Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial.
BACKGROUND: The optimal regimen for adjuvant breast cancer chemotherapy is undefined. We compared sequential to concurrent combination of doxorubicin and cyclophosphamide with docetaxel chemotherapy in women with node-positive non-metastatic breast cancer. We report the final, 10-year analysis of di...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Journal Article |
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Oxford University Press
2016
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| Online Access: | http://hdl.handle.net/20.500.11937/58543 |
| _version_ | 1848760286342807552 |
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| author | Mackey, J. Pienkowski, T. Crown, J. Sadeghi, S. Martin, M. Chan, Arlene Saleh, M. Sehdev, S. Provencher, L. Semiglazov, V. Press, M. Sauter, G. Lindsay, M. Houé, V. Buyse, M. Drevot, P. Hitier, S. Bensfia, S. Eiermann, W. Translational Research In Oncology (TRIO)/ Breast Cancer International Research Group (BCIRG)-005 in |
| author_facet | Mackey, J. Pienkowski, T. Crown, J. Sadeghi, S. Martin, M. Chan, Arlene Saleh, M. Sehdev, S. Provencher, L. Semiglazov, V. Press, M. Sauter, G. Lindsay, M. Houé, V. Buyse, M. Drevot, P. Hitier, S. Bensfia, S. Eiermann, W. Translational Research In Oncology (TRIO)/ Breast Cancer International Research Group (BCIRG)-005 in |
| author_sort | Mackey, J. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | BACKGROUND: The optimal regimen for adjuvant breast cancer chemotherapy is undefined. We compared sequential to concurrent combination of doxorubicin and cyclophosphamide with docetaxel chemotherapy in women with node-positive non-metastatic breast cancer. We report the final, 10-year analysis of disease-free survival (DFS), overall survival (OS), and long-term safety. PATIENTS AND METHODS: A total of 3298 women with HER2 nonamplified breast cancer were randomized to doxorubicin and cyclophosphamide every 3 weeks for four cycles followed by docetaxel (AC ? T) every 3 weeks for four cycles or docetaxel, doxorubicin, and cyclophosphamide (TAC) every 3 weeks for six cycles. The patients received standard radiotherapy and endocrine therapy and were followed up for 10 years with annual clinical evaluation and mammography. RESULTS: The 10-year DFS rates were 66.5% in the AC ? T arm and 66.3% in the TAC arm (P = 0.749). OS was 79.9% in the AC ? T arm and 78.9% in the TAC arm (P = 0.506). TAC was associated with higher rates of febrile neutropenia, although G-CSF primary prophylaxis greatly reduced this risk. AC ? T was associated with a higher rate of myalgia, hand-foot syndrome, fluid retention, and sensory neuropathy. CONCLUSION: This 10-year analysis of the BCIRG-005 trial confirmed that the efficacy of TAC was not superior to AC ? T in women with node-positive early breast cancer. The toxicity profiles differ between arms and were consistent with previous reports. The TAC regimen with G-CSF support provides shorter adjuvant treatment duration with less toxicity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00312208. |
| first_indexed | 2025-11-14T10:13:22Z |
| format | Journal Article |
| id | curtin-20.500.11937-58543 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| last_indexed | 2025-11-14T10:13:22Z |
| publishDate | 2016 |
| publisher | Oxford University Press |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-585432017-11-24T05:46:19Z Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial. Mackey, J. Pienkowski, T. Crown, J. Sadeghi, S. Martin, M. Chan, Arlene Saleh, M. Sehdev, S. Provencher, L. Semiglazov, V. Press, M. Sauter, G. Lindsay, M. Houé, V. Buyse, M. Drevot, P. Hitier, S. Bensfia, S. Eiermann, W. Translational Research In Oncology (TRIO)/ Breast Cancer International Research Group (BCIRG)-005 in BACKGROUND: The optimal regimen for adjuvant breast cancer chemotherapy is undefined. We compared sequential to concurrent combination of doxorubicin and cyclophosphamide with docetaxel chemotherapy in women with node-positive non-metastatic breast cancer. We report the final, 10-year analysis of disease-free survival (DFS), overall survival (OS), and long-term safety. PATIENTS AND METHODS: A total of 3298 women with HER2 nonamplified breast cancer were randomized to doxorubicin and cyclophosphamide every 3 weeks for four cycles followed by docetaxel (AC ? T) every 3 weeks for four cycles or docetaxel, doxorubicin, and cyclophosphamide (TAC) every 3 weeks for six cycles. The patients received standard radiotherapy and endocrine therapy and were followed up for 10 years with annual clinical evaluation and mammography. RESULTS: The 10-year DFS rates were 66.5% in the AC ? T arm and 66.3% in the TAC arm (P = 0.749). OS was 79.9% in the AC ? T arm and 78.9% in the TAC arm (P = 0.506). TAC was associated with higher rates of febrile neutropenia, although G-CSF primary prophylaxis greatly reduced this risk. AC ? T was associated with a higher rate of myalgia, hand-foot syndrome, fluid retention, and sensory neuropathy. CONCLUSION: This 10-year analysis of the BCIRG-005 trial confirmed that the efficacy of TAC was not superior to AC ? T in women with node-positive early breast cancer. The toxicity profiles differ between arms and were consistent with previous reports. The TAC regimen with G-CSF support provides shorter adjuvant treatment duration with less toxicity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00312208. 2016 Journal Article http://hdl.handle.net/20.500.11937/58543 10.1093/annonc/mdw098 Oxford University Press unknown |
| spellingShingle | Mackey, J. Pienkowski, T. Crown, J. Sadeghi, S. Martin, M. Chan, Arlene Saleh, M. Sehdev, S. Provencher, L. Semiglazov, V. Press, M. Sauter, G. Lindsay, M. Houé, V. Buyse, M. Drevot, P. Hitier, S. Bensfia, S. Eiermann, W. Translational Research In Oncology (TRIO)/ Breast Cancer International Research Group (BCIRG)-005 in Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial. |
| title | Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial. |
| title_full | Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial. |
| title_fullStr | Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial. |
| title_full_unstemmed | Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial. |
| title_short | Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial. |
| title_sort | long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: bcirg-005 randomized trial. |
| url | http://hdl.handle.net/20.500.11937/58543 |