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

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 la...

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Autores principales: Kim, Sung-Bae, Do, In-Gu, Tsang, Janice, Kim, Tae-You, Yap, Yoon-Sim, Cornelio, Gerardo, Gong, Gyungyub, Paik, Soonmyung, Lee, Suee, Ng, Ting-Ying, Park, Sarah, Oh, Ho-Suk, Chiu, Joanne, Sohn, Joohyuk, Lee, Moonhee, Choi, Young-Jin, Lee, Eun Mi, Park, Kyong-Hwa, Nathaniel, Christos, Ro, Jungsil
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Korean Cancer Association 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6790855/
https://www.ncbi.nlm.nih.gov/pubmed/31163957
http://dx.doi.org/10.4143/crt.2018.598
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author Kim, Sung-Bae
Do, In-Gu
Tsang, Janice
Kim, Tae-You
Yap, Yoon-Sim
Cornelio, Gerardo
Gong, Gyungyub
Paik, Soonmyung
Lee, Suee
Ng, Ting-Ying
Park, Sarah
Oh, Ho-Suk
Chiu, Joanne
Sohn, Joohyuk
Lee, Moonhee
Choi, Young-Jin
Lee, Eun Mi
Park, Kyong-Hwa
Nathaniel, Christos
Ro, Jungsil
author_facet Kim, Sung-Bae
Do, In-Gu
Tsang, Janice
Kim, Tae-You
Yap, Yoon-Sim
Cornelio, Gerardo
Gong, Gyungyub
Paik, Soonmyung
Lee, Suee
Ng, Ting-Ying
Park, Sarah
Oh, Ho-Suk
Chiu, Joanne
Sohn, Joohyuk
Lee, Moonhee
Choi, Young-Jin
Lee, Eun Mi
Park, Kyong-Hwa
Nathaniel, Christos
Ro, Jungsil
author_sort Kim, Sung-Bae
collection PubMed
description 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.
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spelling pubmed-67908552019-10-21 BioPATH: A Biomarker Study in Asian Patients with HER2+ Advanced Breast Cancer Treated with Lapatinib and Other Anti-HER2 Therapy Kim, Sung-Bae Do, In-Gu Tsang, Janice Kim, Tae-You Yap, Yoon-Sim Cornelio, Gerardo Gong, Gyungyub Paik, Soonmyung Lee, Suee Ng, Ting-Ying Park, Sarah Oh, Ho-Suk Chiu, Joanne Sohn, Joohyuk Lee, Moonhee Choi, Young-Jin Lee, Eun Mi Park, Kyong-Hwa Nathaniel, Christos Ro, Jungsil Cancer Res Treat Original Article 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. Korean Cancer Association 2019-10 2019-06-04 /pmc/articles/PMC6790855/ /pubmed/31163957 http://dx.doi.org/10.4143/crt.2018.598 Text en Copyright © 2019 by the Korean Cancer Association This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Kim, Sung-Bae
Do, In-Gu
Tsang, Janice
Kim, Tae-You
Yap, Yoon-Sim
Cornelio, Gerardo
Gong, Gyungyub
Paik, Soonmyung
Lee, Suee
Ng, Ting-Ying
Park, Sarah
Oh, Ho-Suk
Chiu, Joanne
Sohn, Joohyuk
Lee, Moonhee
Choi, Young-Jin
Lee, Eun Mi
Park, Kyong-Hwa
Nathaniel, Christos
Ro, Jungsil
BioPATH: A Biomarker Study in Asian Patients with HER2+ Advanced Breast Cancer Treated with Lapatinib and Other Anti-HER2 Therapy
title BioPATH: A Biomarker Study in Asian Patients with HER2+ Advanced Breast Cancer Treated with Lapatinib and Other Anti-HER2 Therapy
title_full BioPATH: A Biomarker Study in Asian Patients with HER2+ Advanced Breast Cancer Treated with Lapatinib and Other Anti-HER2 Therapy
title_fullStr BioPATH: A Biomarker Study in Asian Patients with HER2+ Advanced Breast Cancer Treated with Lapatinib and Other Anti-HER2 Therapy
title_full_unstemmed BioPATH: A Biomarker Study in Asian Patients with HER2+ Advanced Breast Cancer Treated with Lapatinib and Other Anti-HER2 Therapy
title_short BioPATH: A Biomarker Study in Asian Patients with HER2+ Advanced Breast Cancer Treated with Lapatinib and Other Anti-HER2 Therapy
title_sort biopath: a biomarker study in asian patients with her2+ advanced breast cancer treated with lapatinib and other anti-her2 therapy
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6790855/
https://www.ncbi.nlm.nih.gov/pubmed/31163957
http://dx.doi.org/10.4143/crt.2018.598
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