A randomised comparative trial of infusional ECisF versus conventional FEC as adjuvant chemotherapy in early breast cancer: the TRAFIC trial |
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| Institution: | 1. Department of Medical Oncology, Max Cancer Centre, Max Healthcare, New Delhi, India (formerly at The Royal Marsden NHS Foundation Trust);2. ICR Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, Surrey;3. Department of Oncology and Centre for Postgraduate Medical Research and Education, Institute of Cancer Research Clinical Trials and Statistics Unit, Royal Bournemouth Hospital, Bournemouth;4. Non-Surgical Oncology, Institute of Cancer Research Clinical Trials and Statistics Unit, St James''s University Hospital, Leeds;5. Medical Oncology, Airedale General Hospital, Keighley;6. Department of Medicine, The Royal Marsden NHS Foundation Trust, London & Sutton;7. Mid Kent Oncology Centre, Maidstone Hospital, Sutton, Surrey;8. Oncology Department, Pembroke Suite, Salisbury District Hospital, Salisbury;9. Breast Unit, Mayday University Hospital, Croydon;10. Department of Surgery, Institute of Cancer Research Clinical Trials and Statistics Unit, Royal Bournemouth Hospital, Bournemouth;11. Department of Oncology, St Luke''s Cancer Centre, Guildford, UK |
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| Abstract: | BackgroundThe 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.MethodsIn 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).ResultsAll 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.ConclusionsWhile 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. |
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