title: [Tolerability and safety of docetaxel plus cyclophosphamide as adjuvant chemotherapy for axillary lymph node-negative breast cancer--JECBC04 trial].
abstract: A recent foreign clinical trial showed that the combination of docetaxel plus cyclophosphamide (TC) is associated with a superior disease-free survival compared with doxorubicin plus cyclophosphamide as adjuvant chemotherapy for breast cancer. To assess the tolerability and safety of TC in a Japanese patient population, we conducted a multicenter, open-labeled clinical trial. Eligible patients were women who had axillary lymph node-negative breast cancer with surgical excision of the primary tumor. Patients were treated with 4 courses of TC (75 and 600 mg/m2, respectively), administered intravenously every 3 weeks. The primary endpoint was feasibility, which was defined as the proportion of patients who completed 4 courses of the chemotherapy. From October 2006 to November 2007, 39 patients were enrolled and 32 were evaluable. Seven patients were excluded because of the inadequate treatment schedule. Feasibility was 96. 9%(31/32). One patient did not complete treatment because of the hypersensitivity. The mean administered dose was 73.2mg/m2 for docetaxel and 588.3mg/m2 for cyclophosphamide, respectively. The mean relative dose intensity was 96. 1% and 95.7%, respectively. The grade 3/4 toxicity including leukopenia, neutropenia, and febrile neutropenia was manageable. From these results, we consider that TC might become a standard non-anthracycline adjuvant regimen for operable breast cancer.
authors.affiliation: Chiba Cancer Center, Division of Breast Surgery, Chiba, Japan.
authors.forename: Naohito
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Toshio
authors.initials: T
authors.lastname: Tabei
authors.forename: Kenichi
authors.initials: K
authors.lastname: Inoue
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Takei
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Sato
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Yanagita
authors.forename: Tomomi
authors.initials: T
authors.lastname: Fujisawa
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Fujii
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Saeki
authors.forename: Masafumi
authors.initials: M
authors.lastname: Kurosumi
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D000077143:Docetaxel; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D000970:Antineoplastic Agents; D018906:Antineoplastic Agents, Alkylating; D043823:Taxoids; D000077143:Docetaxel; D003520:Cyclophosphamide