Radioablation by Image-Guided (HDR) Brachytherapy and Transarterial Chemoembolization in Hepatocellular Carcinoma: A Randomized Phase II Trial
Background and Aims The aim of this single-center, open-label phase II study was to assess the efficacy of image-guided high-dose-rate (HDR) brachytherapy (iBT) compared with conventional transarterial embolization (cTACE) in unresectable hepatocellular carcinoma. Methods Seventy-seven patients were...
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| Veröffentlicht in: | Cardiovascular and interventional radiology 2019-02, Vol.42 (2), p.239-249 |
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| creator | Mohnike, Konrad Steffen, Ingo G. Seidensticker, Max Hass, Peter Damm, Robert Peters, Nils Seidensticker, Ricarda Schütte, Kerstin Arend, Jörg Bornschein, Jan Streitparth, Tina Wybranski, Christian Wieners, Gero Stübs, Patrick Malfertheiner, Peter Pech, Maciej Ricke, Jens |
| description | Background and Aims
The aim of this single-center, open-label phase II study was to assess the efficacy of image-guided high-dose-rate (HDR) brachytherapy (iBT) compared with conventional transarterial embolization (cTACE) in unresectable hepatocellular carcinoma.
Methods
Seventy-seven patients were treated after randomization to iBT or cTACE, as single or repeated interventions. Crossover was allowed if clinically indicated. The primary endpoint was time to untreatable progression (TTUP). Eligibility criteria included a Child–Pugh score of ≤ 8 points, absence of portal vein thrombosis (PVT) at the affected liver lobe, and ≤ 4 lesions. Survival was analyzed by using the Cox proportional hazard model with stratification for Barcelona Clinic Liver Cancer (BCLC) stages.
Results
Twenty patients were classified as BCLC-A (iBT/cTACE 8/12), 35 as BCLC-B (16/19), and 22 as BCLC-C (13/9). The 1-, 2-, and 3-year TTUP probabilities for iBT compared with cTACE were 67.5% versus 55.2%, 56.0% versus 27.4%, and 29.5% versus 11.0%, respectively, with an adjusted hazard ratio (HR) of 0.49 (95% confidence interval 0.27–0.89;
p
= 0.019). The 1-, 2-, and 3-year TTPs for iBT versus cTACE were 56.0% versus 28.2%, 23.9% versus 6.3%, and 15.9% versus 6.3%, respectively, with an adjusted HR of 0.49 (0.29–0.85;
p
= 0.011). The 1-, 2-, and 3-year OS rates were 78.4% versus 67.7%, 62.0% versus 47.3%, and 36.7% versus 27.0%, respectively, with an adjusted HR of 0.62 (0.33–1.16;
p
= 0.136).
Conclusions
This explorative phase II trial showed a superior outcome of iBT compared with cTACE in hepatocellular carcinoma and supports proceeding to a phase III trial. |
| doi_str_mv | 10.1007/s00270-018-2127-5 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_osti_</sourceid><recordid>TN_cdi_osti_scitechconnect_22953144</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2138910698</sourcerecordid><originalsourceid>FETCH-LOGICAL-c400t-a7acd8098b9858aa3285803f9fa49d3c5378c7ba04fc70f5c846ec84763d9b8c3</originalsourceid><addsrcrecordid>eNp1kcFu1DAQhiMEokvhAbggS1zKITC249jhVhbaXakSaFUkbtbEcRpXSby1k8P2IfrMeJXSnrjMHOabbzT6s-w9hc8UQH6JAExCDlTljDKZixfZihac5aDKPy-zFVBZ5FQIepK9ifEWgArFxOvshEOhFAe-yh522DiPdY-T8yOpD2Q74I3NL2fX2Iacbb7vPpFvAU13mDobcH8gODbkOuAYMUw2OOzJurODt0Pte3e_eNxINnaPkze27-ceA1ljMG70A34l52SXHH5w9-nCrw6jJdttUibV2-xVi3207x77afb74sf1epNf_bzcrs-vclMATDlKNI2CStWVEgqRs9SAt1WLRdVwI7hURtYIRWsktMKoorSpyJI3Va0MP80-Ll4fJ6ejcZM1nfHjaM2kGasEp0WRqLOF2gd_N9s46cHF40c4Wj9HzSivRCkpg2fhE3rr5zCmH46UqiiUlUoUXSgTfIzBtnof3IDhoCnoY6R6iVSnSPUxUi3SzodH81wPtnna-JdhAtgCxDQab2x4Pv1_619OKqtN</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2138910698</pqid></control><display><type>article</type><title>Radioablation by Image-Guided (HDR) Brachytherapy and Transarterial Chemoembolization in Hepatocellular Carcinoma: A Randomized Phase II Trial</title><source>SpringerLink Journals</source><creator>Mohnike, Konrad ; Steffen, Ingo G. ; Seidensticker, Max ; Hass, Peter ; Damm, Robert ; Peters, Nils ; Seidensticker, Ricarda ; Schütte, Kerstin ; Arend, Jörg ; Bornschein, Jan ; Streitparth, Tina ; Wybranski, Christian ; Wieners, Gero ; Stübs, Patrick ; Malfertheiner, Peter ; Pech, Maciej ; Ricke, Jens</creator><creatorcontrib>Mohnike, Konrad ; Steffen, Ingo G. ; Seidensticker, Max ; Hass, Peter ; Damm, Robert ; Peters, Nils ; Seidensticker, Ricarda ; Schütte, Kerstin ; Arend, Jörg ; Bornschein, Jan ; Streitparth, Tina ; Wybranski, Christian ; Wieners, Gero ; Stübs, Patrick ; Malfertheiner, Peter ; Pech, Maciej ; Ricke, Jens</creatorcontrib><description>Background and Aims
The aim of this single-center, open-label phase II study was to assess the efficacy of image-guided high-dose-rate (HDR) brachytherapy (iBT) compared with conventional transarterial embolization (cTACE) in unresectable hepatocellular carcinoma.
Methods
Seventy-seven patients were treated after randomization to iBT or cTACE, as single or repeated interventions. Crossover was allowed if clinically indicated. The primary endpoint was time to untreatable progression (TTUP). Eligibility criteria included a Child–Pugh score of ≤ 8 points, absence of portal vein thrombosis (PVT) at the affected liver lobe, and ≤ 4 lesions. Survival was analyzed by using the Cox proportional hazard model with stratification for Barcelona Clinic Liver Cancer (BCLC) stages.
Results
Twenty patients were classified as BCLC-A (iBT/cTACE 8/12), 35 as BCLC-B (16/19), and 22 as BCLC-C (13/9). The 1-, 2-, and 3-year TTUP probabilities for iBT compared with cTACE were 67.5% versus 55.2%, 56.0% versus 27.4%, and 29.5% versus 11.0%, respectively, with an adjusted hazard ratio (HR) of 0.49 (95% confidence interval 0.27–0.89;
p
= 0.019). The 1-, 2-, and 3-year TTPs for iBT versus cTACE were 56.0% versus 28.2%, 23.9% versus 6.3%, and 15.9% versus 6.3%, respectively, with an adjusted HR of 0.49 (0.29–0.85;
p
= 0.011). The 1-, 2-, and 3-year OS rates were 78.4% versus 67.7%, 62.0% versus 47.3%, and 36.7% versus 27.0%, respectively, with an adjusted HR of 0.62 (0.33–1.16;
p
= 0.136).
Conclusions
This explorative phase II trial showed a superior outcome of iBT compared with cTACE in hepatocellular carcinoma and supports proceeding to a phase III trial.</description><identifier>ISSN: 0174-1551</identifier><identifier>EISSN: 1432-086X</identifier><identifier>DOI: 10.1007/s00270-018-2127-5</identifier><identifier>PMID: 30488303</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>BRACHYTHERAPY ; Cardiology ; Chemoembolization ; Clinical Investigation ; COMPUTERIZED TOMOGRAPHY ; Confidence intervals ; Crossovers ; Dosage ; DOSE RATES ; Embolization ; Hepatocellular carcinoma ; HEPATOMAS ; Imaging ; Interventional Oncology ; Lesions ; LIVER ; Liver cancer ; Medical imaging ; Medicine ; Medicine & Public Health ; MULTIVARIATE ANALYSIS ; Nuclear Medicine ; PATIENTS ; Portal vein ; Radiation therapy ; Radiology ; RADIOLOGY AND NUCLEAR MEDICINE ; Randomization ; Statistical models ; STRATIFICATION ; SURGERY ; Thromboembolism ; THROMBOSIS ; Ultrasound ; VEINS</subject><ispartof>Cardiovascular and interventional radiology, 2019-02, Vol.42 (2), p.239-249</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2018</rights><rights>CardioVascular and Interventional Radiology is a copyright of Springer, (2018). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c400t-a7acd8098b9858aa3285803f9fa49d3c5378c7ba04fc70f5c846ec84763d9b8c3</citedby><cites>FETCH-LOGICAL-c400t-a7acd8098b9858aa3285803f9fa49d3c5378c7ba04fc70f5c846ec84763d9b8c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00270-018-2127-5$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00270-018-2127-5$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30488303$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://www.osti.gov/biblio/22953144$$D View this record in Osti.gov$$Hfree_for_read</backlink></links><search><creatorcontrib>Mohnike, Konrad</creatorcontrib><creatorcontrib>Steffen, Ingo G.</creatorcontrib><creatorcontrib>Seidensticker, Max</creatorcontrib><creatorcontrib>Hass, Peter</creatorcontrib><creatorcontrib>Damm, Robert</creatorcontrib><creatorcontrib>Peters, Nils</creatorcontrib><creatorcontrib>Seidensticker, Ricarda</creatorcontrib><creatorcontrib>Schütte, Kerstin</creatorcontrib><creatorcontrib>Arend, Jörg</creatorcontrib><creatorcontrib>Bornschein, Jan</creatorcontrib><creatorcontrib>Streitparth, Tina</creatorcontrib><creatorcontrib>Wybranski, Christian</creatorcontrib><creatorcontrib>Wieners, Gero</creatorcontrib><creatorcontrib>Stübs, Patrick</creatorcontrib><creatorcontrib>Malfertheiner, Peter</creatorcontrib><creatorcontrib>Pech, Maciej</creatorcontrib><creatorcontrib>Ricke, Jens</creatorcontrib><title>Radioablation by Image-Guided (HDR) Brachytherapy and Transarterial Chemoembolization in Hepatocellular Carcinoma: A Randomized Phase II Trial</title><title>Cardiovascular and interventional radiology</title><addtitle>Cardiovasc Intervent Radiol</addtitle><addtitle>Cardiovasc Intervent Radiol</addtitle><description>Background and Aims
The aim of this single-center, open-label phase II study was to assess the efficacy of image-guided high-dose-rate (HDR) brachytherapy (iBT) compared with conventional transarterial embolization (cTACE) in unresectable hepatocellular carcinoma.
Methods
Seventy-seven patients were treated after randomization to iBT or cTACE, as single or repeated interventions. Crossover was allowed if clinically indicated. The primary endpoint was time to untreatable progression (TTUP). Eligibility criteria included a Child–Pugh score of ≤ 8 points, absence of portal vein thrombosis (PVT) at the affected liver lobe, and ≤ 4 lesions. Survival was analyzed by using the Cox proportional hazard model with stratification for Barcelona Clinic Liver Cancer (BCLC) stages.
Results
Twenty patients were classified as BCLC-A (iBT/cTACE 8/12), 35 as BCLC-B (16/19), and 22 as BCLC-C (13/9). The 1-, 2-, and 3-year TTUP probabilities for iBT compared with cTACE were 67.5% versus 55.2%, 56.0% versus 27.4%, and 29.5% versus 11.0%, respectively, with an adjusted hazard ratio (HR) of 0.49 (95% confidence interval 0.27–0.89;
p
= 0.019). The 1-, 2-, and 3-year TTPs for iBT versus cTACE were 56.0% versus 28.2%, 23.9% versus 6.3%, and 15.9% versus 6.3%, respectively, with an adjusted HR of 0.49 (0.29–0.85;
p
= 0.011). The 1-, 2-, and 3-year OS rates were 78.4% versus 67.7%, 62.0% versus 47.3%, and 36.7% versus 27.0%, respectively, with an adjusted HR of 0.62 (0.33–1.16;
p
= 0.136).
Conclusions
This explorative phase II trial showed a superior outcome of iBT compared with cTACE in hepatocellular carcinoma and supports proceeding to a phase III trial.</description><subject>BRACHYTHERAPY</subject><subject>Cardiology</subject><subject>Chemoembolization</subject><subject>Clinical Investigation</subject><subject>COMPUTERIZED TOMOGRAPHY</subject><subject>Confidence intervals</subject><subject>Crossovers</subject><subject>Dosage</subject><subject>DOSE RATES</subject><subject>Embolization</subject><subject>Hepatocellular carcinoma</subject><subject>HEPATOMAS</subject><subject>Imaging</subject><subject>Interventional Oncology</subject><subject>Lesions</subject><subject>LIVER</subject><subject>Liver cancer</subject><subject>Medical imaging</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>MULTIVARIATE ANALYSIS</subject><subject>Nuclear Medicine</subject><subject>PATIENTS</subject><subject>Portal vein</subject><subject>Radiation therapy</subject><subject>Radiology</subject><subject>RADIOLOGY AND NUCLEAR MEDICINE</subject><subject>Randomization</subject><subject>Statistical models</subject><subject>STRATIFICATION</subject><subject>SURGERY</subject><subject>Thromboembolism</subject><subject>THROMBOSIS</subject><subject>Ultrasound</subject><subject>VEINS</subject><issn>0174-1551</issn><issn>1432-086X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><recordid>eNp1kcFu1DAQhiMEokvhAbggS1zKITC249jhVhbaXakSaFUkbtbEcRpXSby1k8P2IfrMeJXSnrjMHOabbzT6s-w9hc8UQH6JAExCDlTljDKZixfZihac5aDKPy-zFVBZ5FQIepK9ifEWgArFxOvshEOhFAe-yh522DiPdY-T8yOpD2Q74I3NL2fX2Iacbb7vPpFvAU13mDobcH8gODbkOuAYMUw2OOzJurODt0Pte3e_eNxINnaPkze27-ceA1ljMG70A34l52SXHH5w9-nCrw6jJdttUibV2-xVi3207x77afb74sf1epNf_bzcrs-vclMATDlKNI2CStWVEgqRs9SAt1WLRdVwI7hURtYIRWsktMKoorSpyJI3Va0MP80-Ll4fJ6ejcZM1nfHjaM2kGasEp0WRqLOF2gd_N9s46cHF40c4Wj9HzSivRCkpg2fhE3rr5zCmH46UqiiUlUoUXSgTfIzBtnof3IDhoCnoY6R6iVSnSPUxUi3SzodH81wPtnna-JdhAtgCxDQab2x4Pv1_619OKqtN</recordid><startdate>20190201</startdate><enddate>20190201</enddate><creator>Mohnike, Konrad</creator><creator>Steffen, Ingo G.</creator><creator>Seidensticker, Max</creator><creator>Hass, Peter</creator><creator>Damm, Robert</creator><creator>Peters, Nils</creator><creator>Seidensticker, Ricarda</creator><creator>Schütte, Kerstin</creator><creator>Arend, Jörg</creator><creator>Bornschein, Jan</creator><creator>Streitparth, Tina</creator><creator>Wybranski, Christian</creator><creator>Wieners, Gero</creator><creator>Stübs, Patrick</creator><creator>Malfertheiner, Peter</creator><creator>Pech, Maciej</creator><creator>Ricke, Jens</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>7TO</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>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>OTOTI</scope></search><sort><creationdate>20190201</creationdate><title>Radioablation by Image-Guided (HDR) Brachytherapy and Transarterial Chemoembolization in Hepatocellular Carcinoma: A Randomized Phase II Trial</title><author>Mohnike, Konrad ; Steffen, Ingo G. ; Seidensticker, Max ; Hass, Peter ; Damm, Robert ; Peters, Nils ; Seidensticker, Ricarda ; Schütte, Kerstin ; Arend, Jörg ; Bornschein, Jan ; Streitparth, Tina ; Wybranski, Christian ; Wieners, Gero ; Stübs, Patrick ; Malfertheiner, Peter ; Pech, Maciej ; Ricke, Jens</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c400t-a7acd8098b9858aa3285803f9fa49d3c5378c7ba04fc70f5c846ec84763d9b8c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>BRACHYTHERAPY</topic><topic>Cardiology</topic><topic>Chemoembolization</topic><topic>Clinical Investigation</topic><topic>COMPUTERIZED TOMOGRAPHY</topic><topic>Confidence intervals</topic><topic>Crossovers</topic><topic>Dosage</topic><topic>DOSE RATES</topic><topic>Embolization</topic><topic>Hepatocellular carcinoma</topic><topic>HEPATOMAS</topic><topic>Imaging</topic><topic>Interventional Oncology</topic><topic>Lesions</topic><topic>LIVER</topic><topic>Liver cancer</topic><topic>Medical imaging</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>MULTIVARIATE ANALYSIS</topic><topic>Nuclear Medicine</topic><topic>PATIENTS</topic><topic>Portal vein</topic><topic>Radiation therapy</topic><topic>Radiology</topic><topic>RADIOLOGY AND NUCLEAR MEDICINE</topic><topic>Randomization</topic><topic>Statistical models</topic><topic>STRATIFICATION</topic><topic>SURGERY</topic><topic>Thromboembolism</topic><topic>THROMBOSIS</topic><topic>Ultrasound</topic><topic>VEINS</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mohnike, Konrad</creatorcontrib><creatorcontrib>Steffen, Ingo G.</creatorcontrib><creatorcontrib>Seidensticker, Max</creatorcontrib><creatorcontrib>Hass, Peter</creatorcontrib><creatorcontrib>Damm, Robert</creatorcontrib><creatorcontrib>Peters, Nils</creatorcontrib><creatorcontrib>Seidensticker, Ricarda</creatorcontrib><creatorcontrib>Schütte, Kerstin</creatorcontrib><creatorcontrib>Arend, Jörg</creatorcontrib><creatorcontrib>Bornschein, Jan</creatorcontrib><creatorcontrib>Streitparth, Tina</creatorcontrib><creatorcontrib>Wybranski, Christian</creatorcontrib><creatorcontrib>Wieners, Gero</creatorcontrib><creatorcontrib>Stübs, Patrick</creatorcontrib><creatorcontrib>Malfertheiner, Peter</creatorcontrib><creatorcontrib>Pech, Maciej</creatorcontrib><creatorcontrib>Ricke, Jens</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Oncogenes and Growth Factors Abstracts</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>AIDS and Cancer Research Abstracts</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 Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</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><collection>OSTI.GOV</collection><jtitle>Cardiovascular and interventional radiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mohnike, Konrad</au><au>Steffen, Ingo G.</au><au>Seidensticker, Max</au><au>Hass, Peter</au><au>Damm, Robert</au><au>Peters, Nils</au><au>Seidensticker, Ricarda</au><au>Schütte, Kerstin</au><au>Arend, Jörg</au><au>Bornschein, Jan</au><au>Streitparth, Tina</au><au>Wybranski, Christian</au><au>Wieners, Gero</au><au>Stübs, Patrick</au><au>Malfertheiner, Peter</au><au>Pech, Maciej</au><au>Ricke, Jens</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Radioablation by Image-Guided (HDR) Brachytherapy and Transarterial Chemoembolization in Hepatocellular Carcinoma: A Randomized Phase II Trial</atitle><jtitle>Cardiovascular and interventional radiology</jtitle><stitle>Cardiovasc Intervent Radiol</stitle><addtitle>Cardiovasc Intervent Radiol</addtitle><date>2019-02-01</date><risdate>2019</risdate><volume>42</volume><issue>2</issue><spage>239</spage><epage>249</epage><pages>239-249</pages><issn>0174-1551</issn><eissn>1432-086X</eissn><abstract>Background and Aims
The aim of this single-center, open-label phase II study was to assess the efficacy of image-guided high-dose-rate (HDR) brachytherapy (iBT) compared with conventional transarterial embolization (cTACE) in unresectable hepatocellular carcinoma.
Methods
Seventy-seven patients were treated after randomization to iBT or cTACE, as single or repeated interventions. Crossover was allowed if clinically indicated. The primary endpoint was time to untreatable progression (TTUP). Eligibility criteria included a Child–Pugh score of ≤ 8 points, absence of portal vein thrombosis (PVT) at the affected liver lobe, and ≤ 4 lesions. Survival was analyzed by using the Cox proportional hazard model with stratification for Barcelona Clinic Liver Cancer (BCLC) stages.
Results
Twenty patients were classified as BCLC-A (iBT/cTACE 8/12), 35 as BCLC-B (16/19), and 22 as BCLC-C (13/9). The 1-, 2-, and 3-year TTUP probabilities for iBT compared with cTACE were 67.5% versus 55.2%, 56.0% versus 27.4%, and 29.5% versus 11.0%, respectively, with an adjusted hazard ratio (HR) of 0.49 (95% confidence interval 0.27–0.89;
p
= 0.019). The 1-, 2-, and 3-year TTPs for iBT versus cTACE were 56.0% versus 28.2%, 23.9% versus 6.3%, and 15.9% versus 6.3%, respectively, with an adjusted HR of 0.49 (0.29–0.85;
p
= 0.011). The 1-, 2-, and 3-year OS rates were 78.4% versus 67.7%, 62.0% versus 47.3%, and 36.7% versus 27.0%, respectively, with an adjusted HR of 0.62 (0.33–1.16;
p
= 0.136).
Conclusions
This explorative phase II trial showed a superior outcome of iBT compared with cTACE in hepatocellular carcinoma and supports proceeding to a phase III trial.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>30488303</pmid><doi>10.1007/s00270-018-2127-5</doi><tpages>11</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0174-1551 |
| ispartof | Cardiovascular and interventional radiology, 2019-02, Vol.42 (2), p.239-249 |
| issn | 0174-1551 1432-086X |
| language | eng |
| recordid | cdi_osti_scitechconnect_22953144 |
| source | SpringerLink Journals |
| subjects | BRACHYTHERAPY Cardiology Chemoembolization Clinical Investigation COMPUTERIZED TOMOGRAPHY Confidence intervals Crossovers Dosage DOSE RATES Embolization Hepatocellular carcinoma HEPATOMAS Imaging Interventional Oncology Lesions LIVER Liver cancer Medical imaging Medicine Medicine & Public Health MULTIVARIATE ANALYSIS Nuclear Medicine PATIENTS Portal vein Radiation therapy Radiology RADIOLOGY AND NUCLEAR MEDICINE Randomization Statistical models STRATIFICATION SURGERY Thromboembolism THROMBOSIS Ultrasound VEINS |
| title | Radioablation by Image-Guided (HDR) Brachytherapy and Transarterial Chemoembolization in Hepatocellular Carcinoma: A Randomized Phase II Trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-20T16%3A31%3A24IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_osti_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Radioablation%20by%20Image-Guided%20(HDR)%20Brachytherapy%20and%20Transarterial%20Chemoembolization%20in%20Hepatocellular%20Carcinoma:%20A%20Randomized%20Phase%20II%20Trial&rft.jtitle=Cardiovascular%20and%20interventional%20radiology&rft.au=Mohnike,%20Konrad&rft.date=2019-02-01&rft.volume=42&rft.issue=2&rft.spage=239&rft.epage=249&rft.pages=239-249&rft.issn=0174-1551&rft.eissn=1432-086X&rft_id=info:doi/10.1007/s00270-018-2127-5&rft_dat=%3Cproquest_osti_%3E2138910698%3C/proquest_osti_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2138910698&rft_id=info:pmid/30488303&rfr_iscdi=true |