The Breast
Volume 19, Issue 2 , Pages 76-83 , April 2010

Aromatase inhibitors versus tamoxifen as adjuvant hormonal therapy for oestrogen sensitive early breast cancer in post-menopausal women: Meta-analyses of monotherapy, sequenced therapy and extended therapy

Received 10 June 2009 ,Revised 21 December 2009 ,Accepted 22 December 2009.

References 

  1. National Institute for Health and Clinical Excellence . NICE technology appraisal guidance 112. Hormonal therapies for the adjuvant treatment of early oestrogen-receptor-positive breast cancer. National Institute for Health and Clinical Excellence; 2006;
  2. Nadji M, Gomez-Fernandez C, Ganjei-Azar P, Morales A. Immunohistochemistry of estrogen and progesterone receptors considered: experience with 5,993 breast cancers. Am J Clin Pathol. 1998;123:21–27
  3. Osborne CK. Tamoxifen in the treatment of breast cancer. N Engl J Med. 1998;33:1609–1618
  4. Early Breast Cancer Trialists' Collaborative Group. Tamoxifen for early breast cancer: an overview of the randomised trials. Lancet. 1998;351:1451–1467
  5. Love RR, Barden HS, MAzess RB, Epstein S, Chappell RJ. Effect of tamoxifen on lumbar spine mineral density in postmenopausal women after 5 years. Arch Intern Med. 1994;154:2585–2588
  6. McDonald CC, Alexander FE, Whyte BW, Forrest AP, Stewart HJ. Cardiac and vascular morbidity in women receiving adjuvant tamoxifen for breast cancer in a randomised trial. BMJ. 1995;311:977–980
  7. The American College of Obstetricians and Gynaecologists . Tamoxifen and endometrial cancer. Obstet Gynecol. 2000;95:1C–3C
  8. Clarke R, Skaar TC, Bouker KB, Davis N, Lee YR, Welch JN, et al. Molecular and pharmacological aspects of antiestrogen resistance. J Steroid Biochem Mol Biol. 2001;76:71–84
  9. Brewster AM, Hortobagyi GN, Broglio KR, Kau SW, Santa-Maria CA, Arun B, et al. Residual risk of breast cancer recurrence 5 years after adjuvant therapy. J Natl Cancer Inst. 2008;100:1179–1183
  10. Saphner T, Torney DC, Gray R. Annual hazard rates of recurrence for breast cancer after primary therapy. J Clin Oncol. 1996;14:2738–2746
  11. Early Breast Cancer Trialist's Collaborative Group. Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005;365:1687–1717
  12. Barron TI, Roisin C, Bennet K, Feely J, Kennedy MJ. Early discontinuation of tamoxifen. Cancer. 2007;109:1–9
  13. Miller WR, Bartletta J, Brodeib AM, Brueggemeier RW, di Salle E, Lønning PE, et al. Aromatase inhibitors: are there differences between steroidal and nonsteroidal aromatase inhibitors and do they matter?. Oncologist. 2008;13:829–837
  14. Monnier A. Effects of adjuvant aromatase inhibitor therapy on lipid profiles. Expert Rev Anticancer Ther. 2006;6:1653–1662
  15. Berry J. Are all Aromatase Inhibitors the same? a review of controlled clinical trials in breast cancer. Clin Ther. 2005;27:1671–1684
  16. Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J, Delozier T, et al. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. [see comment] [erratum appears in N Engl J Med. 2004 Dec 2;351(23):2461 N Engl J Med. 2004;350:1081–1092
  17. Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, et al. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med. 2003;349:1793–1802
  18. Breast International Group (BIG) 1-98 Collaborative Group , Thürlimann B, Keshaviah A, Coates AS, Mouridsen H, Mauriac L, et al. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med. 2005;353:2747–2757
  19. Baum M, Budzar AU, Cuzick J, Forbes J, Houghton JH, Klijn JG, et al. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet. 2002;359:2131–2139
  20. Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, et al. Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17. J Natl Cancer Inst. 2005;97:1262–1271
  21. Jonat W, Gnant M, Boccardo F. Effectiveness of switching from adjuvant tamoxifen to anastrozole in postmenopausal women with hormone-sensitive early-stage breast cancer: a meta-analysis. Lancet Oncol. 2006;7:991–996
  22. Jakesz R, Gnant M, Griel R. Tamoxifen and anastrozole as a sequencing strategy in postmenopausal women with hormone-responsive early breast cancer: updated data from the Austrian breast and colorectal cancer study group trial 8. Cancer Res. 2009;69:67
  23. Winer EP, Hudis C, Burstein HJ, Wolff AC, Pritchard KI, Ingle JN, et al. American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for postmenopausal women with hormone receptor-positive breast cancer: status report 2004. J Clin Oncol. 2005;23:619–629
  24. Higgins JPT, Altman DG. Assessing risk of bias in included studies. In:  Higgins JPT,  Green S editor. Cochrane Handbook for Systematic reviews of Interventions. The Cochrane Collaboration; 2008;
  25. Aksoy S, Altundag K, Dizdar O. Definition of postmenopausal status, age of the breast cancer patients and the outcome of aromatase inhibitors treatment [letter]. Breast. 2008;17:433–435
  26. Jones SE, Seynaeve C, Hasenburg A. Results of the first planned analysis of the TEAM (tamoxifen exemestane adjuvant multinational) prospective randomized phase III trial in hormone sensitive postmenopausal early breast cancer. Cancer Res. 2009;69:67
  27. Mamounas EP, Lembersky B, Jeong J-H, Cronin W, Harkins B, Geyer C, et al. NSABP B-42: a clinical trial to determine the efficacy of five years of letrozole compared with placebo in patients completing five years of hormonal therapy consisting of an aromatase inhibitor (AI) or tamoxifen followed by an AI in prolonging disease-free survival in postmenopausal women with hormone receptor-positive breast cancer. Clin Breast Cancer. 2006;7:416–421
  28. Schmid M, Jakesz R, Samonigg H, Kubista E, Gnant M, Menzel C, et al. Randomized trial of tamoxifen versus tamoxifen plus aminoglutethimide as adjuvant treatment in postmenopausal breast cancer patients with hormone receptor-positive disease: austrian breast and colorectal cancer study group trial 6. J Clin Oncol. 2003;21:984–990
  29. Boccardo F, Rubagotti A, Amoroso D, Mesiti M, Romeo D, Caroti C, et al. Sequential tamoxifen and aminoglutethimide versus tamoxifen alone in the adjuvant treatment of postmenopausal breast cancer patients: results of an Italian cooperative study. J Clin Oncol. 2001;19:4209–4215
  30. The Arimidex Tamoxifen Alone or in Combination (ATAC) Trialists' Group , Forbes JF, Cuzick J, Buzdar A, Howell A, Tobias JS, et al. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial.[see The Arimidex Tamoxifen Alone or in Combination Trialists' Group, comment]. Lancet Oncol. 2008;9:45–53
  31. Jakesz R, Kaufmann M, Gnant M. Benefits of switching postmenopausal women with hormone-sensitive early breast cancer to anastrozole after 2 years adjuvant tamoxifen: combined results from 3,123 women enrolled in the ABCSG Trial 8 and the ARNO 95 Trial. Breast Cancer Res Treat. 2004;88:S7
  32. Baum M, Buzdar A, Cuzick J, Forbes J, Houghton J, Howell A, et al. 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
  33. Buzdar A. Anastrozole as adjuvant therapy for early-stage breast cancer: implications of the ATAC trial. Clin Breast Cancer. 2003;4(Suppl. 1):S42–S48
  34. Arimidex , Tamoxifen , Alone or in Combination Trialists' Group , Buzdar A, Howell A, Cuzick J, et al Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial. Lancet Oncol. 2006;7:633–643
  35. Cuzick J. The ATAC trial: the vanguard trial for use of aromatase inhibitors in early breast cancer. Expert Rev Anticancer Ther. 2007;7:1089–1094
  36. Coates AS, Keshaviah A, Thurlimann B, Mouridsen H, Mauriac L, Forbes JF, et al. Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer: update of study BIG 1-98. [see comment]. J Clin Oncol. 2007;25:486–492
  37. Koeberle D, Thuerlimann B. Letrozole as upfront endocrine therapy for postmenopausal women with hormone-sensitive breast cancer: BIG 1-98. Breast Cancer Research & Treatment. 2007;105(Suppl 1):55–66
  38. Breast International Group 1-98 Collaborative Group. Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer. N Engl J Med. 2009;361:766–776
  39. Kaufmann M, Jonat W, Hilfrich J, Eidtmann H, Gademann G, Zuna I, et al. Improved overall survival in postmenopausal women with early breast cancer after anastrozole initiated after treatment with tamoxifen compared with continued tamoxifen: the ARNO 95 Study. J Clin Oncol. 2007;25:2664–2670
  40. Coombes RC, Kilburn LS, Snowdon CF, Paridaens R, Coleman RE, Jones SE, et al. Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet. 2007;369:559–570
  41. Boccardo F, Rubagotti A, Puntoni M, Guglielmini P, Amoroso D, Fini A, et al. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: preliminary results of the Italian Tamoxifen Anastrozole Trial. J Clin Oncol. 2005;23:5138–5147
  42. Boccardo F, Rubagotti A, Guglielmini P, Fini A, Paladini G, Mesiti M, et al. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer. Updated results of the Italian tamoxifen anastrozole (ITA) trial. Annals of Oncology. 2006;17(Suppl. 7):vii10–vii14
  43. Ingle JN, Tu D, Pater JL, Muss HB, Martino S, Robert NJ, et al. Intent-to-treat analysis of the placebo-controlled trial of letrozole for extended adjuvant therapy in early breast cancer: NCIC CTG MA.17. Annals of Oncology. 2008;19:877–882
  44. Mamounas EP, Jeong J-H, Wickerham DL, Smith RE, Ganz PA, Land SR, et al. Benefit from exemestane as extended adjuvant therapy after 5 years of adjuvant tamoxifen: intention-to-treat analysis of the National Surgical Adjuvant Breast And Bowel Project B-33 trial. J Clin Oncol. 2008;26:1965–1971
  45. Jakesz R, Greil R, Gnant M, Schmid M, Kwasny W, Kubista E, et al. Extended adjuvant therapy with anastrozole among postmenopausal breast cancer patients: results from the randomized Austrian Breast and Colorectal Cancer Study Group Trial 6a. J Natl Cancer Inst. 2007;99:1845–1853
  46. Whelan TJ, Goss PE, Ingle JN, Pater JL, Tu D, Pritchard K, et al. Assessment of quality of life in MA.17: a randomized, placebo-controlled trial of letrozole after 5 years of tamoxifen in postmenopausal women. J Clin Oncol. 2005;23:6931–6940
  47. Cella D, Fallowfield L, Barker P, Cuzick J, Locker G, Howell A, et al. Quality of life of postmenopausal women in the ATAC (“Arimidex”, tamoxifen, alone or in combination) trial after completion of 5 years' adjuvant treatment for early breast cancer. Breast Cancer Res Treat. 2006;100:273–284
  48. Fallowfield LJ, Bliss JM, Porter LS, Price MH, Snowdon CF, Jones SE, et al. Quality of life in the Intergroup Exemestane Study: a randomized trial of exemestane versus continued tamoxifen after 2 to 3 years of tamoxifen in postmenopausal women with primary breast cancer. J Clin Oncol. 2006;24:910–917
  49. Ingle JN, Dowsett M, Cuzick J, Davies C. Aromatase inhibitors versus tamoxifen as adjuvant therapy for postmenopausal women with estrogen receptor positive breast cancer: meta-analyses of randomized trials of monotherapy and switching strategies. In: Presented at December 11, 2008. Annual San Antonio Breast Cancer Symposium (SABCS); 2008. Abstract 12.
  50. Skedgel C, Rayson D, Dewar R, Younis T. Cost-utility of adjuvant hormone therapies with aromatase inhibitors in post-menopausal women with breast cancer: upfront anastrozole, sequential tamoxifen–exemestane and extended tamoxifen–letrozole. Breast. 2007;16:252–261
  51. Lundkvist J, Wilking N, Holmberg S, Jonsson L. Cost-effectiveness of exemestane versus tamoxifen as adjuvant therapy for early-stage breast cancer after 2-3 years treatment with tamoxifen in Sweden. Breast Cancer Res Treat. 2007;102:289–299
  52. Delea TE, El-Ouagari K, Karnon J, Sofrygin O. Cost-effectiveness of letrozole versus tamoxifen as initial adjuvant therapy in postmenopausal women with hormone-receptor positive early breast cancer from a Canadian perspective. Breast Cancer Res Treat. 2008;108:375–387
  53. Karnon J, Delea T, Johnston SRD, Smith R, Brandman J, Sung J, et al. Cost effectiveness of extended adjuvant letrozole in postmenopausal women after adjuvant tamoxifen therapy: the UK perspective. Pharmacoeconomics. 2006;24:237–250
  54. Mansel R, Locker G, Fallowfield L, Benedict A, Jones D. Cost-effectiveness analysis of anastrozole vs tamoxifen in adjuvant therapy for early stage breast cancer in the United Kingdom: the 5-year completed treatment analysis of the ATAC (‘Arimidex’, tamoxifen alone or in combination) tial. Br J Cancer. 2007;97(2):152–161

PII: S0960-9776(09)00182-9

doi: 10.1016/j.breast.2009.12.010

The Breast
Volume 19, Issue 2 , Pages 76-83 , April 2010