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Efficacy of fulvestrant in the treatment of postmenopausal women with endocrine-resistant advanced breast cancer in routine clinical practice

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A Correction to this article was published on 03 October 2018

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Abstract

Introduction

This study aimed to describe the efficacy of fulvestrant 500 mg in postmenopausal women with estrogen receptor (ER)-positive advanced/metastatic breast cancer who had disease progression after receiving anti-estrogen therapy in clinical practice, getting real-world data.

Materials and methods

Multicenter, retrospective, observational study conducted in Spain. Postmenopausal women with locally advanced/metastatic ER-positive breast cancer who received treatment with fulvestrant 500 mg after progression with a previous anti-estrogen therapy were eligible. The primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), clinical benefit rate (CBR), duration of clinical benefit (DoCB), and safety profile.

Results

A total of 263 women were evaluated (median age, 65.8 years). At a median follow-up of 21.5 months, median PFS and OS were 10.6 and 43.2 months, respectively. PFS according to 1st, 2nd, 3rd, and ≥ 4th lines were 11.5, 10.6, 9.9, and 8.5 months, respectively (p = 0.0245). PFS in patients with visceral involvement was 10 months vs 10.6 months in patients without visceral involvement (p = 0.6604), 9.6 months in patients with high Ki67 vs 10 months in patients with low Ki67 (p = 0.7224), and 10.2 months in HER2+ patients vs 10.3 months in HER2− patients (p = 0.6809). The CBR was 56.5% and the DoCB was 18.4 months. The most frequently adverse events were injection site pain (10.3%) and musculoskeletal disorders (7.6%).

Conclusions

Fulvestrant 500 mg administered in clinical practice was shown to be effective (PFS, 10.6 months; CBR, 56.5%) and well tolerated, in accordance with previous trials.

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Change history

  • 03 October 2018

    A sentence under ‘Results’ heading in the Abstract section was published incorrectly. The correct sentence should read as follows:

References

  1. Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015;65(2):87–108.

    Article  Google Scholar 

  2. Hashim D, Boffetta P, La Vecchia C, Rota M, Bertuccio P, Malvezzi M, Negri E. The global decrease in cancer mortality: trends and disparities. Ann Oncol. 2016;27(5):926–33.

    Article  CAS  PubMed  Google Scholar 

  3. Dunnwald LK, Rossing MA, Li CI. Hormone receptor status, tumor characteristics, and prognosis: a prospective cohort of breast cancer patients. Breast Cancer Res. 2007;9(1):R6.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. Miller WR. Aromatase inhibitors: prediction of response and nature of resistance. Expert Opin Pharmacother. 2010;11(11):1873–87.

    Article  CAS  PubMed  Google Scholar 

  5. Robertson JF. Fulvestrant (Faslodex)—how to make a good drug better. Oncologist. 2007;12(7):774–84.

    Article  CAS  PubMed  Google Scholar 

  6. Howell A, Robertson JF, Quaresma AJ, 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(16):3396–403.

    Article  CAS  PubMed  Google Scholar 

  7. 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(16):3386–95.

    Article  CAS  PubMed  Google Scholar 

  8. 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(9):1605–13.

    Article  CAS  PubMed  Google Scholar 

  9. Di LA, Jerusalem G, Petruzelka L, Torres R, Bondarenko IN, Khasanov R, et al. 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. 2010;28(30):4594–600.

    Article  CAS  Google Scholar 

  10. Di LA, Jerusalem G, Petruzelka L, Torres R, Bondarenko IN, Khasanov R, et al. Final overall survival: fulvestrant 500 mg vs 250 mg in the randomized CONFIRM trial. J Natl Cancer Inst. 2014;106(1):djt337.

    Article  CAS  Google Scholar 

  11. Summary of Product Characteristics. Faslodex 250 mg solution for injection. 2015. https://www.medicines.org.uk/emc/medicine/14381. Accessed 15 Mar 16.

  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(27):4530–5.

    Article  CAS  PubMed  Google Scholar 

  13. Robertson JF, Lindemann JP, Llombart-Cussac A, Rolski J, Feltl D, Dewar J, et al. Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of advanced breast cancer: follow-up analysis from the randomized ‘FIRST’ study. Breast Cancer Res Treat. 2012;136(2):503–11.

    Article  CAS  PubMed  Google Scholar 

  14. Ellis MJ, Llombart-Cussac A, Feltl D, Dewar JA, Jasiowka M, Hewson N, et al. Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of advanced breast cancer: overall survival analysis from the phase ii first study. J Clin Oncol. 2015;33(32):3781–7.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  15. Migliaccio I, Malorni L, Hart CD, Guarducci C, Di LA. Endocrine therapy considerations in postmenopausal patients with hormone receptor positive, human epidermal growth factor receptor type 2 negative advanced breast cancers. BMC Med. 2015;13:46.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  16. Iorfida M, Maiorano E, Orvieto E, Maisonneuve P, Bottiglieri L, Rotmensz N, et al. Invasive lobular breast cancer: subtypes and outcome. Breast Cancer Res Treat. 2012;133(2):713–23.

    Article  CAS  PubMed  Google Scholar 

  17. Wasif N, Maggard MA, Ko CY, Giuliano AE. Invasive lobular vs. ductal breast cancer: a stage-matched comparison of outcomes. Ann Surg Oncol. 2010;17(7):1862–9.

    Article  PubMed  Google Scholar 

  18. Adachi Y, Ishiguro J, Kotani H, Hisada T, Ichikawa M, Gondo N, et al. Comparison of clinical outcomes between luminal invasive ductal carcinoma and luminal invasive lobular carcinoma. BMC Cancer. 2016;16(1):248.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  19. Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, et al. Molecular portraits of human breast tumours. Nature. 2000;406(6797):747–52.

    Article  CAS  Google Scholar 

  20. Prat A, Perou CM. Deconstructing the molecular portraits of breast cancer. Mol Oncol. 2011;5(1):5–23.

    Article  CAS  PubMed  Google Scholar 

  21. Anderson WF, Chu KC, Chatterjee N, Brawley O, Brinton LA. Tumor variants by hormone receptor expression in white patients with node-negative breast cancer from the surveillance, epidemiology, and end results database. J Clin Oncol. 2001;19(1):18–27.

    Article  CAS  PubMed  Google Scholar 

  22. Dowsett M, Allred C, Knox J, Quinn E, Salter J, Wale C, et al. Relationship between quantitative estrogen and progesterone receptor expression and human epidermal growth factor receptor 2 (HER-2) status with recurrence in the arimidex, tamoxifen, alone or in combination trial. J Clin Oncol. 2008;26(7):1059–65.

    Article  CAS  PubMed  Google Scholar 

  23. Viale G, Regan MM, Maiorano E, Mastropasqua MG, Dell’Orto P, Rasmussen BB, et al. Prognostic and predictive value of centrally reviewed expression of estrogen and progesterone receptors in a randomized trial comparing letrozole and tamoxifen adjuvant therapy for postmenopausal early breast cancer: BIG 1-98. J Clin Oncol. 2007;25(25):3846–52.

    Article  PubMed  Google Scholar 

  24. Inic Z, Zegarac M, Inic M, Markovic I, Kozomara Z, Djurisic I, et al. Difference between luminal A and luminal B subtypes according to Ki-67, tumor size, and progesterone receptor negativity providing prognostic information. Clin Med Insights Oncol. 2014;8:107–11.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  25. Untch M, Gerber B, Harbeck N, Jackisch C, Marschner N, Mobus V, et al. 13th st. Gallen international breast cancer conference 2013: primary therapy of early breast cancer evidence, controversies, consensus—opinion of a german team of experts (zurich 2013). Breast Care (Basel). 2013;8(3):221–9.

    Google Scholar 

  26. Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, et al. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009;27(33):5538–46.

    Article  CAS  PubMed  Google Scholar 

  27. Kaufman B, Mackey JR, Clemens MR, Bapsy PP, Vaid A, Wardley A, et al. Trastuzumab plus anastrozole versus anastrozole alone for the treatment of postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer: results from the randomized phase III TAnDEM study. J Clin Oncol. 2009;27(33):5529–37.

    Article  CAS  PubMed  Google Scholar 

  28. 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(1):69–75.

    Article  CAS  PubMed  Google Scholar 

  29. Clarke R, Tyson JJ, Dixon JM. Endocrine resistance in breast cancer–an overview and update. Mol Cell Endocrinol. 2015;418(Pt 3):220–34.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  30. Vergote I, Amant F, Leunen K, Van GT, Berteloot P, Neven P. Metastatic breast cancer: sequencing hormonal therapy and positioning of fulvestrant. Int J Gynecol Cancer. 2006;16(Suppl 2):524–6.

    Article  PubMed  Google Scholar 

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Acknowledgements

We thank the participating patients and their families, all nurses and other members of the staff for their valuable contribution. We also appreciate Ana López-Ballesteros and Antonio Torres-Ruiz (Dynamic Science) for their medical-writing support and editorial assistance.

Author information

Authors and Affiliations

  1. Hospital Universitario Clínico San Cecilio, Complejo Hospitalario Universitario, C/Dr. Oloriz, 16, 18012, Granada, Spain

    I. Blancas

  2. Hospital Clinic de Barcelona, illarroel, 170, 08036, Barcelona, Spain

    M. Fontanillas

  3. Hospital Universitario Virgen de las Nieves, Av. de las Fuerzas Armadas, S/N, 18014, Granada, Spain

    V. Conde

  4. Hospital Universitario Miguel Servet, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain

    J. Lao

  5. Hospital Provincial de Castellón, Av. del Dr. Clarà, 19, 12002, Castelló de la Plana, Spain

    E. Martínez

  6. Hospital Universitario Clínico San Carlos, C/del Profesor Martín Lagos, s/n, 28040, Madrid, Spain

    M. J. Sotelo

  7. Hospital de Jaén, Avda. del Ejército Español, nº 10, 23007, Jaén, Spain

    A. Jaen

  8. Hospital Juan Ramón Jiménez, Ronda Exterior Norte s/n, 21005, Huelva, Spain

    J. L. Bayo

  9. Hospital Universitario Carlos Haya, Av. de Carlos Haya, s/n, 29010, Málaga, Spain

    F. Carabantes

  10. Complejo Universitario Hospital de Navarra, Calle Irunlarrea, 3, 31008, Pamplona, Spain

    J. J. Illarramendi

  11. Hospital de Jerez, Ronda de Circunvalación s/n, 11407, Cádiz, Spain

    M. M. Gordon

  12. Hospital Universitario de Canarias, Carretera de Ofra, s/n, 38320, Santa Cruz de Tenerife, Spain

    J. Cruz

  13. Complejo Universitario Asistencial de León, C/Altos de Nava, s/n, León, Spain

    A. García-Palomo

  14. Hospital Universitario, 12 de Octubre, Avenida de Córdoba, s/n, 28041, Madrid, Spain

    C. Mendiola

  15. Hospital Costa del Sol, Autovia A-7, Km 187, 29603, Marbella, Spain

    E. Pérez-Ruiz

  16. Hospital Nuestra Señora De Valme, Av. de Bellavista, s/n, 41014, Seville, Spain

    J. S. Bofill

  17. Hospital Universitario Puerta del Mar, Av. Ana de Viya, 21, 11009, Cádiz, Spain

    J. M. Baena-Cañada

  18. Hospital Ramón y Cajal, Ctra. de Colmenar Viejo, km. 9,100, 28034, Madrid, Spain

    N. M. Jáñez

  19. Clínica Benidorm, Av. Alfonso Puchades, 03501, Benidorm, Spain

    G. Esquerdo

  20. Hospital Universitario Virgen del Rocío, Av. Manuel Siurot, s/n, 41013, Seville, Spain

    M. Ruiz-Borrego

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  1. I. Blancas
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Corresponding author

Correspondence to I. Blancas.

Ethics declarations

Conflict of interest

JMBC participated as an advisor for AstraZeneca; IB, JSB and MRB (study coordinators) received honoraria from AstraZeneca. None of the other authors has declared any conflict of interest.

Ethical standards

The study was conducted in accordance with the 1964 Declaration of Helsinki and its later amendments. The study was approved by the Independent Research Ethics Committee at Hospital Universitario San Cecilio (Granada, Spain).

Informed consent

Informed consent was obtained from all individual participants before being included in the study.

Funding

The study described within the paper was sponsored by Astra Zeneca Spain S.A., Madrid, Spain.

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Blancas, I., Fontanillas, M., Conde, V. et al. Efficacy of fulvestrant in the treatment of postmenopausal women with endocrine-resistant advanced breast cancer in routine clinical practice. Clin Transl Oncol 20, 862–869 (2018). https://doi.org/10.1007/s12094-017-1797-9

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  • DOI: https://doi.org/10.1007/s12094-017-1797-9

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