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 - Université de Rennes Access content directly
Journal Articles Journal of Clinical Oncology Year : 2016

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

Paul Eliadis
  • Function : Author
Richard Isaacs
  • Function : Author
David Price
  • Function : Author
Fred Moeslein
  • Function : Author
Julien Taieb
Geoff Bower
  • Function : Author
Val Gebski
  • Function : Author
Mark van Buskirk
  • Function : Author
David N. Cade
  • Function : Author
Kenneth Thurston
  • Function : Author
Guy A. Van Hazel
  • Function : Author
Volker Heinemann
  • Function : Author
Navesh K. Sharma
  • Function : Author
Michael P. N. Findlay
  • Function : Author
Jens Ricke
Marc Peeters
David Perez
  • Function : Author
Bridget A. Robinson
  • Function : Author
Andrew H. Strickland
  • Function : Author
Tom Ferguson
  • Function : Author
Javier Rodrigez
  • Function : Author
Hendrik Kröning
  • Function : Author
Ido Wolf
  • Function : Author
Vinod Ganju
  • Function : Author
Euan Walpole
  • Function : Author
Thomas Tichler
  • Function : Author
Einat Shacham-Shmueli
  • Function : Author
Alex Powell
  • Function : Author

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

Dates and versions

hal-01282335 , version 1 (03-03-2016)

Identifiers

Cite

Paul Eliadis, Richard Isaacs, David Price, Fred Moeslein, Julien Taieb, et al.. 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. Journal of Clinical Oncology, 2016, 34 (15), pp.1723-31. ⟨10.1200/JCO.2015.66.1181⟩. ⟨hal-01282335⟩
161 View
0 Download

Altmetric

Share

Gmail Facebook X LinkedIn More