Clinical activity of fulvestrant in metastatic breast cancer previously treated with endocrine therapy and/or chemotherapy
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Background/Aims: We conducted a retrospective analysis of the clinical activity of fulvestrant in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) previously treated with endocrine therapy and/or chemotherapy. Methods: We reviewed the medical records of all patients with MBC treated at Samsung Medical Center between January 2009 and August 2016. Patients received fulvestrant 250 mg intramuscularly every 28 days (from January 2009 to November 2010) or 500 mg intramuscularly every 28 days (from December 2010 to August 2016). Tumor responses were assessed every 8 weeks and at the end of treatment, as well as when disease progression was suspected. Results: A total of 84 patients were included in this study. A median of two previous endocrine treatments had been performed; 79% of the patients had received two or more endocrine treatments. Forty-five patients (54%) had been treated with chemotherapy for MBC before the fulvestrant treatment course. Visceral metastasis was found in 49 patients (58%). The estimated median progression-free survival and overall survival were 4.4 months (95% confidence interval [CI], 3.4 to 5.5) and 32.5 months (95% CI, 17.6 to 47.4), respectively. The disease control rate was 40.5% (95% CI, 30.5 to 51.5); partial response was observed in 16% of the patients and stable disease was observed in 25% of the patients. The most frequently reported adverse reactions were mild-to-moderate grade myalgia (10.5% of the patients), injection site pain (7%), and fatigue (7%). Fulvestrant was generally well tolerated. Conclusions: Fulvestrant showed encouraging clinical activity and favorable feasibility in postmenopausal women with MBC who had been treated with multiple endocrine therapies and/or cytotoxic chemotherapies.
Abstract
Background/Aims: We conducted a retrospective analysis of the clinical activity of fulvestrant in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) previously treated with endocrine therapy and/or chemotherapy. Methods: We reviewed the medical records of all patients with MBC treated at Samsung Medical Center between January 2009 and August 2016. Patients received fulvestrant 250 mg intramuscularly every 28 days (from January 2009 to November 2010) or 500 mg intramuscularly every 28 days (from December 2010 to August 2016). Tumor responses were assessed every 8 weeks and at the end of treatment, as well as when disease progression was suspected. Results: A total of 84 patients were included in this study. A median of two previous endocrine treatments had been performed; 79% of the patients had received two or more endocrine treatments. Forty-five patients (54%) had been treated with chemotherapy for MBC before the fulvestrant treatment course. Visceral metastasis was found in 49 patients (58%). The estimated median progression-free survival and overall survival were 4.4 months (95% confidence interval [CI], 3.4 to 5.5) and 32.5 months (95% CI, 17.6 to 47.4), respectively. The disease control rate was 40.5% (95% CI, 30.5 to 51.5); partial response was observed in 16% of the patients and stable disease was observed in 25% of the patients. The most frequently reported adverse reactions were mild-to-moderate grade myalgia (10.5% of the patients), injection site pain (7%), and fatigue (7%). Fulvestrant was generally well tolerated. Conclusions: Fulvestrant showed encouraging clinical activity and favorable feasibility in postmenopausal women with MBC who had been treated with multiple endocrine therapies and/or cytotoxic chemotherapies.
참고문헌 (15)
- Cardoso F, "ESO-ESMO 2nd international consensus guidelines for advanced breast cancer(ABC2)", Breast, 23, pp.489~502 (2014)
- Robertson JF, "Pharmacokinetic profile of intramuscular fulvestrant in advanced breast cancer", Clin Pharmacokinet, 43, pp.529~538 (2004)
- Wakeling AE, "A potent specific pure antiestrogen with clinical potential", Cancer Res, 51, pp.3867~3873 (1991)
- Howell A, "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, pp.1605~1613 (2004)
- Howell A, "Fulves-trant, 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, pp.3396~3403 (2002)
- Robertson JF, "Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women : a prospective combined analysis of two multicenter trials", Cancer, 98, pp.229~238 (2003)
- Chia S, "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, pp.1664~1670 (2008)
- Fry DW, "Specific inhibition of cyclin-dependent kinase 4", 6 by PD 0332991 and associated antitumor activity in human tumor xenografts, 2004, pp.3, 1427~1438
- Toogood PL, "Discovery of a potent and selective inhibitor of cyclin-dependent kinase 4", 6, 2005, pp.48, 2388~2406
- Walker AJ, "FDA approval of palbociclib in combination with fulvestrant for the treatment of hormone receptor-positive, HER2-negative metastatic breast cancer", Clin Cancer Res, 22, pp.4968~4972 (2016)
- Cristofanilli M, "Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy(PALOMA-3) : final analysis of the multicentre, double-blind, phase 3 randomised controlled trial", Lancet Oncol, 17, pp.425~439 (2016)
- Eisenhauer EA, "New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)", Eur J Cancer, 45, pp.228~247 (2009)
- Howell A, "Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma : a prospectively planned combined survival analysis of two multicenter trials", Cancer, 104, pp.236~239 (2005)
- 정용식, "Nation-Wide Korean Breast Cancer Data from 2008 Using the Breast Cancer Registration Program", Journal of Breast Cancer, 14(3), pp.229~236 (2011), 한국유방암학회
- Di Leo A, "Final overall survival: fulvestrant 500 mg vs 250 mg in the randomized CONFIRM trial", J Natl Cancer Inst, 106, pp.djt337~ (2014)