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[Hungarian experience with docetaxel combination (TAC) in the adjuvant treatment of breast cancer. Results of BCIRG 001 randomized, multicentric, phase III trial].
- Source :
-
Magyar onkologia [Magy Onkol] 2003; Vol. 47 (2), pp. 141-8. Date of Electronic Publication: 2003 Sep 16. - Publication Year :
- 2003
-
Abstract
- Aim: 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.<br />Patients and 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.<br />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.<br />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.
- Subjects :
- Adult
Aged
Antineoplastic Agents, Phytogenic adverse effects
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Antineoplastic Combined Chemotherapy Protocols adverse effects
Breast Neoplasms surgery
Chemotherapy, Adjuvant
Cyclophosphamide administration & dosage
Disease-Free Survival
Docetaxel
Doxorubicin administration & dosage
Drug Administration Schedule
Female
Fever etiology
Fluorouracil administration & dosage
Hematologic Diseases etiology
Humans
Hungary
Infections etiology
Middle Aged
Sepsis etiology
Survival Analysis
Taxoids administration & dosage
Taxoids adverse effects
Treatment Outcome
Antineoplastic Agents, Phytogenic therapeutic use
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Breast Neoplasms drug therapy
Taxoids analogs & derivatives
Taxoids therapeutic use
Subjects
Details
- Language :
- Hungarian
- ISSN :
- 0025-0244
- Volume :
- 47
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Magyar onkologia
- Publication Type :
- Academic Journal
- Accession number :
- 12975660
- Full Text :
- https://doi.org/HUON.2003.47.2.0141