Abstract | BACKGROUND: METHODS: Disease-free survival (DFS; secondary end point) and overall survival (OS; tertiary end point) were evaluated in 119 women with stage II/III BC randomised to intravenous ZOL 4 mg every 3 weeks for 1 year or no ZOL (control) starting with the first chemotherapy cycle. RESULTS: At 61.9 months' median follow-up, there was no significant difference in recurrence or survival between study arms. However, time to recurrence or death (DFS) was significantly different between subgroups defined by oestrogen receptor (ER) status (interaction P=0.010 for DFS and 0.025 for OS). Hazard ratios (HRs) for disease recurrence and death were significantly less among patients with ER-negative (ER(-)) tumours who received ZOL vs no ZOL (DFS: HR=0.361, 95% confidence interval (CI) 0.148, 0.880; OS: HR=0.375, 95% CI 0.143, 0.985). CONCLUSION: ZOL administered with chemotherapy may improve DFS and OS in a subset of BC patients with ER(-) tumours. This study was not powered to compare subgroups of patients; thus, these findings should be considered hypothesis generating.
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Authors | R L Aft, M Naughton, K Trinkaus, K Weilbaecher |
Journal | British journal of cancer
(Br J Cancer)
Vol. 107
Issue 1
Pg. 7-11
(Jun 26 2012)
ISSN: 1532-1827 [Electronic] England |
PMID | 22617128
(Publication Type: Clinical Trial, Phase I, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Bone Density Conservation Agents
- Diphosphonates
- Imidazoles
- Receptors, Estrogen
- Zoledronic Acid
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Topics |
- Aged
- Bone Density Conservation Agents
(administration & dosage)
- Breast Neoplasms
(drug therapy, mortality, pathology)
- Chemotherapy, Adjuvant
- Diphosphonates
(administration & dosage)
- Disease-Free Survival
- Female
- Humans
- Imidazoles
(administration & dosage)
- Middle Aged
- Neoadjuvant Therapy
- Neoplasms, Hormone-Dependent
(drug therapy, mortality)
- Receptors, Estrogen
(metabolism)
- Zoledronic Acid
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