Adjuvant Docetaxel for Node-Positive Breast Cancer
- Study type
- Clinical trial
- Study name
- BCIRG 001
- Design
- Randomised trial with an active comparator (TAC versus FAC) as adjuvant chemotherapy after surgery
- Sample size
- 1491 women (745 patients in the TAC group and 746 in the FAC group)
- Source
- N Engl J Med · 2005
In plain words
In this study, two types of chemotherapy after surgery were compared in women with breast cancer that had reached the lymph nodes in the armpit. Women who received the drug combination containing docetaxel (TAC) were more likely than the other group (FAC) to be alive and free of the cancer coming back after 5 years. On the other hand, a severe drop in white blood cells with fever was more common in the TAC group. Quality of life fell during treatment but returned to its previous level after treatment ended.
Key results
Treatment arms and regimens
Docetaxel plus doxorubicin and cyclophosphamide, six cycles as adjuvant chemotherapy after surgery.
Docetaxel 75 mg/m² one hour after doxorubicin 50 mg/m² and cyclophosphamide 500 mg/m², IV every 3 weeks for 6 cycles.
Fluorouracil plus doxorubicin and cyclophosphamide, six cycles as adjuvant chemotherapy after surgery.
Doxorubicin 50 mg/m² followed by fluorouracil 500 mg/m² and cyclophosphamide 500 mg/m², IV every 3 weeks for 6 cycles.
Source of the regimen details: FDA label for docetaxel (DailyMed, section 14, study TAX316 = BCIRG 001)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Women with operable axillary node-positive breast cancer enrolled after surgery. Other inclusion criteria are not given in the abstract.
Endpoints
Primary endpoint: disease-free survival. Other endpoints reported in the abstract: overall survival, adverse events (neutropenia, febrile neutropenia, infection, congestive heart failure, acute myeloid leukaemia) and quality-of-life scores.
Safety and side effects
Grade 3 or 4 neutropenia: 65.5% in the TAC group versus 49.3% in the FAC group (P<0.001). Febrile neutropenia: 24.7% versus 2.5% (P<0.001). Grade 3 or 4 infection: 3.9% versus 2.2% (P=0.05), with no deaths from infection. Two patients in each group died during treatment. Congestive heart failure and acute myeloid leukaemia occurred in less than 2% of patients in each group. Quality-of-life scores fell during chemotherapy but returned to baseline after treatment.
Clinical significance and place in guidelines
This study showed that docetaxel (in the TAC regimen) in place of fluorouracil, compared with FAC, improves disease-free and overall survival in operable node-positive breast cancer, at the cost of more neutropenia and febrile neutropenia. The current status of this regimen in clinical guidelines and drug approvals should be checked separately, as the abstract does not mention them.
Limitations
The abstract does not mention the study's limitations. Median follow-up was 55 months and the results relate to this period. Febrile neutropenia was markedly more frequent in the TAC group. Dose details and inclusion criteria are given in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.