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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. | Authors: | Eliadis P.;Rodriguez J.;Kroning H.;Wolf I.;Ganju V.;Walpole E.;Boucher E.;Tichler T.;Shacham-Shmueli E.;Powell A.;Ferguson T.;Isaacs R.;Price D.;Moeslein F.;Taieb J.;Bower G.;Gebski V.;Van Buskirk M.;Cade D.N.;Thurston K.;Gibbs P.;Van Hazel G.A.;Heinemann V.;Sharma N.K.;Findlay M.P.N.;Ricke J.;Peeters M.;Perez D.;Robinson B.A.;Strickland A.H. | Institution: | (Van Hazel) University of Western Australia, 22/146 Mounts Bay Rd, Perth, WA 6000, Australia (Ferguson) Royal Perth Hospital, Perth, Australia (Price, Bower) Mount Medical Center, Perth, Australia (Powell) Hollywood Private Hospital, Nedlands, WA, Australia (Strickland) Monash Medical Centre, Bentleigh, EV, Australia (Ganju) Frankston Private Hospital Peninsula Oncology Centre, Frankston, Australia (Gibbs) Western Hospital, Footscray, VIC, Australia (Walpole) Princess Alexandra Hospital, Woolloongabba, Australia (Eliadis) Wesley Medical Centre, Milton, QLD, Australia (Gebski) NHMRC Clinical Trials Centre, Camperdown, Australia (Cade, Thurston) Sirtex Medical Limited, North Sydney, NSW, Australia (Heinemann) Ludwig-Maximilian-University of Munich, Munich, Germany (Ricke) University Clinic Magdeburg, Australia (Kroning) Schwerpunktpraxis of Haematology and Oncology, Magdeburg, Germany (Sharma) University of Maryland Medical Center, Australia (Moeslein) University of Maryland School of Medicine, Baltimore, MD, United States (Van Buskirk) Data Reduction LLC, Chester, NJ, United States (Findlay) Cancer Trials New Zealand, Auckland, New Zealand (Perez) Dunedin Hospital, Dunedin, New Zealand (Robinson) Christchurch Hospital, Christchurch, New Zealand (Isaacs) Palmerston North Hospital, Palmerston, New Zealand (Peeters) Antwerp University Hospital, Antwerp, Belgium (Rodriguez) Clinica Universidad DeNavarra, Pamplona, Spain (Wolf, Shacham-Shmueli) Sheba Medical Center, Tel-Hashomer, Israel (Tichler) Shaare-Zedek Medical Center, Jerusalem, Israel (Boucher) Hopital de Jour, Rennes, France (Taieb) Georges Pompidou European Hospital, Paris, France | Issue Date: | 4-Jun-2016 | Copyright year: | 2016 | Publisher: | American Society of Clinical Oncology (E-mail: jcoservice@asco.org) | Place of publication: | United States | Publication information: | Journal of Clinical Oncology. 34 (15) (pp 1723-1731), 2016. Date of Publication: 20 May 2016. | Journal: | Journal of Clinical Oncology | Abstract: | Purpose: 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. Patients and Methods: Chemotherapy-naive 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. Result(s): 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 10.7months 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. Conclusion(s): The addition of SIRT to FOLFOX-based first-line chemotherapy in patients with liver-dominant or liveronly 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.Copyright © 2016 by American Society of Clinical Oncology. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1200/JCO.2015.66.1181 | PubMed URL: | 26903575 [http://www.ncbi.nlm.nih.gov/pubmed/?term=26903575] | ISSN: | 0732-183X | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/39664 | Type: | Article | Subjects: | risk assessment splenomegaly stomach ulcer/co [Complication] thrombocytopenia/si [Side Effect] vomiting/si [Side Effect] *bevacizumab/ae [Adverse Drug Reaction] *bevacizumab/ct [Clinical Trial] *bevacizumab/cb [Drug Combination] *bevacizumab/dt [Drug Therapy] corticosteroid/dt [Drug Therapy] diuretic agent/dt [Drug Therapy] *fluorouracil/ae [Adverse Drug Reaction] *fluorouracil/ct [Clinical Trial] *fluorouracil/cb [Drug Combination] *fluorouracil/dt [Drug Therapy] *folinic acid/ae [Adverse Drug Reaction] *folinic acid/ct [Clinical Trial] *folinic acid/cb [Drug Combination] *folinic acid/dt [Drug Therapy] low molecular weight heparin/dt [Drug Therapy] microsphere *oxaliplatin/ae [Adverse Drug Reaction] *oxaliplatin/ct [Clinical Trial] *oxaliplatin/dt [Drug Therapy] resin yttrium 90 radiation hepatitis/co [Complication] radiation hepatitis/dt [Drug Therapy] *selective internal radiation therapy *oxaliplatin/cb [Drug Combination] article ascites/co [Complication] *cancer combination chemotherapy *cancer radiotherapy cancer survival controlled study diarrhea/si [Side Effect] drug efficacy drug safety duodenum ulcer/co [Complication] fatigue/si [Side Effect] febrile neutropenia/co [Complication] febrile neutropenia/si [Side Effect] hepatitis/co [Complication] hepatitis/dt [Drug Therapy] human abdominal pain/si [Side Effect] adult aged female intermethod comparison liver liver failure/co [Complication] liver failure/dt [Drug Therapy] liver resection lung embolism/si [Side Effect] major clinical study male *metastatic colorectal cancer/dt [Drug Therapy] *metastatic colorectal cancer/rt [Radiotherapy] multicenter study *multimodality cancer therapy nausea/si [Side Effect] neutropenia/si [Side Effect] peripheral neuropathy/si [Side Effect] phase 3 clinical trial priority journal progression free survival radiation injury/co [Complication] radiation injury/dt [Drug Therapy] randomized controlled trial respiratory failure/co [Complication] drug safety duodenum ulcer / complication fatigue / side effect febrile neutropenia / complication / side effect female hepatitis / complication / drug therapy human intermethod comparison liver liver failure / complication / drug therapy liver resection lung embolism / side effect major clinical study male *metastatic colorectal cancer / *drug therapy / *radiotherapy multicenter study *multimodality cancer therapy nausea / side effect neutropenia / side effect peripheral neuropathy / side effect phase 3 clinical trial priority journal progression free survival radiation injury / complication / drug therapy aged respiratory failure / complication risk assessment splenomegaly stomach ulcer / complication thrombocytopenia / side effect vomiting / side effect adult abdominal pain / side effect randomized controlled trial Article ascites / complication *cancer combination chemotherapy *cancer radiotherapy cancer survival controlled study diarrhea / side effect drug efficacy |
Type of Clinical Study or Trial: | Randomised controlled trial |
Appears in Collections: | Articles |
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