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Bisphosphonates in Early Breast Cancer

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Bisphosphonates in Early Breast Cancer Bisphosphonates in early breast cancer A systematic literature review November 2011 Funded by the National Breast Cancer Foundation Bisphosphonates in early breast cancer: a systematic literature review was prepared and produced by: Cancer Australia Locked Bag 3 Strawberry Hills NSW 2012 Australia Tel: +61 2 9357 9400 Fax: +61 2 9357 9477 Website: www.canceraustralia.gov.au © Cancer Australia 2011 ISBN Online: 978-1-74127-168-3 Recommended citation Cancer Australia. Bisphosphonates in early breast cancer: a systematic literature review. Cancer Australia, Surry Hills, NSW, 2011. Copyright statements: Paper-based publications This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from Cancer Australia to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Publications and Copyright contact officer, Cancer Australia, Locked Bag 3, Strawberry Hills, NSW 2012. Internet sites This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from Cancer Australia to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Publications and Copyright contact officer, Cancer Australia, Locked Bag 3, Strawberry Hills, NSW 2012 Copies of Bisphosphonates in early breast cancer: a systematic literature review can be downloaded from the Cancer Australia website: www.canceraustralia.gov.au. Contents Acknowledgements .................................................................................................................... iv Executive summary ..................................................................................................................... 1 1 Background ..................................................................................................................... 2 1.1 Breast cancer in Australia ..................................................................................... 2 1.2 Bisphosphonates in early breast cancer ............................................................... 2 1.3 Clinical practice guidelines .................................................................................... 2 2 Methods ........................................................................................................................... 4 2.1 Criteria for determining study eligibility ................................................................. 4 2.2 Literature search methodology ............................................................................. 4 2.3 Assessment of study eligibility .............................................................................. 5 2.4 Included studies .................................................................................................... 6 2.5 Conference abstracts ............................................................................................ 9 2.6 Appraisal of included studies .............................................................................. 12 2.7 Data analysis ...................................................................................................... 14 3 Description of included studies ................................................................................... 15 3.1 Systematic reviews ............................................................................................. 15 3.2 Primary studies ................................................................................................... 17 4 Results of included studies ......................................................................................... 32 4.1 Disease-free survival, recurrence-free survival, and survival without bone metastasis ....................................................................................................................... 32 4.2 Mortality and overall survival ............................................................................... 34 4.3 Adverse events ................................................................................................... 37 4.4 Cancer recurrence and metastasis ..................................................................... 43 4.5 Quality of life ....................................................................................................... 49 4.6 Spinal bone mineral density (BMD) .................................................................... 49 4.7 Bone mineral density (BMD) at locations other than the spine ........................... 57 4.8 Osteopenia/osteoporosis .................................................................................... 68 4.9 Fracture occurrence ............................................................................................ 74 5 Clinical practice guidelines .......................................................................................... 79 5.1 European Society for Medical Oncology (ESMO) 2010 ...................................... 79 5.2 New Zealand Ministry of Health 2009 ................................................................. 79 5.3 UK Expert Group 2008 ....................................................................................... 80 Systematic review of bisphosphonates in early breast cancer i 6 Discussion ..................................................................................................................... 81 7 Conclusion .................................................................................................................... 83 Abbreviations ............................................................................................................................ 84 Appendix A Contributors ...................................................................................................... 89 Appendix B Literature search strategy ................................................................................ 90 Appendix C Conference abstract literature search ............................................................ 92 Appendix D Clinical practice guideline literature search ................................................... 93 ii Systematic review of bisphosphonates in early breast cancer Tables Table 1 Criteria for determining study eligibility ....................................................................... 4 Table 2 Exclusion criteria ......................................................................................................... 5 Table 3 Included and excluded citations .................................................................................. 6 Table 4 Included systematic reviews ....................................................................................... 6 Table 5 Included randomised controlled trials (RCTs) ............................................................. 7 Table 6 Characteristics of the identified conference abstracts describing unpublished RCTs ......................................................................................................................... 10 Table 7 NHMRC dimensions of evidence8 ............................................................................. 12 Table 8 NHMRC interim levels of evidence9 .......................................................................... 13 Table 9 Quality criteria for different levels of evidence9 ......................................................... 14 Table 10 Key characteristics of included RCTs ....................................................................... 19 Table 11 Disease-free survival, recurrence-free survival, and survival free of bone metastasis ................................................................................................................. 33 Table 12 Mortality and overall survival ..................................................................................... 36 Table 13 Adverse events ......................................................................................................... 40 Table 14 Cancer recurrence and metastasis ........................................................................... 46 Table 15 Spinal BMD ............................................................................................................... 52 Table 16 BMD at locations other than the spine .....................................................................
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