Chemoprevention of breast cancer: The Paradox of evidence versus advocacy inaction

Cancers

Volumn 4, Issue 4, 2012, Pages 1146-1160

  Rahman, Rakhshanda Layeequr ^a   Pruthi, Sandhya ^b  

^a TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER   (United States)

^b MAYO CLINIC   (United States)

Author keywords

Aromatase inhibitors; Chemoprevention; Exemestane; Raloxifene; SERMs; Tamoxifen

Indexed keywords

ACETYLSALICYLIC ACID; ANASTROZOLE; AROMATASE INHIBITOR; ARZOXIFENE; BISPHOSPHONIC ACID DERIVATIVE; COLECALCIFEROL; EXEMESTANE; FENRETINIDE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LAPATINIB; LASOFOXIFENE; LETROZOLE; MELATONIN; METFORMIN; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; RALOXIFENE; TAMOXIFEN; TIBOLONE;

ADJUVANT THERAPY; ARTHRITIS; BREAST CANCER; BREAST CARCINOMA; CANCER COMBINATION CHEMOTHERAPY; CANCER HORMONE THERAPY; CANCER PREVENTION; CANCER RISK; CLINICAL DECISION MAKING; CLINICAL EFFECTIVENESS; CLINICAL PRACTICE; DIARRHEA; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ENDOMETRIUM CANCER; EVIDENCE BASED MEDICINE; FATIGUE; GYNECOLOGIC DISEASE; HIGH RISK PATIENT; HOT FLUSH; HUMAN; INSOMNIA; INTRADUCTAL CARCINOMA; METASTASIS; NON INSULIN DEPENDENT DIABETES MELLITUS; OVARY POLYCYSTIC DISEASE; PATIENT ADVOCACY; PATIENT COUNSELING; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK REDUCTION; THROMBOEMBOLISM; VENOUS THROMBOEMBOLISM;

EID: 84871554058     PISSN: None     EISSN: 20726694     Source Type: Journal    
DOI: 10.3390/cancers4041146     Document Type: Review

References (72)

1. Fisher, B.; Costantino, J.P.; Wickerham, D.L.; Redmond, C.K.; Kavanah, M.; Cronin, W.M.; Vogel, V.; Robidoux, A.; Dimitrov, N.; Atkins, J. et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J. Natl. Cancer Inst. 1998, 90, 1371-1388.
2. DeSantis, C.; Howlader, N.; Cronin, K.A.; Jemal, A. Breast cancer incidence rates in U.S. women are no longer declining. Cancer Epidemiol. Biomarkers Prev. 2011, 20, 733-739.
3. DeSantis, C.; Siegel, R.; Bandi, P.; Jemal, A. Breast cancer statistics, 2011. CA Cancer J. Clin. 2011, 61, 409-418.
4. Cuzick, J.; Powles, T.; Veronesi, U.; Forbes, J.; Edwards, R.; Ashley, S.; Boyle, P. Overview of the main outcomes in breast-cancer prevention trials. Lancet 2003, 361, 296-300.
5. Visvanathan, K.; Chlebowski, R.T.; Hurley, P.; Col, N.F.; Ropka, M.; Collyar, D.; Morrow, M.; Runowicz, C.; Pritchard, K.I.; Hagerty, K. et al. American society of clinical oncology clinical practice guideline update on the use of pharmacologic interventions including tamoxifen, raloxifene, and aromatase inhibition for breast cancer risk reduction. J. Clin. Oncol. 2009, 27, 3235-3258.
6. U.S. Preventive Services Task Force. Chemoprevention of breast cancer: Recommendations and rationale. Ann. Intern. Med. 2002, 137, 56-58.
7. ACOG Committee. Tamoxifen and the prevention of breast cancer in high-risk women. Int. J. Gynaecol. Obstet. 2000, 68, 73-75.
8. National Comprehensive Cancer Network. NCCN breast cancer risk reduction guidelines. National Comprehensive Cancer Network Proceedings Oncology (Huntingt) 1999, 13, 47.
9. Port, E.R.; Montgomery, L.L.; Heerdt, A.S.; Borgen, P.I. Patient reluctance toward tamoxifen use for breast cancer primary prevention. Ann. Surg. Oncol. 2001, 8, 580-585.
10. Bastian, L.A.; Lipkus, I.M.; Kuchibhatla, M.N.; Weng, H.H.; Halabi, S.; Ryan, P.D.; Skinner, C.S.; Rimer, B.K. Women's interest in chemoprevention for breast cancer. Arch. Intern. Med. 2001, 161, 1639-1644.
11. Tchou, J.; Hou, N.; Rademaker, A.; Jordan, V.C.; Morrow, M. Acceptance of tamoxifen chemoprevention by physicians and women at risk. Cancer 2004, 100, 1800-1806.
12. Melnikow, J.; Paterniti, D.; Azari, R.; Kuenneth, C.; Birch, S.; Kuppermann, M.; Nuovo, J.; Keyzer, J.; Henderson, S. Preferences of Women Evaluating Risks of Tamoxifen (POWER) study of preferences for tamoxifen for breast cancer risk reduction. Cancer 2005, 103, 1996-2005.
13. Beatson, G. On the treatment of inoperable cases of carcinoma of the mamma. Suggestions for a new method of treatment with illustrative cases. Lancet 1896, 2, 104-107.
14. Obiorah, I.; Jordan, V.C. Progress in endocrine approaches to the treatment and prevention of breast cancer. Maturitas 2011, 70, 315-321.
15. Powles, T.J.; Ashley, S.; Tidy, A.; Smith, I.E.; Dowsett, M. Twenty-year follow-up of the Royal Marsden randomized, double-blinded tamoxifen breast cancer prevention trial. J. Natl. Cancer Inst. 2007, 99, 283-290.
16. Fisher, B.; Costantino, J.P.; Wickerham, D.L.; Cecchini, R.S.; Cronin, W.M.; Robidoux, A.; Bevers, T.B.; Kavanah, M.T.; Atkins, J.N.; Margolese, R.G. et al. Tamoxifen for the prevention of breast cancer: Current status of the National Surgical Adjuvant Breast and Bowel Project P-1 study. J. Natl. Cancer Inst. 2005, 97, 1652-1662.
17. Veronesi, U.; Maisonneuve, P.; Rotmensz, N.; Bonanni, B.; Boyle, P.; Viale, G.; Costa, A.; Sacchini, V.; Travaglini, R.; D'Aiuto, G. et al. Tamoxifen for the prevention of breast cancer: Late results of the Italian Randomized Tamoxifen Prevention Trial among women with hysterectomy. J. Natl. Cancer Inst. 2007, 99, 727-737.
18. Cuzick, J.; Forbes, J.F.; Sestak, I.; Cawthorn, S.; Hamed, H.; Holli, K.; Howell, A. Long-term results of tamoxifen prophylaxis for breast cancer-96-month follow-up of the randomized IBIS-I trial. J. Natl. Cancer Inst. 2007, 99, 272-282.
19. Cuzick, J. Use of selective estrogen receptor modulators in the prevention of breast cancer: An overview of the randomized trials. Cancer Res. 2009, doi:10.1158/0008-5472.SABCS-09-905.
20. Decensi, A.; Gandini, S.; Serrano, D.; Cazzaniga, M.; Pizzamiglio, M.; Maffini, F.; Pelosi, G.; Daldoss, C.; Omodei, U.; Johansson, H. et al. Randomized dose-ranging trial of tamoxifen at low doses in hormone replacement therapy users. J. Clin. Oncol. 2007, 25, 4201-4209.
21. Decensi, A.; Robertson, C.; Viale, G.; Pigatto, F.; Johansson, H.; Kisanga, E.R.; Veronesi, P.; Torrisi, R.; Cazzaniga, M.; Mora, S. et al. A randomized trial of low-dose tamoxifen on breast cancer proliferation and blood estrogenic biomarkers. J. Natl. Cancer Inst. 2003, 95, 779-790.
22. Lewis-Wambi, J.; Jordan, V. Case Histories: Raloxifene. In Comprehensive Medicinal Chemistry II; Taylor, J., Triggle, D., Eds.; Elsevier Limited: Oxford, UK, 2006; Volume 8, pp. 103-121.
23. Martino, S.; Cauley, J.A.; Barrett-Connor, E.; Powles, T.J.; Mershon, J.; Disch, D.; Secrest, R.J.; Cummings, S.R. Continuing outcomes relevant to Evista: Breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene. J. Natl. Cancer Inst. 2004, 96, 1751-1761.
24. Barrett-Connor, E.; Mosca, L.; Collins, P.; Geiger, M.J.; Grady, D.; Kornitzer, M.; McNabb, M.A.; Wenger, N.K.; Raloxifene Use for The Heart (RUTH) Trial Investigators. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N. Engl. J. Med. 2006, 355, 125-137.
25. Vogel, V.G.; Costantino, J.P.; Wickerham, D.L.; Cronin, W.M.; Cecchini, R.S.; Atkins, J.N.; Bevers, T.B.; Fehrenbacher, L.; Pajon, E.R.; Wade, J.L., 3rd; et al. Update of the National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene (STAR) P-2 Trial: Preventing Breast Cancer. Cancer Prev. Res. 2010, 3, 696-706.
26. Cauley, J.A.; Norton, L.; Lippman, M.E.; Eckert, S.; Krueger, K.A.; Purdie, D.W.; Farrerons, J.; Karasik, A.; Mellstrom, D.; Ng, K.W. et al. Continued breast cancer risk reduction in postmenopausal women treated with raloxifene: 4-Year results from the MORE trial. Multiple outcomes of raloxifene evaluation. Breast Cancer Res. Treat. 2001, 65, 125-134.
27. LaCroix, A.Z.; Powles, T.; Osborne, C.K.; Wolter, K.; Thompson, J.R.; Thompson, D.D.; Allred, D.C.; Armstrong, R.; Cummings, S.R.; Eastell, R. et al. PEARL Investigators, Breast cancer incidence in the randomized PEARL trial of lasofoxifene in postmenopausal osteoporotic women. J. Natl. Cancer Inst. 2010, 102, 1706-1715.
28. Cummings, S.R.; McClung, M.; Reginster, J.Y.; Cox, D.; Mitlak, B.; Stock, J.; Amewou-Atisso, M.; Powles, T.; Miller, P.; Zanchetta, J. et al. Arzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women. J. Bone Miner. Res. 2011, 26, 397-404.
29. Coombes, R.C.; Hall, E.; Gibson, L.J.; Paridaens, R.; Jassem, J.; Delozier, T.; Jones, S.E.; Alvarez, I.; Bertelli, G.; Ortmann, O. et al. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N. Engl. J. Med. 2004, 350, 1081-1092.
30. Baum, M.; Buzdar, A.; Cuzick, J.; Forbes, J.; Houghton, J.; Howell, A.; Sahmoud, T. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early-stage breast cancer: Results of the ATAC (Arimidex, Tamoxifen Alone or in Combination) trial efficacy and safety update analyses. Cancer 2003, 98, 1802-1810.
31. Cuzick, J. Chemoprevention of breast cancer. Breast Cancer 2008, 15, 10-16.
32. Cuzick, J. Aromatase inhibitors for breast cancer prevention. J. Clin. Oncol. 2005, 23, 1636-1643.
33. Richardson, H.; Johnston, D.; Pater, J.; Goss, P. The National Cancer Institute of Canada Clinical Trials Group MAP3 trial: An international breast cancer prevention trial. Curr. Oncol. 2007, 14, 89-96.
34. Goss, P.E.; Ingle, J.N.; Ales-Martinez, J.E.; Cheung, A.M.; Chlebowski, R.T.; Wactawski-Wende, J.; McTiernan, A.; Robbins, J.; Johnson, K.C.; Martin, L.W. et al. Exemestane for breast-cancer prevention in postmenopausal women. N. Engl. J. Med. 2011, 364, 2381-2391.
35. Pujol, P. Letrozole in Preventing Breast Cancer in Postmenopausal Women With a BRCA1 or BRCA2 Mutation (LIBER); Clinical Trials Identifier NCT00673335. Available online: http://clinicaltrials.gov/ct2/show/NCT00673335/(accessed on 22 June 2012).
36. Lopez, A.M. Letrozole in Treating Healthy Postmenopausal Women at High Risk for Breast Cancer; Clinical Trials Identifier NCT01077453. Available online: http://clinicaltrials.gov/ct2/show/NCT01077453/ (accessed on 22 June 2012).
37. Veronesi, U.; Mariani, L.; Decensi, A.; Formelli, F.; Camerini, T.; Miceli, R.; di Mauro, M.G.; Costa, A.; Marubini, E.; Sporn, M.B. et al. Fifteen-year results of a randomized phase III trial of fenretinide to prevent second breast cancer. Ann. Oncol. 2006, 17, 1065-1071.
38. Rennert, G.; Pinchev, M.; Rennert, H.S. Use of bisphosphonates and risk of postmenopausal breast cancer. J. Clin. Oncol. 2010, 28, 3577-3581.
39. Chlebowski, R.T.; Chen, Z.; Cauley, J.A.; Anderson, G.; Rodabough, R.J.; McTiernan, A.; Lane, D.S.; Manson, J.E.; Snetselaar, L.; Yasmeen, S. et al. Oral bisphosphonate use and breast cancer incidence in postmenopausal women. J. Clin. Oncol. 2010, 28, 3582-3590.
40. Bodmer, M.; Meier, C.; Krahenbuhl, S.; Jick, S.S.; Meier, C.R. Long-term metformin use is associated with decreased risk of breast cancer. Diabetes Care 2010, 33, 1304-1308.
41. Bosco, J.L.; Antonsen, S.; Sorensen, H.T.; Pedersen, L.; Lash, T.L. Metformin and incident breast cancer among diabetic women: A population-based case-control study in Denmark. Cancer Epidemiol. Biomarkers Prev. 2011, 20, 101-111.
42. Cummings, S.R.; Ettinger, B.; Delmas, P.D.; Kenemans, P.; Stathopoulos, V.; Verweij, P.; Mol-Arts, M.; Kloosterboer, L.; Mosca, L.; Christiansen, C. et al. The effects of tibolone in older postmenopausal women. N. Engl. J. Med. 2008, 359, 697-708.
43. Browning, D.R.; Martin, R.M. Statins and risk of cancer: A systematic review and metaanalysis. Int. J. Cancer 2007, 120, 833-843.
44. Bonovas, S.; Filioussi, K.; Tsavaris, N.; Sitaras, N.M. Use of statins and breast cancer: A meta-analysis of seven randomized clinical trials and nine observational studies. J. Clin. Oncol. 2005, 23, 8606-8612.
45. Baigent, C.; Keech, A.; Kearney, P.M.; Blackwell, L.; Buck, G.; Pollicino, C.; Kirby, A.; Sourjina, T.; Peto, R.; Collins, R. et al. Efficacy and safety of cholesterol-lowering treatment: Prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005, 366, 1267-1278.
46. Dale, K.M.; Coleman, C.I.; Henyan, N.N.; Kluger, J.; White, C.M. Statins and cancer risk: A meta-analysis. JAMA 2006, 295, 74-80.
47. Zhao, Y.S.; Zhu, S.; Li, X.W.; Wang, F.; Hu, F.L.; Li, D.D.; Zhang, W.C.; Li, X. Association between NSAIDs use and breast cancer risk: A systematic review and meta-analysis. Breast Cancer Res. Treat. 2009, 117, 141-150.
48. Bundred, N.J.; Campbell, I.D.; Davidson, N.; DeBoer, R.H.; Eidtmann, H.; Monnier, A.; Neven, P.; von Minckwitz, G.; Miller, J.C.; Schenk, N.L. et al. Effective inhibition of aromatase inhibitor-associated bone loss by zoledronic acid in postmenopausal women with early breast cancer receiving adjuvant letrozole: ZO-FAST Study results. Cancer 2008, 112, 1001-1010.
49. Gnant, M.; Mlineritsch, B.; Schippinger, W.; Luschin-Ebengreuth, G.; Postlberger, S.; Menzel, C.; Jakesz, R.; Seifert, M.; Hubalek, M.; Bjelic-Radisic, V. et al. Endocrine therapy plus zoledronic acid in premenopausal breast cancer. N. Engl. J. Med. 2009, 360, 679-691.
50. Anisimov, V.N.; Egormin, P.A.; Piskunova, T.S.; Popovich, I.G.; Tyndyk, M.L.; Yurova, M.N.; Zabezhinski, M.A.; Anikin, I.V.; Karkach, A.S.; Romanyukha, A.A. Metformin extends life span of HER-2/neu transgenic mice and in combination with melatonin inhibits growth of transplantable tumors in vivo. Cell Cycle 2010, 9, 188-197.
51. Javling, M.; Gietema, J.A.; Lefrandt, J.D.; de Jong, S.; Reyners, A.K.; Gans, R.O.; de Vries, E.G. Metformin: Taking away the candy for cancer? Eur. J. Cancer 2010, 46, 2369-2380.
52. Guppy, A.; Jamal-Hanjani, M.; Pickering, L. Anticancer effects of metformin and its potential use as a therapeutic agent for breast cancer. Future Oncol. 2011, 7, 727-736.
53. Half, E.; Tang, X.M.; Gwyn, K.; Sahin, A.; Wathen, K.; Sinicrope, F.A. Cyclooxygenase-2 expression in human breast cancers and adjacent ductal carcinoma in situ. Cancer Res. 2002, 62, 1676-1681.
54. Beral, V.; Million Women Study Collaborators. Breast cancer and hormone-replacement therapy in the Million Women Study. Lancet 2003, 362, 419-427.
55. Decensi, A.; Robertson, C.; Guerrieri-Gonzaga, A.; Serrano, D.; Cazzaniga, M.; Mora, S.; Gulisano, M.; Johansson, H.; Galimberti, V.; Cassano, E. et al. Randomized double-blind 2 × 2 trial of low-dose tamoxifen and fenretinide for breast cancer prevention in high-risk premenopausal women. J. Clin. Oncol. 2009, 27, 3749-3756.
56. Howe, L.R.; Brown, P.H. Targeting the HER/EGFR/ErbB family to prevent breast cancer. Cancer Prev. Res. 2011, 4, 1149-1157.
57. Proietti, S.; Cucina, A.; D'Anselmi, F.; Dinicola, S.; Pasqualato, A.; Lisi, E.; Bizzarri, M. Melatonin and vitamin D3 synergistically down-regulate Akt and MDM leading to TGFβ-1- dependent growth inhibition of breast cancer cells. J. Pineal. Res. 2011, 50, 150-158.
58. Freedman, A.N.; Graubard, B.I.; Rao, S.R.; McCaskill-Stevens, W.; Ballard-Barbash, R.; Gail, M.H. Estimates of the number of U.S. women who could benefit from tamoxifen for breast cancer chemoprevention. J. Natl. Cancer Inst. 2003, 95, 526-532.
59. Fagerlin, A.; Dillard, A.J.; Smith, D.M.; Zikmund-Fisher, B.J.; Pitsch, R.; McClure, J.B.; Greene, S.; Alford, SH.; Nair, V.; Hayes, DF. et al. Women's interest in taking tamoxifen and raloxifene for breast cancer prevention: Response to a tailored decision aid. Breast Cancer Res. Treat. 2011, 127, 681-688.
60. Heisy, R.; Pimlott, N.; Clemons, M.; Cummings, S.; Drummond, N. Women's views on chemoprevention of breast cancer: Qualitative study. Can. Fam. Physician 2006, 52, 624-625.
61. Taylor, R.; Taguchi, K. Tamoxifen for breast cancer chemoprevention: Low uptake by high-risk women after evaluation of a breast lump. Ann. Fam. Med. 2005, 3, 242-247.
62. Gail, M.H.; Costantino, J.P.; Bryant, J.; Croyle, R.; Freedman, L.; Helzlsouer, K.; Vogel, V. Weighing the risks and benefits of tamoxifen treatment for preventing breast cancer. J. Natl. Cancer Inst. 1999, 91, 1829-1846.
63. Layeequr Rahman, R.; Crawford, S. Chemoprevention Indication Score: A user-friendly tool for prevention of breast cancer-Pilot analysis. Breast 2009, 18, 289-293.
64. Freedman, A.N.; Yu, B.; Gail, M.H.; Costantino, J.P.; Graubard, B.I.; Vogel, V.G.; Anderson, G.L.; McCaskill-Stevens, W. Benefit/risk assessment for breast cancer chemoprevention with raloxifene or tamoxifen for women age 50 years or older. J. Clin. Oncol. 2011, 29, 2327-2333.
65. Boyd, N.F.; Guo, H.; Martin, L.J.; Sun, L.; Stone, J.; Fishell, E.; Jong, R.A.; Hislop, G.; Chiarelli, A.; Minkin, S. et al. Mammographic density and the risk and detection of breast cancer. N. Engl. J. Med. 2007, 356, 227-236.
66. Cuzick, J.; Warwick, J.; Pinney, E.; Duffy, S.W.; Cawthorn, S.; Howell, A.; Forbes, J.F.; Warren, R.M. Tamoxifen-induced reduction in mammographic density and breast cancer risk reduction: A nested case-control study. J. Natl. Cancer Inst. 2011, 103, 744-752.
67. Waters, E.A.; Cronin, K.A.; Graubard, B.I.; Han, P.K.; Freedman, A.N. Prevalence of tamoxifen use for breast cancer chemoprevention among U.S. women. Cancer Epidemiol. Biomarkers Prev. 2010, 19, 443-446.
68. Hershman, D.L.; Kushi, L.H.; Shao, T.; Buono, D.; Kershenbaum, A.; Tsai, W.Y.; Fehrenbacher, L.; Gomez, S.L.; Miles, S.; Neugut, A.I. Early discontinuation and non adherence to adjuvant hormonal therapy in a cohort of 8,769 early-stage breast cancer patients. 2010, 28, 1420-1428.
69. Position Staement on Chemoprevention, updated June 2011. Available online: http://www.breastcancerdeadline2020.org/(accessed on 22 September 2012).
70. Chemoprevention of Breast Cancer-Recommendations and rationale. Available online: http://www.uspreventiveservicestaskforce.org/3rduspstf/breastchemo/breastchemorr.htm/ (accessed on 22 September 2012).
71. Cuzick, J.; DeCensi, A.; Arun, B.; Brown, P.H.; Castiglione, M.; Dunn, D.; Forbes, J.F.; Glaus, A.; Howell, A.; von Minckwitz, F. et al. Preventive therapy for breast cancer: A consensus statement. Lancet Oncol. 2011, 12, 496-503.
72. Schmidt, C. The Breast Cancer Chemoprevention Debate. J. Natl. Cancer Inst. 2011, 103, 1646-1647.