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

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/m(2), day 1, cisplatin 60 mg/m(2), day 1 and 5-FU 200 mg/m(2) by daily 24-h infusion (n = 172)] or FEC [5-FU 600 mg/m(2), day 1, epirubicin 60 mg/m(2), day 1 and cyclophosphamide 600 mg/m(2), 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.

Block sequential adriamycin CMF--optimal non-myeloablative chemotherapy for high risk adjuvant breast cancer?

After the publication of the 10-year survival data from Milan on the adjuvant use of the block sequential regimen consisting of four cycles of adriamycin followed by eight cycles of intravenous CMF, many centres adopted this as standard of care for high risk, multiple node-positive breast cancer. For this reason it was identified as the standard arm for the Anglo-Celtic adjuvant high-dose chemotherapy trial. This study reports on the experience of this regimen in 329 women with early breast cancer involving at least four axillary nodes, who were treated outside any adjuvant chemotherapy trial. At a median follow-up of 3 years, the overall 5-year disease-free survival is 61%, and the overall survival is 70%. These data confirm the efficacy of this regimen in non-trial patients, and, for the same high risk subgroup, indicate that this approach offers an outcome at least as good as that seen in the CALGB 9344 AC-Taxol arm, and the NCIC days 1 and 8 CEF.

[Feedback-controlled weight bearing following osteosynthesis of the lower extremity]. / Feedbackgesteuerte Belastungsdosierung nach Osteosynthesen an der unteren Extremität.

Truly partial weight bearing by usual mode of mobilisation after an operation of the lower limb is not a realistic goal. Frequent and massive overloading could recently be shown in a series of patients with joint replacements. Significant improvements in the loading pattern could be demonstrated with the use of an acoustic feedback system. Our goal was to test the clinical application of this method by using a similar system in the form of an insole-installed device. In the same trial, data on the real weight bearing pattern with prescribed loading after osteosyntheses was to be collected with and without the feedback device. We measured weight bearing continuously in two groups of patients. The first group was mobilised in the usual manner whereas the second group was acoustically alerted to overloading when passing the limit of 15 kg by a sensor device in the insole. Our results showed that 40.8% of steps made by patients mobilised in the usual manner were massively overloaded whereas 12.7% of steps in the second feedback-group produced even minor overloading. Apart from certain technical difficulties, the method was well accepted by the patients. The usual method of progressive weight bearing is unreliable. The value of partial weight bearing after internal fixation of the lower limb remains to be evaluated. In cases in which partial weight bearing is recommended, more attention should be paid to observing the prescribed limits and a reliable system that alerts the patient of excessive weight bearing would be most useful. For routine use in clinics a technically more reliable PMT Feedback System has to be developed.