First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials.
Identifieur interne : 000525 ( PubMed/Corpus ); précédent : 000524; suivant : 000526First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials.
Auteurs : Harpreet S. Wasan ; Peter Gibbs ; Navesh K. Sharma ; Julien Taieb ; Volker Heinemann ; Jens Ricke ; Marc Peeters ; Michael Findlay ; Andrew Weaver ; Jamie Mills ; Charles Wilson ; Richard Adams ; Anne Francis ; Joanna Moschandreas ; Pradeep S. Virdee ; Peter Dutton ; Sharon Love ; Val Gebski ; Alastair Gray ; Guy Van Hazel ; Ricky A. SharmaSource :
- The Lancet. Oncology [ 1474-5488 ] ; 2017.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antineoplastic Agents (therapeutic use), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Colorectal Neoplasms (pathology), Disease-Free Survival, Female, Humans, Liver Neoplasms (drug therapy), Liver Neoplasms (radiotherapy), Liver Neoplasms (secondary), Male, Middle Aged, Radiotherapy, Adjuvant, Treatment Outcome.
- MESH :
- chemical , therapeutic use : Antineoplastic Agents.
- drug therapy : Liver Neoplasms.
- pathology : Colorectal Neoplasms.
- radiotherapy : Liver Neoplasms.
- secondary : Liver Neoplasms.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Adult, Aged, Aged, 80 and over, Disease-Free Survival, Female, Humans, Male, Middle Aged, Radiotherapy, Adjuvant, Treatment Outcome.
Abstract
Data suggest selective internal radiotherapy (SIRT) in third-line or subsequent therapy for metastatic colorectal cancer has clinical benefit in patients with colorectal liver metastases with liver-dominant disease after chemotherapy. The FOXFIRE, SIRFLOX, and FOXFIRE-Global randomised studies evaluated the efficacy of combining first-line chemotherapy with SIRT using yttrium-90 resin microspheres in patients with metastatic colorectal cancer with liver metastases. The studies were designed for combined analysis of overall survival.
DOI: 10.1016/S1470-2045(17)30457-6
PubMed: 28781171
Links to Exploration step
pubmed:28781171Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials.</title><author><name sortKey="Wasan, Harpreet S" sort="Wasan, Harpreet S" uniqKey="Wasan H" first="Harpreet S" last="Wasan">Harpreet S. Wasan</name><affiliation><nlm:affiliation>Imperial College Healthcare NHS Trust and Imperial College, Hammersmith Hospital, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Gibbs, Peter" sort="Gibbs, Peter" uniqKey="Gibbs P" first="Peter" last="Gibbs">Peter Gibbs</name><affiliation><nlm:affiliation>Western Hospital, Footscray, VIC, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Sharma, Navesh K" sort="Sharma, Navesh K" uniqKey="Sharma N" first="Navesh K" last="Sharma">Navesh K. Sharma</name><affiliation><nlm:affiliation>Division of Radiation Oncology, Penn State Hershey Cancer Centre, School of Medicine, Hershey, PA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Taieb, Julien" sort="Taieb, Julien" uniqKey="Taieb J" first="Julien" last="Taieb">Julien Taieb</name><affiliation><nlm:affiliation>Sorbonne Paris Cité, Université Paris Descartes, Georges Pompidou European Hospital, Department of Hepatogastroenterology and GI Oncology, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Heinemann, Volker" sort="Heinemann, Volker" uniqKey="Heinemann V" first="Volker" last="Heinemann">Volker Heinemann</name><affiliation><nlm:affiliation>Department of Medical Oncology and Comprehensive Cancer Centre, Klinikum Grosshadern, Ludwig-Maximilian, University of Munich, Munich, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Ricke, Jens" sort="Ricke, Jens" uniqKey="Ricke J" first="Jens" last="Ricke">Jens Ricke</name><affiliation><nlm:affiliation>Department of Radiology and Nuclear Medicine, University of Magdeburg, Magdeburg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Peeters, Marc" sort="Peeters, Marc" uniqKey="Peeters M" first="Marc" last="Peeters">Marc Peeters</name><affiliation><nlm:affiliation>Antwerp University Hospital, Antwerp, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Findlay, Michael" sort="Findlay, Michael" uniqKey="Findlay M" first="Michael" last="Findlay">Michael Findlay</name><affiliation><nlm:affiliation>Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.</nlm:affiliation></affiliation></author><author><name sortKey="Weaver, Andrew" sort="Weaver, Andrew" uniqKey="Weaver A" first="Andrew" last="Weaver">Andrew Weaver</name><affiliation><nlm:affiliation>Oxford University NHS Foundation Trust, Churchill Hospital, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Mills, Jamie" sort="Mills, Jamie" uniqKey="Mills J" first="Jamie" last="Mills">Jamie Mills</name><affiliation><nlm:affiliation>Nottingham University Hospitals NHS Trust, Nottingham City Hospital, Nottingham, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Wilson, Charles" sort="Wilson, Charles" uniqKey="Wilson C" first="Charles" last="Wilson">Charles Wilson</name><affiliation><nlm:affiliation>Cambridge University Hospitals NHS Trust, Addenbrooke's Hospital, Cambridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Adams, Richard" sort="Adams, Richard" uniqKey="Adams R" first="Richard" last="Adams">Richard Adams</name><affiliation><nlm:affiliation>School of Medicine, Cardiff University, Cardiff, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Francis, Anne" sort="Francis, Anne" uniqKey="Francis A" first="Anne" last="Francis">Anne Francis</name><affiliation><nlm:affiliation>Oncology Clinical Trials Office, Department of Oncology, University of Oxford, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Moschandreas, Joanna" sort="Moschandreas, Joanna" uniqKey="Moschandreas J" first="Joanna" last="Moschandreas">Joanna Moschandreas</name><affiliation><nlm:affiliation>Centre for Statistics in Medicine, University of Oxford, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Virdee, Pradeep S" sort="Virdee, Pradeep S" uniqKey="Virdee P" first="Pradeep S" last="Virdee">Pradeep S. Virdee</name><affiliation><nlm:affiliation>Centre for Statistics in Medicine, University of Oxford, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Dutton, Peter" sort="Dutton, Peter" uniqKey="Dutton P" first="Peter" last="Dutton">Peter Dutton</name><affiliation><nlm:affiliation>Centre for Statistics in Medicine, University of Oxford, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Love, Sharon" sort="Love, Sharon" uniqKey="Love S" first="Sharon" last="Love">Sharon Love</name><affiliation><nlm:affiliation>Centre for Statistics in Medicine, University of Oxford, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Gebski, Val" sort="Gebski, Val" uniqKey="Gebski V" first="Val" last="Gebski">Val Gebski</name><affiliation><nlm:affiliation>National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Gray, Alastair" sort="Gray, Alastair" uniqKey="Gray A" first="Alastair" last="Gray">Alastair Gray</name><affiliation><nlm:affiliation>Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Van Hazel, Guy" sort="Van Hazel, Guy" uniqKey="Van Hazel G" first="Guy" last="Van Hazel">Guy Van Hazel</name><affiliation><nlm:affiliation>School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Sharma, Ricky A" sort="Sharma, Ricky A" uniqKey="Sharma R" first="Ricky A" last="Sharma">Ricky A. Sharma</name><affiliation><nlm:affiliation>Cancer Research UK Medical Research Council (CRUK-MRC) Oxford Institute for Radiation Oncology, University of Oxford, Oxford, UK; National Institute for Health Research University College London Hospitals Biomedical Research Centre, UCL Cancer Institute, London, UK. Electronic address: ricky.sharma@oncology.ox.ac.uk.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28781171</idno><idno type="pmid">28781171</idno><idno type="doi">10.1016/S1470-2045(17)30457-6</idno><idno type="wicri:Area/PubMed/Corpus">000525</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000525</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials.</title><author><name sortKey="Wasan, Harpreet S" sort="Wasan, Harpreet S" uniqKey="Wasan H" first="Harpreet S" last="Wasan">Harpreet S. Wasan</name><affiliation><nlm:affiliation>Imperial College Healthcare NHS Trust and Imperial College, Hammersmith Hospital, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Gibbs, Peter" sort="Gibbs, Peter" uniqKey="Gibbs P" first="Peter" last="Gibbs">Peter Gibbs</name><affiliation><nlm:affiliation>Western Hospital, Footscray, VIC, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Sharma, Navesh K" sort="Sharma, Navesh K" uniqKey="Sharma N" first="Navesh K" last="Sharma">Navesh K. Sharma</name><affiliation><nlm:affiliation>Division of Radiation Oncology, Penn State Hershey Cancer Centre, School of Medicine, Hershey, PA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Taieb, Julien" sort="Taieb, Julien" uniqKey="Taieb J" first="Julien" last="Taieb">Julien Taieb</name><affiliation><nlm:affiliation>Sorbonne Paris Cité, Université Paris Descartes, Georges Pompidou European Hospital, Department of Hepatogastroenterology and GI Oncology, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Heinemann, Volker" sort="Heinemann, Volker" uniqKey="Heinemann V" first="Volker" last="Heinemann">Volker Heinemann</name><affiliation><nlm:affiliation>Department of Medical Oncology and Comprehensive Cancer Centre, Klinikum Grosshadern, Ludwig-Maximilian, University of Munich, Munich, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Ricke, Jens" sort="Ricke, Jens" uniqKey="Ricke J" first="Jens" last="Ricke">Jens Ricke</name><affiliation><nlm:affiliation>Department of Radiology and Nuclear Medicine, University of Magdeburg, Magdeburg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Peeters, Marc" sort="Peeters, Marc" uniqKey="Peeters M" first="Marc" last="Peeters">Marc Peeters</name><affiliation><nlm:affiliation>Antwerp University Hospital, Antwerp, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Findlay, Michael" sort="Findlay, Michael" uniqKey="Findlay M" first="Michael" last="Findlay">Michael Findlay</name><affiliation><nlm:affiliation>Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.</nlm:affiliation></affiliation></author><author><name sortKey="Weaver, Andrew" sort="Weaver, Andrew" uniqKey="Weaver A" first="Andrew" last="Weaver">Andrew Weaver</name><affiliation><nlm:affiliation>Oxford University NHS Foundation Trust, Churchill Hospital, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Mills, Jamie" sort="Mills, Jamie" uniqKey="Mills J" first="Jamie" last="Mills">Jamie Mills</name><affiliation><nlm:affiliation>Nottingham University Hospitals NHS Trust, Nottingham City Hospital, Nottingham, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Wilson, Charles" sort="Wilson, Charles" uniqKey="Wilson C" first="Charles" last="Wilson">Charles Wilson</name><affiliation><nlm:affiliation>Cambridge University Hospitals NHS Trust, Addenbrooke's Hospital, Cambridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Adams, Richard" sort="Adams, Richard" uniqKey="Adams R" first="Richard" last="Adams">Richard Adams</name><affiliation><nlm:affiliation>School of Medicine, Cardiff University, Cardiff, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Francis, Anne" sort="Francis, Anne" uniqKey="Francis A" first="Anne" last="Francis">Anne Francis</name><affiliation><nlm:affiliation>Oncology Clinical Trials Office, Department of Oncology, University of Oxford, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Moschandreas, Joanna" sort="Moschandreas, Joanna" uniqKey="Moschandreas J" first="Joanna" last="Moschandreas">Joanna Moschandreas</name><affiliation><nlm:affiliation>Centre for Statistics in Medicine, University of Oxford, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Virdee, Pradeep S" sort="Virdee, Pradeep S" uniqKey="Virdee P" first="Pradeep S" last="Virdee">Pradeep S. Virdee</name><affiliation><nlm:affiliation>Centre for Statistics in Medicine, University of Oxford, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Dutton, Peter" sort="Dutton, Peter" uniqKey="Dutton P" first="Peter" last="Dutton">Peter Dutton</name><affiliation><nlm:affiliation>Centre for Statistics in Medicine, University of Oxford, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Love, Sharon" sort="Love, Sharon" uniqKey="Love S" first="Sharon" last="Love">Sharon Love</name><affiliation><nlm:affiliation>Centre for Statistics in Medicine, University of Oxford, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Gebski, Val" sort="Gebski, Val" uniqKey="Gebski V" first="Val" last="Gebski">Val Gebski</name><affiliation><nlm:affiliation>National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Gray, Alastair" sort="Gray, Alastair" uniqKey="Gray A" first="Alastair" last="Gray">Alastair Gray</name><affiliation><nlm:affiliation>Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Van Hazel, Guy" sort="Van Hazel, Guy" uniqKey="Van Hazel G" first="Guy" last="Van Hazel">Guy Van Hazel</name><affiliation><nlm:affiliation>School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Sharma, Ricky A" sort="Sharma, Ricky A" uniqKey="Sharma R" first="Ricky A" last="Sharma">Ricky A. Sharma</name><affiliation><nlm:affiliation>Cancer Research UK Medical Research Council (CRUK-MRC) Oxford Institute for Radiation Oncology, University of Oxford, Oxford, UK; National Institute for Health Research University College London Hospitals Biomedical Research Centre, UCL Cancer Institute, London, UK. Electronic address: ricky.sharma@oncology.ox.ac.uk.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="eISSN">1474-5488</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antineoplastic Agents (therapeutic use)</term><term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term><term>Colorectal Neoplasms (pathology)</term><term>Disease-Free Survival</term><term>Female</term><term>Humans</term><term>Liver Neoplasms (drug therapy)</term><term>Liver Neoplasms (radiotherapy)</term><term>Liver Neoplasms (secondary)</term><term>Male</term><term>Middle Aged</term><term>Radiotherapy, Adjuvant</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Agents</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Liver Neoplasms</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Colorectal Neoplasms</term></keywords><keywords scheme="MESH" qualifier="radiotherapy" xml:lang="en"><term>Liver Neoplasms</term></keywords><keywords scheme="MESH" qualifier="secondary" xml:lang="en"><term>Liver Neoplasms</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Disease-Free Survival</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Radiotherapy, Adjuvant</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Data suggest selective internal radiotherapy (SIRT) in third-line or subsequent therapy for metastatic colorectal cancer has clinical benefit in patients with colorectal liver metastases with liver-dominant disease after chemotherapy. The FOXFIRE, SIRFLOX, and FOXFIRE-Global randomised studies evaluated the efficacy of combining first-line chemotherapy with SIRT using yttrium-90 resin microspheres in patients with metastatic colorectal cancer with liver metastases. The studies were designed for combined analysis of overall survival.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28781171</PMID><DateCreated><Year>2017</Year><Month>08</Month><Day>07</Day></DateCreated><DateCompleted><Year>2017</Year><Month>09</Month><Day>25</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>25</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-5488</ISSN><JournalIssue CitedMedium="Internet"><Volume>18</Volume><Issue>9</Issue><PubDate><Year>2017</Year><Month>Sep</Month></PubDate></JournalIssue><Title>The Lancet. Oncology</Title><ISOAbbreviation>Lancet Oncol.</ISOAbbreviation></Journal><ArticleTitle>First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials.</ArticleTitle><Pagination><MedlinePgn>1159-1171</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1470-2045(17)30457-6</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(17)30457-6</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Data suggest selective internal radiotherapy (SIRT) in third-line or subsequent therapy for metastatic colorectal cancer has clinical benefit in patients with colorectal liver metastases with liver-dominant disease after chemotherapy. The FOXFIRE, SIRFLOX, and FOXFIRE-Global randomised studies evaluated the efficacy of combining first-line chemotherapy with SIRT using yttrium-90 resin microspheres in patients with metastatic colorectal cancer with liver metastases. The studies were designed for combined analysis of overall survival.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">FOXFIRE, SIRFLOX, and FOXFIRE-Global were randomised, phase 3 trials done in hospitals and specialist liver centres in 14 countries worldwide (Australia, Belgium, France, Germany, Israel, Italy, New Zealand, Portugal, South Korea, Singapore, Spain, Taiwan, the UK, and the USA). Chemotherapy-naive patients with metastatic colorectal cancer (WHO performance status 0 or 1) with liver metastases not suitable for curative resection or ablation were randomly assigned (1:1) to either oxaliplatin-based chemotherapy (FOLFOX: leucovorin, fluorouracil, and oxaliplatin) or FOLFOX plus single treatment SIRT concurrent with cycle 1 or 2 of chemotherapy. In FOXFIRE, FOLFOX chemotherapy was OxMdG (oxaliplatin modified de Gramont chemotherapy; 85 mg/m(2) oxaliplatin infusion over 2 h, L-leucovorin 175 mg or D,L-leucovorin 350 mg infusion over 2 h, and 400 mg/m(2) bolus fluorouracil followed by a 2400 mg/m(2) continuous fluorouracil infusion over 46 h). In SIRFLOX and FOXFIRE-Global, FOLFOX chemotherapy was modified FOLFOX6 (85 mg/m(2) oxaliplatin infusion over 2 h, 200 mg leucovorin, and 400 mg/m(2) bolus fluorouracil followed by a 2400 mg/m(2) continuous fluorouracil infusion over 46 h). Randomisation was done by central minimisation with four factors: presence of extrahepatic metastases, tumour involvement of the liver, planned use of a biological agent, and investigational centre. Participants and investigators were not masked to treatment. The primary endpoint was overall survival, analysed in the intention-to-treat population, using a two-stage meta-analysis of pooled individual patient data. All three trials have completed 2 years of follow-up. FOXFIRE is registered with the ISRCTN registry, number ISRCTN83867919. SIRFLOX and FOXFIRE-Global are registered with ClinicalTrials.gov, numbers NCT00724503 (SIRFLOX) and NCT01721954 (FOXFIRE-Global).</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between Oct 11, 2006, and Dec 23, 2014, 549 patients were randomly assigned to FOLFOX alone and 554 patients were assigned FOLFOX plus SIRT. Median follow-up was 43·3 months (IQR 31·6-58·4). There were 411 (75%) deaths in 549 patients in the FOLFOX alone group and 433 (78%) deaths in 554 patients in the FOLFOX plus SIRT group. There was no difference in overall survival (hazard ratio [HR] 1·04, 95% CI 0·90-1·19; p=0·61). The median survival time in the FOLFOX plus SIRT group was 22·6 months (95% CI 21·0-24·5) compared with 23·3 months (21·8-24·7) in the FOLFOX alone group. In the safety population containing patients who received at least one dose of study treatment, as treated, the most common grade 3-4 adverse event was neutropenia (137 [24%] of 571 patients receiving FOLFOX alone vs 186 (37%) of 507 patients receiving FOLFOX plus SIRT). Serious adverse events of any grade occurred in 244 (43%) of 571 patients receiving FOLFOX alone and 274 (54%) of 507 patients receiving FOLFOX plus SIRT. 10 patients in the FOLFOX plus SIRT group and 11 patients in the FOLFOX alone group died due to an adverse event; eight treatment-related deaths occurred in the FOLFOX plus SIRT group and three treatment-related deaths occurred in the FOLFOX alone group.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Addition of SIRT to first-line FOLFOX chemotherapy for patients with liver-only and liver-dominant metastatic colorectal cancer did not improve overall survival compared with that for FOLFOX alone. Therefore, early use of SIRT in combination with chemotherapy in unselected patients with metastatic colorectal cancer cannot be recommended. To further define the role of SIRT in metastatic colorectal cancer, careful patient selection and studies investigating the role of SIRT as consolidation therapy after chemotherapy are needed.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Bobby Moore Fund of Cancer Research UK, Sirtex Medical.</AbstractText><CopyrightInformation>Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Wasan</LastName><ForeName>Harpreet S</ForeName><Initials>HS</Initials><AffiliationInfo><Affiliation>Imperial College Healthcare NHS Trust and Imperial College, Hammersmith Hospital, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gibbs</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Western Hospital, Footscray, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sharma</LastName><ForeName>Navesh K</ForeName><Initials>NK</Initials><AffiliationInfo><Affiliation>Division of Radiation Oncology, Penn State Hershey Cancer Centre, School of Medicine, Hershey, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Taieb</LastName><ForeName>Julien</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Sorbonne Paris Cité, Université Paris Descartes, Georges Pompidou European Hospital, Department of Hepatogastroenterology and GI Oncology, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Heinemann</LastName><ForeName>Volker</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology and Comprehensive Cancer Centre, Klinikum Grosshadern, Ludwig-Maximilian, University of Munich, Munich, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ricke</LastName><ForeName>Jens</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Radiology and Nuclear Medicine, University of Magdeburg, Magdeburg, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Peeters</LastName><ForeName>Marc</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Antwerp University Hospital, Antwerp, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Findlay</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Weaver</LastName><ForeName>Andrew</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Oxford University NHS Foundation Trust, Churchill Hospital, Oxford, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mills</LastName><ForeName>Jamie</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Nottingham University Hospitals NHS Trust, Nottingham City Hospital, Nottingham, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wilson</LastName><ForeName>Charles</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Cambridge University Hospitals NHS Trust, Addenbrooke's Hospital, Cambridge, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Adams</LastName><ForeName>Richard</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>School of Medicine, Cardiff University, Cardiff, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Francis</LastName><ForeName>Anne</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Oncology Clinical Trials Office, Department of Oncology, University of Oxford, Oxford, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Moschandreas</LastName><ForeName>Joanna</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Centre for Statistics in Medicine, University of Oxford, Oxford, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Virdee</LastName><ForeName>Pradeep S</ForeName><Initials>PS</Initials><AffiliationInfo><Affiliation>Centre for Statistics in Medicine, University of Oxford, Oxford, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dutton</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Centre for Statistics in Medicine, University of Oxford, Oxford, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Love</LastName><ForeName>Sharon</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Centre for Statistics in Medicine, University of Oxford, Oxford, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gebski</LastName><ForeName>Val</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gray</LastName><ForeName>Alastair</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, 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