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Fulvestrant for systemic therapy of locally advanced or metastatic breast cancer in postmenopausal women: a systematic review

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Abstract

A systematic review was undertaken to examine all available evidence to develop and support clinical recommendations regarding the use of fulvestrant (Faslodex®) as systemic therapy of locally advanced or metastatic breast cancer in postmenopausal women. MEDLINE, EMBASE, American Society of Clinical Oncology Annual Meeting proceedings, San Antonio Breast Cancer Symposia proceedings, and the Cochrane Library were searched through to April of 2008 for reports of randomized controlled trials that met established inclusion criteria. Four relevant Phase III trials were available for inclusion based on established criteria. Three of four Phase III superiority trials found no significant difference between fulvestrant and control, either anastrozole or exemestane, across efficacy and safety endpoints following prior endocrine therapy failure, with two trials further confirming non-inferiority of fulvestrant to anastrozole retrospectively. Fulvestrant can therefore be considered as alternative therapy to anastrozole or exemestane in postmenopausal women with locally advanced or metastatic breast cancer that has recurred on prior adjuvant endocrine therapy or progressed on prior endocrine therapy for advanced disease. There are, however, important methodological concerns across reviewed trials that should be taken under consideration as they may limit the strength of such a conclusion.

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Acknowledgements

The authors would like to thank Hans Messersmith for contributing to the drafting of this systematic review. The Breast Cancer Disease Site Group thanks Breast Cancer Research and Treatment for their polite and expedient communications in handling the submission of this manuscript.

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Authors and Affiliations

  1. Department of Internal Medicine, Queen’s University, Etherington Hall, Room 3040, 94 Stuart Street, Kingston, ON, Canada, K7L 3N6

    Jennifer Flemming

  2. Cancer Centre of Southeastern Ontario, Kingston General Hospital, 25 King Street West, Kingston, ON, Canada, K7L 5P9

    Yolanda Madarnas

  3. Cancer Care Ontario, Program in Evidence-Based Care, Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West DTC, 3rd Floor, Hamilton, ON, Canada, L8S 4L8

    Jacob A. Franek

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  1. Jennifer Flemming
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Corresponding author

Correspondence to Jacob A. Franek.

Appendices

Appendix A

Combined search strategy applied to Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE

#

Search History

1

exp Breast Neoplasms/ or exp Breast Tumour/

2

((breast or mammary or mammarian) and (cancer? or carcinoma? or neoplasm? or tumo?r? or malignan$)).tw.

3

1 or 2

4

exp Neoplasm Metastasis/ or exp Metastasis/ or (metast$ or advance? or spread or progress$ or distan$ or stage 4 or stage IV or stage IIIB or stage 3B or stage III B or stage 3 B).tw.

5

3 and 4

6

exp Meta-Analysis/ or exp “Systematic Review”/ or meta-analysis.pt. or (meta analys?s or systematic review$ or pooled analys?s or statistical pooling or mathematical pooling or statistical summar$ or mathematical summar$).tw.

7

(exp Review Literature/ or exp Review/ or review.pt.) and systematic.tw.

8

6 or 7

9

guideline.pt. or exp Practice Guideline/ or exp Evidence-Based Medicine/ or (evidence based guideline or evidence based review or evidence based series or practice guideline).tw.

10

exp Phase 3 Clinical Trial/ or exp Phase 4 Clinical Trial/ or exp Randomized Controlled Trial/ or exp Clinical Trials, Phase III/ or exp Clinical Trials, Phase IV/ or exp Randomized Clinical Trials/

11

(clinical trial, phase III or clinical trial, phase IV or randomized controlled trial).pt.

12

(randomi$ control$ trial? or phase III or phase IV or phase 3 or phase 4).tw.

13

10 or 11 or 12

14

exp Clinical Trials/

15

(trial? or stud$ or phase 2 or phase II).tw.

16

(clinical trial or clinical trial, phase II or controlled clinical trial).pt.

17

(14 or 15 or 16) and random$.tw.

18

8 or 9 or 13 or 17

19

5 and 18

20

(fulvestrant or faslodex).tw. or exp Fulvestrant/

21

182780.tw.

22

182,780.tw.

23

20 or 21 or 22

24

23 and 5

25

24 and 19

26

(comment or letter or editorial or note or erratum or short survey or news or newspaper article or patient education handout).pt.

27

25 not 26

28

limit 27 to (human or humans)

29

limit 28 to english language

30

remove duplicates from 29

Appendix B

Fig. B
figure a

Flow diagram of literature results from search strategy, upto April, 2008. Cochrane Library of Systematic Reviews did not yield any relevant results and thus was not included. AOnline search strategy available in Appendix A. Abbreviations: ASCO, American Society of Clinical Oncologists; CENTRAL, Cochrane Central Register of Controlled Trails; EMBASE, Excerpta Medica; MEDLINE, Medical Literature Analysis and Retrieval System Online; SABCS, San Antonio Breast Cancer Symposium

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Flemming, J., Madarnas, Y. & Franek, J.A. Fulvestrant for systemic therapy of locally advanced or metastatic breast cancer in postmenopausal women: a systematic review. Breast Cancer Res Treat 115, 255–268 (2009). https://doi.org/10.1007/s10549-008-0137-8

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