Guy A van Hazel1, Volker Heinemann2, Navesh K Sharma2, Michael P N Findlay2, Jens Ricke2, Marc Peeters2, David Perez2, Bridget A Robinson2, Andrew H Strickland2, Tom Ferguson2, Javier Rodríguez2, Hendrik Kröning2, Ido Wolf2, Vinod Ganju2, Euan Walpole2, Eveline Boucher2, Thomas Tichler2, Einat Shacham-Shmueli2, Alex Powell2, Paul Eliadis2, Richard Isaacs2, David Price2, Fred Moeslein2, Julien Taieb2, Geoff Bower2, Val Gebski2, Mark Van Buskirk2, David N Cade2, Kenneth Thurston2, Peter Gibbs2. 1. Guy A. van Hazel, University of Western Australia; Tom Ferguson, Royal Perth Hospital; David Price and Geoff Bower, Mount Medical Center, Perth; Alex Powell, Hollywood Private Hospital, Nedlands, Western Australia; Andrew H. Strickland, Monash Medical Centre, Bentleigh, East Victoria; Vinod Ganju, Frankston Private Hospital Peninsula Oncology Centre, Frankston; Peter Gibbs, Western Hospital, Footscray, Victoria; Euan Walpole, Princess Alexandra Hospital, Woolloongabba; Paul Eliadis, Wesley Medical Centre, Milton, Queensland; Val Gebski, NHMRC Clinical Trials Centre, Camperdown; David N. Cade and Kenneth Thurston, Sirtex Medical Limited, North Sydney, New South Wales, Australia; Volker Heinemann, Ludwig-Maximilian-University of Munich, Munich; Jens Ricke, University Clinic Magdeburg; Hendrik Kroening, Schwerpunktpraxis of Haematology and Oncology, Magdeburg, Germany; Navesh K. Sharma, University of Maryland Medical Center; Fred Moeslein, University of Maryland School of Medicine, Baltimore, MD; Mark Van Buskirk, Data Reduction LLC, Chester, NJ; Michael P.N. Findlay, Cancer Trials New Zealand, Auckland; David Perez, Dunedin Hospital, Dunedin; Bridget A. Robinson, Christchurch Hospital, Christchurch; Richard Isaacs, Palmerston North Hospital, Palmerston, New Zealand; Marc Peeters, Antwerp University Hospital, Antwerp, Belgium; Javier Rodríguez, Clinica Universidad de Navarra, Pamplona, Spain; Ido Wolf and Einat Shacham-Shmueli, Sheba Medical Center, Tel-Hashomer; Thomas Tichler, Shaare-Zedek Medical Center, Jerusalem, Israel; Eveline Boucher, Hopital de Jour, Rennes; and Julien Taieb, Georges Pompidou European Hospital, Paris, France. gvh@perthoncology.com.au. 2. Guy A. van Hazel, University of Western Australia; Tom Ferguson, Royal Perth Hospital; David Price and Geoff Bower, Mount Medical Center, Perth; Alex Powell, Hollywood Private Hospital, Nedlands, Western Australia; Andrew H. Strickland, Monash Medical Centre, Bentleigh, East Victoria; Vinod Ganju, Frankston Private Hospital Peninsula Oncology Centre, Frankston; Peter Gibbs, Western Hospital, Footscray, Victoria; Euan Walpole, Princess Alexandra Hospital, Woolloongabba; Paul Eliadis, Wesley Medical Centre, Milton, Queensland; Val Gebski, NHMRC Clinical Trials Centre, Camperdown; David N. Cade and Kenneth Thurston, Sirtex Medical Limited, North Sydney, New South Wales, Australia; Volker Heinemann, Ludwig-Maximilian-University of Munich, Munich; Jens Ricke, University Clinic Magdeburg; Hendrik Kroening, Schwerpunktpraxis of Haematology and Oncology, Magdeburg, Germany; Navesh K. Sharma, University of Maryland Medical Center; Fred Moeslein, University of Maryland School of Medicine, Baltimore, MD; Mark Van Buskirk, Data Reduction LLC, Chester, NJ; Michael P.N. Findlay, Cancer Trials New Zealand, Auckland; David Perez, Dunedin Hospital, Dunedin; Bridget A. Robinson, Christchurch Hospital, Christchurch; Richard Isaacs, Palmerston North Hospital, Palmerston, New Zealand; Marc Peeters, Antwerp University Hospital, Antwerp, Belgium; Javier Rodríguez, Clinica Universidad de Navarra, Pamplona, Spain; Ido Wolf and Einat Shacham-Shmueli, Sheba Medical Center, Tel-Hashomer; Thomas Tichler, Shaare-Zedek Medical Center, Jerusalem, Israel; Eveline Boucher, Hopital de Jour, Rennes; and Julien Taieb, Georges Pompidou European Hospital, Paris, France.
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-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. RESULTS: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. CONCLUSION: 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.
RCT Entities:
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-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. RESULTS: 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. CONCLUSION: 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.
Authors: Aaron K T Tong; Yung Hsiang Kao; Chow Wei Too; Kenneth F W Chin; David C E Ng; Pierce K H Chow Journal: Br J Radiol Date: 2016-03-24 Impact factor: 3.039
Authors: Cathal O'Leary; Megan Greally; John McCaffrey; Peter Hughes; Leo L P Lawler; Martin O'Connell; Tony Geoghegan; Cormac Farrelly Journal: Ir J Med Sci Date: 2018-03-06 Impact factor: 1.568