Comparison of fulvestrant versus tamoxifen for the treatment of advanced breast cancer in postmenopausal women previously untreated with endocrine therapy: A multinational, double-blind, randomized trial

Journal of Clinical Oncology

Volumn 22, Issue 9, 2004, Pages 1605-1613

  Howell, Anthony ^a   Robertson, John F R ^a   Abram, Paul ^a   Lichinitser, Mikhail R ^a   Elledge, Richard ^a   Bajetta, Emilio ^a   Watanabe, Toru ^a   Morris, Charles ^a   Webster, Alan ^a   Dimery, Isaiah ^a   Osborne, C Kent ^a  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FULVESTRANT; PROGESTERONE RECEPTOR; TAMOXIFEN; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; DRUG DERIVATIVE; ESTRADIOL; ESTROGEN RECEPTOR;

ARTICLE; BREAST CANCER; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; FOLLOW UP; HORMONAL THERAPY; HUMAN; MULTICENTER STUDY; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; ADULT; AGED; BIOSYNTHESIS; BREAST TUMOR; COMPARATIVE STUDY; DISEASE COURSE; DISEASE FREE SURVIVAL; FEMALE; INTRAMUSCULAR DRUG ADMINISTRATION; MIDDLE AGED; ORAL DRUG ADMINISTRATION; PATHOLOGY;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, HORMONAL; BREAST NEOPLASMS; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; ESTRADIOL; FEMALE; HUMANS; INJECTIONS, INTRAMUSCULAR; MIDDLE AGED; RECEPTORS, ESTROGEN; RECEPTORS, PROGESTERONE; TAMOXIFEN;

EID: 2442648038     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2004.02.112     Document Type: Article

References (21)

1. Jaiyesimi IA, Buzdar AU, Decker DA, et al: Use of tamoxifen for breast cancer: Twenty-eight years later. J Clin Oncol 13:513-529, 1995
2. Early Breast Cancer Trialists' Collaborative Group. Tamoxifen for early breast cancer: An overview of the randomised trials. Lancet 351: 1451-1467, 1998
3. Fisher B, Costantino JP, Wickerham DL, et al: Tamoxifen for prevention of breast cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 90:1371-1388, 1998
4. Wakeling AE, Dukes M, Bowler J: A potent specific pure antiestrogen with clinical potential. Cancer Res 51:3867-3873, 1991
5. Osborne CK, Jarman M, McCague R, et al: The importance of tamoxifen metabolism in tamoxifen-stimulated breast tumor growth. Cancer Chemother Pharmacol 34:89-95, 1994
6. Osborne CK, Coronado-Heinsohn EB, Hilsenbeck SG, et al: Comparison of the effects of a pure steroidal antiestrogen with those of tamoxifen in a model of human breast cancer. J Natl Cancer Inst 87:746-750, 1995
7. Robertson JF, Nicholson RI, Bundred NJ, et al: Comparison of the short-term biological effects of 7alpha-[9-(4,4,5,5,5,- pentafluoropentylsulfinyl)-nonyl]estra-1,3,5, (10)-triene-3,17beta-diol (Faslodex) versus tamoxifen in postmenopausal women with breast cancer. Cancer Res 61:6739-6746, 2001
8. Howell A, Robertson JFR, Quaresma Albano J, et al: Fulvestrant (ICI 182,780) is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. J Clin Oncol 20:3396-3403, 2002
9. Osborne CK, Pippen J, Jones SE, et al: A double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant with anastrozole in post-menopausal women with advanced breast cancer progressing on prior endocrine therapy: Results of a North American trial. J Clin Oncol 20:3386-3395, 2002
10. Cella DF, Tulsky DS, Gray G. et al: The Functional Assessment of Cancer Therapy scale: Development and validation of the general measure. J Clin Oncol 11:570-579, 1993
11. Hurny C, Bernhard J, Coates A, et al: Responsiveness of a single-item indicator versus a multi-item scale: Assessment of emotional well-being in an international adjuvant breast cancer trial. Med Care 34:234-248, 1996
12. Brady MJ, Cella DF, Mo F, et al: Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol 15:974-986, 1997
13. 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 18:3748-3757, 2000
14. Nabholtz JM, Buzdar A, Pollak M: 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 18:3758-3767, 2000
15. Wittliff JL: Steroid-hormone receptors in breast cancer. Cancer 53:630-643, 1984
16. Jakesz R, Samonigg H, Hausmaninger H: Progesterone receptor quality and level have a significant prognostic and predictive impact in pre- and postmenopausal patients with hormone-responsive breast cancer: Six-year results of ABCSG trials 5 and 6. Breast Cancer Res Treat 76:45, 2002 (suppl 1, abstr 129)
17. Bardou VJ, Arpino G, Elledge RM, et al: Progesterone receptor status significantly improves outcome prediction over estrogen receptor status alone for adjuvant endocrine therapy in two large breast cancer databases. J Clin Oncol 21:1973-1979, 2003
18. Erikstein B, Robertson JFR, Osborne CK, et al: ICI 182.780 ('Faslodex') 250 mg monthly intramuscular (I. M.) injection shows consistent PK profile when given as either 1 × 5ml or 2 × 2.5 MI injections in postmenopausal women with advanced breast cancer (ABC). Proc Am Soc Clin Oncol 20:69, 2001 (abstr 2025)
19. Mouridsen H, Gershanovich M, Sun Y: 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 21:2101-2109, 2003
20. Nabholtz JM, Bonneterre J, Buzdar A: Anastrozole (Arimidex™) versus tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: Survival analysis and updated safety results. Eur J Cancer 39:1684-1689, 2003
21. Wakeling AE, Bowler J: Novel antioestrogens without partial agonist activity. J Steroid Biochem 31:645-653, 1988