Фулвестрант в эндокринной терапии рецидивирующего и метастатического рака молочной железы

Владимирова Л.Ю. Фулвестрант в эндокринной терапии рецидивирующего и метастатического рака молочной железы. Современная Онкология. 2016; 18 (4): 23–26.

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Vladimirova L.Yu. Fulvestrant in endocrine therapy of recurrent and metastatic breast cancer. Journal of Modern Oncology. 2016; 18 (4): 23–26.

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Аннотация

Гормонотерапия рецидивирующего рака молочной железы (РМЖ) и метастатического РМЖ располагает достаточно широким спектром лекарственных воздействий. Однако в настоящее время актуальным является вопрос последовательности эндокринотерапии метастатического гормонопозитивного РМЖ в отсутствие висцерального криза. В рекомендациях различных профессиональных сообществ не содержится явных предпочтений в пользу выбора какой-либо конкретной эндокринной терапии или определенной последовательности лечения. По данным, которыми мы располагаем в настоящее время, оптимальной последовательностью терапии при условии отсутствия резистентности к эндокринотерапии и висцерального криза будет являться следующая: 1-я линия – фулвестрант 500 мг, 2-я – ингибиторы ароматазы (например, анастрозол), 3-я – тамоксифен. Решение о выборе терапии должно быть основано на характеристиках не только опухоли, но и пациентки. При этом следует учитывать возраст больной, длительность интервала без проявлений заболевания после адъювантной терапии, характер поражения и вовлеченность в процесс внутренних органов, сопутствующие заболевания, токсические проявления предполагаемых режимов, доступность и стоимость препаратов.

Ключевые слова: фулвестрант, анастрозол, метастатический рак молочной железы.

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Hormone therapy of recurrent and metastatic breast cancer has a wide range of drugs possessing different medical effects. However, the main problem is the sequence of endocrine therapy of hormone receptor-positive metastatic BC in the absence of visceral crisis, nowadays. The recommendations of the different professional communities do not contain visible preference in favor of the choice of any specific endocrine therapy or specific treatment sequence. According to the information we have received, at present the optimal treatment path, in the absence of resistance to endocrine therapy and visceral crisis, will be the following: line 1 – fulvestrant 500 mg; line 2 – AIs (for example anastrozole); line 3 – tamoxifen. The choice of the therapy must be based on the characteristics of not only the tumor, but also the patient. One should take into account the age of the patient, the duration of the interval without disease symptoms after adjuvant chemotherapy, the type of the damage and the involvement of internal organs in the process, the presence of concomitant diseases, toxic manifestations of chemotherapy regimens, the price and availability of the drugs.

Key words: fulvestrant, anastrozole, metastatic breast cancer.

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Список литературы

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2. Nabholtz JM, Buzdar A, Pollak M et al. Anastrozole is to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. Arimidex Study Group. J Clin Oncol 2000; 18: 3758–67.
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26. Howell A, Pippen J, Elledge RM 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: 236–9.
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1. Bonneterre J, Thurlimann B, Robertson JF et al. Anastrozole versus tamoxifen as first-line therapy for advanced breast cancer in 668 postmenopausal women: results of the Tamoxifen or Arimidex Randomized Group Efficacy and Tolerability study. J Clin Oncol 2000; 18: 3748–57.
2. Nabholtz JM, Buzdar A, Pollak M et al. Anastrozole is to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. Arimidex Study Group. J Clin Oncol 2000; 18: 3758–67.
3. Paridaens RJ, Dirix LY, Beex LV et al. Phase III study comparing exemestane with tamoxifen as first-line treatment of metastatic breast cancer in postmenopausal women: the European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group. J Clin Oncol 2008; 26: 4883–90.
4. Vergote I, Bonneterre J, Thurlimann et al. Randomised study of anastrozole versus tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women. Eur J Cancer 2000; 36 (Suppl. 4): S84–85.
5. Gibson L, Lawrence D, Dawson C, Bliss J. Aromatase inhibitors for treatment of advanced breast cancer in postmenopausal women. Cochrane Database Syst Rev 2009.
6. Howell A, Robertson JFR, Albano JQ et al. Fulvestrant, formerly ICI 182,780, is as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. J Clin Oncol 2002; 20: 3396–403.
7. Osborne CK, Pippen J, Jones SE 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: 3386–95.
8. Kaprin A.D., Starinskii V.V., Petrova G.V. Zlokachestvennye novoobrazovaniia v Rossii v 2015 godu. M.: MNIOI im. P.A.Gertsena, 2016. [in Russian]
9. Anderson WF et al. Estrogen receptor breast cancer phenotypes in the Surveillance, Epidemiology, and End Results database. Breast Cancer Res Treat 2002; 76 (1): 27–36.
10. Reinert T, Barrios CH. Optimal management of hormone receptor positive metastatic breast cancer in 2016. Ther Adv Med Oncol 2015; 7 (6): 304–20.
11. Robertson JF, Llombart-Cussac A, Rolski J 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: 4530–5.
12. Robertson JF, Lindemann JP, Llombart-Cussac A et al. Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of dvanced breast cancer: follow-up analysis from the randomized 'FIRST' study. Breast Cancer Res Treat 2012; 136: 503–11.
13. Ellis MJ, Llombart-Cussac A, Feltl D et al. Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of dvanced breast cancer: Overall survival analysis from the phase II FIRST study. J Clin Oncol 2015; 33: 3781–7.
14. Robertson JF, Bondarenko IM, Trishkina E et al. Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial. Lancet 2017; 17; 388 (10063): 2997–3005. DOI: 10.1016/S0140-6736(16)32389-3. Epub 2016 Nov 29.
15. Ingle JN, Suman VJ, Rowland KM et al. Fulvestrant in women with advanced breast cancer after progression on prior aromatase inhibitor therapy: North Central Cancer Treatment Group Trial N0032. J Clin Oncol 2006; 24: 1052–6.
16. Chia S, Gradishar W, Mauriac L 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: 1664–70.
17. Di Leo A, Jerusalem G, Petruzelka L 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: 4594–600.
18. Di Leo A, Jerusalem G, Petruzelka L et al. Final overall survival: fulvestrant 500 mg vs 250 mg in the randomized CONFIRM trial. J Natl Cancer Inst 2014; 106: djt337.
19. Bergh J, Jonsson PE, Lidbrink EK 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 receptor-positive postmenopausal breast cancer. J Clin Oncol 2012; 30: 1919–25.
20. Mehta RS, Barlow WE, Albain KS et al. Combination anastrozole and fulvestrant in metastatic breast cancer. N Engl J Med 2012; 367: 435–44.
21. Johnston SR, Kilburn LS, Ellis P et al. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, mulicentre, phase 3 randomised trial. Lancet Oncol 2013; 14: 989–98.
22. Turner NC, Ro J, Andre F et al. Palbociclib in hormone-receptor-positive advanced breast cancer. N Engl Med 2015; 373: 209–19.
23. Cardoso F, Costa A, Norton L et al. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Ann Oncol 2014.
24. NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. Version 2.2016. http://www.nccn.org/professionals/physician_gls/pdf/ breast.pdf. Accessed 17.07.2016.
25. Mouridsen H, Gershanovich M, Sun Y et al. Phase III study of letrozole versus tamoxifen as first-line therapy of advanced breast cancer in postmenopausal women: analysis of survival and update of efficacy from the International Letrozole Breast Cancer Group. J Clin Oncol 2003; 1; 21 (11): 2101–9.
26. Howell A, Pippen J, Elledge RM 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: 236–9.
27. Robertson J, Osborne CK, Howell A et al. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women: a prospective combined analysis of two multicenter trials. Cancer 2003; 98: 229–38.
28. Faslodex Summary of Product Characteristics. URL: http://www. ema.europa.eu/ema/

Авторы

Л.Ю.Владимирова*

ФГБУ Ростовский научно-исследовательский онкологический институт Минздрава России. 344037, Россия, Ростов-на-Дону, ул. 14-я линия, д. 63
*lubovurievna@gmail.com

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L.Yu.Vladimirova*

Rostov Research Institute of Oncology. 344037, Russian Federation, Rostov-on-Don, ul. 14-ia Liniia, d. 63
*lubovurievna@gmail.com

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