Evidence map›Paper›PMID 38387111›Full record

ArticleESMO open2024

Identifying prognostic biomarkers for palbociclib add-on therapy in fulvestrant-resistant breast cancer using cell-free DNA sequencing.

T Takeshita, T Iwamoto, N Niikura, K Watanabe, Y Kikawa, K Kobayashi, N Iwakuma, T Okamura, H Tada, S Ozaki and 7 more

Open access · goldAbstract read
In one paragraph

Article in ESMO open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 40% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Review
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

17 authors at 16 institutions in 2 countries.

T TakeshitaDepartment of Breast and Endocrine Surgery, Kumamoto City Hospital, Kumamoto. Electronic address: takashi.takeshita@hyper.ocn.ne.jp.
T IwamotoDepartment of Breast and Thyroid Surgery, Kawasaki Medical School Hospital, Kurashiki.
N NiikuraDepartment of Breast Oncology, Tokai University School of Medicine, Isehara, Kanagawa.
K WatanabeDepartment of Breast Surgery, Hokkaido Cancer Center, Sapporo, Hokkaido.
Y KikawaDepartment of Breast Surgery, Kansai Medical University Hospital, Hirakata, Osaka.
K KobayashiDepartment of Medical Oncology, Saitama Red Cross Hospital, Chuo-ku, Saitama.
N IwakumaBreast Center, Department of Breast Surgery, NHO Kyushu Medical Center, Fukuoka.
T OkamuraDepartment of Breast Oncology, Tokai University School of Medicine, Isehara, Kanagawa.
H TadaDivision of Breast and Endocrine Surgery, Tohoku University Graduate School of Medicine, Sendai, Miyagi.
S OzakiDepartment of Gastrointestinal and Breast Surgery, Hiroshima Prefectural Hospital, Hiroshima.
T OkunoDepartment of Breast Surgery, Kobe City Nishi-Kobe Medical Center, Kobe, Hyogo.
U TohDepartment of Breast Surgery, Kurume University Hospital, Kurume, Fukuoka.
Y YamamotoDepartment of Breast and Endocrine Surgery, Kumamoto University Hospital, Kumamoto.
M TsuneizumiDepartment of Breast Surgery, Shizuoka General Hospital, Shizuoka.
H IshiguroBreast Oncology Service, Saitama Medical University International Medical Center, Hidaka, Saitama.
N MasudaDepartment of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine, Nagoya.
S SajiDepartment of Medical Oncology, Fukushima Medical University, School of Medicine, Fukushima, Japan.
Tokai University · JPFukushima Medical University · JPHiroshima Prefectural Hospital · JPHokkaido University Hospital · JPKansai Medical University · JPKawasaki Medical School Hospital · JPKobe City Nishi-Kobe Medical Center · JPKumamoto City Hospital · JPKumamoto University Hospital · JPKurume University Hospital · JPNagoya University · JPNational Kyushu Medical Center · JPSaitama Medical University · JPSaitama Red Cross Hospital · JPShizuoka General Hospital · JPTohoku University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe FUTURE trial (UMIN000029294) demonstrated the safety and efficacy of adding palbociclib after fulvestrant resistance in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced and metastatic breast cancer (ABC/MBC). In this planned sub-study, cancer panel sequencing of cell-free DNA (cfDNA) was utilized to explore prognostic and predictive biomarkers for further palbociclib treatment following fulvestrant resistance. MATERIALS AND

methodsHerein, 149 cfDNA samples from 65 patients with fulvestrant-resistant disease were analysed at the time of palbociclib addition after fulvestrant resistance (baseline), on day 15 of cycle 1, and at the end of treatment using the assay for identifying diverse mutations in 34 cancer-related genes.

resultsDuring the course of treatment, mutations in ESR1, PIK3CA, FOXA1, RUNX1, TBX3, and TP53 were the most common genomic alterations observed. Analysis of genomic mutations revealed that before fulvestrant introduction, baseline PIK3CA mutations were marginally lower in metastatic aromatase inhibitor (AI)-treated patients compared to adjuvant AI-treated patients (P = 0.063). Baseline PIK3CA mutations were associated with poorer progression-free survival [hazard ratio: 1.62, P = 0.04]. Comparative analysis between baseline and early-changing gene mutations identified poor prognostic factors including early-changing MAP3K1 mutations (hazard ratio: 4.66, P = 0.04), baseline AR mutations (hazard ratio: 3.53, P = 0.04), and baseline PIK3CA mutations (hazard ratio: 3.41, P = 0.02). Notably, the relationship between ESR1 mutations and mutations in PIK3CA, MAP3K1, and TP53 weakened as treatment progressed. Instead, PIK3CA mutations became correlated with TP53 and FOXA1 mutations.

conclusionsCancer panel testing for cfDNA identified prognostic and predictive biomarkers for palbociclib add-on therapy after acquiring fulvestrant resistance in patients with HR+/HER2- ABC/MBC.

Indexed as

Biomarkers, TumorBreast NeoplasmsDrug Resistance, NeoplasmFulvestrantPiperazinesPyridinesAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCell-Free Nucleic AcidsFemaleHumansMiddle AgedMutationPrognosisBiomarkers, TumorCell-Free Nucleic AcidsFulvestrantpalbociclibPiperazinesPyridinesadvanced and metastatic breast cancercancer panel sequencingcell-free DNAfulvestrantpalbociclibprognostic and predictive biomarkers

Identifiers

PMID38387111
PMCPMC11076976
OpenAlexW4392016076

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.