title: A randomized controlled study of (2"R)-4'-O-tetrahydropyranyladriamycin and adriamycin in combination with cyclophosphamide and 5-fluorouracil in the treatment of advanced and recurrent breast cancer. Clinical Study Group of THP for Breast Cancer in Japan.
abstract: The chemotherapeutic treatment of advanced and recurrent breast cancer was examined in a randomized controlled comparison test. Group A received (2"R)-4'-O-tetrahydropyranyladriamycin (THP) in combination with 5-fluorouracil (5-FU) and cyclophosphamide (CPA), while Group B was administered adriamycin (ADR) together with 5-FU and CPA. These combined chemotherapies were administered in a dosage regimen that was repeated in a 28-d cycle. On d 1 and d 8, THP and ADR were given at a dose of 30 mg/m2 IV and 5-FU was administered at a dose of 500 mg/m2 IV. CPA was administered at a dose of 100 mg/body, PO on consecutive days from d 3 to d 16. Among 37 complete cases in Group A, a complete response (CR) was noted in one patient and a partial response (PR) in 12, to give a rate of 35.1%. CR was noted in one patient and PR was observed in 7 out of 27 complete cases in Group B, giving a response rate of 29.6%. The mean PR duration was 19 wk (range, 4+--63) in Group A, and 14 wk (range, 4+--51+) in Group B. The 50% survival duration was 20.6 mo and 14.3 mo in Groups A and B, respectively, while mean survival duration was 17.9 mo and 16.6 mo in Groups A and B, respectively. No significant between-group differences were found for any of these measures. There were fewer side effects in Group A than in Group B, with Group A showing significantly less alopecia (P less than 0.01) and a lower incidence of anorexia (P greater than 0.1).(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Department of Surgery, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Tominaga
authors.forename: O
authors.initials: O
authors.lastname: Abe
authors.forename: K
authors.initials: K
authors.lastname: Enomoto
authors.forename: R
authors.initials: R
authors.lastname: Abe
authors.forename: Y
authors.initials: Y
authors.lastname: Iino
authors.forename: H
authors.initials: H
authors.lastname: Koyama
authors.forename: M
authors.initials: M
authors.lastname: Fujimoto
authors.forename: Y
authors.initials: Y
authors.lastname: Nomura
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003520:Cyclophosphamide / Q000627:therapeutic use; D004317:Doxorubicin / Q000031:analogs & derivatives / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D007564:Japan; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D011897:Random Allocation
chemical_list: D004317:Doxorubicin; D003520:Cyclophosphamide; C027260:pirarubicin; D005472:Fluorouracil