|A randomized study comparing oral and standard regimens for metastatic breast cancer|
Authors: Taisuke Hori, Hiroshi Kodama, Satoru Nishimura, Takehiko Hatano, Ryuji Okamura, Koji Fujii, Takashi Kudo, Takashi Inamoto, Kiyoshi Sawai, Masao Kobayashi, Hiroki Ogawa, Norio Yoshimura, Masahiro Hiraoka
Department of Surgery, Kyoto Police Hospital, Kita-ku, Kyoto 603-8142, Japan
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.