Emerging data on the efficacy and safety of fulvestrant, a unique antiestrogen therapy for advanced breast cancer

Bibliography

• Normanno N, Di Maio M, De Maio E, on behalf of the NCI-Naples Breast Cancer Group. Mechanisms of endocrine resistance and novel therapeutic strategies in breast cancer. Endocr Relat Cancer 2005;12:721-47
   PubMed Web of Science ®Google Scholar
• Wakeling AE, Bowler J. Steroidal pure antioestrogens. J Endocrinol 1987;112:R7-10
   PubMed Web of Science ®Google Scholar
• Wakeling AE. Similarities and distinctions in the mode of action of different classes of antioestrogens. Endocr Relat Cancer 2000;7:17-28
   PubMed Web of Science ®Google Scholar
• Faslodex (fulvestrant) Injection [prescribing information]. AstraZeneca Pharmaceuticals LP; Wilmington, DC: 2004
   Google Scholar
• Alarid ET, Bakopoulos N, Solodin N. Proteasome-mediated proteolysis of estrogen receptor: a novel component in autologous down-regulation. Mol Endocrinol 1999;13:1522-34
   PubMed Web of Science ®Google Scholar
• Nawaz Z, Lonard D, Dennis A, Proteasome-dependent degradation of the human estrogen receptor. Proc Natl Acad Sci USA 1999;96:1858-62
   PubMed Web of Science ®Google Scholar
• Lonard D, Nawaz Z, Smith CL, O'Malley BW. The 26S proteasome is required for estrogen receptor-alpha and coactivator turnover and for efficient estrogen receptor- alpha transactivation. Mol Cell 2000;5:939-48
   PubMed Web of Science ®Google Scholar
• Wijayaratne AL, McDonnell DP. The human estrogen receptor-alpha is a ubiquitinated protein whose stability is affected differentially by agonists, antagonists, and selective estrogen receptor modulators. J Biol Chem 2001;276:35684-92
   PubMed Web of Science ®Google Scholar
• McKenna NJ, Lanz RB, O'Malley BW. Nuclear receptor coregulators: cellular and molecular biology. Endocr Rev 1999;20:321-44
   PubMed Web of Science ®Google Scholar
• Tzukerman MT, Esty A, Santiso-Mere D, Human estrogen receptor transactivational capacity is determined by both cellular and promoter context and mediated by two functionally distinct intramolecular regions. Mol Endocrinol 1994;8:21-30
   PubMed Web of Science ®Google Scholar
• Wakeling AE, Dukes M, Bowler J. A potent specific pure antiestrogen with clinical potential. Cancer Res 1991;51:3867-73
   PubMed Web of Science ®Google Scholar
• Robertson JF, Nicholson RI, Bundred NJ, 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 primary breast cancer. Cancer Res 2001;61:6739-46
   PubMed Web of Science ®Google Scholar
• Lupien M, Meyer CA, Bailey ST, Growth factor stimulation induces a distinct ERa cistrome underlying breast cancer endocrine resistance. Genes Dev 2010;24:2219-27
   PubMed Web of Science ®Google Scholar
• Massarweh S, Schiff R. Resistance to endocrine therapy in breast cancer: exploiting estrogen receptor/growth factor signaling crosstalk. Endocr Relat Cancer 2006;13(Suppl 1):S15-24
   PubMedGoogle Scholar
• Osborne CK, Jarman M, McCague R, The importance of tamoxifen metabolism in tamoxifen-stimulated breast tumor growth. Cancer Chemother Pharmacol 1994;34:89-95
   PubMed Web of Science ®Google Scholar
• Osborne CK, Coronado-Heinsohn E, Hilsenbeck SG, Comparison of the effects of the effects of a pure antiestrogen with those of tamoxifen in a model of human breast cancer. J Natl Cancer Inst 1995;87(5):746-50
   PubMedGoogle Scholar
• Lykkesfeldt AE, Madsen MW, Briand P. Altered expression of estrogen-regulated genes in a tamoxifen-resistant and ICI 164,384 and ICI 182,780 sensitive human breast cancer cell line, MCF-7/TAMR-1. Cancer Res 1994;54:1587-95
   PubMed Web of Science ®Google Scholar
• Hu XF, Veroni M, De LM, Circumvention of tamoxifen resistance by the pure anti-estrogen ICI 182,780. Int J Cancer 1993;55:873-6
   PubMed Web of Science ®Google Scholar
• Howell A, DeFriend DJ, Blamey RW, Response to a specific antiestrogen (ICI 182780) in tamoxifen-resistant breast cancer. Lancet 1995;345(8941):911561-1
   Google Scholar
• Osborne CK, Pippen J, Jones SE, Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial. J Clin Oncol 2002;20:3386-95
   PubMed Web of Science ®Google Scholar
• Howell A, Robertson JFR, Quaresma Albano J, Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. J Clin Oncol 2002;20:3396-403
   PubMed Web of Science ®Google Scholar
• Robertson JF, Osborne CK, Howell A, Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women: a prospective combined analysis of two multicenter trials. Cancer 2003;98:229-38
   PubMed Web of Science ®Google Scholar
• Howell A, Pippen J, Elledge RM, Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma: a prospectively planned combined survival analysis of two multicenter trials. Cancer 2005;104:236-9
   PubMed Web of Science ®Google Scholar
• Howell A, Robertson JFR, Abram P, 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. J Clin Oncol 2004;22:1605-13
   PubMed Web of Science ®Google Scholar
• Chia S, Gradishar W, Mauriac L, Double-blind, randomized placebo controlled trial of fulvestrant compared with exemestane after prior nonsteroidal aromatase inhibitor therapy in postmenopausal women with hormone receptor-positive, advanced breast cancer: results from EFECT. J Clin Oncol 2008;26:1664-70
   PubMed Web of Science ®Google Scholar
• Robertson JFR. Fulvestrant (Faslodex®) — how to make a good drug better. Oncologist 2007;12:774-84
   PubMed Web of Science ®Google Scholar
• Pritchard KI, Rolski J, Papai Z, Results of a phase II study comparing three dosing regimens of fulvestrant in postmenopausal women with advanced breast cancer (FINDER2). Breast Cancer Res Treat 2010;123(2):453-61
   PubMed Web of Science ®Google Scholar
• Come SE, Parker LM, Wulf G, Tolerability and efficacy of 500 mg fulvestrant in postmenopausal women with estrogen receptor (ER)+ advanced breast cancer. J Clin Oncol 2009;27(Suppl 15); abstract 1050
   PubMed Web of Science ®Google Scholar
• Robertson JFR, Llombart-Cussac A, Rolski J, Activity of fulvestrant 500 mg versus anastrozole 1 mg as first-line treatment for advanced breast cancer: results from the FIRST study. J Clin Oncol 2009;27:4530-5
   PubMed Web of Science ®Google Scholar
• Robertson JFR, Lindemann JPO, Llombart-Cussac A, A comparison of fulvestrant 500 mg with anastrozole as first-line treatment for advanced breast cancer: follow-up analysis from the ‘FIRST’ study. Abstract presented at the 33rd San Antonio Breast Cancer Symposium; 8 – 12 December 2010
   Google Scholar
• Di Leo A, Jerusalem G, Petruzelka L, Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol 2010;28(30):4594-600
   PubMed Web of Science ®Google Scholar
• Brodie A, Jelovac D, Sabnis G, Model systems: mechanisms involved in the loss of sensitivity to letrozole. J Steroid Biochem Mol Biol 2005;95:41-8
   PubMed Web of Science ®Google Scholar
• Brodie A, Sabnis G, Jelovac D. Aromatase and breast cancer. J Steroid Biochem Mol Biol 2006;102:97-102
   PubMed Web of Science ®Google Scholar
• Long BJ, Jelovac D, Handratta V, Therapeutic strategies using the aromatase inhibitor letrozole and tamoxifen in a breast cancer model. J Natl Cancer Inst 2004;96(6):456-65
   PubMed Web of Science ®Google Scholar
• Jelovac D, Macedo L, Goloubeva OG, Additive antitumor effect of aromatase inhibitor letrozole and antiestrogen fulvestrant in a postmenopausal breast cancer model. Cancer Res 2005;65:5439-44
   PubMed Web of Science ®Google Scholar
• Bergh J, Jonsson PE, Lidbrink E, First results from FACT – An open-label, randomized phase III study investigating loading dose of fulvestrant combined with anastrozole versus anastrozole at first relapse in hormone receptor positive breast cancer. Abstract presented at: 32nd Annual San Antonio Breast Cancer Symposium; 9 – 13 December 2009; San Antonio, TX
   Google Scholar
• Robertson JFR, Dixon JM, Sibbering DM, Tumor biomarker changes following pre-surgical treatment with 500 mg fulvestrant plus anastrozole versus 500 mg fulvestrant alone and 1 mg anastrozole alone. Abstract presented at: 32nd Annual San Antonio Breast Cancer Symposium; 9 – 13 December 2009; San Antonio, TX
   Google Scholar
• ClinicalTrials.gov [Web site] Anastrozole With or Without Fulvestrant as First-Line Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer. Available from: http://www.clinicaltrials.gov/ct/show/NCT00075764 [Accessed 2 February 2010]
   Google Scholar
• ClinicalTrials.gov [Web site]. Fulvestrant With or Without Anastrozole or Exemestane Alone in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer. Available from: http://www.clinicaltrials.gov/ct/show/NCT00253422 [Accessed 2 February 2010]
   Google Scholar
• Young OE, Renshaw L, Macaskill EJ, Effects of fulvestrant 750 mg in premenopausal women with oestrogen-receptor positive primary breast cancer. Eur J Cancer 2008;44(3):391-9
   PubMed Web of Science ®Google Scholar
• Chlebowski RT, Geller ML. Adherence to endocrine therapy for breast cancer. Oncology 2006;71:1-9
   PubMed Web of Science ®Google Scholar
• Barron TI, Connolly R, Bennett K, Early discontinuation of tamoxifen: a lesson for oncologists. Cancer 2007;109:832-9
   PubMed Web of Science ®Google Scholar
• Partridge AH, LaFountain A, Mayer E, Adherence to initial adjuvant anastrozole therapy among women with early-stage breast cancer. J Clin Oncol 2008;26:556-62
   PubMed Web of Science ®Google Scholar
• Hershman DL, Kushi LH, Shao T, Early discontinuation and nonadherence to adjuvant hormonal therapy in a cohort of 8,769 early-stage breast cancer patients. J Clin Oncol 2010;28(27):4120-8
   PubMed Web of Science ®Google Scholar
• Macedo LF, Sabnis G, Brodie A. Preclinical modeling of endocrine response and resistance: focus on aromatase inhibitors. Cancer 2008;112:679-88
   PubMed Web of Science ®Google Scholar
• Santen RJ, Song RX, Zhang Z, Adaptive hypersensitivity to estrogen: mechanism for sequential responses to hormonal therapy in breast cancer. Clin Cancer Res 2004;10:337S-45S
   PubMed Web of Science ®Google Scholar
• Crew KD, Greenlee H, Capodice J, Prevalence of joint symptoms in postmenopausal women taking aromatase inhibitors for early-stage breast cancer. J Clin Oncol 2007;25:3877-83
   PubMed Web of Science ®Google Scholar