Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster lunch

1191 - Overall survival in the FOXFIRE-SIRFLOX-FOXFIRE Global prospective randomized studies of first-line SIRT in patients with mCRC (146P)

Date

18 Nov 2017

Session

Poster lunch

Topics

Cytotoxic Therapy;  Colon and Rectal Cancer

Presenters

Harpreet Wasan

Citation

Annals of Oncology (2017) 28 (suppl_10): x42-x56. 10.1093/annonc/mdx659

Authors

H. Wasan1, G. van Hazel2, V. Heinemann3, N. Sharma4, J. Taieb5, J. Ricke6, M. Peeters7, M. Findlay8, P. Virdee9, S.B. Love9, J. Moschandreas9, P. Dutton9, V. Gebski10, A. Gray11, R. Sharma12, P. Gibbs13

Author affiliations

  • 1 Department Of Surgery & Cancer,, Imperial College Healthcare NHS Trust & Imperial College - Hammersmith Hospital, W12 0HS - London/GB
  • 2 School Of Medicine And Pharmacology, University of Western Australia, 6000 - Perth/AU
  • 3  department Of Medical Oncology And Comprehensive Cancer Center, Ludwig Maximilians University - Grosshadern, 81377 - Munich/DE
  • 4 Division Of Radiation Oncology, Penn State Hershey Cancer Centre, PA 17033 - Hershey/US
  • 5 Gi Oncology Department, Hopital European George Pompidou, 75015 - Paris/FR
  • 6 Department Of Radiology And Nuclear Medicine, Universitätsklinikum Magdeburg - Universitätsklinik für Radiologie und Nuklearmedizin, 39120 - Magdeburg/DE
  • 7 Department Of Oncology, U.Z.A. University Hospital Antwerp, 2650 - Edegem/BE
  • 8 Health Sciences, University of Auckland Faculty of Medical & Health Sciences, 1703 - Auckland/NZ
  • 9 Nuffield Department Of Orthopaedics, Rheumatology And Musculoskeletal Sciences University Of Oxford, Centre for Statistics in Medicine., University in Oxford, OX3 7LD - Oxford/GB
  • 10 Nhmrc Clinical Trials Centre, University of Sydney, NSW 1450 - Sydney/AU
  • 11 Nuffield Department Of Population Health, University of Oxford, Health Economics Research Centre,, OX1 3PA - Oxford/GB
  • 12 Cancer Institute, UCL - University College London, WC1B 5JU - London/GB
  • 13 Department Of Oncology, Western Hospital,, VIC 3011 - Footscray/AU
More

Resources

Abstract 1191

Background

The FOXFIRE randomized studies [FOXFIRE, SIRFLOX and FOXFIRE-Global (FF-SF-FFG)] were designed to evaluate the efficacy and safety of selective internal radiation therapy (SIRT) using yttrium-90 resin microspheres plus first-line chemotherapy for unresectable metastatic colorectal cancer (mCRC). The design and eligibility criteria of the three studies were similar, which facilitated this prospective combined analysis of overall survival (OS).

Methods

Chemotherapy-naïve mCRC patients with liver metastases unsuitable for curative resection/ablation were randomized (1:1) to the Control arm with standard oxaliplatin-based chemotherapy (mFOLFOX6 or OxMdG) ± bevacizumab, or the Test arm to receive the same chemotherapy, plus a single SIRT treatment. Limited extra-hepatic metastases and primary tumor in situ were included. The primary endpoint OS was analysed on an intention-to-treat basis using individual participant data. Secondary endpoints included progression-free survival (PFS), liver PFS, response rate and adverse events (AEs).

Results

A total of 1103 patients (Control arm n = 549; Test arm n = 554) with a median age of 63 years were enrolled. Median follow-up was 43.3 months. There was no difference in median OS between the two treatment arms (pooled hazard ratio [HR] 1.04; 95% confidence interval [CI], 0.90-1.19; p = 0.609) or in median PFS (pooled HR 0.90; 95% CI, 0.79-1.02; p = 0.108). The objective response rate was higher in the SIRT arm than in the Control arm (72.2% and 63.0%, respectively, p = 0.001). The risk of progression in the liver as a first event was lower in patients in the SIRT arm (pooled HR 0.51; CI 0.43-0.62; p 

Conclusions

This combined analysis showed no improvement when SIRT is added to first-line oxaliplatin-fluorouracil chemotherapy. However, the addition of SIRT achieved higher tumor response rates and improved liver-specific PFS. The addition of SIRT appeared to have a significant OS benefit in patients with right-sided tumors.

Clinical trial identification

FOXFIRE has ISRCTN Registry number ISRCTN83867919. SIRFLOX and FOXFIRE-Global are registered with ClinicalTrials.gov with registration numbers NCT00724503 and NCT01721954, respectively.

Legal entity responsible for the study

FOXFIRE, SIRFLOX and FOXFIRE-Global trial investigators.

Funding

Bobby Moore Fund of Cancer Research U.K., the University of Oxford and Sirtex Medical Ltd.

Disclosure

,H. Wasan: grants, personal fees, non-financial support and other uncompensated work from Sirtex Medical., G. van Hazel, V. Gebski: compensation for participation in Advisory Committees from Sirtex., V. Heinemann: honoraria from Amgen, Roche, Sanofi and Sirtex for consulting roles, participation in advisory boards, and his institution has received study grants from Amgen, Merck, Roche, Sanofi and Sirtex., N. Sharma: honoria from Sirtex Medical, J. Taieb: honoraria from Genentech, Merck Serono, Amgen, Celgene, Sanofi, Eli Lilly/ImClone Systems., J. Ricke: personal fees and grants from Sirtex Medical., M. Peeters: research funding and personal fees from Sirtex Medical., M. Findlay: grants from Sirtex Medical., P. Virdee, S.B. Love, J. Moschandreas: h grants from Cancer Research UK, grants from Sirtex Medical and non-financial support from Sirtex Medical., P. Dutton: grants from Cancer Research UK, grants from Sirtex Medical and non-financial support from Sirtex Medical, A. Gray: grants from Cancer Research UK, R. Sharma: research funding, honoraria, and consultancy fees from Sirtex Medical., P. Gibbs: honoraria from Sirtex Medical for participation in advisory boards and for giving presentations.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.