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.
Hori
T
T
Keiji Breast Cancer Study Group, Department of Surgery, Kyoto Police Hospital, Kita-ku, Kyoto 603-8142, Japan. tai-suke@ka2.so-net.ne.jp
Kodama
H
H
Nishimura
S
S
Hatano
T
T
Okamura
R
R
Fujii
K
K
Kudo
T
T
Inamoto
T
T
Sawai
K
K
Kobayashi
M
M
Ogawa
H
H
Yoshimura
N
N
Hiraoka
M
M
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000556:secondary; D000069287:Capecitabine; D003520:Cyclophosphamide / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage; D008875:Middle Aged; D015996:Survival Rate
D005467:Floxuridine; D003841:Deoxycytidine; D000069287:Capecitabine; D004317:Doxorubicin; D003520:Cyclophosphamide; D017258:Medroxyprogesterone Acetate; D005472:Fluorouracil; C025034:doxifluridine