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A prospective clinical trial on sorafenib treatment of hepatocellular carcinoma before liver transplantation
Patients with hepatocellular carcinoma waiting for liver transplantation are commonly treated with locoregional treatments, such as TACE and ablation, to prevent tumor progression and dropout and to improve long-term outcome after transplantation. We wanted to prospectively assess feasibility of sys...
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Published in: | BMC cancer 2019-06, Vol.19 (1), p.568-568, Article 568 |
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description | Patients with hepatocellular carcinoma waiting for liver transplantation are commonly treated with locoregional treatments, such as TACE and ablation, to prevent tumor progression and dropout and to improve long-term outcome after transplantation. We wanted to prospectively assess feasibility of systemic antitumor treatment with sorafenib as neoadjuvant treatment for hepatocellular carcinoma while waiting for liver transplantation, evaluating tolerability, toxicity and posttransplant morbidity. We also wanted to evaluate perfusion CT parameters to assess tumor properties and response early after start of sorafenib treatment in patients with early hepatocellular carcinoma.
Twelve patients assigned for liver transplantation due to hepatocellular carcinoma, within the UCSF and who fulfilled other criteria, were included January 2012-August 2014. After baseline evaluation, sorafenib treatment was started. Treatment was evaluated by perfusion CT at 1, 4 and 12 weeks and thereafter every 8 weeks. Toxicity and quality of life was assessed at 1 and 4 weeks and every 4 weeks thereafter during treatment. Treatment was stopped when patients were prioritized on the transplantation waiting list or when intolerable side effects or tumor progress warranted other treatments. Posttransplant morbidity after 90 days was registered according to Clavien-Dindo.
Baseline perfusion CT parameters in the tumors predicted the outcome according to RECIST/mRECIST at three months, but no change in CTp parameters was detected as a result of sorafenib. Sorafenib as neoadjuvant treatment was associated with intolerability and dose reductions. Therefore the prerequisites for evaluation of the sorafenib effect on both CT parameters and tumor response were impaired.
This study failed to show changes in CTp parameters during sorafenib treatment. Despite the curative treatment intention, tolerability of neoadjuvant sorafenib treatment before liver transplantation was inadequate in this study.
EudraCT number: 2010-024306-36 (date 2011-04-07). |
doi_str_mv | 10.1186/s12885-019-5760-8 |
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Twelve patients assigned for liver transplantation due to hepatocellular carcinoma, within the UCSF and who fulfilled other criteria, were included January 2012-August 2014. After baseline evaluation, sorafenib treatment was started. Treatment was evaluated by perfusion CT at 1, 4 and 12 weeks and thereafter every 8 weeks. Toxicity and quality of life was assessed at 1 and 4 weeks and every 4 weeks thereafter during treatment. Treatment was stopped when patients were prioritized on the transplantation waiting list or when intolerable side effects or tumor progress warranted other treatments. Posttransplant morbidity after 90 days was registered according to Clavien-Dindo.
Baseline perfusion CT parameters in the tumors predicted the outcome according to RECIST/mRECIST at three months, but no change in CTp parameters was detected as a result of sorafenib. Sorafenib as neoadjuvant treatment was associated with intolerability and dose reductions. Therefore the prerequisites for evaluation of the sorafenib effect on both CT parameters and tumor response were impaired.
This study failed to show changes in CTp parameters during sorafenib treatment. Despite the curative treatment intention, tolerability of neoadjuvant sorafenib treatment before liver transplantation was inadequate in this study.
EudraCT number: 2010-024306-36 (date 2011-04-07).</description><identifier>ISSN: 1471-2407</identifier><identifier>EISSN: 1471-2407</identifier><identifier>DOI: 10.1186/s12885-019-5760-8</identifier><identifier>PMID: 31185950</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Ablation (Surgery) ; Adult ; Aged ; Analysis ; Antineoplastic agents ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - adverse effects ; Antineoplastic Agents - therapeutic use ; Blood Flow Velocity ; Cancer ; Cancer and Oncology ; Cancer och onkologi ; Cancer recurrence ; Cancer therapies ; Cancer treatment ; Carcinoma ; Carcinoma, Hepatocellular - drug therapy ; Carcinoma, Hepatocellular - physiopathology ; CAT scans ; Clinical trials ; complications ; Dosage and administration ; double-blind ; Drug therapy ; Drug Tolerance ; Feasibility ; Female ; Follow-Up Studies ; Hepatocellular carcinoma ; Humans ; impact ; increased ; Inhibitor drugs ; Kirurgi ; Laboratories ; Liver cancer ; Liver Neoplasms - drug therapy ; Liver Neoplasms - physiopathology ; Liver Transplantation ; Liver transplants ; locoregional therapy ; Male ; Medical prognosis ; Middle Aged ; modified recist ; Morbidity ; Mortality ; Neoadjuvant ; Neoadjuvant Therapy ; Oncology ; Organ transplantation ; Patients ; Perfusion ; perfusion ct ; Pilot Projects ; Prospective Studies ; Quality of Life ; recurrence ; response evaluation criteria ; Response Evaluation Criteria in Solid Tumors ; Sorafenib ; Sorafenib - administration & dosage ; Sorafenib - adverse effects ; Sorafenib - therapeutic use ; Surgery ; survival ; Targeted cancer therapy ; targeted therapy ; Tomography, X-Ray Computed ; Toxicity ; Transplants & implants ; Tumors</subject><ispartof>BMC cancer, 2019-06, Vol.19 (1), p.568-568, Article 568</ispartof><rights>COPYRIGHT 2019 BioMed Central Ltd.</rights><rights>2019. This work is licensed 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). 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c663t-1295687ead619caf762f34c35da0586c9b3aaec06d9102b3c6c2c1602c63cd9f3</citedby><cites>FETCH-LOGICAL-c663t-1295687ead619caf762f34c35da0586c9b3aaec06d9102b3c6c2c1602c63cd9f3</cites><orcidid>0000-0002-5652-0422 ; 0000-0002-1899-1768 ; 0000-0001-9791-5247 ; 0000-0001-6008-219X ; 0000-0002-5274-7726</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6560824/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2243260915?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,25731,27901,27902,36989,36990,44566,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31185950$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://gup.ub.gu.se/publication/281811$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Eilard, Malin Sternby</creatorcontrib><creatorcontrib>Andersson, Mats</creatorcontrib><creatorcontrib>Naredi, Peter</creatorcontrib><creatorcontrib>Geronymakis, Charalampos</creatorcontrib><creatorcontrib>Lindnér, Per</creatorcontrib><creatorcontrib>Cahlin, Christian</creatorcontrib><creatorcontrib>Bennet, William</creatorcontrib><creatorcontrib>Rizell, Magnus</creatorcontrib><title>A prospective clinical trial on sorafenib treatment of hepatocellular carcinoma before liver transplantation</title><title>BMC cancer</title><addtitle>BMC Cancer</addtitle><description>Patients with hepatocellular carcinoma waiting for liver transplantation are commonly treated with locoregional treatments, such as TACE and ablation, to prevent tumor progression and dropout and to improve long-term outcome after transplantation. We wanted to prospectively assess feasibility of systemic antitumor treatment with sorafenib as neoadjuvant treatment for hepatocellular carcinoma while waiting for liver transplantation, evaluating tolerability, toxicity and posttransplant morbidity. We also wanted to evaluate perfusion CT parameters to assess tumor properties and response early after start of sorafenib treatment in patients with early hepatocellular carcinoma.
Twelve patients assigned for liver transplantation due to hepatocellular carcinoma, within the UCSF and who fulfilled other criteria, were included January 2012-August 2014. After baseline evaluation, sorafenib treatment was started. Treatment was evaluated by perfusion CT at 1, 4 and 12 weeks and thereafter every 8 weeks. Toxicity and quality of life was assessed at 1 and 4 weeks and every 4 weeks thereafter during treatment. Treatment was stopped when patients were prioritized on the transplantation waiting list or when intolerable side effects or tumor progress warranted other treatments. Posttransplant morbidity after 90 days was registered according to Clavien-Dindo.
Baseline perfusion CT parameters in the tumors predicted the outcome according to RECIST/mRECIST at three months, but no change in CTp parameters was detected as a result of sorafenib. Sorafenib as neoadjuvant treatment was associated with intolerability and dose reductions. Therefore the prerequisites for evaluation of the sorafenib effect on both CT parameters and tumor response were impaired.
This study failed to show changes in CTp parameters during sorafenib treatment. Despite the curative treatment intention, tolerability of neoadjuvant sorafenib treatment before liver transplantation was inadequate in this study.
EudraCT number: 2010-024306-36 (date 2011-04-07).</description><subject>Ablation (Surgery)</subject><subject>Adult</subject><subject>Aged</subject><subject>Analysis</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Blood Flow Velocity</subject><subject>Cancer</subject><subject>Cancer and Oncology</subject><subject>Cancer och onkologi</subject><subject>Cancer recurrence</subject><subject>Cancer therapies</subject><subject>Cancer treatment</subject><subject>Carcinoma</subject><subject>Carcinoma, Hepatocellular - drug therapy</subject><subject>Carcinoma, Hepatocellular - physiopathology</subject><subject>CAT scans</subject><subject>Clinical trials</subject><subject>complications</subject><subject>Dosage and administration</subject><subject>double-blind</subject><subject>Drug therapy</subject><subject>Drug Tolerance</subject><subject>Feasibility</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Hepatocellular carcinoma</subject><subject>Humans</subject><subject>impact</subject><subject>increased</subject><subject>Inhibitor drugs</subject><subject>Kirurgi</subject><subject>Laboratories</subject><subject>Liver cancer</subject><subject>Liver Neoplasms - drug therapy</subject><subject>Liver Neoplasms - physiopathology</subject><subject>Liver Transplantation</subject><subject>Liver transplants</subject><subject>locoregional therapy</subject><subject>Male</subject><subject>Medical prognosis</subject><subject>Middle Aged</subject><subject>modified recist</subject><subject>Morbidity</subject><subject>Mortality</subject><subject>Neoadjuvant</subject><subject>Neoadjuvant Therapy</subject><subject>Oncology</subject><subject>Organ transplantation</subject><subject>Patients</subject><subject>Perfusion</subject><subject>perfusion ct</subject><subject>Pilot Projects</subject><subject>Prospective Studies</subject><subject>Quality of Life</subject><subject>recurrence</subject><subject>response evaluation criteria</subject><subject>Response Evaluation Criteria in Solid Tumors</subject><subject>Sorafenib</subject><subject>Sorafenib - administration & dosage</subject><subject>Sorafenib - adverse effects</subject><subject>Sorafenib - therapeutic use</subject><subject>Surgery</subject><subject>survival</subject><subject>Targeted cancer therapy</subject><subject>targeted therapy</subject><subject>Tomography, X-Ray Computed</subject><subject>Toxicity</subject><subject>Transplants & implants</subject><subject>Tumors</subject><issn>1471-2407</issn><issn>1471-2407</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNptkl2L1DAYhYso7rr6A7yRgiB60TUfTZrcCMPix8CC4Md1eJumMxkySU3SVf-9GWddpyKFNLx5zgk5nKp6itElxoK_TpgIwRqEZcM6jhpxrzrHbYcb0qLu_sn-rHqU0g4h3AkkHlZntMiZZOi8cqt6iiFNRmd7Y2rtrLcaXJ2jLWvwdQoRRuNtX0YG8t74XIex3poJctDGudlBrDVEbX3YQ92bMURTu-IWiwR8mhz4DNkG_7h6MIJL5snt_6L6-u7tl6sPzfXH9-ur1XWjOae5wUQyLjoDA8dSw9hxMtJWUzYAYoJr2VMAoxEfJEakp5projFHRHOqBznSi2p99B0C7NQU7R7iTxXAqt-DEDcKYrbaGYVBD21HhZasawFT0WOBzYhg7CW0rCtezdErfTfT3C_cNvOkymgzq2QUEUWJC__myBd4bwZd8orgFrLlibdbtQk3ijOOBGmLwctbgxi-zSZltbfpEDR4E-akCCWdpK1saUGf_4Puwhx9iVaR4kQ4kpj9pTZQHmz9GMq9-mCqVkyijhHEDtTlf6jyDWZvdfBmtGW-ELxaCAqTzY-8gTkltf78acm-OGG3BlzepuDmQynSEsRHUJdSpmjGu-AwUofOq2PnVem8OnReiaJ5dpr4neJPyekv6Gr8IA</recordid><startdate>20190611</startdate><enddate>20190611</enddate><creator>Eilard, Malin Sternby</creator><creator>Andersson, Mats</creator><creator>Naredi, Peter</creator><creator>Geronymakis, Charalampos</creator><creator>Lindnér, Per</creator><creator>Cahlin, Christian</creator><creator>Bennet, William</creator><creator>Rizell, Magnus</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><general>BMC</general><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>ISR</scope><scope>3V.</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>F1U</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-5652-0422</orcidid><orcidid>https://orcid.org/0000-0002-1899-1768</orcidid><orcidid>https://orcid.org/0000-0001-9791-5247</orcidid><orcidid>https://orcid.org/0000-0001-6008-219X</orcidid><orcidid>https://orcid.org/0000-0002-5274-7726</orcidid></search><sort><creationdate>20190611</creationdate><title>A prospective clinical trial on sorafenib treatment of hepatocellular carcinoma before liver transplantation</title><author>Eilard, Malin Sternby ; Andersson, Mats ; Naredi, Peter ; Geronymakis, Charalampos ; Lindnér, Per ; Cahlin, Christian ; Bennet, William ; Rizell, Magnus</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c663t-1295687ead619caf762f34c35da0586c9b3aaec06d9102b3c6c2c1602c63cd9f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Ablation (Surgery)</topic><topic>Adult</topic><topic>Aged</topic><topic>Analysis</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Blood Flow Velocity</topic><topic>Cancer</topic><topic>Cancer and Oncology</topic><topic>Cancer och onkologi</topic><topic>Cancer recurrence</topic><topic>Cancer therapies</topic><topic>Cancer treatment</topic><topic>Carcinoma</topic><topic>Carcinoma, Hepatocellular - drug therapy</topic><topic>Carcinoma, Hepatocellular - physiopathology</topic><topic>CAT scans</topic><topic>Clinical trials</topic><topic>complications</topic><topic>Dosage and administration</topic><topic>double-blind</topic><topic>Drug therapy</topic><topic>Drug Tolerance</topic><topic>Feasibility</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Hepatocellular carcinoma</topic><topic>Humans</topic><topic>impact</topic><topic>increased</topic><topic>Inhibitor drugs</topic><topic>Kirurgi</topic><topic>Laboratories</topic><topic>Liver cancer</topic><topic>Liver Neoplasms - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Göteborgs universitet</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>BMC cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Eilard, Malin Sternby</au><au>Andersson, Mats</au><au>Naredi, Peter</au><au>Geronymakis, Charalampos</au><au>Lindnér, Per</au><au>Cahlin, Christian</au><au>Bennet, William</au><au>Rizell, Magnus</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A prospective clinical trial on sorafenib treatment of hepatocellular carcinoma before liver transplantation</atitle><jtitle>BMC cancer</jtitle><addtitle>BMC Cancer</addtitle><date>2019-06-11</date><risdate>2019</risdate><volume>19</volume><issue>1</issue><spage>568</spage><epage>568</epage><pages>568-568</pages><artnum>568</artnum><issn>1471-2407</issn><eissn>1471-2407</eissn><abstract>Patients with hepatocellular carcinoma waiting for liver transplantation are commonly treated with locoregional treatments, such as TACE and ablation, to prevent tumor progression and dropout and to improve long-term outcome after transplantation. We wanted to prospectively assess feasibility of systemic antitumor treatment with sorafenib as neoadjuvant treatment for hepatocellular carcinoma while waiting for liver transplantation, evaluating tolerability, toxicity and posttransplant morbidity. We also wanted to evaluate perfusion CT parameters to assess tumor properties and response early after start of sorafenib treatment in patients with early hepatocellular carcinoma.
Twelve patients assigned for liver transplantation due to hepatocellular carcinoma, within the UCSF and who fulfilled other criteria, were included January 2012-August 2014. After baseline evaluation, sorafenib treatment was started. Treatment was evaluated by perfusion CT at 1, 4 and 12 weeks and thereafter every 8 weeks. Toxicity and quality of life was assessed at 1 and 4 weeks and every 4 weeks thereafter during treatment. Treatment was stopped when patients were prioritized on the transplantation waiting list or when intolerable side effects or tumor progress warranted other treatments. Posttransplant morbidity after 90 days was registered according to Clavien-Dindo.
Baseline perfusion CT parameters in the tumors predicted the outcome according to RECIST/mRECIST at three months, but no change in CTp parameters was detected as a result of sorafenib. Sorafenib as neoadjuvant treatment was associated with intolerability and dose reductions. Therefore the prerequisites for evaluation of the sorafenib effect on both CT parameters and tumor response were impaired.
This study failed to show changes in CTp parameters during sorafenib treatment. Despite the curative treatment intention, tolerability of neoadjuvant sorafenib treatment before liver transplantation was inadequate in this study.
EudraCT number: 2010-024306-36 (date 2011-04-07).</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>31185950</pmid><doi>10.1186/s12885-019-5760-8</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0002-5652-0422</orcidid><orcidid>https://orcid.org/0000-0002-1899-1768</orcidid><orcidid>https://orcid.org/0000-0001-9791-5247</orcidid><orcidid>https://orcid.org/0000-0001-6008-219X</orcidid><orcidid>https://orcid.org/0000-0002-5274-7726</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Ablation (Surgery) Adult Aged Analysis Antineoplastic agents Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Blood Flow Velocity Cancer Cancer and Oncology Cancer och onkologi Cancer recurrence Cancer therapies Cancer treatment Carcinoma Carcinoma, Hepatocellular - drug therapy Carcinoma, Hepatocellular - physiopathology CAT scans Clinical trials complications Dosage and administration double-blind Drug therapy Drug Tolerance Feasibility Female Follow-Up Studies Hepatocellular carcinoma Humans impact increased Inhibitor drugs Kirurgi Laboratories Liver cancer Liver Neoplasms - drug therapy Liver Neoplasms - physiopathology Liver Transplantation Liver transplants locoregional therapy Male Medical prognosis Middle Aged modified recist Morbidity Mortality Neoadjuvant Neoadjuvant Therapy Oncology Organ transplantation Patients Perfusion perfusion ct Pilot Projects Prospective Studies Quality of Life recurrence response evaluation criteria Response Evaluation Criteria in Solid Tumors Sorafenib Sorafenib - administration & dosage Sorafenib - adverse effects Sorafenib - therapeutic use Surgery survival Targeted cancer therapy targeted therapy Tomography, X-Ray Computed Toxicity Transplants & implants Tumors |
title | A prospective clinical trial on sorafenib treatment of hepatocellular carcinoma before liver transplantation |
url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-29T03%3A27%3A38IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_doaj_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20prospective%20clinical%20trial%20on%20sorafenib%20treatment%20of%20hepatocellular%20carcinoma%20before%20liver%20transplantation&rft.jtitle=BMC%20cancer&rft.au=Eilard,%20Malin%20Sternby&rft.date=2019-06-11&rft.volume=19&rft.issue=1&rft.spage=568&rft.epage=568&rft.pages=568-568&rft.artnum=568&rft.issn=1471-2407&rft.eissn=1471-2407&rft_id=info:doi/10.1186/s12885-019-5760-8&rft_dat=%3Cgale_doaj_%3EA590752055%3C/gale_doaj_%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c663t-1295687ead619caf762f34c35da0586c9b3aaec06d9102b3c6c2c1602c63cd9f3%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2243260915&rft_id=info:pmid/31185950&rft_galeid=A590752055&rfr_iscdi=true |