Efficacy and safety of aromatase inhibitors in early breast cancer

Expert Opinion on Drug Safety

Volumn 7, Issue 5, 2008, Pages 547-558

  Ozair, Sundus ^a   Iqbal, Shabana ^b  

^a YORK UNIVERSITY   (Canada)

^b HUDDERSFIELD ROYAL INFIRMARY   (United Kingdom)

Author keywords

Anastrozole; Aromatase inhibitors; Breast cancer; Exemestane; Letrozole; Tamoxifen

Indexed keywords

AMINOGLUTETHIMIDE; ANASTROZOLE; AROMATASE INHIBITOR; BISPHOSPHONIC ACID DERIVATIVE; CALCIUM; EXEMESTANE; LETROZOLE; PLACEBO; TAMOXIFEN; VITAMIN D; ZOLEDRONIC ACID;

ADJUVANT THERAPY; ARTHRALGIA; ARTHRITIS; ASTHENIA; BONE DEMINERALIZATION; BONE DENSITY; BONE TURNOVER; BREAST CANCER; CANCER HORMONE THERAPY; CANCER SURVIVAL; CARDIOVASCULAR DISEASE; CARDIOVASCULAR EFFECT; CARPAL TUNNEL SYNDROME; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; COGNITION; COMBINATION CHEMOTHERAPY; COST EFFECTIVENESS ANALYSIS; DIARRHEA; DRUG CHOICE; DRUG COST; DRUG DOSE SEQUENCE; DRUG EFFICACY; DRUG ERUPTION; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPAREUNIA; EARLY CANCER; ENDOMETRIUM CANCER; ENDOMETRIUM POLYP; FATIGUE; FRACTURE; GASTROINTESTINAL SYMPTOM; GYNECOLOGIC DISEASE; HAIR LOSS; HEALTH CARE COST; HIGH RISK PATIENT; HIP FRACTURE; HOT FLUSH; HUMAN; HYPERCHOLESTEROLEMIA; INTRADUCTAL CARCINOMA; JOINT STIFFNESS; LIBIDO DISORDER; LIPID METABOLISM; LUNG CANCER; MELANOMA; MEMORY DISORDER; MENTAL DISEASE; MONOTHERAPY; MUSCLE CRAMP; MUSCULOSKELETAL DISEASE; MUSCULOSKELETAL PAIN; MYALGIA; NAUSEA; NIGHT SWEAT; NONHUMAN; OSTEOLYSIS; OSTEOPENIA; OSTEOPOROSIS; OUTCOME ASSESSMENT; PARESTHESIA; POSTMENOPAUSE; QUALITY OF LIFE; RECURRENT CANCER; REVIEW; RISK BENEFIT ANALYSIS; SIDE EFFECT; SLEEP DISORDER; SOMNOLENCE; SWEATING; THROMBOEMBOLISM; THROMBOSIS; TREATMENT DURATION; UTERUS MYOMA; VAGINA BLEEDING; VAGINA DISCHARGE; VAGINAL DRYNESS; VASOMOTOR DISORDER; VENOUS THROMBOEMBOLISM; VISUAL DISORDER; WEIGHT GAIN; BREAST TUMOR; DRUG EFFECT; DRUG MONITORING; FEMALE; METHODOLOGY; NEOPLASM; RANDOMIZED CONTROLLED TRIAL; TIME;

AROMATASE INHIBITORS; BONE DENSITY; BREAST NEOPLASMS; DRUG MONITORING; FEMALE; HUMANS; NEOPLASMS, HORMONE-DEPENDENT; POSTMENOPAUSE; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIME FACTORS;

EID: 54449099575     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740338.7.5.547     Document Type: Review

References (51)

1. Jemal A, Murray T, Ward E, et al. Cancer statistics, 2005. CA Cancer J Clin 205;55:10-30
2. 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;365:1687-717
3. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005;353(16): 1659-72
4. Henderson IC, Berry DA, Demetri GD, et al. Improved outcomes from adding sequential paclitaxel but not from the escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol 2003;21:976-83
5. Mamounas EP, Bryant J, Lembersky B, et al. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol 2005;23(16):3686-96
6. Clemons M, Goss P. Estrogen and risk of breast cancer. N Engl J Med 2001;344:276-85
7. Beatson GT. On the treatment of inoperable cases of carcinoma of the mamma: suggestions for a new method of treatment with illustrative cases. Lancet 1896;2:104-7
8. Taylor CW, Green S, Dalton WS, et al. Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer: an intergroup study. J Clin Oncol 1998;16(3):994-9
9. Early Breast Cancer Trialists' Collaborative Group. Ovarian ablation in early breast cancer: overview of the randomised trials. Lancet 1996;348(9036):1189-96
10. Santen RJ, Samojlik E, Lipton A, et al. Kinetic, hormonal and clinical studies with aminoglutethimide in breast cancer. Cancer 1977;39:2948-58
11. Buzdar AU, Smith R, Vogel C, et al. Fadrozole HCL (CGS-16949A) versus megestrol acetate treatment of postmenopausal patients with metastatic breast carcinoma: results of two randomized double blind controlled multiinstitutional trials. Cancer 1996;77:2503-13
12. Thürlimann B, Castiglione M, Hsu-Schmitz SF, et al. Formestane versus megestrol acetate in postmenopausal breast cancer patients after failure of tamoxifen: a phase III prospective randomised cross over trial of second-line hormonal treatment (SAKK 20/90). Eur J Cancer 1997;33(7):1017-24
13. Plourde PV, Dyroff M, Dukes M. Arimidex: a potent and selective fourth-generation aromarase inhibitor. Breast Cancer Res Treat 1994;30(1):103-11
14. Iveson TJ, Smith IE, Ahern J, et al. Phase I study of the oral nonsteroidal aromatase inhibitor CGS 20267 in postmenopausal patients with advanced breast cancer. Cancer Res 1993;53:266-70
15. Evans RTJ, Di Salle E, Ornati G, et al. Phase I and endocrine study of exemestane (FCE24304), a new aromatase inhibitor, in postmenopausal women. Cancer Res 1992;52:5933-9
16. Riggs BL, Hartmann LC. Selective estrogen-receptor modulators - mechanisms of action and application to clinical practice. N Engl J Med 2003;348:618-29
17. Bevilacqua G, Silingardi V, Marchetti P. Exemestane for the prevention of breast cancer in postmenopausal unaffected carriers of BRCA1/2 mutations - Aromasin Prevention Study (Apres). Breast Cancer Research Treatment. Special Issue: 24th Annual San Antonio Breast Cancer Symposium. 2001;69:226
18. Cuzick J. Aromatase inhibitors in prevention - data from the ATAC (arimidex, tamoxifen alone or in combination) trial and the design of IBIS-II (the second International Breast Cancer Intervention Study). Recent Results Cancer Res 2003;163:96-103
19. Howell A, Cuzick J, Baum M, 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 randomized trial. Lancet 202;359:2131-39
20. Breast International Group (BIG) 1-98 Collaborative Group. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med 2005;353:2747-57
21. Howell A, Cuzick J, Baum M, et al. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancer 2005;365:60-2
22. The Arimidex, Tamoxifen, Alone or in Combination (ATAC) Trialists' Group. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial. Lancet Oncol 2008;9:45-53
23. Coates AS, Keshaviah A, Thürlimann B, 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. J Clin Oncol 2007;25:486-92
24. West Midlands Breast Group. WMBG - study details. Breast Cancer Online 2006;9:S1
25. Coombes RC, Hall E, Gibson LJ, 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;350:1081-92
26. Boccardo F, Rubagotti A, Puntoni M, 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;23:5138-47
27. Jakesz R, Jonat W, Gnant M, et al. Switching of postmenopausal women with endocrineresponsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial. Lancet 2005;366:455-62
28. Coombes RC, Kilburn LS, Snowdown CF, et al. Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet 2007;369:559-70
29. Boccardol F, Rubagotti A, Guglielmini P, et al. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer. Updated results of the Italian tamoxifen anastrozole (ITA) trial. Ann Oncol 2006;17(S 7):vii10-4
30. Goss PE, Ingle JN, Martino S, 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;34:1793-803
31. Mamounas E, Jeong JH, Wickerham L, et al. Benefit from exemestane (EXE) as extended adjuvant therapy after 5 years of tamoxifen (TAM): intent-to-treat analysis of NSABP B-33. Breast Can Res Treat 2006;100(Suppl 1):A49
32. Jakesz R, Greil R, Gnant M, 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;99:1845-53
33. 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;97:1262-71
34. Goss PE. Preventing relapse beyond 5 years: the MA17 extended adjuvant trial. Semin Oncol 2006;33(2 Suppl 7):S8-12
35. Eastell R, Hannon RA, Cuzick J, et al. Effect of an aromatase inhibitor on BMD and Bone turnover markers: 2-Year results of the Anastrozole, Tamoxifen, Alone or in Combination (ATAC) Trial 18233230. J Bone Miner Res 2006;21:1215-23
36. Coleman RE, Banks LM, Girgis SI, et al. Skeletal effects of exemestane on bone-mineral density, bone biomarkers, and fracture incidence in postmenopausal women with early breast cancer participating in the Intergroup Exemestane Study (IES): a randomised controlled study. Lancet 2007;8:119-27
37. Perez EA, Josse RG, Pritchard KI, et al. Effect of letrozole versus placebo on bone mineral density in women with primary breast cancer completing 5 or more years of adjuvant tamoxifen: a companion study to NCIC CTG MA.17. J Clin Oncol 2006;24:3629-35
38. McCloskey E, Hannon R, Lakner G, et al. The letrozole (L), exemestane (E), and anastrozole (A) pharmacodynamics (LEAP) trial: a direct comparison of bone biochemical measurements between aromatase inhibitors (AIs) in healthy postmenopausal women. J Clin Oncol 2006;24:555
39. Bundred NJ, Campbell ID, Davidson N, et al. Effective inhibition of aromatase inhibitor-associated bone loss by zoledronic acid in postmenopausal women with early breast cancer receiving adjuvant letrozole. Cancer 2008;112(5):1001-10
40. Wasan KM, Goss PE, Pritchard PH, et al. The influence of letrozole on serum lipid concentrations in postmenopausal women with primary breast cancer who have completed 5 years of adjuvant tamoxifen (NCIC CTG MA 17L). Ann Oncol 2005;16:707-15
41. Fallowfield LJ, Cella D, Cuzick J, et al. Quality of life of post menopausal women in the Arimidex, Tamosifen, Alone or in Combination (ATAC) adjuvant breast cancer trial. J Clin Oncol 2004;22:4261-71
42. Fallowfield LJ, Bliss JM, Porter LS, et al. Quality of life in the intergroup exemestane study: a randomized triai of exemestane versus continued tamoxifen after 2 to 3 years of tamoxifen in postmenopausal women with primary breast cancer. J Clin Oncol 2006;24:910-7
43. 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;23:6931-40
44. Jenkins V, Atkins L, Fallowfield U Does endocrine therapy for the treatment and prevention of breast cancer affect memory and cognition? Eur J Cancer 2007;43(9):1342-7
45. Shilling V, Jenkins V, Fallowfield L, et al. The effects of hormone therapy on cognition in breast cancer. J Steroid Biochem Mol Biol 2003;86(3-5):405-12
46. Jenkins V, Atkins L, Ambroisine L, et al. Preliminary results from the IBIS II (prevention) cognitive sub-protocol. Breast Can Res Treat 2006
47. Goss PE, Richardson H, Chlebowski R, et al. National Cancer Institute of Canada Clinical Trials Group MAP.3 Trial: evaluation of exemestane to prevent breast cancer in postmenopausal women. Clin Breast Cancer 2007;7(11):895-900
48. Freedman GM, Anderson PR, Hanlon AL, et al. Pattern of local recurrence after conservative surgery and whole-breast irradiation. Int J Radiat Oncol Biol Phys 2005;61(5):1328-36
49. Mansell R, Locker G, Fallowfield L, et al. 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) trial. Br J Cancer 2007;97:152-61
50. Karnon J, Delea T, Johnston SRD, 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. Thompson D, Taylor DCA, Montoya EL, et al. Cost-effectiveness of switching to exemestane after 2 to 3 years of therapy with tamoxifen in postmenopausal women with early-stage breast cancer. Value Health 2007;10:367-76