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Annals of Oncology 15:751-758, 2004
© 2004 European Society for Medical Oncology

Original Paper

A novel continuous infusional 5-fluorouracil-based chemotherapy regimen compared with conventional chemotherapy in the neo-adjuvant treatment of early breast cancer: 5 year results of the TOPIC trial

Received 29 September 2003; revised 13 January 2004; accepted 15 January 2004

Background:

To compare the efficacy of continuous infusional 5-fluorouracil (5-FU)-based chemotherapy against conventional bolus chemotherapy in the preoperative treatment of patients with large operable early breast cancer.

Patients and methods:

Four hundred and twenty-six women with histologically proven ³3 cm invasive early breast cancer were randomised to receive pre-operative infusional 5-FU 200 mg/m2 by daily 24 h continuous infusion via a Hickman line for 18 weeks with epirubicin 60 mg/m2 intravenous (i.v.) bolus on day 1 and cisplatin 60 mg/m2 i.v. bolus on day 1, both repeating 3-weekly (infusional ECisF), or conventional bolus doxorubicin 60 mg/m2 i.v. on day 1 and cyclophosphamide 600 mg/m2 i.v. on day 1, both repeating 3-weekly (AC), both schedules for six courses. Patients subsequently had local therapy (surgery or radiotherapy or both) and tamoxifen 20 mg orally daily as appropriate.

Results:

The 5 year results for AC and infusional ECisF, respectively, were as follows: overall response, 75% and 77%; complete clinical remission, 31% and 34%; pathological complete remission (pathCR), 16% for both; and pathCR with residual ductal carcinoma in situ (DCIS), 25% and 24%. Mastectomy rates were 37% and 34%, respectively. Five-year overall survival was 74% for AC and 82% for infusional ECisF (hazard ratio 0.76, 95% confidence interval 0.51–1.13; P = 0.18). Both treatments were well tolerated. Grade III/IV lethargy, vomiting, alopecia and plantar-palmar erythema were significantly greater for infusional ECisF; grade III/IV leucopenia was significantly greater for AC.

Conclusions:

Preoperative continuous infusional 5-FU-based chemotherapy is no more active than conventional AC for early breast cancer; with a median 5 year follow-up, the infusion-based schedule shows a non-significant trend towards improved survival.

I. E. Smith1,*, R. P. A’Hern1, G. A. Coombes2, A. Howell3, S. R. Ebbs4, T. F. Hickish5, M. E. R. O’Brien6, J. L. Mansi7, C. B. Wilson8, A. C. Robinson9, P. A. Murray10, C. G. A. Price11, T. J. Perren12, R. W. Laing13 and J. M. Bliss2

1 Royal Marsden Hospital; 2 Institute of Cancer Research, London and Sutton; 3 Christie Hospital, Manchester; 4 Mayday University Hospital, Croydon; 5 Royal Bournemouth Hospital; 6 Kent Oncology Centre, Maidstone; 7 St George’s Hospital, London; 8 Addenbrooke’s Hospital, Cambridge; 9 Southend Hospital, Southend-on-Sea; 10 Essex County Hospital, Colchester; 11 Bristol Oncology Centre, Bristol; 12 St James Hospital, Leeds; 13 St Luke’s Cancer Centre, Guildford, UK

Key words: breast neoplasm, chemotherapy, cisplatin, infusional 5-FU, neo-adjuvant, phase III


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