoshihisa TokumaruDepartment of Breast Surgery, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan.ORCID http://orcid.org/0000-0003-2481-7739
Norikazu MasudaDepartment of Surgery Breast Oncology, NHO Osaka National Hospital, Osaka, Japan.ORCID http://orcid.org/0000-0002-7302-0278
Gifu University Hospital · JPKyoto Prefectural University of Medicine · JPOsaka International Cancer Institute · JPOsaka National Hospital · JPThe University of Osaka · JPItami City Hospital · JPMie University Hospital · JPOsaka Police Hospital · JPOtemae Hospital · JPSaiseikai Shigaken Hospital · JPTakarazuka City Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCyclin-dependent kinase 4/6 inhibitors (CDK4/6i) improve the prognosis of hormone receptor-positive HER2-negative advanced/metastatic breast cancer (HR+/HER2- mBC). However, some cancers show resistance to CDK4/6i and have a poor prognosis. The non-luminal disease score (NOLUS) was developed to predict non-luminal disease using immunohistochemical analysis.

methodsThe association between the efficacy of CDK4/6i and NOLUS was investigated by evaluating pathological and clinical data, including real-world progression-free survival (rw-PFS) and overall survival (OS). Real-world data of patients with HR+/HER2- mBC who received CDK4/6i therapy [palbociclib or abemaciclib] as first- or second-line endocrine treatments was obtained. NOLUS was calculated using the formula: NOLUS (0-100) = - 0.45 × estrogen receptor (ER) (%) - 0.28 × progesterone receptor (PR) (%) + 0.27 × Ki67(%) + 73, and the patients were divided into two groups: NOLUS-positive (≥ 51.38) and NOLUS-negative (< 51.38).

resultsOf the 300 patients, 28 (9.3%) were NOLUS-positive, and 272 (90.7%) were NOLUS-negative. The expression rates (%) of ER and PgR in NOLUS-positive patients were lower than those in NOLUS-negative patients (p < 0.001). Ki67 expression was higher in NOLUS-positive patients. There were statistically significant differences in prognosis (rw-PFS and OS) between the two groups. Moreover, NOLUS-negative patients showed statistically better rw-PFS with first-line therapy than second-line therapy. However, NOLUS-positive patients showed poor prognoses with both the first and second therapeutic lines, suggesting CDK4/6i inefficacy for NOLUS-positive patients.

conclusionsThe efficacy and prognosis of CDK4/6i significantly differed between the NOLUS-positive and NOLUS-negative patients. This feasible method can predict patients with HR+/HER2- mBC resistant to CDK4/6i and help select a better therapeutic approach to overcome resistance.

Indexed as

Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Erb-b2 Receptor Tyrosine KinasesFemaleHumansJapanKi-67 AntigenProgression-Free SurvivalProtein Kinase InhibitorsReceptors, EstrogenCDK4 protein, humanCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Erb-b2 Receptor Tyrosine KinasesKi-67 AntigenProtein Kinase InhibitorsReceptors, EstrogenCDK4/6 inhibitorLuminalMetastatic breast cancerNOLUSResistant

Identifiers

PMID37486454
PMCPMC10587336
OpenAlexW4385186242

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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.