title: [Hungarian experience with docetaxel combination (TAC) in the adjuvant treatment of breast cancer. Results of BCIRG 001 randomized, multicentric, phase III trial].
abstract: OBJECTIVE
  The authors present the Hungarian interim analysis and experience with the BCIRG 001 randomized, multicentric, phase III clinical trial comparing TAC (docetaxel, doxorubicin, cyclophosphamide) and FAC (5-fluorouracil, doxorubicin, cyclophosphamide) in the adjuvant treatment of node positive breast cancer patients. The results are presented according to international data.
  
  
  METHODS
  Three Hungarian centers - St. Margit Hospital, Budapest, National Institute of Oncology, Budapest, Petz Aladár Hospital, Gyôr - participated in the international trial. Between June 1997 and June 1999, 61 patients with node positive breast cancer were enrolled in the study after the surgery. Thirty-four patients were randomized to TAC (75/50/500 mg/m2 6x q3wk) and 27 patients were randomized to FAC (500/50/500 mg/m2 6x q3wk) chemotherapy, with prospective stratification by node (1-3, 4+). In the case of patients with ER and/or PR positive tumours 5 years tamoxifen treatment was started. Radiotherapy was performed after the 6th cycle of chemotherapy.
  
  
  RESULTS
  36 months of follow up was performed. In both arms the hematological toxicity was more frequent. The TAC group showed a higher incidence of neutropenia (76%) compared to the FAC (22%), as well as a higher incidence of febrile neutropenia (26%), without grade 3-4 infection and there were no cases of septic death. Regarding non-hematological toxicity more grade 3-4 nausea and vomiting was observed in the FAC group. At three years follow up, the international results show statistically significant improvement in disease-free survival (82% vs. 74%, p=0.0011) in favour of TAC, and similar tendency was observed in the case of overall survival (92% vs. 87%, p=0.11). This benefit with TAC was seen regardless of hormone receptor status. Due to the low number of Hungarian patients we cannot declare the same results.
  
  
  CONCLUSIONS
  Based on the international analysis TAC was superior to FAC chemotherapy. Additional follow up data will evaluate the role of TAC in the adjuvant setting of early breast cancer treatment. The results indicate that TAC has the potential to be incorporated in the new strategies of adjuvant breast cancer treatments.
authors.affiliation: Onkológiai Osztály, Szent Margit Kórház, Budapest, 1032 Hungary. kboer@freemail.hu
authors.forename: Katalin
authors.initials: K
authors.lastname: Boér
authors.forename: István
authors.initials: I
authors.lastname: Láng
authors.forename: Eva
authors.initials: E
authors.lastname: Juhos
authors.forename: Tamás
authors.initials: T
authors.lastname: Pintér
authors.forename: János
authors.initials: J
authors.lastname: Szántó
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D005334:Fever / Q000209:etiology; D005472:Fluorouracil / Q000008:administration & dosage; D006402:Hematologic Diseases / Q000209:etiology; D006801:Humans; D006814:Hungary; D007239:Infections / Q000209:etiology; D008875:Middle Aged; D018805:Sepsis / Q000209:etiology; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D004317:Doxorubicin; D003520:Cyclophosphamide; D005472:Fluorouracil
vernacular_title: Docetaxel kombinációs kezeléssel (TAC) szerzett tapasztalataink az emlôrák adjuváns kemoterápiájában. BCIRG 001 randomizált, multicentrikus fázis III vizsgálat hazai eredményei.