Comprehensive genomic profiling of ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(−) metastatic breast cancer: prevalence along treatment course and predictive value for endocrine therapy resistance in real-world practice
Background The treatment landscape for HR(+)HER2(−) metastatic breast cancer (MBC) is evolving for patients with ESR1 mutations (mut) and PI3K/AKT pathway genomic alterations (GA). We sought to inform clinical utility for comprehensive genomic profiling (CGP) using tissue (TBx) and liquid biopsies (...
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| creator | Bhave, Manali A. Quintanilha, Julia C. F. Tukachinsky, Hanna Li, Gerald Scott, Takara Ross, Jeffrey S. Pasquina, Lincoln Huang, Richard S. P. McArthur, Heather Levy, Mia A. Graf, Ryon P. Kalinsky, Kevin |
| description | Background
The treatment landscape for HR(+)HER2(−) metastatic breast cancer (MBC) is evolving for patients with
ESR1
mutations (mut) and PI3K/AKT pathway genomic alterations (GA). We sought to inform clinical utility for comprehensive genomic profiling (CGP) using tissue (TBx) and liquid biopsies (LBx) in HR(+)HER2(−) MBC.
Methods
Records from a de-identified breast cancer clinicogenomic database for patients who underwent TBx/LBx testing at Foundation Medicine during routine clinical care at ~ 280 US cancer clinics between 01/2011 and 09/2023 were assessed. GA prevalence [
ESR1
mut,
PIK3CA
mut,
AKT1
mut,
PTEN
mut, and
PTEN
homozygous copy loss (
PTEN
loss)] were calculated in TBx and LBx [stratified by ctDNA tumor fraction (TF)] during the first three lines of therapy. Real-world progression-free survival (rwPFS) and overall survival (rwOS) were compared between groups by Cox models adjusted for prognostic factors.
Results
~ 60% of cases harbored 1 + GA in 1st-line TBx (1266/2154) or LBx TF ≥ 1% (80/126) and 26.5% (43/162) in LBx TF |
| doi_str_mv | 10.1007/s10549-024-07376-w |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11420341</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3068759707</sourcerecordid><originalsourceid>FETCH-LOGICAL-c426t-2bc04cf629942a3f54aaf246bccd52661e8095a9c4a5699241ba817735951c703</originalsourceid><addsrcrecordid>eNp9ks9uEzEQxlcIREvhBTggS1xa0QXb67V3uaAoCqRqBVUIZ8txZhNXu3ZqbxL1DTjzeBx5EiZNKX8OnOzRfPObGfvLsueMvmaUqjeJ0VLUOeUip6pQMt8-yA5ZqYpccaYeZoeUSZXLisqD7ElKV5TSWtH6cXZQVJXiVPLD7PswdKsIS_DJbYAswIfOWbKKoXGt8wsSGjL6PGGn5PLsvBgOTsngfIqR8XNyOR19JM6T8eT41cl4NOHHP75-OyEd9Cb1pkfMLAJeiTXeQnyLVNiYFjAgpg0I7zHfd-BREtYxwS0WVXNn-904qF4DaUIk4OfBRueB9EuIZnVDIiSHbXYwnAFBbb4Nsd3VG6y28DR71Jg2wbO78yj78n40HY7zi08fzoaDi9wKLvuczywVtpG8rgU3RVMKYxou5MzaecmlZFDRujS1FaaUdc0Fm5mKKVWUdcmsosVR9m7PXa1nHcwtrhNNq1fRdSbe6GCc_jvj3VIvwkYzJjgtBEPC8R0hhus1pF53LlloW-MhrJMuqKxUiX-nUPryH-kVvpzH_XTBaCVkXcrdSHyvsjGkFKG5n4ZRvfOO3ntHo3f0rXf0Fote_LnHfckvs6Cg2AsSpvwC4u_e_8H-BJXg0lM</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3108469560</pqid></control><display><type>article</type><title>Comprehensive genomic profiling of ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(−) metastatic breast cancer: prevalence along treatment course and predictive value for endocrine therapy resistance in real-world practice</title><source>SpringerLink Journals</source><creator>Bhave, Manali A. ; Quintanilha, Julia C. F. ; Tukachinsky, Hanna ; Li, Gerald ; Scott, Takara ; Ross, Jeffrey S. ; Pasquina, Lincoln ; Huang, Richard S. P. ; McArthur, Heather ; Levy, Mia A. ; Graf, Ryon P. ; Kalinsky, Kevin</creator><creatorcontrib>Bhave, Manali A. ; Quintanilha, Julia C. F. ; Tukachinsky, Hanna ; Li, Gerald ; Scott, Takara ; Ross, Jeffrey S. ; Pasquina, Lincoln ; Huang, Richard S. P. ; McArthur, Heather ; Levy, Mia A. ; Graf, Ryon P. ; Kalinsky, Kevin</creatorcontrib><description>Background
The treatment landscape for HR(+)HER2(−) metastatic breast cancer (MBC) is evolving for patients with
ESR1
mutations (mut) and PI3K/AKT pathway genomic alterations (GA). We sought to inform clinical utility for comprehensive genomic profiling (CGP) using tissue (TBx) and liquid biopsies (LBx) in HR(+)HER2(−) MBC.
Methods
Records from a de-identified breast cancer clinicogenomic database for patients who underwent TBx/LBx testing at Foundation Medicine during routine clinical care at ~ 280 US cancer clinics between 01/2011 and 09/2023 were assessed. GA prevalence [
ESR1
mut,
PIK3CA
mut,
AKT1
mut,
PTEN
mut, and
PTEN
homozygous copy loss (
PTEN
loss)] were calculated in TBx and LBx [stratified by ctDNA tumor fraction (TF)] during the first three lines of therapy. Real-world progression-free survival (rwPFS) and overall survival (rwOS) were compared between groups by Cox models adjusted for prognostic factors.
Results
~ 60% of cases harbored 1 + GA in 1st-line TBx (1266/2154) or LBx TF ≥ 1% (80/126) and 26.5% (43/162) in LBx TF < 1%.
ESR1
mut was found in 8.1% TBx, 17.5% LBx TF ≥ 1%, and 4.9% LBx TF < 1% in 1st line, increasing to 59% in 3rd line (LBx TF ≥ 1%).
PTEN
loss was detected at higher rates in TBx (4.3%) than LBx (1% in TF ≥ 1%). Patients receiving 1st-line aromatase inhibitor + CDK4/6 inhibitor (
n
= 573) with
ESR1
mut had less favorable rwPFS and rwOS versus
ESR1
wild-type; no differences were observed for fulvestrant + CDK4/6 inhibitor (
n
= 348).
Conclusion
Our study suggests obtaining TBx for CGP at time of de novo/recurrent diagnosis, followed by LBx for detecting acquired GA in 2nd + lines. Reflex TBx should be considered when ctDNA TF < 1%.</description><identifier>ISSN: 0167-6806</identifier><identifier>ISSN: 1573-7217</identifier><identifier>EISSN: 1573-7217</identifier><identifier>DOI: 10.1007/s10549-024-07376-w</identifier><identifier>PMID: 38872062</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>1-Phosphatidylinositol 3-kinase ; AKT protein ; AKT1 protein ; Aromatase ; Biopsy ; Breast cancer ; Cyclin-dependent kinase 4 ; Endocrine therapy ; ErbB-2 protein ; ESR1 protein ; Fulvestrant ; Genomics ; Medical prognosis ; Medicine ; Medicine & Public Health ; Metastases ; Metastasis ; Oncology ; Patients ; PTEN protein ; Survival</subject><ispartof>Breast cancer research and treatment, 2024-10, Vol.207 (3), p.599-609</ispartof><rights>The Author(s) 2024. corrected publication 2024</rights><rights>2024. The Author(s).</rights><rights>The Author(s) 2024. corrected publication 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2024, corrected publication 2024 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c426t-2bc04cf629942a3f54aaf246bccd52661e8095a9c4a5699241ba817735951c703</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10549-024-07376-w$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10549-024-07376-w$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27903,27904,41467,42536,51297</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38872062$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bhave, Manali A.</creatorcontrib><creatorcontrib>Quintanilha, Julia C. F.</creatorcontrib><creatorcontrib>Tukachinsky, Hanna</creatorcontrib><creatorcontrib>Li, Gerald</creatorcontrib><creatorcontrib>Scott, Takara</creatorcontrib><creatorcontrib>Ross, Jeffrey S.</creatorcontrib><creatorcontrib>Pasquina, Lincoln</creatorcontrib><creatorcontrib>Huang, Richard S. P.</creatorcontrib><creatorcontrib>McArthur, Heather</creatorcontrib><creatorcontrib>Levy, Mia A.</creatorcontrib><creatorcontrib>Graf, Ryon P.</creatorcontrib><creatorcontrib>Kalinsky, Kevin</creatorcontrib><title>Comprehensive genomic profiling of ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(−) metastatic breast cancer: prevalence along treatment course and predictive value for endocrine therapy resistance in real-world practice</title><title>Breast cancer research and treatment</title><addtitle>Breast Cancer Res Treat</addtitle><addtitle>Breast Cancer Res Treat</addtitle><description>Background
The treatment landscape for HR(+)HER2(−) metastatic breast cancer (MBC) is evolving for patients with
ESR1
mutations (mut) and PI3K/AKT pathway genomic alterations (GA). We sought to inform clinical utility for comprehensive genomic profiling (CGP) using tissue (TBx) and liquid biopsies (LBx) in HR(+)HER2(−) MBC.
Methods
Records from a de-identified breast cancer clinicogenomic database for patients who underwent TBx/LBx testing at Foundation Medicine during routine clinical care at ~ 280 US cancer clinics between 01/2011 and 09/2023 were assessed. GA prevalence [
ESR1
mut,
PIK3CA
mut,
AKT1
mut,
PTEN
mut, and
PTEN
homozygous copy loss (
PTEN
loss)] were calculated in TBx and LBx [stratified by ctDNA tumor fraction (TF)] during the first three lines of therapy. Real-world progression-free survival (rwPFS) and overall survival (rwOS) were compared between groups by Cox models adjusted for prognostic factors.
Results
~ 60% of cases harbored 1 + GA in 1st-line TBx (1266/2154) or LBx TF ≥ 1% (80/126) and 26.5% (43/162) in LBx TF < 1%.
ESR1
mut was found in 8.1% TBx, 17.5% LBx TF ≥ 1%, and 4.9% LBx TF < 1% in 1st line, increasing to 59% in 3rd line (LBx TF ≥ 1%).
PTEN
loss was detected at higher rates in TBx (4.3%) than LBx (1% in TF ≥ 1%). Patients receiving 1st-line aromatase inhibitor + CDK4/6 inhibitor (
n
= 573) with
ESR1
mut had less favorable rwPFS and rwOS versus
ESR1
wild-type; no differences were observed for fulvestrant + CDK4/6 inhibitor (
n
= 348).
Conclusion
Our study suggests obtaining TBx for CGP at time of de novo/recurrent diagnosis, followed by LBx for detecting acquired GA in 2nd + lines. Reflex TBx should be considered when ctDNA TF < 1%.</description><subject>1-Phosphatidylinositol 3-kinase</subject><subject>AKT protein</subject><subject>AKT1 protein</subject><subject>Aromatase</subject><subject>Biopsy</subject><subject>Breast cancer</subject><subject>Cyclin-dependent kinase 4</subject><subject>Endocrine therapy</subject><subject>ErbB-2 protein</subject><subject>ESR1 protein</subject><subject>Fulvestrant</subject><subject>Genomics</subject><subject>Medical prognosis</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Oncology</subject><subject>Patients</subject><subject>PTEN protein</subject><subject>Survival</subject><issn>0167-6806</issn><issn>1573-7217</issn><issn>1573-7217</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><recordid>eNp9ks9uEzEQxlcIREvhBTggS1xa0QXb67V3uaAoCqRqBVUIZ8txZhNXu3ZqbxL1DTjzeBx5EiZNKX8OnOzRfPObGfvLsueMvmaUqjeJ0VLUOeUip6pQMt8-yA5ZqYpccaYeZoeUSZXLisqD7ElKV5TSWtH6cXZQVJXiVPLD7PswdKsIS_DJbYAswIfOWbKKoXGt8wsSGjL6PGGn5PLsvBgOTsngfIqR8XNyOR19JM6T8eT41cl4NOHHP75-OyEd9Cb1pkfMLAJeiTXeQnyLVNiYFjAgpg0I7zHfd-BREtYxwS0WVXNn-904qF4DaUIk4OfBRueB9EuIZnVDIiSHbXYwnAFBbb4Nsd3VG6y28DR71Jg2wbO78yj78n40HY7zi08fzoaDi9wKLvuczywVtpG8rgU3RVMKYxou5MzaecmlZFDRujS1FaaUdc0Fm5mKKVWUdcmsosVR9m7PXa1nHcwtrhNNq1fRdSbe6GCc_jvj3VIvwkYzJjgtBEPC8R0hhus1pF53LlloW-MhrJMuqKxUiX-nUPryH-kVvpzH_XTBaCVkXcrdSHyvsjGkFKG5n4ZRvfOO3ntHo3f0rXf0Fote_LnHfckvs6Cg2AsSpvwC4u_e_8H-BJXg0lM</recordid><startdate>20241001</startdate><enddate>20241001</enddate><creator>Bhave, Manali A.</creator><creator>Quintanilha, Julia C. F.</creator><creator>Tukachinsky, Hanna</creator><creator>Li, Gerald</creator><creator>Scott, Takara</creator><creator>Ross, Jeffrey S.</creator><creator>Pasquina, Lincoln</creator><creator>Huang, Richard S. P.</creator><creator>McArthur, Heather</creator><creator>Levy, Mia A.</creator><creator>Graf, Ryon P.</creator><creator>Kalinsky, Kevin</creator><general>Springer US</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TO</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20241001</creationdate><title>Comprehensive genomic profiling of ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(−) metastatic breast cancer: prevalence along treatment course and predictive value for endocrine therapy resistance in real-world practice</title><author>Bhave, Manali A. ; Quintanilha, Julia C. F. ; Tukachinsky, Hanna ; Li, Gerald ; Scott, Takara ; Ross, Jeffrey S. ; Pasquina, Lincoln ; Huang, Richard S. P. ; McArthur, Heather ; Levy, Mia A. ; Graf, Ryon P. ; Kalinsky, Kevin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c426t-2bc04cf629942a3f54aaf246bccd52661e8095a9c4a5699241ba817735951c703</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>1-Phosphatidylinositol 3-kinase</topic><topic>AKT protein</topic><topic>AKT1 protein</topic><topic>Aromatase</topic><topic>Biopsy</topic><topic>Breast cancer</topic><topic>Cyclin-dependent kinase 4</topic><topic>Endocrine therapy</topic><topic>ErbB-2 protein</topic><topic>ESR1 protein</topic><topic>Fulvestrant</topic><topic>Genomics</topic><topic>Medical prognosis</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Metastases</topic><topic>Metastasis</topic><topic>Oncology</topic><topic>Patients</topic><topic>PTEN protein</topic><topic>Survival</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bhave, Manali A.</creatorcontrib><creatorcontrib>Quintanilha, Julia C. F.</creatorcontrib><creatorcontrib>Tukachinsky, Hanna</creatorcontrib><creatorcontrib>Li, Gerald</creatorcontrib><creatorcontrib>Scott, Takara</creatorcontrib><creatorcontrib>Ross, Jeffrey S.</creatorcontrib><creatorcontrib>Pasquina, Lincoln</creatorcontrib><creatorcontrib>Huang, Richard S. P.</creatorcontrib><creatorcontrib>McArthur, Heather</creatorcontrib><creatorcontrib>Levy, Mia A.</creatorcontrib><creatorcontrib>Graf, Ryon P.</creatorcontrib><creatorcontrib>Kalinsky, Kevin</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Breast cancer research and treatment</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bhave, Manali A.</au><au>Quintanilha, Julia C. F.</au><au>Tukachinsky, Hanna</au><au>Li, Gerald</au><au>Scott, Takara</au><au>Ross, Jeffrey S.</au><au>Pasquina, Lincoln</au><au>Huang, Richard S. P.</au><au>McArthur, Heather</au><au>Levy, Mia A.</au><au>Graf, Ryon P.</au><au>Kalinsky, Kevin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comprehensive genomic profiling of ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(−) metastatic breast cancer: prevalence along treatment course and predictive value for endocrine therapy resistance in real-world practice</atitle><jtitle>Breast cancer research and treatment</jtitle><stitle>Breast Cancer Res Treat</stitle><addtitle>Breast Cancer Res Treat</addtitle><date>2024-10-01</date><risdate>2024</risdate><volume>207</volume><issue>3</issue><spage>599</spage><epage>609</epage><pages>599-609</pages><issn>0167-6806</issn><issn>1573-7217</issn><eissn>1573-7217</eissn><abstract>Background
The treatment landscape for HR(+)HER2(−) metastatic breast cancer (MBC) is evolving for patients with
ESR1
mutations (mut) and PI3K/AKT pathway genomic alterations (GA). We sought to inform clinical utility for comprehensive genomic profiling (CGP) using tissue (TBx) and liquid biopsies (LBx) in HR(+)HER2(−) MBC.
Methods
Records from a de-identified breast cancer clinicogenomic database for patients who underwent TBx/LBx testing at Foundation Medicine during routine clinical care at ~ 280 US cancer clinics between 01/2011 and 09/2023 were assessed. GA prevalence [
ESR1
mut,
PIK3CA
mut,
AKT1
mut,
PTEN
mut, and
PTEN
homozygous copy loss (
PTEN
loss)] were calculated in TBx and LBx [stratified by ctDNA tumor fraction (TF)] during the first three lines of therapy. Real-world progression-free survival (rwPFS) and overall survival (rwOS) were compared between groups by Cox models adjusted for prognostic factors.
Results
~ 60% of cases harbored 1 + GA in 1st-line TBx (1266/2154) or LBx TF ≥ 1% (80/126) and 26.5% (43/162) in LBx TF < 1%.
ESR1
mut was found in 8.1% TBx, 17.5% LBx TF ≥ 1%, and 4.9% LBx TF < 1% in 1st line, increasing to 59% in 3rd line (LBx TF ≥ 1%).
PTEN
loss was detected at higher rates in TBx (4.3%) than LBx (1% in TF ≥ 1%). Patients receiving 1st-line aromatase inhibitor + CDK4/6 inhibitor (
n
= 573) with
ESR1
mut had less favorable rwPFS and rwOS versus
ESR1
wild-type; no differences were observed for fulvestrant + CDK4/6 inhibitor (
n
= 348).
Conclusion
Our study suggests obtaining TBx for CGP at time of de novo/recurrent diagnosis, followed by LBx for detecting acquired GA in 2nd + lines. Reflex TBx should be considered when ctDNA TF < 1%.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>38872062</pmid><doi>10.1007/s10549-024-07376-w</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0167-6806 |
| ispartof | Breast cancer research and treatment, 2024-10, Vol.207 (3), p.599-609 |
| issn | 0167-6806 1573-7217 1573-7217 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11420341 |
| source | SpringerLink Journals |
| subjects | 1-Phosphatidylinositol 3-kinase AKT protein AKT1 protein Aromatase Biopsy Breast cancer Cyclin-dependent kinase 4 Endocrine therapy ErbB-2 protein ESR1 protein Fulvestrant Genomics Medical prognosis Medicine Medicine & Public Health Metastases Metastasis Oncology Patients PTEN protein Survival |
| title | Comprehensive genomic profiling of ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(−) metastatic breast cancer: prevalence along treatment course and predictive value for endocrine therapy resistance in real-world practice |
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