The adjuvant endocrine treatment revolution: Focus on anastrozole

Expert Opinion on Drug Metabolism and Toxicology

Volumn 2, Issue 2, 2006, Pages 301-312

  Jakesz, Raimund ^a  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

Author keywords

Anastrozole; Aromatase inhibitor; Breast cancer; Endocrine treatment

Indexed keywords

ANASTROZOLE; ANTIESTROGEN; AROMATASE; AROMATASE INHIBITOR; NONSTEROID ANTIINFLAMMATORY AGENT; TAMOXIFEN; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; NITRILE; TRIAZOLE DERIVATIVE;

ADJUVANT THERAPY; ADVANCED CANCER; BREAST CANCER; DRUG EFFICACY; DRUG TOLERABILITY; ESTROGEN SYNTHESIS; HORMONAL THERAPY; HORMONE RESPONSIVE ELEMENT; HUMAN; MENOPAUSAL SYNDROME; REVIEW; STEROIDOGENESIS; ADJUVANT CHEMOTHERAPY; BREAST TUMOR; CHEMICAL STRUCTURE; CHEMISTRY; CLINICAL TRIAL; FEMALE; METABOLISM; METHODOLOGY; TREATMENT OUTCOME;

ANTINEOPLASTIC AGENTS, HORMONAL; AROMATASE INHIBITORS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CLINICAL TRIALS; FEMALE; HUMANS; MOLECULAR STRUCTURE; NITRILES; TREATMENT OUTCOME; TRIAZOLES;

EID: 33847733165     PISSN: 17425255     EISSN: None     Source Type: Journal    
DOI: 10.1517/17425255.2.2.301     Document Type: Review

References (65)

1. JEMAL A, MURRAY T, WARD E et al.: Cancer statistics, 2005. CA Cancer J. Clin. (2005) 55(1):10-30.
2. SAPHNER T, TORMEY DC, GRAY R: Annual hazard rates of recurrence for breast cancer after primary therapy. J. Clin. Oncol. (1996) l4(10):2738-2746.
3. DICKSON RB, LIPPMAN ME: Estrogenic regulation of growth and polypeptide growth factor secretion in human breast carcinoma. Endocr. Rev. (1987) 8(1):29-43.
4. 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)2:105-107.
5. JENSEN EV, JORDAN VC: The estrogen receptor: a model for molecular medicine. Clin. Cancer Res. (2003) 9:1980-1989.
6. SANTEN RJ, WORGUL TJ, LIPTON A et al.: Aminoglutethimide as treatment of postmenopausal women with advanced breast carcinoma. Ann. Intern. Med. (1982) 96(1):94-101.
7. 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). Swiss Group for Clinical Cancer Research (SAKK). Eur. J. Cancer(1997) 33(7):1017-1024.
8. WISEMAN LR, MCTAVISH D: Formestane. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in the management of breast cancer and prostatic cancer. Drugs (1993) 45(1):66-84.
9. NJAR VCO, BRODIE AMH: Comprehensive pharmacology and clinical efficacy of aromastase inhibitors. Drugs (1999) 58(2):235-255.
10. MILLER WR: Aromatase inhibitors in the treatment of advanced breast cancer. Cancer Treat. Rev. (1989) 16(2):83-93.
11. 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 acetate. J. Clin. Oncol. (2001) 19(14):3357-3366.
12. 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 acetate in postmenopausal women with advanced breast carcinoma. Arimidex Study Group. Cancer (1997) 79(4):730-739.
13. BUZDAR AU, JONAT W, HOWELL A et al.: Anastrozole versus megestrol acetate 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. Cancer (1998) 83(6):1142-1152.
14. 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 acetate. J. Clin. Oncol. (1998) 16(2):453-461.
15. JONAT W, HOWELL A, BLOMQVIST C et al.: A randomised trial comparing two doses of the new selective aromatase inhibitor anastrozole (Arimidex) with megestrol acetate in postmenopausal patients with advanced breast cancer. Eur. J. Cancer (1996) 32A(3):404-412.
16. KAUFMANN M, BAJETTA E, DIRIX LY et al.: Exemestane is superior to megestrol acetate 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(7):1399-1411.
17. BONNETERRE J, THÜRLIMANN B, ROBERTSON JF et al.: Anastrozole versus tamoxifen as first-line therapy for advanced breast cancer in 668 postmenopausal women: results of the Tamoxifen or Arimidex Randomized Group Efficacy and Tolerability study. J. Clin. Oncol. (2000) 18(22):3748-3757.
18. BONNETERRE J, BUZDAR A, NABHOLTZ JM et al.: Anastrozole is superior to tamoxifen as first-line therapy in hormone receptor positive advanced breast carcinoma. Cancer (2001) 92(9):2247-2258.
19. MILLA-SANTOS A, MILLA L, PORTELLA J et al.: 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):317-322.
20. 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. J. Clin. Oncol. (2001) 19(10):2596-2606.
21. 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(11):2101-2109.
22. NABHOLTZ JM, BUZDAR A, POLLAK 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(22):3758-3767.
23. NABHOLTZ JM, BONNETERRE J, BUZDAR A et al.: Anastrozole (Arimidex™) versus tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: survival analysis and updated safety results. Eur. J. Cancer (2003) 39(12):1684-1689.
24. PARIDAENS R, THERASSE P, DIRIX L et al.: First results of a randomized Phase III trial comparing exemestane versus tamoxifen as first-line hormone therapy (HT) for postmenopausal women with metastatic breast cancer (MBC) - EORTC 10951 in collaboration with the exemestane working group and NCIC. Eur. J. Cancer (2004) 2(Suppl. 3):126 (abstract 241).
25. ATAC TRIALISTS' GROUP: Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet (2005) 365(9451):60-62. The Completed Treatment Analysis of the ATAC trial provides the only mature data evaluating an AI as initial adjuvant treatment. ATAC demonstrated that anastrozole was superior to tamoxifen in newly diagnosed, postmenopausal women with hormone-responsive breast cancer.
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(22):5138-5147.
27. JAKESZ R, SAMONIGG H, GREIL R et al.: Extended adjuvant treatment with anastrozole: results from the Austrian Breast and Colorectal Cancer Study Group Trial 6a (ABCSG-6a). J. Clin. Oncol. (Meeting Abstracts) (2005) 23(16s part I of II):10s (abstract 527). Evidence from a large randomised trial in women with postmenopausal women with hormone-responsive breast cancer part way through a course of tamoxifen. This trial supports switching treatment to anastrozole.
28. JAKESZ R, JONAT W, GNANT M et al.: Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial. Lancet (2005) 366(9484):455-462.
29. COOMBES RC, HALL E, SNOWDON CF, BLISS JM; on behalf of the INTERGROUP EXEMESTANE STUDY (IES): The Intergroup Exemestane Study: a randomized trial in postmenopausal patients with early breast cancer who remain disease-free after two to three years of tamoxifen - updated survival analysis. Breast Cancer Res. Treat. (2004) 88(Suppl. 1):S7 (abstract 3).
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) 349(19):1793-1802.
31. THÜRLIMANN B, KESAVIAH A, MOURIDSEN H et al.: BIG 1-98: Randomized double-blind Phase III study to evaluate letrozole (L) versus tamoxifen (T) as adjuvant endocrine therapy for postmenopausal women with receptor-positive breast cancer. J. Clin. Oncol. (Meeting Abstracts) (2005) 23:6s (abstract 511).
32. MILLER WR, DIXON JM: Antiaromatase agents: preclinical data and neoadjuvant therapy. Clin Breast Cancer (2000) 1(Suppl. 1):S9-SI4.
33. BUZDAR A, ROBERTSON JFR, EIERMANN W, NABHOLTZ JM: An overview of the pharmacology and pharmacokinetics of the newer generation aromatase inhibitors anastrozole, letrozole and exemestane. Cancer (2002) 95(9):2006-2016. A comprehensive overview of the pharmacodynamic/pharmacokinetic profiles of the third-generation AIs.
34. PLOURDE PV, DYROFF M, DUKES M: Arimidex®: a potent and selective fourth-generation aromatase inhibitor. Breast Cancer Res. Treat. (1994) 30(1):103-111. Summary of the pharmacokinetic data for anastrozole in animals and human volunteers.
35. PLOURDE PV, DYROFF M, DOWSETT M et al.: Arimidex™: a new oral, once-a-day aromatase inhibitor. J. Steroid Biochem. Mol. Biol. (1995) 53:175-179.
36. YATES RA, DOWSETT M, FISHER GV, SELEN A, WYLD PJ: Arimidex (ZD-1033): a selective, potent inhibitor of aromatase in postmenopausal female volunteers. Br. J. Cancer (1996) 73(4):543-548.
37. GEISLER J, KING N, DOWSETT M et al.: Influence of anastrozole (Arimidex), a selective, nonsteroidal aromatase inhibitor, on in vivo aromatisation and plasma oestrogen levels in postmenopausal women with breast cancer. Br. J. Cancer (1996) 74(8):1286-1291.
38. GEISLER J, BERNSTEN H, OTTESTAD L et al.: Neoadjuvant treatment with anastrozole ('Arimidex') causes profound suppression of intra-tumor estrogen levels. Proc. Am. Soc. Clin. Oncol. (1999) 18:82a.
39. GRIMM SW, DYROFF MC: Inhibition of human drug metabolizing cytochromes P450 by anastrozole, a potent and selective inhibitor of aromatase. Drug Metab. Dispos. (1997) 25(5):598-602.
40. ST PETER J, THYRUM P, YEH C, DYROFF M, SELEN A: Lack of effect of anastrozole, an aromatase inhibitor, on antipyrine pharmacokinetics in postmenopausal women. Clin. Pharm. Ther. (1997) 61:172 (abstract pii-27).
41. YATES RA, WONG J, SEIBERLING M et al.: The effect of anastrozole on the single-dose pharmacokinetics and anticoagulant activity of warfarin in healthy volunteers. Br. J. Clin. Pharmacol. (2001) 51(5):429-435.
42. LIEN EA, ANKER G, LONNING PE, SOLHEIM E, UELAND PM: Decreased serum concentrations of tamoxifen and its metabolites induced by aminoglutethimide. Cancer Res. (1990) 50(18):5851-5857.
43. DOWSETT M, TOBIAS JS, HOWELL A et al.: The effect of anastrozole on the pharmacokinetics of tamoxifen in post-menopausal women with early breast cancer. Br. J. Cancer (1999) 79(2):311-315.
44. THE ATAC TRIALISTS' GROUP: Pharmacokinetics of anastrozole and tamoxifen alone, and in combination, during adjuvant endocrine therapy for early breast cancer in postmenopausal women: a sub-protocol of the 'Arimidex and tamoxifen alone or in combination' (ATAC) trial. Br. J. Cancer (2001) 85(3):317-324. Pharmacokinetic data for anastrozole in women with breast cancer in a clinical trial setting, in particular the influence of anastrozole on circulating levels of tamoxifen.
45. DEWAR J, NABHOLTZ J-MA, BONNETERRE J et al.: The effect of anastrozole (Arimidex™) on serum lipids - data from a randomized comparison of anastrozole (AN) versus Tamoxifen (TAM) in postmenopausal (PM) women with advanced breast cancer (ABC). Breast Cancer Res. Treat. (2000) 64(Suppl.):S51 (abstract 164).
46. BANERJEE S, SMITH IE, FOLKERD L et al.: Comparative effects of anastrozole, tamoxifen alone and in combination on plasma lipids and bone-derived resorption during neoadjuvant therapy in the impact trial. Ann. Oncol. (2005) 16:1632-1638.
47. CHAPURLAT RD, BAUER DC, CUMMINGS SR: Association between endogenous hormones and sex hormone-binding globulin and bone turnover in older women: study of osteoporotic fractures. Bone (2001) 29(4):381-387.
48. ETTINGER B, PRESSMAN A, SKLARIN P et al.: Associations between low levels of serum estradiol, bone density, and fractures among elderly women: the study of osteoporotic fractures. J. Clin. Endocrinol. Metab. (1998) 83(7):2239-2243.
49. GARNERO P, SORNAY-RENDU E, CLAUSTRAT B, DELMAS PD: Biochemical markers of bone turnover, endogenous hormones and the risk of fractures in postmenopausal women: the OFELY study. J. Bone Miner. Res. (2000) 15(8):1526-1536.
50. LAI JM, TAXEL P, RAISZ LG: The effect of aromatase inhibition on bone turnover in older men. J. Am. Geriatr. Soc. (1998) 46:S79.
51. 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(11):1081-1092.
52. EASTELL R, ADAMS J: Results of the 'Arimidex' (anastrozole, A), Tamoxifen (T), Alone or in Combination (C) (ATAC) trial: effects on bone mineral density (BMD) and bone turnover (ATAC Trialists' Group). Ann. Oncol. (2002) 13(Suppl. 5):32 (abstract 113).
53. THE ATAC TRIALISTS' GROUP: 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(9324):2131-2139.
54. 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):1687-1717.
55. DUFFY S; on behalf of the ATAC TRIALISTS' GROUP: Gynecological events including hysterctomy with anastrozole tamoxifen: Data from the ATAC ('Arimidex', Tamoxifen, Alone or in Combination) Trial. J. Clin. Oncol. (Meeting Abstracts) (2005) 23(16S part I of II):58s (abstract 723).
56. DUFFY S, JACKSON TL, LANSDOWN M et al.: The ATAC ('Arimidex', Tamoxifen, Alone or in Combination) adjuvant breast cancer trial: first results of the endometrial sub-protocol following 2 years of treatment. Hum. Reprod. (2006) 21(2):545-553.
57. WINER EP: Optimizing endocrine therapy for breast cancer. J. Clin. Oncol. (2005) 23(8):1609-1610.
58. CELLA D, FALLOWFIELD L; on behalf of the ATAC TRIALISTS' GROUP: Five-year quality of life (QOL) follow-up of adjuvant endocrine therapy for postmenopausal women in the Arimidex (A), Tamoxifen (T), Alone or in Combination (ATAC) Trial. J. Clin. Oncol. {Meeting Abstracts) (2005) 23(16s part I of II):23s (abstract 577).
59. FALLOWFIELD L, CELLA D, CUZICK J et al.: Quality of life of postmenopausal women in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) Adjuvant Breast Cancer Trial. J. Clin. Oncol. (2004) 22(21):4261-4271.
60. GNANT M, JAKESZ R, MLINERITSCH B et al.: Zoledronic acid effectively counteracts cancer treatment induced bone loss (CTIBL) in premenopausal breast cancer patients receiving adjuvant endocrine treatment with goserelin plus anastrozole versus goserelin plus tamoxifen - bone density subprotocol results of a randomized multi-center trial (ABCSG-12). Breast Cancer Res. Treat. (2004) 88(Suppl. 1):S8 (abstract 6).
61. BRADBURY BD, LASH TL, KAYE JA, JICK SS: Tamoxifen-treated breast carcinoma patients and the risk of acute myocardial infarction and newly-diagnosed angina. Cancer (2005) 103(6):1114-1121.
62. BRAITHWAITE RS, CHLEBOWSKI RT, LAU J et al.: Meta-analysis of vascular and neoplastic events associated with tamoxifen. J. Gen. Intern. Med. (2003) 18(11):937-947.
63. JAKESZ R, KAUFMANN M, GNANT M et al.: Benefits of switching postmenopausal women with hormone-sensitive early breast cancer to anastroiole after 2 years adjuvant tamoxifen: combined results from 3123 women enrolled in the ABCSG Trial 8 and the ARNO 95 Trial. Breast Cancer Res. Treat. (2004) 88(Suppl. 1):S7 (abstract 2).
64. EARLY BREAST CANCER TRIALISTS' COLLABORATIVE GROUP: Tamoxifen for early breast cancer: an overview of the randomised trials. Lancet (1998) 351(9114):1451-1467.
65. HOUGHTON J; on behalf of the ATAC TRIALISTS' GROUP: Using anastrozole as initial adjuvant treatment prevents early recurrences and reduces adverse events: updated data from the ATAC ('Arimidex', Alone or in Combination) Trial. J. Clin. Oncol. (Meeting Abstracts) (2005) 23(16S part I of II):24s (abstract 582).