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The Evidence Base for the Treatment of Breast Cancer - The Cochrane Network

The Evidence Base for the Treatment of Breast Cancer - The Cochrane Network. Mark Lodge, Cochrane Cancer Network, Wolfson College, University of Oxford, Oxford UK mlodge@canet.org. Vannevar Bush US Director, Office of Scientific R & D. 1945.

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The Evidence Base for the Treatment of Breast Cancer - The Cochrane Network

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  1. The Evidence Base for the Treatment of Breast Cancer - The Cochrane Network Mark Lodge, Cochrane Cancer Network, Wolfson College, University of Oxford, Oxford UK mlodge@canet.org Annual Meeting 2005

  2. Vannevar BushUS Director, Office of Scientific R & D. 1945 “A record if it is to be useful to Science, must be continuously extended, it must be stored, and above all it must be consulted.” Bush V As We May Think Atlantic Monthly July 1945

  3. Archie CochraneUK epidemiologist, 1979 • "It is surely a great criticism of our profession that we have not organised a critical summary, by specialty or subspecialty, adapted periodically, of all relevant randomised controlled trials." • Cochrane AL. 1931-1971: a critical review, with particular reference to the medical profession. In: Medicines for the year 2000. London: Office of Health Economics, 1979, 1-11.

  4. The Evidence Base for the Treatment of Breast Cancer • Who prepared the evidence? • Is the evidence from a reliable source? • What level of evidence is it? • What does it say? • Is the evidence relevant?

  5. Who prepared the evidence? The Cochrane Collaboration is an international not-for-profit organization that aims to help people make well-informed decisions about health care by preparing, maintaining, and promoting the accessibility of systematic reviews of the effects of healthcare interventions.

  6. Definition: Systematic Review • A review of a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant research, and to collect and analyse data from the studies that are included in the review. • Statistical methods (meta-analysis) may or may not be used to analyse and summarise the results of the included studies. • (Source: Cochrane Reviewers' Handbook 2005)

  7. The Cochrane Collaboration • 90 independently financed bases worldwide • 11,000 + contributors • 50 Cochrane Review Groups (CRGs) • Multi-national, multi-disciplinary editorial teams • Developing country involvement encouraged • Cochrane Breast Cancer Review Group (Sydney, Australia)

  8. What use can be made of systematic reviews? Categories • There is evidence of effectiveness • Insufficient or no evidence of effectiveness (More research?) • Evidence of no effectiveness • Harmful to patients

  9. What use can be made of systematic reviews? • Clinical practice • determine the effects & effectiveness of health care interventions • Used by individual clinicians • very useful to guideline developers.

  10. What use can be made systematic reviews? • Clinical research • Establish baseline of knowledge • Identify gaps in research • Prevent wasteful duplication of effort • Identify adverse effects of interventions • Identify methodological difficulties • Protect patients from unnecessary or inappropriate research

  11. Is the evidence from a reliable source? • Cochrane systematic reviews designed to minimise bias • Transparent methodology • Explicit inclusion/exclusion criteria • Extensive literature searches • Peer reviewed protocols and reviews • Published protocols on Cochrane Library

  12. What level of evidence is it? • Breast cancer treatment: 14 systematic reviews • Primarily based on evidence from randomized controlled trials (RCTs) • 4,898 reports of RCTs in breast cancer (SR-BREASTCA) in CENTRAL database on The Cochrane Library

  13. Evidence of effectiveness • Polychemotherapy can reduce the number of deaths from breast cancer, as well as recurrences, especially in women under 50 • Early Breast Cancer Trialists' Collaborative Group. Multi-agent chemotherapy for early breast cancer. The Cochrane Database of Systematic Reviews 2001, Issue 4 • Hormone therapy and chemotherapy improve survival of women with metastatic breast cancer, but hormone therapy may have fewer side-effects • Wilcken N, Hornbuckle J, Ghersi D. Chemotherapy alone versus endocrine therapy alone for metastatic breast cancer. The Cochrane Database of Systematic Reviews 2003, Issue 2.

  14. Evidence of effectiveness • Tamoxifen can increase 10-year survival rates for women with ER-positive breast cancers • Early Breast Cancer Trialists' Collaborative Group. Tamoxifen for early breast cancer. The Cochrane Database of Systematic Reviews 2001, Issue 1. • “Decision making in breast cancer: Making the best of the evidence” • 25 October 2005 Melbourne Australia

  15. Insufficient or no evidence of effectiveness • Chemotherapy including taxane could improve survival and disease progression in women with advanced breast cancer, but more research is needed on which regimens help most. • Ghersi D, Wilcken N, Simes J, Donoghue E. Taxane containing regimens for metastatic breast cancer. The Cochrane Database of Systematic Reviews 2005, Issue 2. • There is insufficient evidence to support the routine use of high dose chemotherapy with autograft for women with early poor prognosis breast cancer. • Farquhar C, Marjoribanks J, Basser R, Lethaby A. High dose chemotherapy and autologous bone marrow or stem cell transplantation versus conventional chemotherapy for women with early poor prognosis breast cancer. The Cochrane Database of Systematic Reviews 2005, Issue 3 • There is currently insufficient evidence to show that women with metastatic breast cancer live longer if they undergo high dose chemotherapy with bone marrow or peripheral stem cell transplantation • Farquhar C, Marjoribanks J, Basser R, Hetrick S, Lethaby A. High dose chemotherapy and autologous bone marrow or stem cell transplantation versus conventional chemotherapy for women with metastatic breast cancer.

  16. Insufficient or no evidence of effectiveness • There is insufficient evidence to determine the relative efficacy of non-anthracycline anti-tumour antibiotic regimens compared to non-antitumour antibiotics. • Lord S, Ghersi D, Gattellari M, Wortley S, Wilcken N, Simes J. Antitumour antibiotic containing regimens for metastatic breast cancer. The Cochrane Database of Systematic Reviews 2004, Issue 4. • Systemic therapy for treating locoregional recurrence in women with breast cancer… insufficient evidence to do other than conclude that the most appropriate form of practice might be participation in RCTs of systemic treatment versus observation. • Rauschecker H, Clarke M, Gatzemeier W, Recht A. Systemic therapy for treating locoregional recurrence in women with breast cancer. The Cochrane Database of Systematic Reviews 2001, Issue 4

  17. Evidence of no effectiveness • Regimens that contain antitumour antibiotics do not offer any additional benefit in overall survival over regimens that do not contain these agents in the first-line management of metastatic breast cancer. • Lord S, Ghersi D, Gattellari M, Wortley S, Wilcken N, Simes J. Antitumour antibiotic containing regimens for metastatic breast cancer. The Cochrane Database of Systematic Reviews 2004, Issue 4. • No strong evidence has been found that support groups can increase survival from advanced breast cancer, or that this and other psychological interventions can improve psychological wellbeing • Edwards AGK, Hailey S, Maxwell M. Psychological interventions for women with metastatic breast cancer. The Cochrane Database of Systematic Reviews 2004, Issue 2.

  18. Forthcoming Cochrane reviews • Pre-operative care • Sequencing • Chemotherapy for locally advanced breast cancer • Single agent chemotherapy for advanced breast cancer • Multi-agent chemotherapy for advanced breast cancer (3) • Endocrine therapy (2) • Radiotherapy (2) • Surgery (2) • Control of treatment side effects (2)

  19. Is the evidence relevant? • Relevance to current treatment options • Appropriate to Developing Country setting? • Reflect the priorities? • Reflect the realities?

  20. Review Authors AUSTRALIA: 14 DENMARK:3 GERMANY: 2 ITALY: 11 NEW ZEALAND: 6 SPAIN 5 UK: 9 USA: 5 Protocol Authors AUSTRALIA: 18 CANADA 9 CHILE: 7 CHINA: 14 GERMANY: 3 ITALY2 NEW ZEALAND: 6 NETHERLANDS: 3 SINGAPORE: 3 SPAIN: 6 SWITZERLAND1 UK: 15 USA: 13 Where is the evidence coming from?

  21. Cochrane Developing Countries Initiative • Human Reproduction Library (WHO) • Evidence Aid • South Asia Cochrane Network • Base: Christian Medical College, Vellore TN, India • Cancer hub: Tata Memorial Hospital, Mumbai, India

  22. Cochrane Developing Countries Initiative • Cochrane Branch Centre in Bahrain • Cancer meeting in 2006? • Cochrane bases : Argentina, Brazil, Chile, Colombia, Costa Rica, Cuba, Ecuador, Mexico, Peru, Venezuela, China , Russia, South Africa, Thailand,

  23. Cochrane/INCTR collboration • Draw up a short list of three questions relevant to the effectiveness of health care interventions in breast cancer   • Send shortlists to mlodge@canet.org • Referred to Cochrane Breast cancer Group •  Invitation to prepare & maintain a Cochrane systematic review

  24. Contributing to the evidence-base in cancer research & treatment • The Cochrane Library • http://www.cochrane.org • The Cochrane Cancer Network • mlodge@canet.org • Cochrane Breast Cancer Review Group • http://www.ctc.usyd.edu.au/cochrane • Breast Cancer Forum (25 Oct. 2005) • http://www.ctc.usyd.edu.au/cochrane/index.html

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