J Breast Cancer.  2011 Jun;14(2):135-139. 10.4048/jbc.2011.14.2.135.

Efficacy of Fulvestrant in Heavily Pretreated Postmenopausal Women with Advanced Breast Cancer: A Preliminary Report

• Yoo C
• Kim SB
• Ahn JH
• Jung KH
• Ahn Y
• Gong G
• Kim HH
• Kim HJ
• Son BH
• Ahn SH

• KMID: 2286513
• DOI: http://doi.org/10.4048/jbc.2011.14.2.135

Abstract

PURPOSE
Fulvestrant, a potent estrogen receptor (ER) antagonist with a novel mechanism of action, has shown efficacy in pretreated patients with advanced breast cancer. We assessed the efficacy and tolerability of fulvestrant in Korean postmenopausal women.
METHODS
Of the 25 candidates identified at Asan Medical Center, Seoul, Korea, six were deemed ineligible due to inadequate baseline and follow-up imaging. The 19 patients included in this retrospective analysis received the approved dose of fulvestrant (250 mg intramuscular injection, once per month) as second- (n=8), third- (n=7), or fourth-line (n=4) endocrine therapy.
RESULTS
At a median follow-up of 7.4 months (range, 1.2-34.8 months), the 19 patients received a median of four cycles (range, 1-34 cycles) of fulvestrant. Median time to progression was 5.5 months (95% confidence interval [CI], 0.4-10.7 months), and median overall survival was 17.9 months (95% CI, 2.7-33.1 months). Among 17 evaluable patients, one (5.3%) achieved a partial response, 10 (52.6%) showed stable disease, and six (31.6%) showed progressive disease. The clinical benefit rate was 26.3%. Four patients (21.1%) reported adverse events, but all were grade 1 or 2.
CONCLUSION
Fulvestrant was effective and well tolerated in patients with advanced breast cancer who had been previously treated with several lines of endocrine and chemotherapeutic agents.

Keyword

Breast neoplasms; Endocrine therapy; Fulvestrant

MeSH Terms

Breast
Breast Neoplasms
Estradiol
Estrogens
Female
Follow-Up Studies
Humans
Injections, Intramuscular
Korea
Retrospective Studies
Estradiol
Estrogens

Figure

• 

  Figure 1 Time to progression (TTP) and overall survival (OS).

Reference

1. Osborne CK, Wakeling A, Nicholson RI. Fulvestrant: an oestrogen receptor antagonist with a novel mechanism of action. Br J Cancer. 2004. 90:Suppl 1. S2–S6.

2. Addo S, Yates RA, Laight A. A phase I trial to assess the pharmacology of the new oestrogen receptor antagonist fulvestrant on the endometrium in healthy postmenopausal volunteers. Br J Cancer. 2002. 87:1354–1359.

3. Osborne CK, Coronado-Heinsohn EB, Hilsenbeck SG, McCue BL, Wakeling AE, McClelland RA, 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. 1995. 87:746–750.

4. Osborne CK, Pippen J, Jones SE, Parker LM, Ellis M, Come S, et al. 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. 20:3386–3395.

5. Howell A, Robertson JF, Quaresma Albano J, Aschermannova A, Mauriac L, Kleeberg UR, et al. 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. 20:3396–3403.

6. Chia S, Gradishar W, Mauriac L, Bines J, Amant F, Federico M, et al. 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. 26:1664–1670.

7. Mlineritsch B, Psenak O, Mayer P, Moik M, Namberger K, Hauser-Kronberger C, et al. Fulvestrant ('Faslodex') in heavily pretreated postmenopausal patients with advanced breast cancer: single centre clinical experience from the compassionate use programme. Breast Cancer Res Treat. 2007. 106:105–112.

8. Steger GG, Bartsch R, Wenzel C, Pluschnig U, Hussian D, Sevelda U, et al. Fulvestrant ('Faslodex') in pre-treated patients with advanced breast cancer: a single-centre experience. Eur J Cancer. 2005. 41:2655–2661.

9. Safra T, Greenberg J, Ron IG, Ben-Yosef R, Inbar M, Sarid D, et al. Fulvestrant in heavily pretreated metastatic breast cancer: is it still effective as a very advanced line of treatment? Isr Med Assoc J. 2008. 10:339–343.

10. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000. 92:205–216.

11. Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, et al. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 2003. 13:176–181.

12. Robertson JF, Llombart-Cussac A, Rolski J, Feltl D, Dewar J, Macpherson E, et al. 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. 27:4530–4535.

13. Howell A, Robertson JF, Abram P, Lichinitser MR, Elledge R, Bajetta E, et al. 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. 22:1605–1613.

14. Howell A, Pippen J, Elledge RM, Mauriac L, Vergote I, Jones SE, et al. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma: a prospectively planned combined survival analysis of two multicenter trials. Cancer. 2005. 104:236–239.

15. Robertson JF. Fulvestrant (Faslodex): how to make a good drug better. Oncologist. 2007. 12:774–784.

16. Di Leo A, Jerusalem G, Petruzelka L, Torres R, Bondarenko I, Khasanov R, et al. Confirm: a phase III, randomized, parallel-group trial comparing fulvestrant 250 mg vs fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. Cancer Res. 2009. 69:24 Suppl. Abstract #25.

17. Young OE, Renshaw L, Macaskill EJ, White S, Faratian D, Thomas JS, et al. Effects of fulvestrant 750mg in premenopausal women with oestrogen-receptor-positive primary breast cancer. Eur J Cancer. 2008. 44:391–399.

18. Matsuno RK, Anderson WF, Yamamoto S, Tsukuma H, Pfeiffer RM, Kobayashi K, et al. Early- and late-onset breast cancer types among women in the United States and Japan. Cancer Epidemiol Biomarkers Prev. 2007. 16:1437–1442.