Evidence map›Paper›PMID 31163957›Full record

Observational studyCancer research and treatment2019

BioPATH: A Biomarker Study in Asian Patients with HER2+ Advanced Breast Cancer Treated with Lapatinib and Other Anti-HER2 Therapy.

Sung-Bae Kim, In-Gu Do, Janice Tsang, Tae-You Kim, Yoon-Sim Yap, Gerardo Cornelio, Gyungyub Gong, Soonmyung Paik, Suee Lee, Ting-Ying Ng and 10 more

Abstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in 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 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
–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.

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.

  1. Pooled it
  2. Article
  3. Comparison ofJCO precision oncology · 2022
    Article
  4. 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

20 authors.

Sung-Bae KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
In-Gu DoDepartment of Pathology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Janice TsangDepartment of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong, China.
Tae-You KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Yoon-Sim YapDivision of Medical Oncology, National Cancer Centre Singapore, Singapore.
Gerardo CornelioDepartment of Medicine, San Juan De Dios Hospital, Manila, Philippines.
Gyungyub GongDepartment of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Soonmyung PaikDepartment of Medical Oncology and Severance Biomedical Research Institute, Yonsei University College of Medicine, Seoul, Korea.
Suee LeeDepartment of Internal Medicine, Dong-A University Hospital, Busan, Korea.
Ting-Ying NgDepartment of Clinical Oncology, Tuen Mun Hospital, Hong Kong, China.
Sarah ParkThe Center for Anti-Cancer Companion Diagnostics, Bio-MAX/ N-Bio, Seoul National University, Seoul, Korea.
Ho-Suk OhDepartment of Hematology- Oncology, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea.
Joanne ChiuDepartment of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong, China.
Joohyuk SohnDivision of Medical Oncology, Yonsei Cancer Center, Seoul, Korea.
Moonhee LeeDivision of Hematology-Oncology, Inha University Hospital, Incheon, Korea.
Young-Jin ChoiDepartment of Hematology- Oncology, Pusan National University Hospital, Busan, Korea.
Eun Mi LeeDepartment of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea.
Kyong-Hwa ParkDepartment of Internal Medicine, Korea University Anam Hospital, Seoul, Korea.
Christos NathanielNovartis Pharmaceuticals Corporation, APSA, Midrand, South Africa.
Jungsil RoGraduate School of Cancer Science and Policy, National Cancer Center, Goyang, Korea.

Funding

GlaxoSmithKline
6 · The paper itself

Abstract

purposeBioPATH is a non-interventional study evaluating the relationship of molecular biomarkers (PTEN deletion/downregulation, PIK3CA mutation, truncated HER2 receptor [p95HER2], and tumor HER2 mRNA levels) to treatment responses in Asian patients with HER2+ advanced breast cancer treated with lapatinib and other HER2-targeted agents. MATERIALS AND

methodsFemale Asian HER2+ breast cancer patients (n=154) who were candidates for lapatinib-based treatment following metastasis and having an available primary tumor biopsy specimen were included. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, overall survival on lapatinib, correlation between biomarker status and PFS for any previous trastuzumab-based treatment, and conversion/conservation rates of the biomarker status between tissue samples collected at primary diagnosis and at recurrence/metastasis. Potential relationships between tumor mRNA levels of HER2 and response to lapatinib-based therapy were also explored.

resultsp95HER2, PTEN deletion/downregulation, and PIK3CA mutation did not demonstrate any significant co-occurrence pattern and were not predictive of clinical outcomes on either lapatinib-based treatment or any previous trastuzumab-based therapy in the metastatic setting. Proportions of tumors positive for p95HER2 expression, PIK3CA mutation, and PTEN deletion/down-regulation at primary diagnosis were 32%, 31.2%, and 56.2%, respectively. Despite limited availability of paired samples, biomarker status patterns were conserved in most samples. HER2 mRNA levels were not predictive of PFS on lapatinib.

conclusionThe prevalence of p95HER2 expression, PIK3CA mutation, and PTEN deletion/downregulation at primary diagnosis were similar to previous reports. Importantly, no difference was observed in clinical outcome based on the status of these biomarkers, consistent with reports from other studies.

Indexed as

AdultAgedBiomarkers, TumorBreast NeoplasmsClass I Phosphatidylinositol 3-KinasesErb-b2 Receptor Tyrosine KinasesFemaleGene Expression Regulation, NeoplasticHumansLapatinibMiddle AgedPrognosisProtein Kinase InhibitorsPTEN PhosphohydrolaseRepublic of KoreaSurvival AnalysisBiomarkers, TumorClass I Phosphatidylinositol 3-KinasesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLapatinibPIK3CA protein, humanProtein Kinase InhibitorsPTEN PhosphohydrolasePTEN protein, humanBiomarkersBreast neoplasmsHER2LapatinibTrastuzumab

Identifiers

PMID31163957
PMCPMC6790855

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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.