A prediction model for early systemic recurrence in breast cancer using a molecular diagnostic analysis of sentinel lymph nodes: A large‐scale, multicenter cohort study
Background The one‐step nucleic acid amplification (OSNA) assay can quantify the cytokeratin 19 messenger RNA copy number as a proxy for sentinel lymph node (SN) metastasis in breast cancer. A large‐scale, multicenter cohort study was performed to determine the prognostic value of the SN tumor burde...
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| Veröffentlicht in: | Cancer 2022-05, Vol.128 (10), p.1913-1920 |
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| creator | Osako, Tomo Matsuura, Masaaki Yotsumoto, Daisuke Takayama, Shin Kaneko, Koji Takahashi, Mina Shimazu, Kenzo Yoshidome, Katsuhide Kuraoka, Kazuya Itakura, Masayuki Tani, Mayumi Ishikawa, Takashi Ohi, Yasuyo Kinoshita, Takayuki Sato, Nobuaki Tsujimoto, Masahiko Nakamura, Seigo Tsuda, Hitoshi Noguchi, Shinzaburo Akiyama, Futoshi |
| description | Background
The one‐step nucleic acid amplification (OSNA) assay can quantify the cytokeratin 19 messenger RNA copy number as a proxy for sentinel lymph node (SN) metastasis in breast cancer. A large‐scale, multicenter cohort study was performed to determine the prognostic value of the SN tumor burden based on a molecular readout and to establish a model for the prediction of early systemic recurrence in patients using the OSNA assay.
Methods
SN biopsies from 4757 patients with breast cancer were analyzed with the OSNA assay. The patients were randomly assigned to the training or validation cohort at a ratio of 2:1. On the basis of the training cohort, the threshold SN tumor burden value for stratifying distant recurrence was determined with Youden's index; predictors of distant recurrence were investigated via multivariable analyses. Based on the selected predictors, a model for estimating 5‐year distant recurrence–free survival was constructed, and predictive performance was measured with the validation cohort.
Results
The prognostic cutoff value for the SN tumor burden was 1100 copies/μL. The following variables were significantly associated with distant recurrence and were used to construct the prediction model: SN tumor burden, age, pT classification, grade, progesterone receptor, adjuvant cytotoxic chemotherapy, and adjuvant anti–human epidermal growth factor receptor 2 therapy. The values for the area under the curve, sensitivity, specificity, and accuracy of the prediction model were 0.83, 63.4%, 81.7%, and 81.1%, respectively.
Conclusions
Using the OSNA assay, the molecular readout–based SN tumor burden is an independent prognostic factor for early breast cancer. This model accurately predicts early systemic recurrence and may facilitate decision‐making related to treatment.
The molecular‐based tumor burden in sentinel lymph nodes is an independent prognostic factor for early breast cancer. This model can accurately predict early systemic recurrence, and the one‐step nucleic acid amplification assay may guide therapeutic decision‐making for patients. |
| doi_str_mv | 10.1002/cncr.34144 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9311203</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2654300800</sourcerecordid><originalsourceid>FETCH-LOGICAL-c5144-b332d74c215600a8848faa63201d8a86d505ac9203414c3db9fe1c28c61f34483</originalsourceid><addsrcrecordid>eNp9ks-KFDEQxoMo7rh68QEk4EXEXvO3p8eDMAz-g0VBFLyFmnR6Jks6mU26lb75CD6Hj-WTWO2si3rwFIr8vq-Kr4qQ-5ydccbEUxttPpOKK3WDLDhbLSvGlbhJFoyxptJKfjohd0q5wHIptLxNTqQWopZ6uSDf1_SQXevt4FOkfWpdoF3K1EEOEy1TGVzvLc3Ojjm7aB31kW6zgzJQC1hnOhYfdxRQHJAKkGnrYRdTGVAIEcJUfKGpo8XFwUdsEKb-sKcRm5VndE1RsnM_vn4rFoJ7QvsxoBJZ9LZpn_JAyzC2011yq4NQ3L2r95R8fPniw-Z1df7u1ZvN-ryyGiOotlKKdqms4LpmDJpGNR1ALQXjbQNN3Wqmwa4EmxOzst2uOsetaGzNO6lUI0_J86PvYdz2rp0nyRDMIfse8mQSePP3T_R7s0ufzUpyjrZo8OjKIKfL0ZXB9L5YFwJEl8ZiMHqlueS1RvThP-hFGjNmNlO4OVwgY0g9PlI2p1Ky666H4czMJ2DmEzC_TgDhB3-Of43-3jkC_Ah88cFN_7Eym7eb90fTny_WwGI</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2654300800</pqid></control><display><type>article</type><title>A prediction model for early systemic recurrence in breast cancer using a molecular diagnostic analysis of sentinel lymph nodes: A large‐scale, multicenter cohort study</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Access via Wiley Online Library</source><source>Wiley Online Library (Open Access Collection)</source><source>Alma/SFX Local Collection</source><creator>Osako, Tomo ; Matsuura, Masaaki ; Yotsumoto, Daisuke ; Takayama, Shin ; Kaneko, Koji ; Takahashi, Mina ; Shimazu, Kenzo ; Yoshidome, Katsuhide ; Kuraoka, Kazuya ; Itakura, Masayuki ; Tani, Mayumi ; Ishikawa, Takashi ; Ohi, Yasuyo ; Kinoshita, Takayuki ; Sato, Nobuaki ; Tsujimoto, Masahiko ; Nakamura, Seigo ; Tsuda, Hitoshi ; Noguchi, Shinzaburo ; Akiyama, Futoshi</creator><creatorcontrib>Osako, Tomo ; Matsuura, Masaaki ; Yotsumoto, Daisuke ; Takayama, Shin ; Kaneko, Koji ; Takahashi, Mina ; Shimazu, Kenzo ; Yoshidome, Katsuhide ; Kuraoka, Kazuya ; Itakura, Masayuki ; Tani, Mayumi ; Ishikawa, Takashi ; Ohi, Yasuyo ; Kinoshita, Takayuki ; Sato, Nobuaki ; Tsujimoto, Masahiko ; Nakamura, Seigo ; Tsuda, Hitoshi ; Noguchi, Shinzaburo ; Akiyama, Futoshi</creatorcontrib><description>Background
The one‐step nucleic acid amplification (OSNA) assay can quantify the cytokeratin 19 messenger RNA copy number as a proxy for sentinel lymph node (SN) metastasis in breast cancer. A large‐scale, multicenter cohort study was performed to determine the prognostic value of the SN tumor burden based on a molecular readout and to establish a model for the prediction of early systemic recurrence in patients using the OSNA assay.
Methods
SN biopsies from 4757 patients with breast cancer were analyzed with the OSNA assay. The patients were randomly assigned to the training or validation cohort at a ratio of 2:1. On the basis of the training cohort, the threshold SN tumor burden value for stratifying distant recurrence was determined with Youden's index; predictors of distant recurrence were investigated via multivariable analyses. Based on the selected predictors, a model for estimating 5‐year distant recurrence–free survival was constructed, and predictive performance was measured with the validation cohort.
Results
The prognostic cutoff value for the SN tumor burden was 1100 copies/μL. The following variables were significantly associated with distant recurrence and were used to construct the prediction model: SN tumor burden, age, pT classification, grade, progesterone receptor, adjuvant cytotoxic chemotherapy, and adjuvant anti–human epidermal growth factor receptor 2 therapy. The values for the area under the curve, sensitivity, specificity, and accuracy of the prediction model were 0.83, 63.4%, 81.7%, and 81.1%, respectively.
Conclusions
Using the OSNA assay, the molecular readout–based SN tumor burden is an independent prognostic factor for early breast cancer. This model accurately predicts early systemic recurrence and may facilitate decision‐making related to treatment.
The molecular‐based tumor burden in sentinel lymph nodes is an independent prognostic factor for early breast cancer. This model can accurately predict early systemic recurrence, and the one‐step nucleic acid amplification assay may guide therapeutic decision‐making for patients.</description><identifier>ISSN: 0008-543X</identifier><identifier>EISSN: 1097-0142</identifier><identifier>DOI: 10.1002/cncr.34144</identifier><identifier>PMID: 35226357</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Assaying ; Biomarkers, Tumor - metabolism ; Biopsy ; Breast cancer ; Breast Neoplasms - diagnosis ; Breast Neoplasms - genetics ; Breast Neoplasms - metabolism ; Cancer therapies ; Chemotherapy ; Cohort analysis ; Cohort Studies ; Copy number ; Cytokeratin ; cytokeratin 19 ; Cytotoxicity ; Decision making ; Epidermal growth factor ; Female ; Growth factors ; Humans ; Lymph nodes ; Lymph Nodes - pathology ; Lymphatic Metastasis - pathology ; Medical diagnosis ; Metastases ; mRNA ; multicenter study ; Neoplasm Recurrence, Local - pathology ; Nucleic acids ; Oncology ; one‐step nucleic acid amplification (OSNA) assay ; Original ; Pathology, Molecular ; Patients ; Performance prediction ; prediction model ; Prediction models ; Progesterone ; Quality ; Receptors ; sentinel lymph node ; Sentinel Lymph Node - pathology ; total tumor load ; Training ; Tumors</subject><ispartof>Cancer, 2022-05, Vol.128 (10), p.1913-1920</ispartof><rights>2022 The Authors. published by Wiley Periodicals LLC on behalf of American Cancer Society</rights><rights>2022 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.</rights><rights>2022. This article is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5144-b332d74c215600a8848faa63201d8a86d505ac9203414c3db9fe1c28c61f34483</citedby><cites>FETCH-LOGICAL-c5144-b332d74c215600a8848faa63201d8a86d505ac9203414c3db9fe1c28c61f34483</cites><orcidid>0000-0002-0837-2357 ; 0000-0001-9250-4035</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fcncr.34144$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fcncr.34144$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,315,781,785,886,1418,1434,27929,27930,45579,45580,46414,46838</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35226357$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Osako, Tomo</creatorcontrib><creatorcontrib>Matsuura, Masaaki</creatorcontrib><creatorcontrib>Yotsumoto, Daisuke</creatorcontrib><creatorcontrib>Takayama, Shin</creatorcontrib><creatorcontrib>Kaneko, Koji</creatorcontrib><creatorcontrib>Takahashi, Mina</creatorcontrib><creatorcontrib>Shimazu, Kenzo</creatorcontrib><creatorcontrib>Yoshidome, Katsuhide</creatorcontrib><creatorcontrib>Kuraoka, Kazuya</creatorcontrib><creatorcontrib>Itakura, Masayuki</creatorcontrib><creatorcontrib>Tani, Mayumi</creatorcontrib><creatorcontrib>Ishikawa, Takashi</creatorcontrib><creatorcontrib>Ohi, Yasuyo</creatorcontrib><creatorcontrib>Kinoshita, Takayuki</creatorcontrib><creatorcontrib>Sato, Nobuaki</creatorcontrib><creatorcontrib>Tsujimoto, Masahiko</creatorcontrib><creatorcontrib>Nakamura, Seigo</creatorcontrib><creatorcontrib>Tsuda, Hitoshi</creatorcontrib><creatorcontrib>Noguchi, Shinzaburo</creatorcontrib><creatorcontrib>Akiyama, Futoshi</creatorcontrib><title>A prediction model for early systemic recurrence in breast cancer using a molecular diagnostic analysis of sentinel lymph nodes: A large‐scale, multicenter cohort study</title><title>Cancer</title><addtitle>Cancer</addtitle><description>Background
The one‐step nucleic acid amplification (OSNA) assay can quantify the cytokeratin 19 messenger RNA copy number as a proxy for sentinel lymph node (SN) metastasis in breast cancer. A large‐scale, multicenter cohort study was performed to determine the prognostic value of the SN tumor burden based on a molecular readout and to establish a model for the prediction of early systemic recurrence in patients using the OSNA assay.
Methods
SN biopsies from 4757 patients with breast cancer were analyzed with the OSNA assay. The patients were randomly assigned to the training or validation cohort at a ratio of 2:1. On the basis of the training cohort, the threshold SN tumor burden value for stratifying distant recurrence was determined with Youden's index; predictors of distant recurrence were investigated via multivariable analyses. Based on the selected predictors, a model for estimating 5‐year distant recurrence–free survival was constructed, and predictive performance was measured with the validation cohort.
Results
The prognostic cutoff value for the SN tumor burden was 1100 copies/μL. The following variables were significantly associated with distant recurrence and were used to construct the prediction model: SN tumor burden, age, pT classification, grade, progesterone receptor, adjuvant cytotoxic chemotherapy, and adjuvant anti–human epidermal growth factor receptor 2 therapy. The values for the area under the curve, sensitivity, specificity, and accuracy of the prediction model were 0.83, 63.4%, 81.7%, and 81.1%, respectively.
Conclusions
Using the OSNA assay, the molecular readout–based SN tumor burden is an independent prognostic factor for early breast cancer. This model accurately predicts early systemic recurrence and may facilitate decision‐making related to treatment.
The molecular‐based tumor burden in sentinel lymph nodes is an independent prognostic factor for early breast cancer. This model can accurately predict early systemic recurrence, and the one‐step nucleic acid amplification assay may guide therapeutic decision‐making for patients.</description><subject>Assaying</subject><subject>Biomarkers, Tumor - metabolism</subject><subject>Biopsy</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - diagnosis</subject><subject>Breast Neoplasms - genetics</subject><subject>Breast Neoplasms - metabolism</subject><subject>Cancer therapies</subject><subject>Chemotherapy</subject><subject>Cohort analysis</subject><subject>Cohort Studies</subject><subject>Copy number</subject><subject>Cytokeratin</subject><subject>cytokeratin 19</subject><subject>Cytotoxicity</subject><subject>Decision making</subject><subject>Epidermal growth factor</subject><subject>Female</subject><subject>Growth factors</subject><subject>Humans</subject><subject>Lymph nodes</subject><subject>Lymph Nodes - pathology</subject><subject>Lymphatic Metastasis - pathology</subject><subject>Medical diagnosis</subject><subject>Metastases</subject><subject>mRNA</subject><subject>multicenter study</subject><subject>Neoplasm Recurrence, Local - pathology</subject><subject>Nucleic acids</subject><subject>Oncology</subject><subject>one‐step nucleic acid amplification (OSNA) assay</subject><subject>Original</subject><subject>Pathology, Molecular</subject><subject>Patients</subject><subject>Performance prediction</subject><subject>prediction model</subject><subject>Prediction models</subject><subject>Progesterone</subject><subject>Quality</subject><subject>Receptors</subject><subject>sentinel lymph node</subject><subject>Sentinel Lymph Node - pathology</subject><subject>total tumor load</subject><subject>Training</subject><subject>Tumors</subject><issn>0008-543X</issn><issn>1097-0142</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp9ks-KFDEQxoMo7rh68QEk4EXEXvO3p8eDMAz-g0VBFLyFmnR6Jks6mU26lb75CD6Hj-WTWO2si3rwFIr8vq-Kr4qQ-5ydccbEUxttPpOKK3WDLDhbLSvGlbhJFoyxptJKfjohd0q5wHIptLxNTqQWopZ6uSDf1_SQXevt4FOkfWpdoF3K1EEOEy1TGVzvLc3Ojjm7aB31kW6zgzJQC1hnOhYfdxRQHJAKkGnrYRdTGVAIEcJUfKGpo8XFwUdsEKb-sKcRm5VndE1RsnM_vn4rFoJ7QvsxoBJZ9LZpn_JAyzC2011yq4NQ3L2r95R8fPniw-Z1df7u1ZvN-ryyGiOotlKKdqms4LpmDJpGNR1ALQXjbQNN3Wqmwa4EmxOzst2uOsetaGzNO6lUI0_J86PvYdz2rp0nyRDMIfse8mQSePP3T_R7s0ufzUpyjrZo8OjKIKfL0ZXB9L5YFwJEl8ZiMHqlueS1RvThP-hFGjNmNlO4OVwgY0g9PlI2p1Ky666H4czMJ2DmEzC_TgDhB3-Of43-3jkC_Ah88cFN_7Eym7eb90fTny_WwGI</recordid><startdate>20220515</startdate><enddate>20220515</enddate><creator>Osako, Tomo</creator><creator>Matsuura, Masaaki</creator><creator>Yotsumoto, Daisuke</creator><creator>Takayama, Shin</creator><creator>Kaneko, Koji</creator><creator>Takahashi, Mina</creator><creator>Shimazu, Kenzo</creator><creator>Yoshidome, Katsuhide</creator><creator>Kuraoka, Kazuya</creator><creator>Itakura, Masayuki</creator><creator>Tani, Mayumi</creator><creator>Ishikawa, Takashi</creator><creator>Ohi, Yasuyo</creator><creator>Kinoshita, Takayuki</creator><creator>Sato, Nobuaki</creator><creator>Tsujimoto, Masahiko</creator><creator>Nakamura, Seigo</creator><creator>Tsuda, Hitoshi</creator><creator>Noguchi, Shinzaburo</creator><creator>Akiyama, Futoshi</creator><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TO</scope><scope>7U7</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-0837-2357</orcidid><orcidid>https://orcid.org/0000-0001-9250-4035</orcidid></search><sort><creationdate>20220515</creationdate><title>A prediction model for early systemic recurrence in breast cancer using a molecular diagnostic analysis of sentinel lymph nodes: A large‐scale, multicenter cohort study</title><author>Osako, Tomo ; Matsuura, Masaaki ; Yotsumoto, Daisuke ; Takayama, Shin ; Kaneko, Koji ; Takahashi, Mina ; Shimazu, Kenzo ; Yoshidome, Katsuhide ; Kuraoka, Kazuya ; Itakura, Masayuki ; Tani, Mayumi ; Ishikawa, Takashi ; Ohi, Yasuyo ; Kinoshita, Takayuki ; Sato, Nobuaki ; Tsujimoto, Masahiko ; Nakamura, Seigo ; Tsuda, Hitoshi ; Noguchi, Shinzaburo ; Akiyama, Futoshi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5144-b332d74c215600a8848faa63201d8a86d505ac9203414c3db9fe1c28c61f34483</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Assaying</topic><topic>Biomarkers, Tumor - metabolism</topic><topic>Biopsy</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - diagnosis</topic><topic>Breast Neoplasms - genetics</topic><topic>Breast Neoplasms - metabolism</topic><topic>Cancer therapies</topic><topic>Chemotherapy</topic><topic>Cohort analysis</topic><topic>Cohort Studies</topic><topic>Copy number</topic><topic>Cytokeratin</topic><topic>cytokeratin 19</topic><topic>Cytotoxicity</topic><topic>Decision making</topic><topic>Epidermal growth factor</topic><topic>Female</topic><topic>Growth factors</topic><topic>Humans</topic><topic>Lymph nodes</topic><topic>Lymph Nodes - pathology</topic><topic>Lymphatic Metastasis - pathology</topic><topic>Medical diagnosis</topic><topic>Metastases</topic><topic>mRNA</topic><topic>multicenter study</topic><topic>Neoplasm Recurrence, Local - pathology</topic><topic>Nucleic acids</topic><topic>Oncology</topic><topic>one‐step nucleic acid amplification (OSNA) assay</topic><topic>Original</topic><topic>Pathology, Molecular</topic><topic>Patients</topic><topic>Performance prediction</topic><topic>prediction model</topic><topic>Prediction models</topic><topic>Progesterone</topic><topic>Quality</topic><topic>Receptors</topic><topic>sentinel lymph node</topic><topic>Sentinel Lymph Node - pathology</topic><topic>total tumor load</topic><topic>Training</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Osako, Tomo</creatorcontrib><creatorcontrib>Matsuura, Masaaki</creatorcontrib><creatorcontrib>Yotsumoto, Daisuke</creatorcontrib><creatorcontrib>Takayama, Shin</creatorcontrib><creatorcontrib>Kaneko, Koji</creatorcontrib><creatorcontrib>Takahashi, Mina</creatorcontrib><creatorcontrib>Shimazu, Kenzo</creatorcontrib><creatorcontrib>Yoshidome, Katsuhide</creatorcontrib><creatorcontrib>Kuraoka, Kazuya</creatorcontrib><creatorcontrib>Itakura, Masayuki</creatorcontrib><creatorcontrib>Tani, Mayumi</creatorcontrib><creatorcontrib>Ishikawa, Takashi</creatorcontrib><creatorcontrib>Ohi, Yasuyo</creatorcontrib><creatorcontrib>Kinoshita, Takayuki</creatorcontrib><creatorcontrib>Sato, Nobuaki</creatorcontrib><creatorcontrib>Tsujimoto, Masahiko</creatorcontrib><creatorcontrib>Nakamura, Seigo</creatorcontrib><creatorcontrib>Tsuda, Hitoshi</creatorcontrib><creatorcontrib>Noguchi, Shinzaburo</creatorcontrib><creatorcontrib>Akiyama, Futoshi</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Online Library (Open Access Collection)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Osako, Tomo</au><au>Matsuura, Masaaki</au><au>Yotsumoto, Daisuke</au><au>Takayama, Shin</au><au>Kaneko, Koji</au><au>Takahashi, Mina</au><au>Shimazu, Kenzo</au><au>Yoshidome, Katsuhide</au><au>Kuraoka, Kazuya</au><au>Itakura, Masayuki</au><au>Tani, Mayumi</au><au>Ishikawa, Takashi</au><au>Ohi, Yasuyo</au><au>Kinoshita, Takayuki</au><au>Sato, Nobuaki</au><au>Tsujimoto, Masahiko</au><au>Nakamura, Seigo</au><au>Tsuda, Hitoshi</au><au>Noguchi, Shinzaburo</au><au>Akiyama, Futoshi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A prediction model for early systemic recurrence in breast cancer using a molecular diagnostic analysis of sentinel lymph nodes: A large‐scale, multicenter cohort study</atitle><jtitle>Cancer</jtitle><addtitle>Cancer</addtitle><date>2022-05-15</date><risdate>2022</risdate><volume>128</volume><issue>10</issue><spage>1913</spage><epage>1920</epage><pages>1913-1920</pages><issn>0008-543X</issn><eissn>1097-0142</eissn><abstract>Background
The one‐step nucleic acid amplification (OSNA) assay can quantify the cytokeratin 19 messenger RNA copy number as a proxy for sentinel lymph node (SN) metastasis in breast cancer. A large‐scale, multicenter cohort study was performed to determine the prognostic value of the SN tumor burden based on a molecular readout and to establish a model for the prediction of early systemic recurrence in patients using the OSNA assay.
Methods
SN biopsies from 4757 patients with breast cancer were analyzed with the OSNA assay. The patients were randomly assigned to the training or validation cohort at a ratio of 2:1. On the basis of the training cohort, the threshold SN tumor burden value for stratifying distant recurrence was determined with Youden's index; predictors of distant recurrence were investigated via multivariable analyses. Based on the selected predictors, a model for estimating 5‐year distant recurrence–free survival was constructed, and predictive performance was measured with the validation cohort.
Results
The prognostic cutoff value for the SN tumor burden was 1100 copies/μL. The following variables were significantly associated with distant recurrence and were used to construct the prediction model: SN tumor burden, age, pT classification, grade, progesterone receptor, adjuvant cytotoxic chemotherapy, and adjuvant anti–human epidermal growth factor receptor 2 therapy. The values for the area under the curve, sensitivity, specificity, and accuracy of the prediction model were 0.83, 63.4%, 81.7%, and 81.1%, respectively.
Conclusions
Using the OSNA assay, the molecular readout–based SN tumor burden is an independent prognostic factor for early breast cancer. This model accurately predicts early systemic recurrence and may facilitate decision‐making related to treatment.
The molecular‐based tumor burden in sentinel lymph nodes is an independent prognostic factor for early breast cancer. This model can accurately predict early systemic recurrence, and the one‐step nucleic acid amplification assay may guide therapeutic decision‐making for patients.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>35226357</pmid><doi>10.1002/cncr.34144</doi><tpages>0</tpages><orcidid>https://orcid.org/0000-0002-0837-2357</orcidid><orcidid>https://orcid.org/0000-0001-9250-4035</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Cancer, 2022-05, Vol.128 (10), p.1913-1920 |
| issn | 0008-543X 1097-0142 |
| language | eng |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Access via Wiley Online Library; Wiley Online Library (Open Access Collection); Alma/SFX Local Collection |
| subjects | Assaying Biomarkers, Tumor - metabolism Biopsy Breast cancer Breast Neoplasms - diagnosis Breast Neoplasms - genetics Breast Neoplasms - metabolism Cancer therapies Chemotherapy Cohort analysis Cohort Studies Copy number Cytokeratin cytokeratin 19 Cytotoxicity Decision making Epidermal growth factor Female Growth factors Humans Lymph nodes Lymph Nodes - pathology Lymphatic Metastasis - pathology Medical diagnosis Metastases mRNA multicenter study Neoplasm Recurrence, Local - pathology Nucleic acids Oncology one‐step nucleic acid amplification (OSNA) assay Original Pathology, Molecular Patients Performance prediction prediction model Prediction models Progesterone Quality Receptors sentinel lymph node Sentinel Lymph Node - pathology total tumor load Training Tumors |
| title | A prediction model for early systemic recurrence in breast cancer using a molecular diagnostic analysis of sentinel lymph nodes: A large‐scale, multicenter cohort study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-15T21%3A45%3A08IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20prediction%20model%20for%20early%20systemic%20recurrence%20in%20breast%20cancer%20using%20a%20molecular%20diagnostic%20analysis%20of%20sentinel%20lymph%20nodes:%20A%20large%E2%80%90scale,%20multicenter%20cohort%20study&rft.jtitle=Cancer&rft.au=Osako,%20Tomo&rft.date=2022-05-15&rft.volume=128&rft.issue=10&rft.spage=1913&rft.epage=1920&rft.pages=1913-1920&rft.issn=0008-543X&rft.eissn=1097-0142&rft_id=info:doi/10.1002/cncr.34144&rft_dat=%3Cproquest_pubme%3E2654300800%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2654300800&rft_id=info:pmid/35226357&rfr_iscdi=true |