A randomised comparative trial of infusional ECisF versus conventional FEC as adjuvant chemotherapy in early breast cancer: the TRAFIC trial

Sirohi, B., A'Hern, R., Coombes, G., Bliss, J.M., Hickish, T., Perren, T., Crawford, M., O'Brien, M., Iveson, T., Ebbs, S., Skene, A., Laing, R. and Smith, I.E. (2010) A randomised comparative trial of infusional ECisF versus conventional FEC as adjuvant chemotherapy in early breast cancer: the TRAFIC trial. Annals of Oncology. (doi:10.1093/annonc/mdp602).

Abstract

Background: the epirubicin with cisplatin and infusional 5-fluorouracil (5-FU) (ECisF) regimen was found to be highly active in the treatment of metastatic breast cancer and as neoadjuvant therapy. The UK TRAFIC (trial of adjuvant 5-FU infusional chemotherapy) trial (CRUK/95/007) compared this schedule with 5-FU, epirubicin and cyclophosphamide (FEC60) as adjuvant therapy in patients with early breast cancer.

Methods: in this multicentre, open-label, phase III randomised controlled trial, 349 women were randomly assigned to receive i.v. ECisF [epirubicin 60 mg/m2, day 1, cisplatin 60 mg/m2, day 1 and 5-FU 200 mg/m2 by daily 24-h infusion (n = 172)] or FEC [5-FU 600 mg/m2, day 1, epirubicin 60 mg/m2, day 1 and cyclophosphamide 600 mg/m2, day 1 (n = 177)]. Both treatments were delivered every 3 weeks for six cycles. The primary end point was relapse-free interval (RFI). TRAFIC is registered as an International Standard Randomised Controlled Trial (ISRCTN 83324925).

Results: all randomised patients were included in the intent-to-treat population. With a median follow-up of 112 months, there was no significant difference in RFI between the treatment groups [hazard ratio 0.84 (95% confidence interval 0.60–1.19); P = 0.33]. Toxic effects were more frequent in patients allocated to ECisF.

Conclusions: while limited by size, TRAFIC has long follow-up. No evidence of a clinically worthwhile benefit for the infusional treatment compared with standard treatment was observed which would justify further investigation or widespread use.

This record has no associated files available for download.

Contributors

Author: T. Iveson

Download statistics