title: Phase III study to evaluate the use of high-dose chemotherapy as consolidation of treatment for high-risk postoperative breast cancer: Japan Clinical Oncology Group study, JCOG 9208.
abstract: A randomized controlled trial was conducted to evaluate the efficacy of high-dose chemotherapy (HDC) as consolidation of the treatment of high-risk postoperative breast cancer. Patients under 56 years of age with stage I to IIIB breast cancer involving 10 or more axillary lymph nodes were eligible. The primary endpoint was relapse-free survival (RFS). Between May 1993 and March 1999, 97 patients were enrolled, and two patients became ineligible. The median age of the 97 patients was 46 years (range 27-55 years), and 72 (74%) were premenopausal. The median number of involved axillary nodes was 16 (range 10-49). All patients had undergone a radical mastectomy. Major characteristics were well balanced between the treatment arms. Forty-eight patients in the standard-dose (STD) arm received six courses of cyclophosphamide, doxorubicin, and 5-fluorouracil followed by tamoxifen. Forty-nine patients were assigned to undergo HDC with cyclophosphamide and thiotepa after six courses of cyclophosphamide, doxorubicin, and 5-fluorouracil followed by tamoxifen; however, 15 of these patients (31%) did not undergo HDC. HDC was well tolerated without any treatment-related mortality. At a median follow-up of 63 months, the 5-year RFS of 47 eligible patients in the STD arm and 48 eligible patients in the HDC arm was 37% and 52% on an intent-to-treat basis, respectively (P = 0.17). Five-year overall survival of all randomized patients was 62% for the STD arm and 63% for the HDC arm (P = 0.78). Although the prespecified values of the two arms were not so accurate as to allow detection of the observed difference, no advantage of HDC was observed in terms of RFS or overall survival.
authors.affiliation: Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan. tokuda@is.icc.u-tokai.ac.jp
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Tokuda
authors.forename: Tomoo
authors.initials: T
authors.lastname: Tajima
authors.forename: Masaru
authors.initials: M
authors.lastname: Narabayashi
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Takeyama
authors.forename: Toru
authors.initials: T
authors.lastname: Watanabe
authors.forename: Takashi
authors.initials: T
authors.lastname: Fukutomi
authors.forename: Takaaki
authors.initials: T
authors.lastname: Chou
authors.forename: Muneaki
authors.initials: M
authors.lastname: Sano
authors.forename: Tadahiko
authors.initials: T
authors.lastname: Igarashi
authors.forename: Yasutsuna
authors.initials: Y
authors.lastname: Sasaki
authors.forename: Michinori
authors.initials: M
authors.lastname: Ogura
authors.forename: Shigeto
authors.initials: S
authors.lastname: Miura
authors.forename: Shin-ichiro
authors.initials: S
authors.lastname: Okamoto
authors.forename: Masami
authors.initials: M
authors.lastname: Ogita
authors.forename: Masaharu
authors.initials: M
authors.lastname: Kasai
authors.forename: Tadashi
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.forename: Shigemitsu
authors.initials: S
authors.lastname: Takashima
authors.forename: Kensei
authors.initials: K
authors.lastname: Tobinai
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D013852:Thiotepa / Q000008:administration & dosage
chemical_list: D004317:Doxorubicin; D003520:Cyclophosphamide; D013852:Thiotepa; D005472:Fluorouracil