Fulvestrant revisited: Efficacy and safety of the 500-mg dose

Clinical Breast Cancer

Volumn 11, Issue 4, 2011, Pages 204-210

  Howell, Anthony ^a   Sapunar, Francisco ^b  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b ASTRAZENECA   (United Kingdom)

Author keywords

Advanced breast cancer; Faslodex; Fulvestrant; Hormone receptor; Postmenopausal

Indexed keywords

ANASTROZOLE; ESTROGEN RECEPTOR; EXEMESTANE; FULVESTRANT; TAMOXIFEN;

ARTHROPATHY; BREAST CANCER; CARDIOVASCULAR DISEASE; CROSS RESISTANCE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; GASTROINTESTINAL SYMPTOM; HOT FLUSH; HUMAN; INJECTION SITE REACTION; LOADING DRUG DOSE; METASTASIS; OSTEOPOROSIS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POSTMENOPAUSE; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENT CANCER; REVIEW; RISK BENEFIT ANALYSIS; SIDE EFFECT; SINGLE DRUG DOSE; THROMBOEMBOLISM; URINARY TRACT INFECTION; VAGINITIS; WEIGHT GAIN;

EID: 80052736785     PISSN: 15268209     EISSN: 19380666     Source Type: Journal    
DOI: 10.1016/j.clbc.2011.02.002     Document Type: Review

References (38)

1. J. Ferlay, P. Autier, and M. Boniol Estimates of the cancer incidence and mortality in Europe in 2006 Ann Oncol 18 2007 581 592 (Pubitemid 46359643)
2. A. Jemal, R. Siegel, and E. Ward Cancer statistics, 2009 CA Cancer J Clin 59 2009 225 249
3. F. Cardoso, and M. Castiglione Locally recurrent or metastatic breast cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up Ann Oncol 20 suppl 4 2009 15 18
4. V. Guarneri, and P.F. Conte The curability of breast cancer and the treatment of advanced disease Eur J Nucl Med Mol Imaging 31 suppl 1 2004 S149 S161
5. S. Harichand-Herdt, A. Zelnak, and R. O'Regan Endocrine therapy for the treatment of postmenopausal women with breast cancer Expert Rev Anticancer Ther 9 2009 187 198
6. H. Mouridsen, M. Gershanovich, and Y. Sun 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 19 2001 2596 2606 (Pubitemid 32451796)
7. R.J. Paridaens, L.Y. Dirix, and L.V. Beex Phase III study comparing exemestane with tamoxifen as first-line hormonal treatment of metastatic breast cancer in postmenopausal women: the European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group J Clin Oncol 26 2008 4883 4890
8. J. Bonneterre, B. Thrlimann, and J.F. Robertson 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 2000 3748 3757
9. J.M. Nabholtz, A. Buzdar, and M. Pollak 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 2000 3758 3767
10. D. Dodwell, A. Wardley, and S. Johnston Postmenopausal advanced breast cancer: options for therapy after tamoxifen and aromatase inhibitors Breast 15 2006 584 594 (Pubitemid 44509773)
11. A.E. Wakeling, M. Dukes, and J. Bowler A potent specific pure antiestrogen with clinical potential Cancer Res 51 1991 3867 3873
12. S. Chia, W. Gradishar, and L. Mauriac 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 26 2008 1664 1670
13. J.N. Ingle, V.J. Suman, and K.M. Rowland Fulvestrant in women with advanced breast cancer after progression on prior aromatase inhibitor therapy: North Central Cancer Treatment Group trial N0032 J Clin Oncol 24 2006 1052 1056 (Pubitemid 46638801)
14. P. Neven, R. Paridaens, and G. Pelgrims Fulvestrant (Faslodex™) in advanced breast cancer: clinical experience from a Belgian cooperative study Breast Cancer Res Treat 109 2008 59 65 (Pubitemid 351538758)
15. L. Perey, R. Paridaens, and H. Hawle Clinical benefit of fulvestrant in postmenopausal women with advanced breast cancer and primary or acquired resistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical Cancer Research Trial (SAKK 21/00) Ann Oncol 18 2007 64 69 (Pubitemid 46152501)
16. A. Howell, J.F.R. Robertson, and J. Quaresma Albano 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 20 2002 3396 3403
17. C.K. Osborne, J. Pippen, and S.E. Jones A 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 North American trial J Clin Oncol 20 2002 3386 3395
18. J.F. Robertson, C.K. Osborne, and A. Howell Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women: a prospective combined analysis of two multicenter trials Cancer 98 2003 229 238 (Pubitemid 36828445)
19. J.F. Robertson, R.I. Nicholson, and N.J. Bundred 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 61 2001 6739 6746 (Pubitemid 32896496)
20. D.J. DeFriend, A. Howell, and R.I. Nicholson Investigation of a new pure antiestrogen (ICI 182780) in women with primary breast cancer Cancer Res 54 1994 408 414 (Pubitemid 24053178)
21. J.F. Robertson, B. Erikstein, and K.C. Osborne Pharmacokinetic profile of intramuscular fulvestrant in advanced breast cancer Clin Pharmacokinet 43 2004 529 538 (Pubitemid 38858305)
22. J.F.R. Robertson Fulvestrant (Faslodex) - how to make a good drug better Oncologist 12 2007 774 784 (Pubitemid 47328221)
23. A. Di Leo, G. Jerusalem, and L. Petruzelka 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 28 2010 4594 4600
24. Fujiwara Y, Ohno S, Iwata H, et al. Tolerability of fulvestrant high-dose (HD) in postmenopausal Japanese women with hormone receptor-positive (HR+) advanced (ABC) or recurrent breast cancer (RBC). Abstract 192 presented at the ASCO Breast Cancer Symposium, San Francisco, CA, USA September 7-8, 2007.
25. I. Kuter, R. Hegg, and C.F. Singer Fulvestrant 500 mg vs 250 mg: first results from NEWEST, a randomized, phase II neoadjuvant trial in postmenopausal women with locally advanced, estrogen receptor-positive breast cancer Breast Cancer Res Treat 106 suppl 1 2007 S7 (abstr 23)
26. S. Ohno, Y. Rai, and H. Iwata Three dose regimens of fulvestrant in postmenopausal Japanese women with advanced breast cancer: results from a double-blind, phase II comparative study (FINDER1) Ann Oncol 21 2010 2342 2347
27. K.I. Pritchard, J. Rolski, and Z. Papai Results of a phase II study comparing three dosing regimens of fulvestrant in postmenopausal women with advanced breast cancer (FINDER2) Breast Cancer Res Treat 123 2010 453 461
28. J.F.R. Robertson, A. Llombart, and J. Rolski 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 27 2009 4530 4535
29. P. McCormack, and F. Sapunar Pharmacokinetic profile of the fulvestrant loading dose regimen in postmenopausal women with hormone receptor-positive advanced breast cancer Clin Breast Cancer 8 2008 347 351
30. I. Kuter, F. Sapunar, and P. McCormack Pharmacokinetic profile of fulvestrant 500 mg vs 250 mg: results from the NEWEST study J Clin Oncol 26 2008 (abstr 579)
31. J.F.R. Robertson, J. Lindemann, and A. Llombart-Cussac A comparison of fulvestrant 500 mg with anastrozole as first-line treatment for advanced breast cancer: Follow-up analysis from the 'FIRST' study Cancer Res 70 2010 76s
32. R.W. Carlson, and I.C. Henderson Sequential hormonal therapy for metastatic breast cancer after adjuvant tamoxifen or anastrozole Breast Cancer Res Treat 80 suppl 1 2003 S19 S26
33. G. Arpino, L. Wiechmann, and C.K. Osborne Crosstalk between the estrogen receptor and the HER tyrosine kinase receptor family: molecular mechanism and clinical implications for endocrine therapy resistance Endocr Rev 29 2008 217 233 (Pubitemid 351519691)
34. Early Breast Cancer Trialists' Collaborative Group Tamoxifen for early breast cancer: an overview of the randomised trials Lancet 351 1998 1451 1467
35. M.N. Levine, M. Gent, and J. Hirsh The thrombogenic effect of anticancer drug therapy in women with stage II breast cancer N Engl J Med 318 1988 404 407 (Pubitemid 18044179)
36. 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 365 2005 60 62
37. P.E. Goss, J.N. Ingle, and S. Martino A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer N Engl J Med 349 2003 1793 1802 (Pubitemid 37362955)
38. A. Howell, J.F.R. Robertson, and P. Abram 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 22 2004 1605 1613 (Pubitemid 41079798)