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Implementation Issues for Chemoprevention of Breast Cancer

This article discusses the challenges and obstacles in implementing chemoprevention strategies for breast cancer. It explores various prevention trials using tamoxifen and raloxifene, as well as the efficacy and potential side effects of these drugs. The article also highlights the importance of addressing the lack of approved prevention agents in Europe.

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Implementation Issues for Chemoprevention of Breast Cancer

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  1. Implementation Issues for Chemoprevention of Breast Cancer Jack Cuzick, Ph.D. Wolfson Institute of Preventive Medicine St Bartholomew’s Medical School London, United Kingdom

  2. World-wide Burden of Cancer in Women Incidence Mortality thousands GLOBOCAN 2002

  3. Breast Cancer Prevention Trials using Tamoxifen

  4. Tamoxifen Overview : ER Positive Invasive Breast Cancer Marsden P1 Italian IBIS All Tam Prev .1 .3 .52 1 1.5 Odds Ratio

  5. Outcome in 1000 women at high risk of breast cancer followed for 5 years Tamoxifen for 5 years No Treatment Breast Cancer 30 19 VTE 6 12 2 5 Endometrial Cancer

  6. Prevention Trialsusing Raloxifene

  7. ALL INVASIVE BREAST CANCERS, 0-10ySERM vs. placebo Tamoxifen vs. placebo Italian NSABP P1 IBIS1 Marsden Raloxifene vs. placebo MORE/CORE RUTH STAR Lasofoxifene vs. placebo PEARL 25 mg PEARL 50 mg Combined .1 .2 .5 1 2 5 10 Hazard ratio Fixed-effect model: -38.3% [-44.2%;-29.6%], p<0.001 Random-effect model: -39.3% [-51.1%;-24.7%], p<0.001 Test for heterogeneity: Q(8df) = 23.79, p=0.002

  8. Contralateral Tumours in Aromatase Inhibitor Trials ATAC BIG 1-98 ITA/ARNO/ABCSG IES MA-17 B-33 Combined .3 .5 1 1.5 Odds Ratio (log scale)

  9. New (Contralateral)Breast Primaries - AI adjuvant trials 100 90 80 47% EBCTCG 70 60 50 ? 75% 50% 40 30 20 ATAC 10 0 Anastrozole Tamoxifen Placebo

  10. MAP3 - Cumulative Incidence of Invasive Breast Cancer Goss et al NEJM, 2011

  11. PLACEBO IBIS II- PREVENTION STRATUM • High Risk Post-menopausal women, aged 40-70. • Placebo controlled 2-arm trial for high risk • 5 Year Treatment RANDOMISATION ANASTROZOLE 1mg n = 4,000 High Risk

  12. Implementation Issues • No agents licensed for prevention in Europe • Tamoxifen and Raloxifene approved in the US • Only manufacturer can apply for license • All drugs off patent protection

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