Controlled study with L PAM and 5 FU (IV or PO) plus or minus prednisone in advanced breast cancer

There is initial evidence that adjuvant combination chemotherapy can favourably affect the realapse rate in operable breast cancer with N+ axillary nodes. Therefore, an effective combination which could be administered orally can be useful for a long term therapy in asymptomatic patients. This randomized pilot study was designed in order to assess the effect of a combination with L PAM (4 mg/m ² po) plus 5 FU (300 mg/m ² iv vs. po) plus or minus prednisone (30 mg/m ² po). All drugs were given from day 1 to 5 of each cycle and repeated on day 28. From July to October 1974 a total of 45 patients (15 in each group) previously untreated with chemotherapy were entered on study. At the time of this abstract, 22 are evaluable for therapeutic response. Regressions lasting for a minimum of 4 weeks were as follows: L PAM + FU po 3/7, L PAM + FU iv 5/10, L PAM + FU iv + prednisone 2/5. Although the observations are preliminary, all 3 combinations appear effective at a comparable rate. GI toxicity was minimal, alopecia was nil. Leukopenia occurred in a total of 32%, thrombocytopenia in 55%.