Capecitabine named-patient programme for patients with advanced breast cancer. the UK experience

Following the encouraging results achieved with the oral fluoropyrimidine capecitabine in clinical trials, a named patient programme was initiated in the UK, through which patients with advanced breast cancer were prescribed capecitabine monotherapy. In this programme, patients were treated with the standard dose of oral capecitabine (1250 mg/m(2) twice daily on days 1-14 of a 21-day treatment cycle). Efficacy and safety data were collected and analysed from 102 patients receiving outpatient treatment with capecitabine. All patients had previously received chemotherapy and for the majority (75%) this was in the metastatic setting. In total, 482 treatment cycles were administered, with a median of 4.5 treatment cycles (range 1-22) per patient. Tumour responses were observed in 20 patients (20%), with an additional 47 patients (46%) achieving disease stabilisation. The median time to disease progression was 4.1 months and median overall survival was 7.7 months. The most common treatment-related adverse events were palmar-plantar erythrodysaesthesia (PPE) (36%) and gastrointestinal toxicities (diarrhoea (33%) and nausea (24%)). Dose reductions due to adverse events were required in 33% of patients, but capecitabine was administered without a dose reduction for 90% of cycles. The results achieved with capecitabine in this named-patient programme confirm that, under 'real practice' conditions, capecitabine is active and well tolerated in patients with advanced breast cancer.