Circulating Tumor DNA as a Predictive Biomarker for Clinical Outcomes With Margetuximab and Pembrolizumab in Pretreated HER2-Positive Gastric/Gastroesophageal Adenocarcinoma
PURPOSE. To assess the ability of circulating tumor DNA (ctDNA)-based testing to identify patients with HER2 (encoded by ERBB2)-positive gastric/gastroesophageal adenocarcinoma (GEA) who progressed on or after trastuzumab-containing treatments were treated with combination therapy of anti-HER2 and a...
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| Veröffentlicht in: | Oncology (Williston Park, N.Y.) N.Y.), 2023-04, Vol.37 (4), p.175 |
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| creator | Catenacci, Daniel V.T Kang, Yoon-Koo Uronis, Hope E Lee, Keun-Wook Ng, Matthew C.H Enzinger, Peter C Park, Se Hoon Gold, Philip J Lacy, Jill Hochster, Howard S Oh, Sang Cheul Kim, Yeul Hong Marrone, Kristen A Kelly, Ronan J Juergens, Rosalyn A Kim, Jong Gwang Alcindor, Thierry Sym, Sun Jin Song, Eun-Kee Chee, Cheng Ean Chao, Yee Kim, Sunnie Oh, Do-Youn Yen, Jennifer Odegaard, Justin I Lagow, Errin Li, Daner Sun, Jichao Kaminker, Patrick Moore, Paul A Rosales, Minori Koshiji Park, Haeseong |
| description | PURPOSE. To assess the ability of circulating tumor DNA (ctDNA)-based testing to identify patients with HER2 (encoded by ERBB2)-positive gastric/gastroesophageal adenocarcinoma (GEA) who progressed on or after trastuzumab-containing treatments were treated with combination therapy of anti-HER2 and anti-PD-1 agents. METHODS. ctDNA analysis was performed retrospectively using plasma samples collected at study entry from 86 patients participating in the phase 1/2 CP-MGAH22-05 study (NCT02689284). RESULTS. Objective response rate (ORR) was significantly higher in evaluable ERBB2 amplification-positive vs negative patients based on ctDNA analysis at study entry (37% vs 6%, respectively; P = .00094). ORR was 23% across all patients who were evaluable for response. ERBB2 amplification was detected at study entry in 57% of patients (all HER2 positive at diagnosis), and detection was higher (88%) when HER2 status was determined by immunohistochemistry fewer than 6 months before study entry. ctDNA was detected in 98% (84/86) of patients tested at study entry. Codetected ERBB2-activating mutations were not associated with response. CONCLUSIONS. Current ERBB2 status may be more effective than archival status at predicting clinical benefit from margetuximab plus pembrolizumab therapy. ctDNA testing for ERBB2 status prior to treatment will spare patients from repeat tissue biopsies, which may be reserved for reflex testing when ctDNA is not detected. KEYWORDS. gastric/gastroesophageal adenocarcinoma; HER2; ctDNA; and margetuximab plus pembrolizumab |
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| fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_journals_2806790886</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A748878730</galeid><sourcerecordid>A748878730</sourcerecordid><originalsourceid>FETCH-LOGICAL-g249t-87561ef2f5f3cfd6eee7384864a5643001b4392d5b59aac8d0baa4de38e137413</originalsourceid><addsrcrecordid>eNptkFtLw0AQhfOg4PU_LAi-RTf3zWOtWgW1RRQfy2R3kk5NduvuRsT_5H80XsAKZR4ODN85Z5itYJeLkoclL6OdYM-5JedxnnOxG3yMycq-BU-6YQ99Zyw7vxsxcAzYzKIi6ekV2RmZDuwzWlYPxLglTRJaNu29NB069kR-wW7BNuj7N-qgYqAVm2FXWdPSe_-1If2V6C2CR8WuLu7jcGYcfedPwHlL8vRbDTqzWkCDQ8NIoTYSrCQ9XHAQbNfQOjz81f3g8fLiYXwV3kwn1-PRTdjEaelDUWR5hHVcZ3Uia5UjYpGIVOQpZHmacB5VaVLGKquyEkAKxSuAVGEiMEqKNEr2g6Of3JU1Lz06P1-a3uqhch4LnhclFyL_oxpocU66Nt6C7MjJ-ahIhShEkfCBCjdQDWq00BqNNQ3rf_zJBn4YhR3JjYbjNcNi-JpfONP2nox26-AnL7ekbQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2806790886</pqid></control><display><type>article</type><title>Circulating Tumor DNA as a Predictive Biomarker for Clinical Outcomes With Margetuximab and Pembrolizumab in Pretreated HER2-Positive Gastric/Gastroesophageal Adenocarcinoma</title><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><creator>Catenacci, Daniel V.T ; Kang, Yoon-Koo ; Uronis, Hope E ; Lee, Keun-Wook ; Ng, Matthew C.H ; Enzinger, Peter C ; Park, Se Hoon ; Gold, Philip J ; Lacy, Jill ; Hochster, Howard S ; Oh, Sang Cheul ; Kim, Yeul Hong ; Marrone, Kristen A ; Kelly, Ronan J ; Juergens, Rosalyn A ; Kim, Jong Gwang ; Alcindor, Thierry ; Sym, Sun Jin ; Song, Eun-Kee ; Chee, Cheng Ean ; Chao, Yee ; Kim, Sunnie ; Oh, Do-Youn ; Yen, Jennifer ; Odegaard, Justin I ; Lagow, Errin ; Li, Daner ; Sun, Jichao ; Kaminker, Patrick ; Moore, Paul A ; Rosales, Minori Koshiji ; Park, Haeseong</creator><creatorcontrib>Catenacci, Daniel V.T ; Kang, Yoon-Koo ; Uronis, Hope E ; Lee, Keun-Wook ; Ng, Matthew C.H ; Enzinger, Peter C ; Park, Se Hoon ; Gold, Philip J ; Lacy, Jill ; Hochster, Howard S ; Oh, Sang Cheul ; Kim, Yeul Hong ; Marrone, Kristen A ; Kelly, Ronan J ; Juergens, Rosalyn A ; Kim, Jong Gwang ; Alcindor, Thierry ; Sym, Sun Jin ; Song, Eun-Kee ; Chee, Cheng Ean ; Chao, Yee ; Kim, Sunnie ; Oh, Do-Youn ; Yen, Jennifer ; Odegaard, Justin I ; Lagow, Errin ; Li, Daner ; Sun, Jichao ; Kaminker, Patrick ; Moore, Paul A ; Rosales, Minori Koshiji ; Park, Haeseong</creatorcontrib><description>PURPOSE. To assess the ability of circulating tumor DNA (ctDNA)-based testing to identify patients with HER2 (encoded by ERBB2)-positive gastric/gastroesophageal adenocarcinoma (GEA) who progressed on or after trastuzumab-containing treatments were treated with combination therapy of anti-HER2 and anti-PD-1 agents. METHODS. ctDNA analysis was performed retrospectively using plasma samples collected at study entry from 86 patients participating in the phase 1/2 CP-MGAH22-05 study (NCT02689284). RESULTS. Objective response rate (ORR) was significantly higher in evaluable ERBB2 amplification-positive vs negative patients based on ctDNA analysis at study entry (37% vs 6%, respectively; P = .00094). ORR was 23% across all patients who were evaluable for response. ERBB2 amplification was detected at study entry in 57% of patients (all HER2 positive at diagnosis), and detection was higher (88%) when HER2 status was determined by immunohistochemistry fewer than 6 months before study entry. ctDNA was detected in 98% (84/86) of patients tested at study entry. Codetected ERBB2-activating mutations were not associated with response. CONCLUSIONS. Current ERBB2 status may be more effective than archival status at predicting clinical benefit from margetuximab plus pembrolizumab therapy. ctDNA testing for ERBB2 status prior to treatment will spare patients from repeat tissue biopsies, which may be reserved for reflex testing when ctDNA is not detected. KEYWORDS. gastric/gastroesophageal adenocarcinoma; HER2; ctDNA; and margetuximab plus pembrolizumab</description><identifier>ISSN: 0890-9091</identifier><language>eng</language><publisher>Monmouth Junction: Intellisphere, LLC</publisher><subject>Adenocarcinoma ; Biomarkers ; Biopsy ; Breast cancer ; Cancer therapies ; Chemotherapy ; DNA ; Gene amplification ; Immunohistochemistry ; Immunotherapy ; Kinases ; Medical research ; Medicine, Experimental ; Metastasis ; Monoclonal antibodies ; Patient outcomes ; Patients ; Pharmaceutical industry ; Plasma ; Response rates ; Targeted cancer therapy ; Tumors</subject><ispartof>Oncology (Williston Park, N.Y.), 2023-04, Vol.37 (4), p.175</ispartof><rights>COPYRIGHT 2023 Intellisphere, LLC</rights><rights>Copyright MultiMedia Healthcare Inc. 2023</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780</link.rule.ids></links><search><creatorcontrib>Catenacci, Daniel V.T</creatorcontrib><creatorcontrib>Kang, Yoon-Koo</creatorcontrib><creatorcontrib>Uronis, Hope E</creatorcontrib><creatorcontrib>Lee, Keun-Wook</creatorcontrib><creatorcontrib>Ng, Matthew C.H</creatorcontrib><creatorcontrib>Enzinger, Peter C</creatorcontrib><creatorcontrib>Park, Se Hoon</creatorcontrib><creatorcontrib>Gold, Philip J</creatorcontrib><creatorcontrib>Lacy, Jill</creatorcontrib><creatorcontrib>Hochster, Howard S</creatorcontrib><creatorcontrib>Oh, Sang Cheul</creatorcontrib><creatorcontrib>Kim, Yeul Hong</creatorcontrib><creatorcontrib>Marrone, Kristen A</creatorcontrib><creatorcontrib>Kelly, Ronan J</creatorcontrib><creatorcontrib>Juergens, Rosalyn A</creatorcontrib><creatorcontrib>Kim, Jong Gwang</creatorcontrib><creatorcontrib>Alcindor, Thierry</creatorcontrib><creatorcontrib>Sym, Sun Jin</creatorcontrib><creatorcontrib>Song, Eun-Kee</creatorcontrib><creatorcontrib>Chee, Cheng Ean</creatorcontrib><creatorcontrib>Chao, Yee</creatorcontrib><creatorcontrib>Kim, Sunnie</creatorcontrib><creatorcontrib>Oh, Do-Youn</creatorcontrib><creatorcontrib>Yen, Jennifer</creatorcontrib><creatorcontrib>Odegaard, Justin I</creatorcontrib><creatorcontrib>Lagow, Errin</creatorcontrib><creatorcontrib>Li, Daner</creatorcontrib><creatorcontrib>Sun, Jichao</creatorcontrib><creatorcontrib>Kaminker, Patrick</creatorcontrib><creatorcontrib>Moore, Paul A</creatorcontrib><creatorcontrib>Rosales, Minori Koshiji</creatorcontrib><creatorcontrib>Park, Haeseong</creatorcontrib><title>Circulating Tumor DNA as a Predictive Biomarker for Clinical Outcomes With Margetuximab and Pembrolizumab in Pretreated HER2-Positive Gastric/Gastroesophageal Adenocarcinoma</title><title>Oncology (Williston Park, N.Y.)</title><description>PURPOSE. To assess the ability of circulating tumor DNA (ctDNA)-based testing to identify patients with HER2 (encoded by ERBB2)-positive gastric/gastroesophageal adenocarcinoma (GEA) who progressed on or after trastuzumab-containing treatments were treated with combination therapy of anti-HER2 and anti-PD-1 agents. METHODS. ctDNA analysis was performed retrospectively using plasma samples collected at study entry from 86 patients participating in the phase 1/2 CP-MGAH22-05 study (NCT02689284). RESULTS. Objective response rate (ORR) was significantly higher in evaluable ERBB2 amplification-positive vs negative patients based on ctDNA analysis at study entry (37% vs 6%, respectively; P = .00094). ORR was 23% across all patients who were evaluable for response. ERBB2 amplification was detected at study entry in 57% of patients (all HER2 positive at diagnosis), and detection was higher (88%) when HER2 status was determined by immunohistochemistry fewer than 6 months before study entry. ctDNA was detected in 98% (84/86) of patients tested at study entry. Codetected ERBB2-activating mutations were not associated with response. CONCLUSIONS. Current ERBB2 status may be more effective than archival status at predicting clinical benefit from margetuximab plus pembrolizumab therapy. ctDNA testing for ERBB2 status prior to treatment will spare patients from repeat tissue biopsies, which may be reserved for reflex testing when ctDNA is not detected. KEYWORDS. gastric/gastroesophageal adenocarcinoma; HER2; ctDNA; and margetuximab plus pembrolizumab</description><subject>Adenocarcinoma</subject><subject>Biomarkers</subject><subject>Biopsy</subject><subject>Breast cancer</subject><subject>Cancer therapies</subject><subject>Chemotherapy</subject><subject>DNA</subject><subject>Gene amplification</subject><subject>Immunohistochemistry</subject><subject>Immunotherapy</subject><subject>Kinases</subject><subject>Medical research</subject><subject>Medicine, Experimental</subject><subject>Metastasis</subject><subject>Monoclonal antibodies</subject><subject>Patient outcomes</subject><subject>Patients</subject><subject>Pharmaceutical industry</subject><subject>Plasma</subject><subject>Response rates</subject><subject>Targeted cancer therapy</subject><subject>Tumors</subject><issn>0890-9091</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><recordid>eNptkFtLw0AQhfOg4PU_LAi-RTf3zWOtWgW1RRQfy2R3kk5NduvuRsT_5H80XsAKZR4ODN85Z5itYJeLkoclL6OdYM-5JedxnnOxG3yMycq-BU-6YQ99Zyw7vxsxcAzYzKIi6ekV2RmZDuwzWlYPxLglTRJaNu29NB069kR-wW7BNuj7N-qgYqAVm2FXWdPSe_-1If2V6C2CR8WuLu7jcGYcfedPwHlL8vRbDTqzWkCDQ8NIoTYSrCQ9XHAQbNfQOjz81f3g8fLiYXwV3kwn1-PRTdjEaelDUWR5hHVcZ3Uia5UjYpGIVOQpZHmacB5VaVLGKquyEkAKxSuAVGEiMEqKNEr2g6Of3JU1Lz06P1-a3uqhch4LnhclFyL_oxpocU66Nt6C7MjJ-ahIhShEkfCBCjdQDWq00BqNNQ3rf_zJBn4YhR3JjYbjNcNi-JpfONP2nox26-AnL7ekbQ</recordid><startdate>20230401</startdate><enddate>20230401</enddate><creator>Catenacci, Daniel V.T</creator><creator>Kang, Yoon-Koo</creator><creator>Uronis, Hope E</creator><creator>Lee, Keun-Wook</creator><creator>Ng, Matthew C.H</creator><creator>Enzinger, Peter C</creator><creator>Park, Se 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Inc</general><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope></search><sort><creationdate>20230401</creationdate><title>Circulating Tumor DNA as a Predictive Biomarker for Clinical Outcomes With Margetuximab and Pembrolizumab in Pretreated HER2-Positive Gastric/Gastroesophageal Adenocarcinoma</title><author>Catenacci, Daniel V.T ; Kang, Yoon-Koo ; Uronis, Hope E ; Lee, Keun-Wook ; Ng, Matthew C.H ; Enzinger, Peter C ; Park, Se Hoon ; Gold, Philip J ; Lacy, Jill ; Hochster, Howard S ; Oh, Sang Cheul ; Kim, Yeul Hong ; Marrone, Kristen A ; Kelly, Ronan J ; Juergens, Rosalyn A ; Kim, Jong Gwang ; Alcindor, Thierry ; Sym, Sun Jin ; Song, Eun-Kee ; Chee, Cheng Ean ; Chao, Yee ; Kim, Sunnie ; Oh, Do-Youn ; Yen, Jennifer ; Odegaard, Justin I ; Lagow, Errin ; Li, Daner ; Sun, Jichao ; Kaminker, Patrick ; Moore, Paul A ; Rosales, Minori Koshiji ; Park, Haeseong</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-g249t-87561ef2f5f3cfd6eee7384864a5643001b4392d5b59aac8d0baa4de38e137413</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adenocarcinoma</topic><topic>Biomarkers</topic><topic>Biopsy</topic><topic>Breast cancer</topic><topic>Cancer therapies</topic><topic>Chemotherapy</topic><topic>DNA</topic><topic>Gene amplification</topic><topic>Immunohistochemistry</topic><topic>Immunotherapy</topic><topic>Kinases</topic><topic>Medical research</topic><topic>Medicine, Experimental</topic><topic>Metastasis</topic><topic>Monoclonal antibodies</topic><topic>Patient outcomes</topic><topic>Patients</topic><topic>Pharmaceutical industry</topic><topic>Plasma</topic><topic>Response rates</topic><topic>Targeted cancer therapy</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Catenacci, Daniel V.T</creatorcontrib><creatorcontrib>Kang, Yoon-Koo</creatorcontrib><creatorcontrib>Uronis, Hope E</creatorcontrib><creatorcontrib>Lee, Keun-Wook</creatorcontrib><creatorcontrib>Ng, Matthew C.H</creatorcontrib><creatorcontrib>Enzinger, Peter C</creatorcontrib><creatorcontrib>Park, Se Hoon</creatorcontrib><creatorcontrib>Gold, Philip J</creatorcontrib><creatorcontrib>Lacy, Jill</creatorcontrib><creatorcontrib>Hochster, Howard S</creatorcontrib><creatorcontrib>Oh, Sang Cheul</creatorcontrib><creatorcontrib>Kim, Yeul Hong</creatorcontrib><creatorcontrib>Marrone, Kristen A</creatorcontrib><creatorcontrib>Kelly, Ronan J</creatorcontrib><creatorcontrib>Juergens, Rosalyn 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Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><jtitle>Oncology (Williston Park, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Catenacci, Daniel V.T</au><au>Kang, Yoon-Koo</au><au>Uronis, Hope E</au><au>Lee, Keun-Wook</au><au>Ng, Matthew C.H</au><au>Enzinger, Peter C</au><au>Park, Se Hoon</au><au>Gold, Philip J</au><au>Lacy, Jill</au><au>Hochster, Howard S</au><au>Oh, Sang Cheul</au><au>Kim, Yeul Hong</au><au>Marrone, Kristen A</au><au>Kelly, Ronan J</au><au>Juergens, Rosalyn A</au><au>Kim, Jong Gwang</au><au>Alcindor, Thierry</au><au>Sym, Sun Jin</au><au>Song, Eun-Kee</au><au>Chee, Cheng Ean</au><au>Chao, Yee</au><au>Kim, Sunnie</au><au>Oh, Do-Youn</au><au>Yen, Jennifer</au><au>Odegaard, Justin I</au><au>Lagow, Errin</au><au>Li, Daner</au><au>Sun, Jichao</au><au>Kaminker, Patrick</au><au>Moore, Paul A</au><au>Rosales, Minori Koshiji</au><au>Park, Haeseong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Circulating Tumor DNA as a Predictive Biomarker for Clinical Outcomes With Margetuximab and Pembrolizumab in Pretreated HER2-Positive Gastric/Gastroesophageal Adenocarcinoma</atitle><jtitle>Oncology (Williston Park, N.Y.)</jtitle><date>2023-04-01</date><risdate>2023</risdate><volume>37</volume><issue>4</issue><spage>175</spage><pages>175-</pages><issn>0890-9091</issn><abstract>PURPOSE. To assess the ability of circulating tumor DNA (ctDNA)-based testing to identify patients with HER2 (encoded by ERBB2)-positive gastric/gastroesophageal adenocarcinoma (GEA) who progressed on or after trastuzumab-containing treatments were treated with combination therapy of anti-HER2 and anti-PD-1 agents. METHODS. ctDNA analysis was performed retrospectively using plasma samples collected at study entry from 86 patients participating in the phase 1/2 CP-MGAH22-05 study (NCT02689284). RESULTS. Objective response rate (ORR) was significantly higher in evaluable ERBB2 amplification-positive vs negative patients based on ctDNA analysis at study entry (37% vs 6%, respectively; P = .00094). ORR was 23% across all patients who were evaluable for response. ERBB2 amplification was detected at study entry in 57% of patients (all HER2 positive at diagnosis), and detection was higher (88%) when HER2 status was determined by immunohistochemistry fewer than 6 months before study entry. ctDNA was detected in 98% (84/86) of patients tested at study entry. Codetected ERBB2-activating mutations were not associated with response. CONCLUSIONS. Current ERBB2 status may be more effective than archival status at predicting clinical benefit from margetuximab plus pembrolizumab therapy. ctDNA testing for ERBB2 status prior to treatment will spare patients from repeat tissue biopsies, which may be reserved for reflex testing when ctDNA is not detected. KEYWORDS. gastric/gastroesophageal adenocarcinoma; HER2; ctDNA; and margetuximab plus pembrolizumab</abstract><cop>Monmouth Junction</cop><pub>Intellisphere, LLC</pub></addata></record> |
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| subjects | Adenocarcinoma Biomarkers Biopsy Breast cancer Cancer therapies Chemotherapy DNA Gene amplification Immunohistochemistry Immunotherapy Kinases Medical research Medicine, Experimental Metastasis Monoclonal antibodies Patient outcomes Patients Pharmaceutical industry Plasma Response rates Targeted cancer therapy Tumors |
| title | Circulating Tumor DNA as a Predictive Biomarker for Clinical Outcomes With Margetuximab and Pembrolizumab in Pretreated HER2-Positive Gastric/Gastroesophageal Adenocarcinoma |
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