SIRFLOX: Randomized phase III trial comparing first-line mFOLFOX6 (plus or minus Bevacizumab) versus mFOLFOX6 (plus or minus Bevacizumab) plus Selective Internal Radiation Therapy in patients with metastatic colorectal cancer

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dc.contributor.author van Hazel, GA en
dc.contributor.author Heinemann, V en
dc.contributor.author Sharma, NK en
dc.contributor.author Findlay, Michael en
dc.contributor.author Ricke, J en
dc.contributor.author Peeters, M en
dc.contributor.author Perez, D en
dc.contributor.author Robinson, BA en
dc.contributor.author Strickland, AH en
dc.contributor.author Ferguson, T en
dc.contributor.author Rodríguez, J en
dc.contributor.author Kröning, H en
dc.contributor.author Wolf, I en
dc.contributor.author Ganju, V en
dc.contributor.author Walpole, E en
dc.contributor.author Boucher, E en
dc.contributor.author Tichler, T en
dc.contributor.author Shacham-Shmueli, E en
dc.contributor.author Powell, A en
dc.contributor.author Eliadis, P en
dc.contributor.author Isaacs, R en
dc.contributor.author Price, D en
dc.contributor.author Moeslein, F en
dc.contributor.author Taieb, J en
dc.contributor.author Bower, G en
dc.contributor.author Gebski, V en
dc.contributor.author Van Buskirk, M en
dc.contributor.author Cade, DN en
dc.contributor.author Thurston, K en
dc.contributor.author Gibbs, P en
dc.date.accessioned 2017-10-08T23:08:00Z en
dc.date.issued 2016-05 en
dc.identifier.citation Journal of Clinical Oncology 34(15):1723-1731 May 2016 en
dc.identifier.issn 0732-183X en
dc.identifier.uri http://hdl.handle.net/2292/35911 en
dc.description.abstract SIRFLOX was a randomized, multicenter trial designed to assess the efficacy and safety of adding selective internal radiation therapy (SIRT) using yttrium-90 resin microspheres to standard fluorouracil, leucovorin, and oxaliplatin (FOLFOX)-based chemotherapy in patients with previously untreated metastatic colorectal cancer. Chemotherapy-naïve patients with liver metastases plus or minus limited extrahepatic metastases were randomly assigned to receive either modified FOLFOX (mFOLFOX6; control) or mFOLFOX6 plus SIRT (SIRT) plus or minus bevacizumab. The primary end point was progression-free survival (PFS) at any site as assessed by independent centralized radiology review blinded to study arm.Between October 2006 and April 2013, 530 patients were randomly assigned to treatment (control, 263; SIRT, 267). Median PFS at any site was 10.2 v 10.7 months in control versus SIRT (hazard ratio, 0.93; 95% CI, 0.77 to 1.12; P = .43). Median PFS in the liver by competing risk analysis was 12.6 v 20.5 months in control versus SIRT (hazard ratio, 0.69; 95% CI, 0.55 to 0.90; P = .002). Objective response rates (ORRs) at any site were similar (68.1% v 76.4% in control v SIRT; P = .113). ORR in the liver was improved with the addition of SIRT (68.8% v 78.7% in control v SIRT; P = .042). Grade ≥ 3 adverse events, including recognized SIRT-related effects, were reported in 73.4% and 85.4% of patients in control versus SIRT. The addition of SIRT to FOLFOX-based first-line chemotherapy in patients with liver-dominant or liver-only metastatic colorectal cancer did not improve PFS at any site but significantly delayed disease progression in the liver. The safety profile was as expected and was consistent with previous studies. en
dc.format.medium Print-Electronic en
dc.language eng en
dc.publisher American Society of Clinical Oncology en
dc.relation.ispartofseries Journal of Clinical Oncology en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. en
dc.rights.uri https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm en
dc.subject Humans en
dc.subject Colorectal Neoplasms en
dc.subject Neoplasm Metastasis en
dc.subject Organoplatinum Compounds en
dc.subject Fluorouracil en
dc.subject Leucovorin en
dc.subject Antineoplastic Combined Chemotherapy Protocols en
dc.subject Combined Modality Therapy en
dc.subject Brachytherapy en
dc.subject Adult en
dc.subject Aged en
dc.subject Aged, 80 and over en
dc.subject Middle Aged en
dc.subject Female en
dc.subject Male en
dc.title SIRFLOX: Randomized phase III trial comparing first-line mFOLFOX6 (plus or minus Bevacizumab) versus mFOLFOX6 (plus or minus Bevacizumab) plus Selective Internal Radiation Therapy in patients with metastatic colorectal cancer en
dc.type Journal Article en
dc.identifier.doi 10.1200/jco.2015.66.1181 en
pubs.issue 15 en
pubs.begin-page 1723 en
pubs.volume 34 en
dc.rights.holder Copyright: American Society of Clinical Oncology en
dc.identifier.pmid 26903575 en
pubs.end-page 1731 en
pubs.publication-status Published en
dc.rights.accessrights http://purl.org/eprint/accessRights/RestrictedAccess en
pubs.subtype Rapid Communication en
pubs.elements-id 524116 en
pubs.org-id Medical and Health Sciences en
pubs.org-id Medical Sciences en
pubs.org-id Oncology en
pubs.org-id Science en
pubs.org-id Science Research en
pubs.org-id Maurice Wilkins Centre (2010-2014) en
dc.identifier.eissn 1527-7755 en
pubs.record-created-at-source-date 2017-10-09 en
pubs.dimensions-id 26903575 en


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