A PILOT-STUDY OF INFUSIONAL CMF (CMF-INF) - ACTIVE AND WELL TOLERATEDIN BREAST-CANCER

Background: We have previously shown that 5-fluorouracil (5-FU) given by continuous infusion is well tolerated and active in the treatment o f breast cancer [1, 2]. We found that given infusional 5-FU could prod uce responses in patients whose disease was resistant to bolus 5-FU an d speculated that it could be combined safely with methotrexate/cyclop hosphamide in a manner analogous to i.v. CMF bobs. Using a modificatio n of the i.v. CMF regimen, comprising a standard dosage of bolus cyclo phosphamide at 750 mg/m(2) and bolus methotrexate at 50 mg/m(2) given every 3 weeks we altered the continuously infused 5-FU schedule to 200 mg/m(2)/24 hours and treated 28 patients of whom 23 had had previous chemotherapy (18 containing anthracycline, 4 bolus CMF and 19 infusion al 5-FU alone or in combination with other drugs) and 4 post menopausa l patients with locally advanced breast cancer. Results: Fourteen resp onded (2 CR, 12 PR) out of 27 evaluable patients with onset of respons e between 3 and 9 weeks. Toxicity was relatively mild in the 28 evalua ble patients and did not require cessation of treatment, with one exce ption (vomiting leading to dehydration at home and moderate transient uraemia). The main toxicities seen were WHO grade 3 neutropenia in 13/ 28 patients and grade 2 mucositis in 2 further patients. Grade 2 palma r/planter syndrome was reported in 4/28 patients and grade 2 or 3 naus ea/vomiting was reported in 7/28 patients. Conclusion: This well toler ated regimen is clearly active in patients with heavily pretreated bre ast cancer and should be tested against intravenous or classical CMF i n a randomised trial.