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

Cancer Research and Treatment 2019년 51권 4호 p.1527 ~ 1539
 ( Kim Sung-Bae ) - University of Ulsan College of Medicine Asan Medical Center Department of Oncology

 ( Do In-Gu ) - Sungkyunkwan University School of Medicine Kangbuk Samsung Medical Center Department of Pathology
 ( Tsang Janice ) - University of Hong Kong Queen Mary Hospital Department of Medicine
 ( Kim Tae-You ) - Seoul National University Hospital Department of Internal Medicine
 ( Yap Yoon-Sim ) - National Cancer Centre Singapore Department of Medical Oncology
 ( Cornelio Gerardo ) - San Juan De Dios Hospital Department of Medicine
 ( Gong Gyung-Yub ) - University of Ulsan College of Medicine Asan Medical Center Department of Pathology
 ( Lee Sue-E ) - Dong-A University Hospital Department of Internal Medicine
 ( Ng Ting-Ying ) - Tuen Mun Hospital Department of Clinical Oncology
 ( Park Sa-Rah ) - Seoul National University Center for Anti-Cancer Companion Diagnostics
 ( Oh Ho-Suk ) - University of Ulsan College of Medicine Gangneung Asan Medical Center Department of Internal Medicine
 ( Chiu Joanne ) - University of Hong Kong Queen Mary Hospital Department of Medicine
손주혁 ( Sohn Joo-Hyuk ) - Yonsei University College of Medicine Yonsei Cancer Center Department of Internal Medicine Division of Medical Oncology
 ( Lee Moon-Hee ) - Inha University Hospital Department of Internal Medicine
 ( Choi Young-Jin ) - Pusan National University Hospital Department of Internal Medicine
 ( Lee Eun-Mi ) - Kosin University Gaspel Hospital Department of Internal Medicine
 ( Park Kyong-Hwa ) - Korea University Anam Hospital Department of Internal Medicine
 ( Nathaniel Christos ) - Novartis Pharmaceuticals Corporation
 ( Ro Jung-Sil ) - National Cancer Center Graduate School of Cancer Science and Policy

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.

키워드

Biomarkers; Breast neoplasms; HER2; Lapatinib; Trastuzumab
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