Anastrozole versus tamoxifen as first-line therapy in postmenopausal patients with hormone-dependent advanced breast cancer: A prospective, randomized, phase III study

American Journal of Clinical Oncology: Cancer Clinical Trials

Volumn 26, Issue 3, 2003, Pages 317-322

  Milla Santos, Alfredo ^a   Milla, Lidon ^c   Portella, Jordi ^b   Rallo, Lidon ^a   Pons, Maria ^b   Rodes, Esther ^b   Casanovas, Jose ^a   Puig Gali, Margarita ^a  

^a HOSPITAL CLÍNIC   (Spain)

^b Service of Obstetrics and Gynecology   (Spain)

^c HOSPITAL UNIVERSITARI SANT JOAN DE REUS   (Spain)

Author keywords

Anastrozole; First line therapy; Hormone dependent advanced breast cancer; Postmenopausal; Tamoxifen

Indexed keywords

AMINOGLUTETHIMIDE; ANASTROZOLE; ANTIESTROGEN; AROMATASE INHIBITOR; FADROZOLE; FORMESTANE; MEGESTROL ACETATE; TAMOXIFEN;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER HORMONE THERAPY; CANCER SURVIVAL; CATARACT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; EYE TOXICITY; FEMALE; FLUID RETENTION; HOT FLUSH; HUMAN; MAJOR CLINICAL STUDY; PHASE 3 CLINICAL TRIAL; POSTMENOPAUSE; PROSPECTIVE STUDY; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SOMNOLENCE; SWEATING; THROMBOEMBOLISM; TREATMENT OUTCOME; VAGINA BLEEDING; VAGINA DISCHARGE;

AGED; ANTINEOPLASTIC AGENTS, HORMONAL; AROMATASE INHIBITORS; BONE NEOPLASMS; BREAST NEOPLASMS; ENZYME INHIBITORS; FEMALE; HUMANS; LUNG NEOPLASMS; MIDDLE AGED; NEOPLASMS, HORMONE-DEPENDENT; NITRILES; POSTMENOPAUSE; PROSPECTIVE STUDIES; REMISSION INDUCTION; SURVIVAL ANALYSIS; TAMOXIFEN; TRIAZOLES;

EID: 0037841365     PISSN: 02773732     EISSN: None     Source Type: Journal    
DOI: 10.1097/00000421-200306000-00022     Document Type: Article

References (31)

1. 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.
2. Fisher B, Constantino JP, Redmond CK, et al. Endometrial cancer in tamoxifen treated breast cancer patients: findings from the National Adjuvant Breast and Bowel Project (NSABP) B-14. J Natl Cancer Inst 1994;86:527-37.
3. Rutqvist LE, Johansson H, Signumklao T, et al. Adjuvant tamoxifen therapy and second primary malignancies. Stockholm Breast Cancer Study Group. J Natl Cancer Inst 1995;87:645-51.
4. Gershanovich M, Garin A, Baltina D, et al. A phase III comparison of two toremifene doses to tamoxifen in postmenopausal women with advanced breast cancer. Eastern European Study Group. Breast Cancer Res Treat 1997;45:251-62.
5. Milla-Santos A, Milla L, Rallo L, et al. Phase III randomized trial of toremifene vs tamoxifen in hormonodependent advanced breast cancer. Breast Cancer Res Treat 2001;65:119-24.
6. Plourde PV, Dyroff M, Dowsett M, et al. Arimidex™: a new oral, once-a-day aromatase inhibitor. J Steroid Biochem Mol Biol 1995; 53:175-9.
7. Bonneterre J, Thurlimann B, Robertson JFR, 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;18:3748-57.
8. Bonneterre J, Buzdar A, Nabholtz JM, et al. Anastrozole ('Arimidex') is superior to tamoxifen as first-line therapy in hormone receptor-positive advanced breast cancer: results of two randomized trials designed for combined analysis. Cancer 2001;92:2248-58.
9. 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: 3758-67.
10. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatments. Cancer 1981;47:207-14.
11. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of Eastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-55.
12. WHO adverse reactions dictionary. Uppsala, Sweden: WHO Collaborating Center for International Drug Monitoring, 1988.
13. Milla L. Estudio comparativo de dos dosificaciones de tamoxifeno en el cáncer de mama avanzado [Abstract]. Oncologia 1996;19:49.
14. Miller WR. Estrogens and endocrine therapy for breast cancer. In: Miller WR, ed. Estrogens and breast cancer. Austin: Landes Co., 1996:125-50.
15. Miller WR. Aromatase inhibitors and breast cancer. Cancer Treat Rev 1997;23:171-87.
16. Lonning PE, Kvinnsland S. Mechanisms of action of aminoglutethimide as endocrine therapy of breast cancer. Drugs 1988;35:685-710.
17. Ibrahim NK, Buzdar AU. Aromatase inhibitors: current status. Am J Clin Oncol 1995;18:407-17.
18. Lonning PE. Pharmacology of new aromatase inhibitors. Breast 1996;5:202-8.
19. Stein RC, Dowsett M, Hedley A, et al. Treatment of advanced breast cancer in postmenopausal women with 4-hydroxyandrostenodione. Cancer Chemother Pharmacol 1990;26:75-8.
20. Buzdar AU, Smith R, Vogel C, et al. Fadrozole HCL (CSG-16949) versus megestrol acetate treatment of postmenopausal patients with metastatic breast carcinoma: results of two randomized double blind controlled multi-institutional trials. Cancer 1996;77: 2503-13.
21. Buzdar A, Jonat W, Howell A, et al. Anastrozole, a potent and selective aromatase inhibitor, versus megestrol acetate in post-menopausal women with advanced breast cancer: results and overview analysis of two phase III trials. J Clin Oncol 1996;14: 2000-11.
22. Buzdar A, Jonat W, Howell A, et al. Anastrozole versus megestrol acetate in the treatment of postmenopausal women with advanced breast carcinoma. Cancer 1998;83:1142-52.
23. Brown M. Estrogen receptor molecular biology. Hematol Oncol Clin North Am 1994;8:101-12.
24. Osborne CK, Coronado E, Alfred DC, et al. Acquired tamoxifen resistance: correlation with reduced breast tumor levels of tamoxifen and isomerization of trans-4-hydroxytamoxifen. J Natl Cancer Inst 1991;83:1477-82.
25. Fuqua SA, Fitzgerald SD, Alfred DC, et al. Inhibition of estrogen receptor action by a naturally occurring variant in human breast tumours. Cancer Res 1992;52:483-6.
26. Pakdel KD, Katzenellenbogen BS. Human estrogen receptor mutants with altered estrogen and antiestrogen ligand discrimination. J Biol Chem 1992;267:3429-37.
27. Howell A, Mackintosh J, Jones M, et al. The definition of the 'no change' category in patients treated with endocrine therapy and chemotherapy for advanced carcinoma of the breast. Eur J Cancer Clin Oncol 1988;24:1567-72.
28. Robertson JF, Willsher PC, Cheung KL, et al. The clinical relevance of static disease (no change) category for 6 months on endocrine therapy in patients with breast cancer. Eur J Cancer 1997;33:1774-9.
29. Robertson JF, Howell A, Buzdar A, et al. Static disease on anastrozole provides similar benefits as objective response in patients with advanced breast cancer. Breast Cancer Res Treat 1999;58:157-62.
30. Rose C, Mouridsen HT. Endocrine therapy of advanced breast cancer. Acta Oncol 1998;27:721-8.
31. Henderson IC. Endocrine therapy of metastatic breast cancer. Breast Dis 1991;2:559-603.