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Опыт применения эрибулина в рамках клинического исследования у ранее леченных больных с метастатическим и местно-рецидивирующим раком молочной железы
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Аннотация
В статье приводится опыт применения нового цитостатика – эрибулина (Халавен). На основании клинического исследования III фазы EMBRACE авторы провели лечение 6 больных препаратом Халавен (от 6 до 35 циклов), при этом у 3 больных достигнут частичный регресс опухолевых очагов, у 3 – стабилизация болезни. Медиана выживаемости без прогрессирования в группе эрибулина составила 15,3 мес, медиана длительности ответа – 13 мес, в группе больных терапии по выбору врача – соответственно 5,3 и 3,3 мес. В статье приводится описание 3 клинических случаев. Сделано заключение, что эрибулин демонстрирует высокую эффективность и позволяет существенно увеличить продолжительность жизни больных, сохранив при этом ее высокое качество.
Ключевые слова: рак молочной железы, антрациклины, таксаны, Халавен, продолжительность жизни.
Ключевые слова: рак молочной железы, антрациклины, таксаны, Халавен, продолжительность жизни.
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The article deals with the results of the administration of new cytostatic – eribulin (Halaven). In EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) phase III clinical study, Halaven had been administrated to 6 patients (between
6 and 35 cycles), at that, partial tumor regression was observed in 3 patients and other 3 patients achieved stabilization. Median progression-free survival (PFS) was 15,3 months and median duration of response (DOR) was 13 months in eribulin group, in group of treatment of physician's choice – median PFS was 5,3 and median DOR was 3,3 months. This article demonstrates 3 clinical cases. The authors concluded that eribulin showed high effectiveness and meaningful improvement in overall survival, maintaining the high quality of life.
Key words: breast cancer, anthracyclines, taxanes, Halaven, lifetime.
Полный текст
Список литературы
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3. Morris PG. Advances in therapy: eribulin improves survival for metastatic breast cancer. Anticancer Drugs 2010; 21 (10): 885–9.
4. Cardoso F, Harbeck N, Fallowfield L et al. Locally recurrent or metastatic breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2012; 23 (Suppl. 7): 11–9.
5. NCCN Guidelines Version 3.2014, Invasive Breast Cancer BINV-20. http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
6. Gennari A, Conte PF, Rosso R et al. Survival of metastatic breast carcinoma patients over a 20-year period. A retrospective analysis based on individual patient data from six consecutive studies. Cancer 2005; 104 (I.8.): 1742–50.
7. Hirata Y, Uemura D. Halichondrins antitumor polyether macrolides from a marine sponge. Pure Appl Chem 1986; 58: 701–10.
8. Kuznetsov G et al. Induction of morphological and biochemical apoptosis following prolonged mitotic blockage by halichondrin B macrocyclic ketone analog E7389. Cancer Res 2004; 64: 5760–6.
9. Towle MJ et al. In vitro and in vivo anticancer activities of synthetic macrocyclic ketone analogues of halichondrin B. Cancer Res 2001; 61: 1013–21.
10. Jordan MA et al. The primary antimitotic mechanism of action of the synthetic halichondrin E7389 is suppression of microtubule growth. Mol Cancer Ther 2005; 4: 1086–95.
11. Okouneva T et al. Inhibition of centromere dynamics by eribulin (E7389) during mitotic metaphase. Mol Cancer Ther 2008; 7: 2003–11.
12. Smith JA et al. Eribulin binds at microtubule ends to a single site on tubulin to suppress dynamic instability. Biochemistry 2010; 49: 1331–7.
13. Towle MJ et al. Eribulin induces irreversible mitotic blockade: implications of cell-based pharmacodynamics for in vivo efficacy under intermittent dosing conditions. Cancer Res 2011; 71: 496–505.
14. Goel S et al. A Phase I study of eribulin mesylate (E7389), a mechanistically novel inhibitor of microtubule dynamics, in patients with advanced solid malignancies. Clin Cancer Res 2009; 15: 4207–12.
15. Tan AR et al. Phase I study of eribulin mesylate administered once every 21 days in patients with advanced solid tumors. Clin Cancer Res 2009; 15: 4213–9.
16. Synold TW et al. A Phase I pharmacokinetic and target validation study of the novel anti-tubulin agent E7389: A California Cancer Consortium trial. J Clin Oncol 2005; 23 (Suppl. 16): 3036.
17. Minami H et al. A Phase I study of eribulin mesylate (E7389) in patients with refractory cancers. Eur J Cancer 2008; 6 (Suppl.): 140 (Abstract 446).
18. Vahdat LT et al. Phase II study of eribulin mesylate, a halichondrin B analog, in patients with metastatic breast cancer previously treated with an anthracycline and a taxanes. J Clin Oncol 2009; 27: 2954–61.
19. Cortes J et al. Phase II study of the halichondrin B analog eribulin mesylate in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline, a taxane, and capecitabine. J Clin Oncol 2010; 28: 3922–8.
20. Twelves C, Loesch D et al. Updated survival analysis of a Phase III study (EMBRACE) of eribulin mesylate versus treatment of physician’s choice in subjects with locally recurrent or metastatic breast cancer previously treated with an anthracycline and a taxane. Presented at the 33rd Annual San Antonio Breast Cancer Symposium (SABCS), December 8–12, 2010; San Antonio, TX, USA; p. 6–14–8.
Авторы
Ф.Ш.Ахметзянов, Ф.Ф.Ахметзянова
Кафедра онкологии, лучевой диагностики и лучевой терапии ГБОУ ВПО Казанский государственный медицинский университет Минздрава России
Кафедра онкологии, лучевой диагностики и лучевой терапии ГБОУ ВПО Казанский государственный медицинский университет Минздрава России
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F.Sh.Ahmetzanov, F.F.Ahmetzanova
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