TOPIC I

Disease site: Breast Cancer

Treatment Modality: Chemotherapy

Status: In active follow-up

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 Hospital, Sutton.

ISRCTN: 19831176.

Publication

Smith, A'Hern, Coombes et al, 2004. Ann Oncol 15: 751-758. 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.