| Title |
Safety of zoledronic acid and incidence of osteonecrosis of the jaw (ONJ) during adjuvant therapy in a randomised phase III trial (AZURE: BIG 01–04) for women with stage II/III breast cancer
|
|---|---|
| Published in |
Breast Cancer Research and Treatment, March 2011
|
| DOI | 10.1007/s10549-011-1429-y |
| Pubmed ID | |
| Authors |
R. Coleman, E. Woodward, J. Brown, D. Cameron, R. Bell, D. Dodwell, M. Keane, M. Gil, C. Davies, R. Burkinshaw, S. J. Houston, R. J. Grieve, P. J. Barrett-Lee, H. Thorpe |
| Abstract |
The AZURE trial is an ongoing phase III, academic, multi-centre, randomised trial designed to evaluate the role of zoledronic acid (ZOL) in the adjuvant therapy of women with stage II/III breast cancer. Here, we report the safety and tolerability profile of ZOL in this setting. Eligible patients received (neo)adjuvant chemotherapy and/or endocrine therapy and were randomised to receive neither additional treatment nor intravenous ZOL 4 mg. ZOL was administered after each chemotherapy cycle to exploit potential sequence-dependent synergy. ZOL was continued for 60 months post-randomisation (six doses in the first 6 months, eight doses in the following 24 months and five doses in the final 30 months). Serious (SAE) and non-serious adverse event (AE) data generated during the first 36 months on study were analysed for the safety population. 3,360 patients were recruited to the AZURE trial. The safety population comprised 3,340 patients (ZOL 1,665; control 1,675). The addition of ZOL to standard treatment did not significantly impact on chemotherapy delivery. SAE were similar in both treatment arms. No significant safety differences were seen apart from the occurrence of osteonecrosis of the jaw (ONJ) in the ZOL group (11 confirmed cases; 0.7%; 95% confidence interval 0.3-1.1%). ZOL in the adjuvant setting is well tolerated, and can be safely administered in addition to adjuvant therapy including chemotherapy. The adverse events were consistent with the known safety profile of ZOL, with a low incidence of ONJ. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 112 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United Kingdom | 1 | <1% |
| Spain | 1 | <1% |
| Taiwan | 1 | <1% |
| Unknown | 109 | 97% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Bachelor | 15 | 13% |
| Student > Ph. D. Student | 14 | 13% |
| Researcher | 13 | 12% |
| Student > Postgraduate | 12 | 11% |
| Student > Master | 8 | 7% |
| Other | 23 | 21% |
| Unknown | 27 | 24% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 53 | 47% |
| Biochemistry, Genetics and Molecular Biology | 3 | 3% |
| Agricultural and Biological Sciences | 3 | 3% |
| Veterinary Science and Veterinary Medicine | 2 | 2% |
| Decision Sciences | 2 | 2% |
| Other | 12 | 11% |
| Unknown | 37 | 33% |
Attention Score in Context
This research output has an Altmetric Attention Score of 4. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 16 April 2015.
All research outputs
#6,940,716
of 22,757,090 outputs
Outputs from Breast Cancer Research and Treatment
#1,513
of 4,652 outputs
Outputs of similar age
#36,683
of 108,136 outputs
Outputs of similar age from Breast Cancer Research and Treatment
#25
of 56 outputs
Altmetric has tracked 22,757,090 research outputs across all sources so far. This one has received more attention than most of these and is in the 68th percentile.
So far Altmetric has tracked 4,652 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 7.2. This one has gotten more attention than average, scoring higher than 66% of its peers.
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We're also able to compare this research output to 56 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 55% of its contemporaries.