Idarubicin and cyclophosphamide - an active oral chemotherapy regimen for advanced breast cancer

Between October 1993 and September 1994, 33 women with metastatic breast ca ncer aged between 29 and 74 years with a median age of 58 were entered into a study of oral chemotherapy from three UK centres. Patients by definition had metastatic disease and were fit and well with performance status 0 or 1 in 23 cases, 2 in seven cases and 3 in two cases (one missing). Five pati ents had received prior adjuvant CMF chemotherapy, nine first line non-anth racycline containing chemotherapy for relapse, eight patients second line n on-anthracycline containing chemotherapy and all patients had had hormone t herapy either as adjuvant or for relapsed disease. Adjuvant radiotherapy ha d been given to 17 and palliative radiotherapy to 12 patients. In nine pati ents there was one site of disease at start of therapy, in 10 two sites, in 11 three sites and in three patients four or more sites. The regimen compr ised oral idarubicin 15 mg/m(2) on day 1, 10 mg/m(2) on days 2 and 3 and or al cyclophosphamide 250 mg/m(2) (maximum 400 mg) on days 1, 2 and 3. Treatm ent was continued until disease progression or toxicity. Results: Overall 2 5% of 32 evaluable patients responded objectively including one complete re sponse; 50% of patients had stable disease and 25% of patients progression. Among patients who had had no prior chemotherapy the objective response ra te was 37.5%; 45% of patients had symptomatic improvement. The most common severe toxicity was granulocytopenia WHO grade 3 or more in 69.7% of patien ts. Thrombocytopenia grade 3 or 4 was seen in four patients. Six patients h ad documented infections and all but four patients had alopecia. All patien ts complained of mild or moderate fatigue. Nausea and vomiting occurred in 75% of patients but only four individuals had grade 3 toxicity. Two patient s stopped therapy after myocardial infarction and one after impaired cardia c function was noted. The median time to progression was 2.7 months (1-11.5 months) and median survival time 8.8 months (1-13+ months). Conclusion: Th e combination chemotherapy is active in heavily treated patients with manag eable toxicity but there are problems in heavily pre-treated patients. Ther e was good compliance in taking medication and at the doses chosen the drug s appear to be suitable for younger fitter patients. (C) 2000 Elsevier Scie nce Ireland Ltd. All rights reserved.