A randomized study comparing oral and standard regimens for metastatic breast cancer

We conducted a randomized controlled trial comparing oral regimen [doxifluridine, an intermediate metabolite of capecitabine, + medroxyprogesterone acetate (MPA) + cyclophosphamide (CPA)] (Method A) with a standard regimen (5-fluorouracil + adriamycin + CPA) plus MPA (Method B) as first line chemotherapy for metastatic breast cancer. Overall response rate was 55.8% for Method A, 46.3% for Method B. The total ratio of responder and long stable disease was significantly higher with Method A (p=0.006). Median time to progression and survival were not differences between Methods. Incidence of toxicity was 56.3% with Method A and 80.0% with Method B (p=0.014). Oral regimen is more useful than standard therapy.