Diagnostic accuracy and safety of 16α-[18F]fluoro-17β-oestradiol PET-CT for the assessment of oestrogen receptor status in recurrent or metastatic lesions in patients with breast cancer: a prospective cohort study
A biopsy of first recurrence or metastatic disease is recommended to re-evaluate oestrogen receptor status in patients with breast cancer and to select appropriate treatment. However, retesting for oestrogen receptor status with rebiopsy is not always feasible, depending on lesion location and the r...
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| Veröffentlicht in: | The lancet oncology 2019-04, Vol.20 (4), p.546-555 |
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| creator | Chae, Sun Young Ahn, Sei Hyun Kim, Sung-Bae Han, Sangwon Lee, Suk Hyun Oh, Seung Jun Lee, Sang Ju Kim, Hee Jeong Ko, Beom Seok Lee, Jong Won Son, Byung Ho Kim, Jisun Ahn, Jin-Hee Jung, Kyung Hae Kim, Jeong Eun Kim, Seog-Young Choi, Woo Jung Shin, Hee Jung Gong, Gyungyub Lee, Hyo Sang Lee, Jung Bok Moon, Dae Hyuk |
| description | A biopsy of first recurrence or metastatic disease is recommended to re-evaluate oestrogen receptor status in patients with breast cancer and to select appropriate treatment. However, retesting for oestrogen receptor status with rebiopsy is not always feasible, depending on lesion location and the risk associated with biopsy, and in these cases clinicians continue to treat patients according to the oestrogen receptor status of the primary tumour. Consequently suboptimal therapy might be offered to these patients. We assessed the diagnostic accuracy and safety of 16α-[18F]fluoro-17β-oestradiol (18F-FES) PET-CT to assess oestrogen receptor status in patients with recurrent or metastatic breast cancer.
We did a prospective cohort study at the Asan Medical Center, Seoul, South Korea. Eligible patients had breast cancer, with first recurrence or metastatic disease at presentation, were 19 years or older, and had an Eastern Cooperative Oncology Group performance status of 0–2. The primary objective was to show the agreement between qualitative 18F-FES PET-CT interpretation and the results of oestrogen receptor expression by immunohistochemical assay, a non-reference standard test. Whole-body 18F-FES PET-CT imaging was done after intravenous injection of 111–222 MBq of 18F-FES, with dosing primarily determined by radiation dosimetry analysis. 18F-FES uptake above background intensity was interpreted as positive. Efficacy was assessed in all patients with histologically confirmed recurrent or metastatic breast cancer who received 18F-FES and had PET-CT images available (intention-to-diagnose analysis), and safety was assessed in all patients who received 18F-FES. This study is registered with ClinicalTrials.gov, number NCT01986569.
Between Nov 27, 2013, and Nov 10, 2016, 93 patients were enrolled. Of the 85 patients included in the efficacy analysis, 47 (55%) were oestrogen receptor-positive and 38 (45%) were oestrogen receptor-negative. Positive status percent agreement between the 18F-FES PET-CT results and oestrogen receptor status by immunohistochemical assay was 76·6% (95% CI 62·0–87·7) and the negative status percent agreement was 100·0% (90·8–100·0). Patients who were oestrogen receptor-positive and had a positive 18F-FES PET-CT result had a significantly higher progesterone receptor expression than those who were oestrogen receptor-positive and had a negative 18F-FES PET-CT result (23 [68%] of 34 patients vs 0 of 11 patients; p |
| doi_str_mv | 10.1016/S1470-2045(18)30936-7 |
| format | Article |
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We did a prospective cohort study at the Asan Medical Center, Seoul, South Korea. Eligible patients had breast cancer, with first recurrence or metastatic disease at presentation, were 19 years or older, and had an Eastern Cooperative Oncology Group performance status of 0–2. The primary objective was to show the agreement between qualitative 18F-FES PET-CT interpretation and the results of oestrogen receptor expression by immunohistochemical assay, a non-reference standard test. Whole-body 18F-FES PET-CT imaging was done after intravenous injection of 111–222 MBq of 18F-FES, with dosing primarily determined by radiation dosimetry analysis. 18F-FES uptake above background intensity was interpreted as positive. Efficacy was assessed in all patients with histologically confirmed recurrent or metastatic breast cancer who received 18F-FES and had PET-CT images available (intention-to-diagnose analysis), and safety was assessed in all patients who received 18F-FES. This study is registered with ClinicalTrials.gov, number NCT01986569.
Between Nov 27, 2013, and Nov 10, 2016, 93 patients were enrolled. Of the 85 patients included in the efficacy analysis, 47 (55%) were oestrogen receptor-positive and 38 (45%) were oestrogen receptor-negative. Positive status percent agreement between the 18F-FES PET-CT results and oestrogen receptor status by immunohistochemical assay was 76·6% (95% CI 62·0–87·7) and the negative status percent agreement was 100·0% (90·8–100·0). Patients who were oestrogen receptor-positive and had a positive 18F-FES PET-CT result had a significantly higher progesterone receptor expression than those who were oestrogen receptor-positive and had a negative 18F-FES PET-CT result (23 [68%] of 34 patients vs 0 of 11 patients; p<0·0001). The most common adverse event was procedural pain in nine (10%) of 90 patients injected with 18F-FES. No adverse events were related to the study drug except injection site pain in one (1%) patient. No serious adverse events were recorded.
The high negative percent agreement between 18F-FES PET-CT and oestrogen receptor status by immunohistochemical assay in this cohort suggests that positive 18F-FES uptake by recurrent or metastatic oestrogen receptor-positive breast cancer lesions could be an alternative to oestrogen receptor assays in this setting. Staging assessment should include 18F-FES PET-CT when retesting oestrogen receptor status is not feasible.
Asan Institute for Life Sciences, Ministry of Health and Welfare, South Korea.</description><identifier>ISSN: 1470-2045</identifier><identifier>EISSN: 1474-5488</identifier><identifier>DOI: 10.1016/S1470-2045(18)30936-7</identifier><identifier>PMID: 30846327</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Accuracy ; Biopsy ; Breast cancer ; Cancer therapies ; Chemotherapy ; Cohort analysis ; Computed tomography ; Dosimetry ; Hypotheses ; Injection ; Intravenous administration ; Lymphatic system ; Medical diagnosis ; Metastases ; Metastasis ; Oncology ; Pain ; Patients ; Progesterone ; R&D ; Radiation therapy ; Research & development ; Safety ; Studies ; Surgery ; Tumors</subject><ispartof>The lancet oncology, 2019-04, Vol.20 (4), p.546-555</ispartof><rights>2019 Elsevier Ltd</rights><rights>Copyright © 2019 Elsevier Ltd. All rights reserved.</rights><rights>2019. Elsevier Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-4735881cfeefb41b4361d082907bfe151a8761b1a96dcd24236983f9585966bc3</citedby><cites>FETCH-LOGICAL-c393t-4735881cfeefb41b4361d082907bfe151a8761b1a96dcd24236983f9585966bc3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1470204518309367$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30846327$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chae, Sun Young</creatorcontrib><creatorcontrib>Ahn, Sei Hyun</creatorcontrib><creatorcontrib>Kim, Sung-Bae</creatorcontrib><creatorcontrib>Han, Sangwon</creatorcontrib><creatorcontrib>Lee, Suk Hyun</creatorcontrib><creatorcontrib>Oh, Seung Jun</creatorcontrib><creatorcontrib>Lee, Sang Ju</creatorcontrib><creatorcontrib>Kim, Hee Jeong</creatorcontrib><creatorcontrib>Ko, Beom Seok</creatorcontrib><creatorcontrib>Lee, Jong Won</creatorcontrib><creatorcontrib>Son, Byung Ho</creatorcontrib><creatorcontrib>Kim, Jisun</creatorcontrib><creatorcontrib>Ahn, Jin-Hee</creatorcontrib><creatorcontrib>Jung, Kyung Hae</creatorcontrib><creatorcontrib>Kim, Jeong Eun</creatorcontrib><creatorcontrib>Kim, Seog-Young</creatorcontrib><creatorcontrib>Choi, Woo Jung</creatorcontrib><creatorcontrib>Shin, Hee Jung</creatorcontrib><creatorcontrib>Gong, Gyungyub</creatorcontrib><creatorcontrib>Lee, Hyo Sang</creatorcontrib><creatorcontrib>Lee, Jung Bok</creatorcontrib><creatorcontrib>Moon, Dae Hyuk</creatorcontrib><title>Diagnostic accuracy and safety of 16α-[18F]fluoro-17β-oestradiol PET-CT for the assessment of oestrogen receptor status in recurrent or metastatic lesions in patients with breast cancer: a prospective cohort study</title><title>The lancet oncology</title><addtitle>Lancet Oncol</addtitle><description>A biopsy of first recurrence or metastatic disease is recommended to re-evaluate oestrogen receptor status in patients with breast cancer and to select appropriate treatment. However, retesting for oestrogen receptor status with rebiopsy is not always feasible, depending on lesion location and the risk associated with biopsy, and in these cases clinicians continue to treat patients according to the oestrogen receptor status of the primary tumour. Consequently suboptimal therapy might be offered to these patients. We assessed the diagnostic accuracy and safety of 16α-[18F]fluoro-17β-oestradiol (18F-FES) PET-CT to assess oestrogen receptor status in patients with recurrent or metastatic breast cancer.
We did a prospective cohort study at the Asan Medical Center, Seoul, South Korea. Eligible patients had breast cancer, with first recurrence or metastatic disease at presentation, were 19 years or older, and had an Eastern Cooperative Oncology Group performance status of 0–2. The primary objective was to show the agreement between qualitative 18F-FES PET-CT interpretation and the results of oestrogen receptor expression by immunohistochemical assay, a non-reference standard test. Whole-body 18F-FES PET-CT imaging was done after intravenous injection of 111–222 MBq of 18F-FES, with dosing primarily determined by radiation dosimetry analysis. 18F-FES uptake above background intensity was interpreted as positive. Efficacy was assessed in all patients with histologically confirmed recurrent or metastatic breast cancer who received 18F-FES and had PET-CT images available (intention-to-diagnose analysis), and safety was assessed in all patients who received 18F-FES. This study is registered with ClinicalTrials.gov, number NCT01986569.
Between Nov 27, 2013, and Nov 10, 2016, 93 patients were enrolled. Of the 85 patients included in the efficacy analysis, 47 (55%) were oestrogen receptor-positive and 38 (45%) were oestrogen receptor-negative. Positive status percent agreement between the 18F-FES PET-CT results and oestrogen receptor status by immunohistochemical assay was 76·6% (95% CI 62·0–87·7) and the negative status percent agreement was 100·0% (90·8–100·0). Patients who were oestrogen receptor-positive and had a positive 18F-FES PET-CT result had a significantly higher progesterone receptor expression than those who were oestrogen receptor-positive and had a negative 18F-FES PET-CT result (23 [68%] of 34 patients vs 0 of 11 patients; p<0·0001). The most common adverse event was procedural pain in nine (10%) of 90 patients injected with 18F-FES. No adverse events were related to the study drug except injection site pain in one (1%) patient. No serious adverse events were recorded.
The high negative percent agreement between 18F-FES PET-CT and oestrogen receptor status by immunohistochemical assay in this cohort suggests that positive 18F-FES uptake by recurrent or metastatic oestrogen receptor-positive breast cancer lesions could be an alternative to oestrogen receptor assays in this setting. Staging assessment should include 18F-FES PET-CT when retesting oestrogen receptor status is not feasible.
Asan Institute for Life Sciences, Ministry of Health and Welfare, South Korea.</description><subject>Accuracy</subject><subject>Biopsy</subject><subject>Breast cancer</subject><subject>Cancer therapies</subject><subject>Chemotherapy</subject><subject>Cohort analysis</subject><subject>Computed tomography</subject><subject>Dosimetry</subject><subject>Hypotheses</subject><subject>Injection</subject><subject>Intravenous administration</subject><subject>Lymphatic system</subject><subject>Medical diagnosis</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Oncology</subject><subject>Pain</subject><subject>Patients</subject><subject>Progesterone</subject><subject>R&D</subject><subject>Radiation therapy</subject><subject>Research & 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Sei Hyun</creator><creator>Kim, Sung-Bae</creator><creator>Han, Sangwon</creator><creator>Lee, Suk Hyun</creator><creator>Oh, Seung Jun</creator><creator>Lee, Sang Ju</creator><creator>Kim, Hee Jeong</creator><creator>Ko, Beom Seok</creator><creator>Lee, Jong Won</creator><creator>Son, Byung Ho</creator><creator>Kim, Jisun</creator><creator>Ahn, Jin-Hee</creator><creator>Jung, Kyung Hae</creator><creator>Kim, Jeong Eun</creator><creator>Kim, Seog-Young</creator><creator>Choi, Woo Jung</creator><creator>Shin, Hee Jung</creator><creator>Gong, Gyungyub</creator><creator>Lee, Hyo Sang</creator><creator>Lee, Jung Bok</creator><creator>Moon, Dae Hyuk</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TZ</scope><scope>3V.</scope><scope>7RV</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8C2</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>H94</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><scope>PRINS</scope></search><sort><creationdate>201904</creationdate><title>Diagnostic accuracy and safety of 16α-[18F]fluoro-17β-oestradiol PET-CT for the assessment of oestrogen receptor status in recurrent or metastatic lesions in patients with breast cancer: a prospective cohort study</title><author>Chae, Sun Young ; Ahn, Sei Hyun ; Kim, Sung-Bae ; Han, Sangwon ; Lee, Suk Hyun ; Oh, Seung Jun ; Lee, Sang Ju ; Kim, Hee Jeong ; Ko, Beom Seok ; Lee, Jong Won ; Son, Byung Ho ; Kim, Jisun ; Ahn, Jin-Hee ; Jung, Kyung Hae ; Kim, Jeong Eun ; Kim, Seog-Young ; Choi, Woo Jung ; Shin, Hee Jung ; Gong, Gyungyub ; Lee, Hyo Sang ; Lee, Jung Bok ; Moon, Dae Hyuk</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c393t-4735881cfeefb41b4361d082907bfe151a8761b1a96dcd24236983f9585966bc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Accuracy</topic><topic>Biopsy</topic><topic>Breast cancer</topic><topic>Cancer therapies</topic><topic>Chemotherapy</topic><topic>Cohort analysis</topic><topic>Computed tomography</topic><topic>Dosimetry</topic><topic>Hypotheses</topic><topic>Injection</topic><topic>Intravenous administration</topic><topic>Lymphatic system</topic><topic>Medical diagnosis</topic><topic>Metastases</topic><topic>Metastasis</topic><topic>Oncology</topic><topic>Pain</topic><topic>Patients</topic><topic>Progesterone</topic><topic>R&D</topic><topic>Radiation therapy</topic><topic>Research & development</topic><topic>Safety</topic><topic>Studies</topic><topic>Surgery</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chae, Sun Young</creatorcontrib><creatorcontrib>Ahn, Sei Hyun</creatorcontrib><creatorcontrib>Kim, Sung-Bae</creatorcontrib><creatorcontrib>Han, Sangwon</creatorcontrib><creatorcontrib>Lee, Suk Hyun</creatorcontrib><creatorcontrib>Oh, Seung Jun</creatorcontrib><creatorcontrib>Lee, Sang Ju</creatorcontrib><creatorcontrib>Kim, Hee Jeong</creatorcontrib><creatorcontrib>Ko, Beom Seok</creatorcontrib><creatorcontrib>Lee, Jong Won</creatorcontrib><creatorcontrib>Son, Byung Ho</creatorcontrib><creatorcontrib>Kim, Jisun</creatorcontrib><creatorcontrib>Ahn, 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oestrogen receptor status in recurrent or metastatic lesions in patients with breast cancer: a prospective cohort study</atitle><jtitle>The lancet oncology</jtitle><addtitle>Lancet Oncol</addtitle><date>2019-04</date><risdate>2019</risdate><volume>20</volume><issue>4</issue><spage>546</spage><epage>555</epage><pages>546-555</pages><issn>1470-2045</issn><eissn>1474-5488</eissn><abstract>A biopsy of first recurrence or metastatic disease is recommended to re-evaluate oestrogen receptor status in patients with breast cancer and to select appropriate treatment. However, retesting for oestrogen receptor status with rebiopsy is not always feasible, depending on lesion location and the risk associated with biopsy, and in these cases clinicians continue to treat patients according to the oestrogen receptor status of the primary tumour. Consequently suboptimal therapy might be offered to these patients. We assessed the diagnostic accuracy and safety of 16α-[18F]fluoro-17β-oestradiol (18F-FES) PET-CT to assess oestrogen receptor status in patients with recurrent or metastatic breast cancer.
We did a prospective cohort study at the Asan Medical Center, Seoul, South Korea. Eligible patients had breast cancer, with first recurrence or metastatic disease at presentation, were 19 years or older, and had an Eastern Cooperative Oncology Group performance status of 0–2. The primary objective was to show the agreement between qualitative 18F-FES PET-CT interpretation and the results of oestrogen receptor expression by immunohistochemical assay, a non-reference standard test. Whole-body 18F-FES PET-CT imaging was done after intravenous injection of 111–222 MBq of 18F-FES, with dosing primarily determined by radiation dosimetry analysis. 18F-FES uptake above background intensity was interpreted as positive. Efficacy was assessed in all patients with histologically confirmed recurrent or metastatic breast cancer who received 18F-FES and had PET-CT images available (intention-to-diagnose analysis), and safety was assessed in all patients who received 18F-FES. This study is registered with ClinicalTrials.gov, number NCT01986569.
Between Nov 27, 2013, and Nov 10, 2016, 93 patients were enrolled. Of the 85 patients included in the efficacy analysis, 47 (55%) were oestrogen receptor-positive and 38 (45%) were oestrogen receptor-negative. Positive status percent agreement between the 18F-FES PET-CT results and oestrogen receptor status by immunohistochemical assay was 76·6% (95% CI 62·0–87·7) and the negative status percent agreement was 100·0% (90·8–100·0). Patients who were oestrogen receptor-positive and had a positive 18F-FES PET-CT result had a significantly higher progesterone receptor expression than those who were oestrogen receptor-positive and had a negative 18F-FES PET-CT result (23 [68%] of 34 patients vs 0 of 11 patients; p<0·0001). The most common adverse event was procedural pain in nine (10%) of 90 patients injected with 18F-FES. No adverse events were related to the study drug except injection site pain in one (1%) patient. No serious adverse events were recorded.
The high negative percent agreement between 18F-FES PET-CT and oestrogen receptor status by immunohistochemical assay in this cohort suggests that positive 18F-FES uptake by recurrent or metastatic oestrogen receptor-positive breast cancer lesions could be an alternative to oestrogen receptor assays in this setting. Staging assessment should include 18F-FES PET-CT when retesting oestrogen receptor status is not feasible.
Asan Institute for Life Sciences, Ministry of Health and Welfare, South Korea.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>30846327</pmid><doi>10.1016/S1470-2045(18)30936-7</doi><tpages>10</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1470-2045 |
| ispartof | The lancet oncology, 2019-04, Vol.20 (4), p.546-555 |
| issn | 1470-2045 1474-5488 |
| language | eng |
| recordid | cdi_proquest_journals_2201731858 |
| source | Elsevier ScienceDirect Journals |
| subjects | Accuracy Biopsy Breast cancer Cancer therapies Chemotherapy Cohort analysis Computed tomography Dosimetry Hypotheses Injection Intravenous administration Lymphatic system Medical diagnosis Metastases Metastasis Oncology Pain Patients Progesterone R&D Radiation therapy Research & development Safety Studies Surgery Tumors |
| title | Diagnostic accuracy and safety of 16α-[18F]fluoro-17β-oestradiol PET-CT for the assessment of oestrogen receptor status in recurrent or metastatic lesions in patients with breast cancer: a prospective cohort study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-01T00%3A20%3A47IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Diagnostic%20accuracy%20and%20safety%20of%2016%CE%B1-%5B18F%5Dfluoro-17%CE%B2-oestradiol%20PET-CT%20for%20the%20assessment%20of%20oestrogen%20receptor%20status%20in%20recurrent%20or%20metastatic%20lesions%20in%20patients%20with%20breast%20cancer:%20a%20prospective%20cohort%20study&rft.jtitle=The%20lancet%20oncology&rft.au=Chae,%20Sun%20Young&rft.date=2019-04&rft.volume=20&rft.issue=4&rft.spage=546&rft.epage=555&rft.pages=546-555&rft.issn=1470-2045&rft.eissn=1474-5488&rft_id=info:doi/10.1016/S1470-2045(18)30936-7&rft_dat=%3Cproquest_cross%3E2201731858%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2201731858&rft_id=info:pmid/30846327&rft_els_id=S1470204518309367&rfr_iscdi=true |