Letrozole: A pharmacoeconomic review of its use in postmenopausal women with breast cancer

PharmacoEconomics

Volumn 24, Issue 5, 2006, Pages 495-517

  Dunn, Christopher ^a   Keam, Susan J ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ANASTROZOLE; LETROZOLE; MEGESTROL; TAMOXIFEN; TRASTUZUMAB;

ADJUVANT THERAPY; ADVANCED CANCER; ALOPECIA; ANOREXIA; ARTHRALGIA; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER MORTALITY; CANCER RECURRENCE; CANCER SURVIVAL; CARDIOVASCULAR DISEASE; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; DIARRHEA; DISEASE COURSE; DRUG COST; DRUG TOLERABILITY; DYSPNEA; ENDOMETRIUM CANCER; ESTROGEN SYNTHESIS; HAIR DISEASE; HEADACHE; HEALTH CARE COST; HEALTH CARE SYSTEM; HEART INJURY; HOT FLUSH; HUMAN; HYPERCHOLESTEROLEMIA; INCREASED APPETITE; MORBIDITY; MYALGIA; NAUSEA; NIGHT SWEAT; OSTEOPOROSIS; OVERALL SURVIVAL; POSTMENOPAUSE; PREVALENCE; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW; SENSITIVITY ANALYSIS; SHORT FORM 36; SIDE EFFECT; THROMBOEMBOLISM; TREATMENT FAILURE; VAGINA BLEEDING; WEIGHT GAIN;

ANTINEOPLASTIC AGENTS; AROMATASE INHIBITORS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; COST-BENEFIT ANALYSIS; DRUG COSTS; FEMALE; HUMANS; NEOPLASM STAGING; NITRILES; POSTMENOPAUSE; QUALITY-ADJUSTED LIFE YEARS; TAMOXIFEN; TREATMENT OUTCOME; TRIAZOLES;

EID: 33646786138     PISSN: 11707690     EISSN: 11707690     Source Type: Journal    
DOI: 10.2165/00019053-200624050-00007     Document Type: Review

References (87)

1. Travis RC, Key TJ. Oestrogen exposure and breast cancer risk. Breast Cancer Res 2003; 5: 239-47
2. Miller WR. Biology of aromatase inhibitors: pharmacology/endocrinology within the breast. Endocr Relat Cancer 1999; 6: 187-95
3. Szymcak J, Milewicz A, Thijssen JH, et al. Concentration of sex steroids in adipose tissue after menopause. Steroids 1998; 63: 319-21
4. National Comprehensive Cancer Network. Clinical practice guidelines in oncology: v.2.2006. Breast Cancer version 2.2006 [online]. Available from URL: http://www.nccn.org [Accessed 2005 Nov 28]
5. National Institute for Clinical Excellence. Guidance on cancer services: improving outcomes in breast cancer. Manual update [online]. Available from URL: http://www.nice.org.uk [Accessed 2005 Oct 17]
6. Jaiyesimi IA, Buzdar AU, Decker DA, et al. Use of tamoxifen for breast cancer: twenty-eight years later. J Clin Oncol 1995; 13: 513-29
7. Early Breast Cancer Trialists' 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 (9472): 1687-717
8. Buzdar AU. Pharmacology and pharmacokinetics of the newer generation aromatase inhibitors. Clin Cancer Res 2003; 9 Suppl.: 468S-72S
9. Choueiri TK, Alemany CA, Abou-Jawde RM, et al. Role of aromatase inhibitors in the treatment of breast cancer. Clin Ther 2004; 26 (8): 1199-214
10. Cuzick J, Powles T, Veronesi U, et al. Overview of the main outcomes in breast-cancer prevention trials. Lancet 2003; 361: 296-300
11. Fisher B, Dignam J, Bryant J, et al. Five versus more than five years of tamoxifen for lymph node-negative breast cancer: updated findings from the National Surgical Adjuvant Breast and Bowel Project B-14 randomized trial. J Natl Cancer Inst 2001; 93 (9): 684-90
12. Karnon J. Aromatase inhibitors in breast cancer: a review of cost considerations and cost effectiveness. Pharmacoeconomics 2006; 24 (3): 215-32
13. Femara® (letrozole tablets) 2.5mg tablets. US prescribing information. East Hanover (NJ): Novartis Pharmaceuticals Corporation [online]. Available from URL: http://www.femara.com [Accessed 2006 Mar 6]
14. Novartis Pharmaceuticals UK Ltd. Femara SPC from the eMC [online]. Available from URL: http://emc.medicines.org.uk [Accessed 2006 Mar 6]
15. Femara® (letrozole). European summary of product characteristics. Novartis Oncology [online]. Available from URL: http://www.femarainfo.com/ european/index.jsp [Accessed 2006 Mar 6]
16. Parkin DM, Bray F, Ferlay J, et al. Global cancer statistics 2002. CA Cancer J Clin 2005; 55: 74-108
17. Ferlay J, Bray F, Pisani P, et al. GLOBOCAN 2002: cancer incidence, mortality and prevalence worldwide. IARC CancerBase No. 5. version 2.0. Lyon: IARCPress, 2004 [online]. Available from URL: http://www-dep.iarc.fr/ [Accessed 2006 Mar 1]
18. Office for National Statistics. Breast cancer: incidence rate rises while death rate falls [online]. Available from URL: http://www.statistics.gov.uk/ cci/nugget.asp [Accessed 2005 Aug 16]
19. Tyczynski JE, Bray F, Parkin DM. European Network of Cancer Registries/International Agency for Research on Cancer ENCR cancer fact sheets vol. 2 December 2002. Breast cancer in Europe [online]. Available from URL: http://www.encr.com.fr [Accessed 2005 Aug 15]
20. American Cancer Society. Cancer facts and figures 2006. Atlanta (GA): American Cancer Society, 2006
21. Radice D, Redaelli A. Breast cancer management: quality-of-life and cost considerations. Pharmacoeconomics 2003; 21 (6): 383-96
22. Rao S, Kubisiak J, Gilden D. Cost of illness associated with metastatic breast cancer. Breast Cancer Res Treat 2004 Jan; 83 (1): 25-32
23. Berkowitz N, Gupta S, Silberman G. Estimates of the lifetime direct costs of treatment for metastatic breast cancer. Value Health 2000 Jan; 3 (1): 23-30
24. Will BP, Berthelot J-M, Le Petit C, et al. Estimates of the lifetime costs of breast cancer treatment in Canada. Eur J Cancer 2000; 36: 724-35
25. Reḿak E, Brazil L. Cost of managing women presenting with stage IV breast cancer in the United Kingdom. Br J Cancer 2004 Jul 5; 91 (1): 77-83
26. Winer EP, Hudis C, Burstein HJ, 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 2004; 23 (3): 619-29
27. Goldhirsch A, Glick JH, Gelber RD, et al. Meeting highlights: international expert consensus on the primary therapy of early breast cancer 2005. Ann Oncol 2005; 16 (10): 1569-83
28. Baum M. Current status of aromatase inhibitors in the management of breast cancer and critique of the NCIC MA-17 trial. Cancer Control 2004; 11 (4): 217-21
29. Tḧurlimann B, Keshaviah A, Coates AS, et al. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. The Breast International Group (BIG) 1-98 Collaborative Group. New Engl J Med 2005; 353 (26): 2747-57
30. Goss PE, Ingle JN, Martino S, 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 (17): 1262-71
31. Mouridsen H, Gershanovich M, Sun Y, et al. Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: results of a phase III study of the International Letrozole Breast Cancer Group [published erratum appears in J Clin Oncol 2001; 19 (13): 3302]. J Clin Oncol 2001; 19 (10): 2596-606
32. Dombernowsky P, Smith I, Falkson G, et al. Letrozole, a new oral aromatase inhibitor for advanced breast cancer: double-blind randomized trial showing a dose effect and improved efficacy and tolerability compared with megestrol. J Clin Oncol 1998; 16: 453-61
33. Rose C, Vtoraya O, Pluzanska A, et al. An open randomised trial of second-line endocrine therapy in advanced breast cancer: comparison of the aromatase inhibitors letrozole and anastrozole. Eur J Cancer 2003; 39: 2318-27
34. Buzdar A, Douma J, Davidson N, et al. Phase III, multicenter, double-blind, randomized study of letrozole, an aromatase inhibitor, for advanced breast cancer versus megestrol. J Clin Oncol 2001; 19 (14): 3357-66
35. Scott L, Keam SJ. Letrozole in post-menopausal hormone-responsive, early-stage breast cancer. Drugs 2006; 66 (3): 353-62
36. Keating GM, Jarvis B. Letrozole: an updated review of its use in postmenopausal women with advanced breast cancer. Am J Cancer 2002; 1 (5): 351-71
37. Simpson D, Curran MP, Perry CM. Letrozole: a review of its use in postmenopausal women with breast cancer. Drugs 2004; 64 (11): 1213-30
38. Whelan TJ, Goss PE, Ingle JN, 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 Oct; 23 (28): 6931-40
39. Abetz L, Barghout V, de la Loge C, et al. No differences in quality of life for letrozole relative to placebo in postmenopausal women with early breast cancer regardless of age: results from the MA.17 study [abstract no. 342]. Eur J Cancer Suppl 2005; 3 (2): 96
40. Irish W, Sherrill B, Cole B, et al. Quality-adjusted survival in a crossover trial of letrozole versus tamoxifen in postmenopausal women with advanced breast cancer. Ann Oncol 2005; 16: 1458-62
41. Thomas R. Examining quality of life issues in relation to endocrine therapy for breast cancer. Am J Clin Oncol 2003 Aug; 26 (4 Suppl. 1): S40-4
42. Viale G, Regan M, Dell'Orto P, et al. Central review of ER, PgR and HER-2 in BIG 1-98 evaluating letrozole vs tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive breast cancer [abstract no. 44]. 28th Annual San Antonio Breast Cancer Symposium; 2005 Dec 8-11; San Antonio (TX)
43. Goss PE, Ingle JN, Palmer MJ, et al. Updated analysis of NCIC CTG MA.17 (letrozole vs placebo to letrozole vs placebo) post unblinding [abstract no. 16]. Breast Cancer Res Treat 2005; 94 Suppl. 1: 10-11. Plus oral presentation at the 28th Annual San Antonio Breast Cancer Symposium; 2005 Dec 8-11; San Antonio (TX)
44. Ingle JN, Goss PE, Tu DE. Analysis of duration of letrozole as extended adjuvant therapy as measured by hazard ratios of disease recurrence over time for patients on NCIC CTG MA.17 [abstract no. 17]. Breast Cancer Res Treat 2005; 94 Suppl. 1: 11. Plus oral presentation at the 28th Annual San Antonio Breast Cancer Symposium; 2005 Dec 8-11; San Antonio (TX)
45. Mouridsen H, Gershanovich M, Sun Y, et al. Phase III study of letrozole versus tamoxifen as first-line therapy of advanced breast cancer in postmenopausal women: analysis of survival and update of efficacy from the International Letrozole Breast Cancer Group. J Clin Oncol 2003; 21: 2101-9
46. Mann BS, Johnson JR, Kelly R, et al. Letrozole in the extended adjuvant treatment of postmenopausal women with history of early-stage breast cancer who have completed 5 years of adjuvant tamoxifen. Clin Cancer Res 2005; 11 (16): 5671-7
47. Karnon J, Delea TE, Barghout V, et al. Cost-effectiveness analysis of letrozole versus tamoxifen as initial adjuvant therapy in hormone-receptor positive postmenopausal women with early breast cancer: the UK perspective [abstract no. 2058 plus poster]. 28th San Antonio Breast Cancer Symposium; 2005 Dec 8-11; San Antonio (TX)
48. Delea TE, Karnon J, Thomas SK, et al. Cost-effectiveness of letrozole versus tamoxifen as initial adjuvant therapy in hormone-receptor positive postmenopausal women with early breast cancer from a US perspective [abstract no. 2054 plus poster]. 28th Annual San Antonio Breast Cancer Symposium; 2005 Dec 8-11; San Antonio (TX)
49. Delea TE, Karnon J, Smith RE, et al. Cost-effectiveness of five years of extended adjuvant letrozole in postmenopausal women with early breast cancer who have completed five years of adjuvant tamoxifen [abstract no. 1050]. Breast Cancer Res Treat 2004; 88 Suppl. 1: 58. Plus poster presented at the 27th Annual San Antonio Breast Cancer Symposium; 2004 Dec 8-11; San Antonio (TX)
50. Karnon J, Delea T, Johnson S, et al. Cost-effectiveness of extended adjuvant letrozole in postmenopausal women after adjuvant tamoxifen therapy: the UK perspective. Pharmacoeconomics 2006; 24 (3): 237-50
51. El Ouagari K, Talbot W. Letrozole (Femara) is a cost-effective treatment in the extended adjuvant setting in women with early breast cancer: an application to Canada [abstract no. PCN18]. Value Health 2005; 8 (6): A38. Plus poster presented at the 8th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research; 2005 Nov 6-8; Florence
52. Karnon J, Brown J. Tamoxifen plus chemotherapy versus tamoxifen alone as adjuvant therapies for node-positive postmenopausal women with early breast cancer: a stochastic economic evaluation. The Adjuvant Breast Cancer (ABC) Steering Committee. Pharmacoeconomics 2002; 20 (2): 119-37
53. Sorensen SV, Brown R, Benedict A, et al. Patient-rated utilities in postmenopausal early breast cancer (EBC): a cross-country comparison [abstract no. QL4]. Value Health 2004; 7 (6): 641-2
54. Rawlins MD, Culyer AJ. National Institute for Clinical Excellence and its value judgements. BMJ 2004; 329: 224-7
55. Data on file. Novartis Oncology, 2006
56. Kanis JA, Brazier JE, Stevenson M, et al. Treatment of established osteoporosis: a systematic review and cost-utility analysis. Health Technol Assess 2002; 6 (29): 1-146
57. de Haes JCJM, de Koning HJ, van Oortmarssen GJ, et al. The impact of a breast cancer screening programme on quality-adjusted life-years. Int J Cancer 1991; 49: 538-44
58. J̈onsson B. Changing health environment: the challenge to demonstrate cost-effectiveness of new compounds. Pharmacoeconomics 2004; 22 Suppl. 4: 5-10
59. Earle CC, Chapman RH, Baker CS, et al. Systematic overview of cost-utility assessments in oncology. J Clin Oncol 2000; 18: 3302-17
60. Karnon J, Johnston SRD, Jones T, et al. A trial-based cost-effectiveness analysis of letrozole followed by tamoxifen versus tamoxifen followed by letrozole for postmenopausal advanced breast cancer. Ann Oncol 2003; 14 (11): 1629-33
61. Karnon J, Jones T. A stochastic economic evaluation of letrozole versus tamoxifen as a first-line hormonal therapy for advanced breast cancer in postmenopausal patients. Pharmacoeconomics 2003; 21 (7): 513-25
62. Dranitsaris G, Verma S, Trudeau M. Cost utility analysis of first-line hormonal therapy in advanced breast cancer: comparison of two aromatase inhibitors to tamoxifen. Am J Clin Oncol 2003 Jun; 26 (3): 289-96
63. Marchetti M, Caruggi M, Colombo G. Cost utility and budget impact of third-generation aromatase inhibitors for advanced breast cancer: a literature-based model analysis of costs in the Italian National Health Service. Clin Ther 2004; 26 (9): 1546-61
64. Okubo I, Kondo M, Toi M, et al. Cost-effectiveness of letrozole versus tamoxifen as first-line hormonal therapy in treating postmenopausal women with advanced breast cancer in Japan. Jpn J Cancer Chemother 2005; 32 (3): 351-63
65. Delea T, Smith R, Karnon J. Cost-effectiveness of letrozole vs tamoxifen as 1st line hormonal therapy for postmenopausal women with advanced breast cancer: the US perspective [abstract no. 542]. 25th Annual San Antonio Breast Cancer Symposium; 2002 Dec 11-14; San Antonio (TX)
66. Fricke F-U, Quednau K, Pirk O. A stochastic economic evaluation of letrozole versus tamoxifen as a first-line hormonal therapy for advanced breast cancer in postmenopausal patients in Germany [abstract no. CN1]. Value Health 2002; 5 (6): 443
67. Bonneterre J, Tḧurlimann B, Robertson JFR, et al. Anastrozole versus tamoxifen as first-line therapy for advanced cancer in 668 postmenopausal women: results of the tamoxifen or Arimidex randomised group efficacy and tolerability study. J Clin Oncol 2000; 18 (22): 3748-57
68. Nabholtz JM, Budzar A, Pollack M, et al. Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. Arimidex Study Group. J Clin Oncol 2000; 18: 3758-67
69. Kaufmann M, Bajetta E, Dirix LY, et al. Exemestane is superior to megestrol after tamoxifen failure in postmenopausal women with advanced breast cancer: results of a phase III randomized double-blind trial. The Exemestane Study Group. J Clin Oncol 2000; 18: 1399-411
70. Falkson CI, Falkson HC. A randomised study of CGS 16949A (fadrozole) versus tamoxifen in previously untreated postmenopausal patients with metastatic breast cancer. Ann Oncol 1996; 7: 465-9
71. Tḧurlimann B, Beretta K, Bacchi M, et al. First-line fadrozole HCl (CGS 16949A) versus tamoxifen in postmenopausal women with advanced breast cancer: prospective randomised trial of the Swiss Group for Clinical Cancer Research SAKK 20/88. Ann Oncol 1996; 7: 471-9
72. Hayes DF, Van Zyl JA, Hacking A, et al. Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer. J Clin Oncol 1995; 13: 2556-66
73. Stuart NS, Warwick J, Blackledge GR, et al. A randomised phase III cross-over study of tamoxifen versus megestrol in advanced and recurrent breast cancer. Eur J Cancer 1996; 32A: 1888-92
74. Milla-Santos A, Milla L, Portello J. Anastrozole versus tamoxifen as first-line therapy in postmenopausal patients with hormone-dependent advanced breast cancer: a prospective, randomized, phase III study. Am J Clin Oncol 2003; 26 (3): 317-22
75. Dranitsaris G, Leung P, Mather J, et al. Cost-utility analysis of second-line hormonal therapy in advanced breast cancer: a comparison of two aromatase inhibitors to megestrol. Anticancer Drugs 2000 Aug; 11: 591-601
76. Nuijten M, Meester L, Waibel F, et al. Cost effectiveness of letrozole in the treatment of advanced breast cancer in postmenopausal women in the UK. Pharmacoeconomics 1999; 16 (4): 379-97
77. Smith TJ, Hillner BE. Tamoxifen should be cost-effective in reducing breast cancer risk in high-risk women. J Clin Oncol 2000; 18: 284-6
78. Laupacis A, Feeny D, Detsky AS, et al. How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations. CMAJ 1992; 146 (4): 473-81
79. Nuijten M, McCormick J, Waibel F, et al. Economic evaluation of letrozole in the treatment of advanced breast cancer in postmenopausal women in Canada. Value Health 2000; 3 (1): 31-9
80. Verma S, Rocchi A. Economic evaluation of antiaromatase agents in the second-line treatment of metastatic breast cancer. Support Care Cancer 2003; 11: 728-34
81. Gershanovich M, Chaudri HA, Campos D, et al. Letrozole, a new aromatase inhibitor: randomised trial comparing 2.5mg daily, 0.5mg daily and aminoglutethimide in postmenopausal women with advanced breast cancer. Ann Oncol 1998; 9: 639-45
82. Bajetta E, Zilembo N, Dowsett M, et al. Double-blind, randomised, multicentre endocrine trial comparing two letrozole doses, in postmenopausal breast cancer patients. Eur J Cancer 1999; 35 (2): 208-13
83. Buzdar AU, Jones SE, Vogel CL, et al. A phase III trial comparing anastrozole (1 and 10 milligrams), a potent and selective aromatase inhibitor, with megestrol in postmenopausal women with advanced breast carcinoma. The Arimidex Study Group. Cancer 1997; 79: 730-9
84. Jonat W, Howell A, Blomqvist C, et al. A randomised trial comparing two doses of the new selective aromatase inhibitor anastrozole (Arimidex) with megestrol in postmenopausal patients with advanced breast cancer. Eur J Cancer 1996; 32A (3): 404-12
85. Buzdar AU, Jonat W, Howell A, et al. Anastrozole versus megestrol in the treatment of postmenopausal women with advanced breast carcinoma: results of a survival update based on a combined analysis of data from two mature phase III trials. Arimidex Study Group [published erratum appears in Cancer 1999; 85 (4): 1010]. Cancer 1998; 83 (6): 1142-52
86. Karnon J, Johnston SRD, Delea T, et al. Letrozole is cost-effective versus tamoxifen as adjuvant therapy in postmenopausal women with early breast cancer: BIG 1-98 [abstract no. 341]. Eur J Cancer Supplements 2005; 3 (2): 96. Plus poster presented at ECCO 13 - the European Cancer Conference; 2005 Oct 30-Nov 3; Paris
87. Novartis Oncology. UK leads Europe and US in milestone postop breast cancer treatment decision [media release]. Available from URL: http://www.femara.com [Accessed 2005 Oct 17]