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BioPATH: A Biomarker Study in Asian Patients with HER2+ Advanced Breast Cancer Treated with Lapatinib and Other Anti-HER2 Therapy
- Source :
- Cancer Research and Treatment : Official Journal of Korean Cancer Association
- Publication Year :
- 2019
- Publisher :
- Korean Cancer Association, 2019.
-
Abstract
- Purpose BioPATH 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 methods Female 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. Results p95HER2, 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. Conclusion The 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.
- Subjects :
- Adult
0301 basic medicine
Oncology
Cancer Research
medicine.medical_specialty
Class I Phosphatidylinositol 3-Kinases
Receptor, ErbB-2
Breast Neoplasms
Lapatinib
Metastasis
03 medical and health sciences
0302 clinical medicine
Breast cancer
Trastuzumab
HER2
Internal medicine
Republic of Korea
Biomarkers, Tumor
medicine
Humans
PTEN
skin and connective tissue diseases
Protein Kinase Inhibitors
neoplasms
Aged
biology
business.industry
PTEN Phosphohydrolase
Cancer
Middle Aged
Prognosis
medicine.disease
Survival Analysis
Primary tumor
Gene Expression Regulation, Neoplastic
Treatment Outcome
030104 developmental biology
030220 oncology & carcinogenesis
biology.protein
Biomarker (medicine)
Female
Original Article
business
Biomarkers
medicine.drug
Subjects
Details
- ISSN :
- 20059256 and 15982998
- Volume :
- 51
- Database :
- OpenAIRE
- Journal :
- Cancer Research and Treatment
- Accession number :
- edsair.doi.dedup.....dfb41273514b2d44569de9831fb2f412