Smith, I. E., A'Hern, R.P., Coombes, G.A., Howell, A., Ebbs, S.R., Hickish, T. F., O’Brien, M. E.R., Mansi, J. L., Wilson, C.B., Robinson, A.C., Murray, P.A., Price, C.G.A., Perren, T.J., Laing, R.W. and Bliss, J.M., 2004. 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. Annals of Oncology, 15 (5), pp. 751-758.
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Official URL: http://dx.doi.org/10.1093/annonc/mdh175
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.
|Subjects:||Technology > Medicine and Health|
|Group:||School of Health and Social Care > Centre for Postgraduate Medical Research and Education|
|Deposited By:||INVALID USER|
|Deposited On:||21 Oct 2008 21:52|
|Last Modified:||07 Mar 2013 14:51|
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