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Trial of primary infusional chemotherapy

Disease site: Breast cancer

Treatment modality: Chemotherapy

Status: Closed

Trial details

Multicentre randomised trial comparing the efficacy and toxicity of pre-operative chemotherapy in women with histologically proven 3cm3 invasive early breast cancer. 426 patients from 18 centres were randomised between October 1993 and February 1999 to receive either 5-fluorouracil (5-FU) by daily 24 hour continuous infusion via a Hickman line for 18 weeks with epirubicin and cisplatin given as intravenous bolus injections, or conventional bolus doxorubicin (AC) and cyclophosphamide. Both schedules were repeated 3 weekly for 6 courses and oral tamoxifen was prescribed as appropriate. The need for conservative surgery with axillary resection or mastectomy and/or radiotherapy was reviewed post-chemotherapy based on clinical tumour size after treatment. Publication concluded that preoperative continuous infusional 5FU based chemotherapy is no more active than conventional AC for early breast cancer with a median 5 year follow-up. Long-term follow-up needs to be reviewed to assess whether differences in clinical response can predict for long-term outcome.

Chief Investigator: Professor I. Smith, Royal Marsden NHS Foundation Trust, Sutton

ISRCTN: 19831176

Publications and presentations

Smith IE, A'Hern RP, Coombes GA, Howell A, Ebbs SR, Hickish TF, O'Brien ME, Mansi JL, Wilson CB, Robinson AC, Murray PA, Price CG, Perren TJ, Laing RW, Bliss JM. 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. Ann. Oncol. 2004;15(5):751-58

Smith IE, A'Hern R, Howell A, Hickish T, O'Brien M, Mansi JL, Wilson C, Robinson A, Pratt W, Price C, Perren T, Laing R. Preoperative continuous infusional ECISF (Epirubicin, Cisplatin and Infusional 5FU) vs conventional AC chemotherapy for early breast cancer: A phase III multicentre randomised trial by the Topic Trial Group. Proc Am Soc Clin Oncol 2000;19:#320

Smith IE. Intensive primary infusional chemotherapy for large early breast cancer. Br J Cancer Supplements 1994;22:5 #S9

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.