Evidence mapPaperPMID 39105849Full record

Trial reportCancer immunology, immunotherapy : CII2024

Genomic and transcriptomic profiles associated with response to eribulin and nivolumab combination in HER-2-negative metastatic breast cancer.

Changhee Park, Koung Jin Suh, Se Hyun Kim, Kyung-Hun Lee, Seock-Ah Im, Min Hwan Kim, Joohyuk Sohn, Jae Ho Jeong, Kyung Hae Jung, Kyoung Eun Lee and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04061863 (A Phase IB/II, Single Arm, Multi-center Study of Nivolumab in Combination With Eribulin in HER2 Negative Metastatic Breast Cancer Patients), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
field-weighted citation impact
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.

NCT04061863 phase1 / phase2unknown statusnot on this map

A Phase IB/II, Single Arm, Multi-center Study of Nivolumab in Combination With Eribulin in HER2 Negative Metastatic Breast Cancer Patients

TypeinterventionalSponsorSeoul National University HospitalRan2019 to 2022Enrolled90ConditionsMetastatic Breast CancerArmsNivolumab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

18 authors.

Changhee ParkDivision of Hematology-Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-Ro, Bundang-Gu, Seongnam, 13620, Republic of Korea.
Koung Jin SuhDivision of Hematology-Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-Ro, Bundang-Gu, Seongnam, 13620, Republic of Korea.
Se Hyun KimDivision of Hematology-Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-Ro, Bundang-Gu, Seongnam, 13620, Republic of Korea. sehyunkim@snubh.org.
Kyung-Hun LeeDepartment of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, Republic of Korea.
Seock-Ah ImDepartment of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, Republic of Korea.
Min Hwan KimDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Joohyuk SohnDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Jae Ho JeongDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Kyung Hae JungDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Kyoung Eun LeeDepartment of Hematology and Oncology, Ewha Womans University Hospital, Seoul, Korea.
Yeon Hee ParkHematology-Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, Korea.
Hee-Jun KimDepartment of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Eun Kyung ChoDivision of Oncology, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.
In Sil ChoiDepartment of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea.
Seung-Jae NohPentaMedix Co., Ltd, Seongnam, Korea.
Inkyung ShinPentaMedix Co., Ltd, Seongnam, Korea.
Dae-Yeon ChoPentaMedix Co., Ltd, Seongnam, Korea.
Jee Hyun KimDivision of Hematology-Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-Ro, Bundang-Gu, Seongnam, 13620, Republic of Korea.

Funding

PROVIDE RABBITS, RATS MICE, HAMSTERS GERBILS, GUINEA PIGS27307C0012 · NIEHS · PI BOLEN, WAYNE · 2007 to 2007
$1.0M
Ministry of Health and Welfare, Republic of Korea HA22C0012NIEHS NIH HHS 27307C0012Seoul National University Bundang Hospital 02-2020-0048
6 · The paper itself

Abstract

backgroundBiomarkers for predicting response to the immunotherapy and chemotherapy combination in breast cancer patients are not established. In this study, we report exploratory genomic and transcriptomic analyses of pretreatment tumor tissues from patients enrolled in phase II clinical trial of a combination of eribulin and nivolumab for HER-2-negative metastatic breast cancer (MBC) (KORNELIA trial, NCT04061863).

methodsWe analyzed associations between tumor molecular profiles based on genomic (n = 76) and transcriptomic data (n = 58) and therapeutic efficacy. Patients who achieved progression-free survival (PFS) ≥ 6 months were defined as PFS6-responders and PFS6-nonresponders otherwise.

findingsAnalyses on tumor mutation burden (TMB) showed a tendency toward a favorable effect on efficacy, while several analyses related to homologous recombination deficiency (HRD) indicated a potentially negative impact on efficacy. Patients harboring TP53 mutations showed significantly poor PFS6 rate and PFS, which correlated with the enrichment of cell cycle-related signatures in PFS6-nonresponders. High antigen presentation gene set enrichment scores (≥ median) were significantly associated with longer PFS. Naïve B-cell and plasma cell proportions were considerably higher in long responders (≥ 18 months).

interpretationGenomic features including TMB, HRD, and TP53 mutations and transcriptomic features related to immune cell profiles and cell cycle may distinguish responders. Our findings provide insights for further exploring the combination regimen and its biomarkers in these tumors.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesFuransKetonesNivolumabTranscriptomeAdultAgedBiomarkers, TumorFemaleGene Expression ProfilingGenomicsHumansMiddle AgedMutationBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinaseseribulinFuransKetonesNivolumabPolyether PolyketidesBiomarkerEribulinGenomicsHER-2-negative metastatic breast cancerImmunotherapyTranscriptomics

Identifiers

PMID39105849
PMCPMC11303363

What Socratic holds

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LicenceCC BY
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Registered trials

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.