HIFU for the treatment of difficult colorectal liver metastases with unsuitable indications for resection and radiofrequency ablation: a phase I clinical trial
Background The goal of this study is to evaluate the safety and efficacy of high intensity focused ultrasound (HIFU) for patients with colorectal liver metastases (CRLM) but were contraindicated for resection and radiofrequency ablation. Methods Patients between 20 and 80 years of age with 1–3 liver...
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Veröffentlicht in: | Surgical endoscopy 2021-05, Vol.35 (5), p.2306-2315 |
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creator | Yang, Tong Ng, Derry Minyao Du, Nannan He, Ning Dai, Xiaoyu Chen, Ping Wu, Feng Chen, Bo Fan, Xiaoxiang Yan, Kun Zhou, Xinfeng Dong, Mingjun Zheng, Zhi Gu, Lihu |
description | Background
The goal of this study is to evaluate the safety and efficacy of high intensity focused ultrasound (HIFU) for patients with colorectal liver metastases (CRLM) but were contraindicated for resection and radiofrequency ablation.
Methods
Patients between 20 and 80 years of age with 1–3 liver metastases from colorectal cancer were selected. Included patients have had their primary lesions removed with no evidence of extrahepatic metastasis prior to the study. Ultrasound-guided HIFU was employed and target regions’ ablation was achieved with repeated sonications from the deep to shallow regions of the tumors section by section.
Results
Thirteen patients were enrolled. The most common adverse events (AEs) were pain (
n
= 8), followed by fatigue (
n
= 7), increased aspartate aminotransferase (AST) (
n
= 7), increased alanine aminotransferase (ALT) (
n
= 5), and skin edema (
n
= 4). No grade ≥ 3 AEs occurred and while most patients (76.9%) achieved a complete response, three patients achieved a partial response. The objective response rate was 100% after the first HIFU treatment. Nine patients relapsed but the tumors were mostly isolated to the liver (8/9). The median follow-up period was 25 months. The 2-year progression-free survival (PFS) was 16.7%, and the median PFS was 9 months. Notably, the 2-year overall survival (OS) was 77.8%, and the median OS was 25 months.
Conclusion
This study indicates that the HIFU treatment is safe, is able to achieve a good tumor response rate and long-term prognosis even when the foci were in high-risk locations, and should be considered for patients who were considered unsuitable for other local treatments. |
doi_str_mv | 10.1007/s00464-020-07644-y |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2405336262</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2515478258</sourcerecordid><originalsourceid>FETCH-LOGICAL-c375t-728a7e9d703f830d2f9625fbe262c7bf355791e6425aff7b85aa0329742bdc263</originalsourceid><addsrcrecordid>eNp9kUFvFCEYhonR2G31D3gwJF68jDIfMMx4M421mzTxYs-EYT5cGoZZgbHZX-NfFXdbTTyYkBDC8z585CXkVcvetYyp95kx0YmGAWuY6oRoDk_IphUcGoC2f0o2bOCsATWIM3Ke8x2r_NDK5-SMg-By6GBDfl5vr26pWxItO6QloSkzxkIXRyfvnLdrKNQuYUloiwk0-B-Y6IzF5Low03tfdnSNefXFjAGpj5O3pvgl5qM2Ya7JeqQmTjSZyS8u4fcVoz3QmjiiH6ih-1310S21wcdqCHUYb8IL8syZkPHlw35Bbq8-fb28bm6-fN5efrxpLFeyNAp6o3CYFOOu52wCV38n3YjQgVWj41KqocVOgDTOqbGXxjAOgxIwThY6fkHenrz7tNThctGzzxZDMBGXNWsQTHLeVV1F3_yD3i1rinU6DbKVQvUg-0rBibJpyTmh0_vkZ5MOumX6d336VJ-u9eljffpQQ68f1Os44_Qn8thXBfgJyPUqfsP09-3_aH8Bgc-odA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2515478258</pqid></control><display><type>article</type><title>HIFU for the treatment of difficult colorectal liver metastases with unsuitable indications for resection and radiofrequency ablation: a phase I clinical trial</title><source>SpringerLink Journals - AutoHoldings</source><creator>Yang, Tong ; Ng, Derry Minyao ; Du, Nannan ; He, Ning ; Dai, Xiaoyu ; Chen, Ping ; Wu, Feng ; Chen, Bo ; Fan, Xiaoxiang ; Yan, Kun ; Zhou, Xinfeng ; Dong, Mingjun ; Zheng, Zhi ; Gu, Lihu</creator><creatorcontrib>Yang, Tong ; Ng, Derry Minyao ; Du, Nannan ; He, Ning ; Dai, Xiaoyu ; Chen, Ping ; Wu, Feng ; Chen, Bo ; Fan, Xiaoxiang ; Yan, Kun ; Zhou, Xinfeng ; Dong, Mingjun ; Zheng, Zhi ; Gu, Lihu</creatorcontrib><description>Background
The goal of this study is to evaluate the safety and efficacy of high intensity focused ultrasound (HIFU) for patients with colorectal liver metastases (CRLM) but were contraindicated for resection and radiofrequency ablation.
Methods
Patients between 20 and 80 years of age with 1–3 liver metastases from colorectal cancer were selected. Included patients have had their primary lesions removed with no evidence of extrahepatic metastasis prior to the study. Ultrasound-guided HIFU was employed and target regions’ ablation was achieved with repeated sonications from the deep to shallow regions of the tumors section by section.
Results
Thirteen patients were enrolled. The most common adverse events (AEs) were pain (
n
= 8), followed by fatigue (
n
= 7), increased aspartate aminotransferase (AST) (
n
= 7), increased alanine aminotransferase (ALT) (
n
= 5), and skin edema (
n
= 4). No grade ≥ 3 AEs occurred and while most patients (76.9%) achieved a complete response, three patients achieved a partial response. The objective response rate was 100% after the first HIFU treatment. Nine patients relapsed but the tumors were mostly isolated to the liver (8/9). The median follow-up period was 25 months. The 2-year progression-free survival (PFS) was 16.7%, and the median PFS was 9 months. Notably, the 2-year overall survival (OS) was 77.8%, and the median OS was 25 months.
Conclusion
This study indicates that the HIFU treatment is safe, is able to achieve a good tumor response rate and long-term prognosis even when the foci were in high-risk locations, and should be considered for patients who were considered unsuitable for other local treatments.</description><identifier>ISSN: 0930-2794</identifier><identifier>EISSN: 1432-2218</identifier><identifier>DOI: 10.1007/s00464-020-07644-y</identifier><identifier>PMID: 32435962</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Abdominal Surgery ; Ablation ; Colorectal cancer ; Gastroenterology ; Gynecology ; Hepatology ; Liver ; Medical prognosis ; Medicine ; Medicine & Public Health ; Metastasis ; Proctology ; Response rates ; Surgery ; Tumors ; Ultrasonic imaging</subject><ispartof>Surgical endoscopy, 2021-05, Vol.35 (5), p.2306-2315</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature 2020</rights><rights>Springer Science+Business Media, LLC, part of Springer Nature 2020.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-728a7e9d703f830d2f9625fbe262c7bf355791e6425aff7b85aa0329742bdc263</citedby><cites>FETCH-LOGICAL-c375t-728a7e9d703f830d2f9625fbe262c7bf355791e6425aff7b85aa0329742bdc263</cites><orcidid>0000-0003-3750-2939</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00464-020-07644-y$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00464-020-07644-y$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32435962$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yang, Tong</creatorcontrib><creatorcontrib>Ng, Derry Minyao</creatorcontrib><creatorcontrib>Du, Nannan</creatorcontrib><creatorcontrib>He, Ning</creatorcontrib><creatorcontrib>Dai, Xiaoyu</creatorcontrib><creatorcontrib>Chen, Ping</creatorcontrib><creatorcontrib>Wu, Feng</creatorcontrib><creatorcontrib>Chen, Bo</creatorcontrib><creatorcontrib>Fan, Xiaoxiang</creatorcontrib><creatorcontrib>Yan, Kun</creatorcontrib><creatorcontrib>Zhou, Xinfeng</creatorcontrib><creatorcontrib>Dong, Mingjun</creatorcontrib><creatorcontrib>Zheng, Zhi</creatorcontrib><creatorcontrib>Gu, Lihu</creatorcontrib><title>HIFU for the treatment of difficult colorectal liver metastases with unsuitable indications for resection and radiofrequency ablation: a phase I clinical trial</title><title>Surgical endoscopy</title><addtitle>Surg Endosc</addtitle><addtitle>Surg Endosc</addtitle><description>Background
The goal of this study is to evaluate the safety and efficacy of high intensity focused ultrasound (HIFU) for patients with colorectal liver metastases (CRLM) but were contraindicated for resection and radiofrequency ablation.
Methods
Patients between 20 and 80 years of age with 1–3 liver metastases from colorectal cancer were selected. Included patients have had their primary lesions removed with no evidence of extrahepatic metastasis prior to the study. Ultrasound-guided HIFU was employed and target regions’ ablation was achieved with repeated sonications from the deep to shallow regions of the tumors section by section.
Results
Thirteen patients were enrolled. The most common adverse events (AEs) were pain (
n
= 8), followed by fatigue (
n
= 7), increased aspartate aminotransferase (AST) (
n
= 7), increased alanine aminotransferase (ALT) (
n
= 5), and skin edema (
n
= 4). No grade ≥ 3 AEs occurred and while most patients (76.9%) achieved a complete response, three patients achieved a partial response. The objective response rate was 100% after the first HIFU treatment. Nine patients relapsed but the tumors were mostly isolated to the liver (8/9). The median follow-up period was 25 months. The 2-year progression-free survival (PFS) was 16.7%, and the median PFS was 9 months. Notably, the 2-year overall survival (OS) was 77.8%, and the median OS was 25 months.
Conclusion
This study indicates that the HIFU treatment is safe, is able to achieve a good tumor response rate and long-term prognosis even when the foci were in high-risk locations, and should be considered for patients who were considered unsuitable for other local treatments.</description><subject>Abdominal Surgery</subject><subject>Ablation</subject><subject>Colorectal cancer</subject><subject>Gastroenterology</subject><subject>Gynecology</subject><subject>Hepatology</subject><subject>Liver</subject><subject>Medical prognosis</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Metastasis</subject><subject>Proctology</subject><subject>Response rates</subject><subject>Surgery</subject><subject>Tumors</subject><subject>Ultrasonic imaging</subject><issn>0930-2794</issn><issn>1432-2218</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kUFvFCEYhonR2G31D3gwJF68jDIfMMx4M421mzTxYs-EYT5cGoZZgbHZX-NfFXdbTTyYkBDC8z585CXkVcvetYyp95kx0YmGAWuY6oRoDk_IphUcGoC2f0o2bOCsATWIM3Ke8x2r_NDK5-SMg-By6GBDfl5vr26pWxItO6QloSkzxkIXRyfvnLdrKNQuYUloiwk0-B-Y6IzF5Low03tfdnSNefXFjAGpj5O3pvgl5qM2Ya7JeqQmTjSZyS8u4fcVoz3QmjiiH6ih-1310S21wcdqCHUYb8IL8syZkPHlw35Bbq8-fb28bm6-fN5efrxpLFeyNAp6o3CYFOOu52wCV38n3YjQgVWj41KqocVOgDTOqbGXxjAOgxIwThY6fkHenrz7tNThctGzzxZDMBGXNWsQTHLeVV1F3_yD3i1rinU6DbKVQvUg-0rBibJpyTmh0_vkZ5MOumX6d336VJ-u9eljffpQQ68f1Os44_Qn8thXBfgJyPUqfsP09-3_aH8Bgc-odA</recordid><startdate>20210501</startdate><enddate>20210501</enddate><creator>Yang, Tong</creator><creator>Ng, Derry Minyao</creator><creator>Du, Nannan</creator><creator>He, Ning</creator><creator>Dai, Xiaoyu</creator><creator>Chen, Ping</creator><creator>Wu, Feng</creator><creator>Chen, Bo</creator><creator>Fan, Xiaoxiang</creator><creator>Yan, Kun</creator><creator>Zhou, Xinfeng</creator><creator>Dong, Mingjun</creator><creator>Zheng, Zhi</creator><creator>Gu, Lihu</creator><general>Springer US</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</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><scope>PRINS</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-3750-2939</orcidid></search><sort><creationdate>20210501</creationdate><title>HIFU for the treatment of difficult colorectal liver metastases with unsuitable indications for resection and radiofrequency ablation: a phase I clinical trial</title><author>Yang, Tong ; Ng, Derry Minyao ; Du, Nannan ; He, Ning ; Dai, Xiaoyu ; Chen, Ping ; Wu, Feng ; Chen, Bo ; Fan, Xiaoxiang ; Yan, Kun ; Zhou, Xinfeng ; Dong, Mingjun ; Zheng, Zhi ; Gu, Lihu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-728a7e9d703f830d2f9625fbe262c7bf355791e6425aff7b85aa0329742bdc263</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Abdominal Surgery</topic><topic>Ablation</topic><topic>Colorectal cancer</topic><topic>Gastroenterology</topic><topic>Gynecology</topic><topic>Hepatology</topic><topic>Liver</topic><topic>Medical prognosis</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Metastasis</topic><topic>Proctology</topic><topic>Response rates</topic><topic>Surgery</topic><topic>Tumors</topic><topic>Ultrasonic imaging</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yang, Tong</creatorcontrib><creatorcontrib>Ng, Derry Minyao</creatorcontrib><creatorcontrib>Du, Nannan</creatorcontrib><creatorcontrib>He, Ning</creatorcontrib><creatorcontrib>Dai, Xiaoyu</creatorcontrib><creatorcontrib>Chen, Ping</creatorcontrib><creatorcontrib>Wu, Feng</creatorcontrib><creatorcontrib>Chen, Bo</creatorcontrib><creatorcontrib>Fan, Xiaoxiang</creatorcontrib><creatorcontrib>Yan, Kun</creatorcontrib><creatorcontrib>Zhou, Xinfeng</creatorcontrib><creatorcontrib>Dong, Mingjun</creatorcontrib><creatorcontrib>Zheng, Zhi</creatorcontrib><creatorcontrib>Gu, Lihu</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical 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><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Surgical endoscopy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yang, Tong</au><au>Ng, Derry Minyao</au><au>Du, Nannan</au><au>He, Ning</au><au>Dai, Xiaoyu</au><au>Chen, Ping</au><au>Wu, Feng</au><au>Chen, Bo</au><au>Fan, Xiaoxiang</au><au>Yan, Kun</au><au>Zhou, Xinfeng</au><au>Dong, Mingjun</au><au>Zheng, Zhi</au><au>Gu, Lihu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>HIFU for the treatment of difficult colorectal liver metastases with unsuitable indications for resection and radiofrequency ablation: a phase I clinical trial</atitle><jtitle>Surgical endoscopy</jtitle><stitle>Surg Endosc</stitle><addtitle>Surg Endosc</addtitle><date>2021-05-01</date><risdate>2021</risdate><volume>35</volume><issue>5</issue><spage>2306</spage><epage>2315</epage><pages>2306-2315</pages><issn>0930-2794</issn><eissn>1432-2218</eissn><abstract>Background
The goal of this study is to evaluate the safety and efficacy of high intensity focused ultrasound (HIFU) for patients with colorectal liver metastases (CRLM) but were contraindicated for resection and radiofrequency ablation.
Methods
Patients between 20 and 80 years of age with 1–3 liver metastases from colorectal cancer were selected. Included patients have had their primary lesions removed with no evidence of extrahepatic metastasis prior to the study. Ultrasound-guided HIFU was employed and target regions’ ablation was achieved with repeated sonications from the deep to shallow regions of the tumors section by section.
Results
Thirteen patients were enrolled. The most common adverse events (AEs) were pain (
n
= 8), followed by fatigue (
n
= 7), increased aspartate aminotransferase (AST) (
n
= 7), increased alanine aminotransferase (ALT) (
n
= 5), and skin edema (
n
= 4). No grade ≥ 3 AEs occurred and while most patients (76.9%) achieved a complete response, three patients achieved a partial response. The objective response rate was 100% after the first HIFU treatment. Nine patients relapsed but the tumors were mostly isolated to the liver (8/9). The median follow-up period was 25 months. The 2-year progression-free survival (PFS) was 16.7%, and the median PFS was 9 months. Notably, the 2-year overall survival (OS) was 77.8%, and the median OS was 25 months.
Conclusion
This study indicates that the HIFU treatment is safe, is able to achieve a good tumor response rate and long-term prognosis even when the foci were in high-risk locations, and should be considered for patients who were considered unsuitable for other local treatments.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>32435962</pmid><doi>10.1007/s00464-020-07644-y</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-3750-2939</orcidid></addata></record> |
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source | SpringerLink Journals - AutoHoldings |
subjects | Abdominal Surgery Ablation Colorectal cancer Gastroenterology Gynecology Hepatology Liver Medical prognosis Medicine Medicine & Public Health Metastasis Proctology Response rates Surgery Tumors Ultrasonic imaging |
title | HIFU for the treatment of difficult colorectal liver metastases with unsuitable indications for resection and radiofrequency ablation: a phase I clinical trial |
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