Journal of Pharmacoeconomics and Pharmaceutical Management 2015. 1(2):49-52.

The Effectiveness of Fulvestrant in postmenopausal advanced breast cancer; systematic review of clinical evidence
Amir Hashemi-Meshkini, Khosro Keshavarz, Mehdi Varmaghani, Abbas Kebriaeezadeh, Shekoufeh Nikfar

Abstract


Background: In this study we aim to assess the clinical evidence on the effectiveness of Fulvestrant compared with other alternatives to explore whether it has any
advantage in the treatment outcomes of postmenopausal advanced breast cancer or not. Experimental: A systematic review was conducted through Medline, Scopus, ISI
Web of Science and Google Scholar. The used keywords were “Fulvestrant” and “breast cancer”, and the search was limited to articles published during 1990- 2012. The
inclusion criteria were English language studies on advanced breast cancer and with one arm of Fulvestrant. The outcomes of interest included time to progression (TTP),
objective response (OR), clinical benefit (CB), time to treatment failure (TTF) and overall survival (OS). Results: The included studies were classified into two groups based on
the Fulvestrant arm: “Fulvestrant as single treatment strategy” and “Fulvestrant as combination treatment strategy”. In the first group the included studies comparing
Fulvestrant with Anastrozole (three reports), Exemestane (one report) and Tamoxifen (one report) indicated no significant advantage of Fulvestrant. In second group based
on one study there was no significant difference between Anastrozol and Fulvestrant compared with Fulvestrant in terms of TTP, CB, OR, TTF, and OS and based on the
second randomized controlled trial (RCT) the combination therapy was significantly more effective in term of OS and TTP but not CB and OR. Conclusion: Regarding the
reviewed evidence, Fulvestrant neither as single treatment strategy compared with Exemestane, Anastrozole and Tamoxifen nor as combination treatment strategy by being
added to Anastrozole could be considered advantageous in term of effectiveness.

Keywords


Breast cancer, Effectiveness, Evidence-based medicine, Fulvestrant, Systematic review.

Full Text:

PDF

References


(1) Screening for Breast Cancer. Available at: http://www.who.int/cancer/

detection/breastcancer/en. Access date: March 2012.

(2) Bray F, McCarron P, Parkin DM. The changing global patterns of

female breast cancer incidence and mortality. Breast Cancer

Res. 2004; 6(6):229-239.

(3) Mousavi SM, Montazeri A, Mohagheghi AM, et al. Breast Cancer in

Iran: An Epidemiological Review. Breast J. 2007;13(4):383-91.

(4) Davari M, Yazdanpanah F, Aslani A, Hosseini M, Nazari AR, Mokarian

F. The direct medical costs of breast cancer in Iran: Analyzing the

Patient's Level Data from a Cancer Specific Hospital in Isfahan. Int J

Prev Med. 2013; 4(7): 748–754.

(5) Bross PF, Cohen MH, Williams GA, Pazdur R. FDA Drug Approval

Summaries: Fulvestrant. The Oncologist 2002; 7(4):77-480.

(6) Buzdar AU. Endocrine therapy in the treatment of metastatic breast

cancer. Semin Oncol 2001; 28:291-304.

(7) Jordan VC. The development of tamoxifen for breast cancer therapy.

In: Jordan VC, ed. Long-term tamoxifen treatment for breast cancer.

Madison: University of Wisconsin Press, 1994:3-26.

(8) Fulvestrant drug details [online]. http://www.accessdata.fda.gov/

scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails.

Access date: April 2012.

(9) 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-3,17betadiol

(Faslodex) versus tamoxifen in postmenopausal women with

primary breast cancer. Cancer Res. 2001; 61(18):6739-46.

(10) Muylder XD, Neven P, Belle VY. Tamoxifen and benign endometrial

lesions. Eur J Cancer 1998; 34 (Suppl. 4): S18-S19.

(11) Jadad, A. Randomized controlled trials. BMJ Books, London 1998.

(12) Howell A, Robertson JFR, Albano Q, Aschermannova A, Mauriac L,

Kleeberg UR, et al. Fulvestrant, Formerly ICI 182,780, is aseffective

as anastrozole in postmenopausal women with advanced breast

cancer progressing after prior endocrine treatment. J Clin Oncol.

; 20(16):3396-403.

(13) Osborne CK, Pippen J, Jones SE, Parker LM, Ellis M, Comes S, et al.

Double-blind, randomized trial comparing the effectiveness 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;

(16):3386-95.

(14) Xu B, Jiang Z, Shao Z, Wang J, Feng J, Song S, et al. Fulvestrant 250

mg versus anastrozole for Chinese patients with advanced breast

cancer: results of a multicentre, double-blind, randomized phase III

trial. Cancer Chemother Pharmacol 2011; 67:223–230.

(15) Chia S, Gradishar W, Mauriac L, Bines J, Amant F, 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;

(10). DOI: 10.1200/JCO.2007.13.5822.

(16) Howell A, Robertson JFR, 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(9): 1605-1613.

(17) Bergh J, Jonsson PE, Lidbrink EK, Trudeau M, Eiermann W,

Brattstrom D, et al. FACT: An open-label randomized phase III study

of Fulvestrant and anastrozole in combination compared with

anastrozole alone as first-line therapy for patients with receptorpositive

postmenopausal breast cancer. J Clin Oncol. 2012;

(16):1919-1925.

(18) Mehta RS, Barlow WE, Albain KS, Vandenberg TA, Dakhil SR, Tirumali

NR, et al. Combination anastrozole and Fulvestrant in metastatic

breast cancer. N Engl J Med 2012; 367:435-44.

(19) Mauriac L, Romieu G, Bines J. Activity of Fulvestrant versus

exemestane in advanced breast cancer patients with or without

visceral metastases: data from the EFECT trial. Breast Cancer Res

Treat 2009; 117:69–75.

(20) Al-Mubarak M, Sacher AG, Ocana A, Vera-Badillo F, Seruga B, Amir

E. Fulvestrant for advanced breast cancer: A meta-analysis. Cancer

Treat Rev. 2013; 39(7):753-8.

(21) Tan PS, Haaland B, Montero AJ, Lopes G. A meta-analysis of

anastrozole in combination with Fulvestrant in the first line

treatment of hormone receptor positive advanced breast

cancer. Breast Cancer Res Treat. 2013; 138(3):961-5.

(22) Hashemi-Meshkini A, Keshavarz K, Gharibnaseri Z, Kheirandish M,

Kebriaeezadeh A, Nikfar S, Abdollahi M. Cost-effectiveness analysis

review of exemestane in the treatment of primary and advanced

breast cancer. Arch Med Sci. 2013 June 20; 9(3): 472–478.


Refbacks

  • There are currently no refbacks.


Creative Commons Attribution-NonCommercial 3.0

This work is licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License which allows users to read, copy, distribute and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited properly.