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Бевацизумаб в комбинации с химиотерапией при раке молочной железы
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Аннотация
Авастин (Бевацизумаб) – первый антиангиогенный препарат, прочно вошедший в клиническую практику при ряде онкологических заболеваний. В работе приводятся промежуточные результаты наблюдательного нерандомизированного исследования в ежедневной клинической практике, целью которого является оценка переносимости и эффективности химиотерапии (ХТ) в комбинации с Авастином у больных HER2-негативным раком молочной железы (РМЖ). В исследование включены 20 больных РМЖ (4 – местно-распространенным, 16 – метастатическим) в возрасте от 34 до 66 лет (средний возраст 49,2 года). Авастин вводили в дозе 10 мг/кг в виде внутривенной инфузии 1 раз в 3 нед в комбинации с ХТ. Всего проведено 154 курса (от 2 до 20; медиана – 9). Полные регрессии отмечены в 3 (15%) наблюдениях, частичные – в 5 (25%), стабилизация – у 9 (45%) больных, прогрессирование выявлено у 3 (15%) пациенток. Таким образом, общая эффективность лечения составила 40%. Медиана выживаемости без прогрессирования (ВБП) в группе метастатического РМЖ составила 10 мес. Характерные для Авастина нежелательные явления, такие как гипертензия, протеинурия, были умеренно выражены и встречались редко: соответственно, у 3 (15,0%) больных в 3,2% курсов и у 2 (10,0%) – в 2% курсов. Ни одной пациентке лечение не было отменено из-за токсичности, обусловленной Авастином.
Заключение: Авастин в комбинации с ХТ для лечения РМЖ позволяет достичь высоких показателей объективного эффекта и ВБП.
Ключевые слова: рак молочной железы, тройной негативный рак молочной железы, Авастин, химиотерапия, объективный эффект, выживаемость без прогрессирования.
Заключение: Авастин в комбинации с ХТ для лечения РМЖ позволяет достичь высоких показателей объективного эффекта и ВБП.
Ключевые слова: рак молочной железы, тройной негативный рак молочной железы, Авастин, химиотерапия, объективный эффект, выживаемость без прогрессирования.
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Avastin (Bevacizumab) is the first antiangiogenic drug that has become the clinical practice to treat a number of cancers. The paper gives the intermediate results of an observational nonrandomized trial in daily clinical practice, the purpose of which is to evaluate the tolerability and efficiency of chemotherapy (CT) in combination with Avastin in patients with HER2-negative breast cancer (BC). The investigation enrolled 20 patients with BC, including 4 and 16 with locally advanced and metastatic BC, respectively, at the age of 34 to 66 years (mean age 49,2 years). Avastin was administered in a dose of 10 mg/kg as intravenous infusion once three weeks in combination with CT. A total of 154 courses (from 2 to 20; median 9) were performed. Complete and partial regressions were observed in 3 (15%) and 5 (25%) cases, respectively; stabilization was seen in 9 (45%) patients and progression was in 3 (15%). Thus, the total efficiency of treatment was 40%. In the metastatic BC group, the median progression-free survival (PFS) was 10 months. Avastin-related adverse events, such as hypertension and proteinuria, were moderate and rare: in 3 (15,0%) and 2 (10%) patients in 3,2 and 2% of the courses, respectively. Treatment was discontinued because of Avastin-induced toxicity in none of the patients.
Conclusion. Avastin in combination with CT in the treatment of BC allows high objective effect and PFS rates to be achieved.
Key words: breast cancer, triple negative breast cancer, Avastin, chemotherapy, objective response, progression-free survival.
Полный текст
Список литературы
1. Lang I, Brodowicz T, Ryvo L et al. Bevacizumab plus paclitaxel vs bevacizumab plus capecitabine as first-line treatment for HER2-negative metastatic breast cancer: interim efficacy results of the randomised, open-label, non-inferiority, phase 3 TURANDOT trial 2013. http://dx.doi.org/10.1016/S1470-2045(12)70566-1
2. Rossari JR, Metzger-Filho O, Paesmans M et al. Bevacizumab and breast cancer: a meta-analysis of first-line phase III studies and a critical reappraisal of available evidence. J Oncol 2012; 417 673.
3. Brufsky A, Valero V, Tiangco B et al. Second-line bevacizumab-containing therapy in patients with triple-negative breast cancer: subgroup analysis of the RIBBON-2 trial. Breast Cancer Res Treat 2012; 133 (3): 1067–75.
4. von Minckwitz G, Eidtmann H, Rezai M et al. Neoadjuvant chemotherapy and bevacizumab for HER2-negative breast cancer. N Engl J Med 2012; 366 (4): 299–309.
5. Lang I, Brodowicz T, Ryvo L et al. Central European Cooperative Oncology Group. Bevacizumab plus paclitaxel vs bevacizumab plus capecitabine as first-line treatment for HER2-negative metastatic breast cancer: interim efficacy results of the randomised, open-label, non-inferiority, phase 3 TURANDOT trial. Lancet Oncol 2013; 14 (2): 125–33.
6. Cortes J, Calvo V, Ramírez-Merino N et al. Adverse events risk associated with bevacizumab addition to breast cancer chemotherapy: a meta-analysis. Ann Oncol 2012; 23 (5): 1130–7.
7. Gray R, Bhattacharya S et al. Independent review of E2100: a phase III trial of bevacizumab plus paclitaxel vs paclitaxel in women with metastatic breast cancer. J Clin Oncol 2009; 27 (30): 4966–72. http://doi:10.1200/ JCO.2008.21.6630
8. Miles DW, Chan A, Dirix LY et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2010; 28 (20): 3239–47.
9. Croom KF, Dhillon S. Bevacizumab: a review of its use in combination with paclitaxel or capecitabine as first-line therapy for HER2-negative metastatic breast cancer. Drugs 2011; 71 (16): 2213–29.
10. Miller K, Wang M, Gralow J et al. Paclitaxel plus bevacizumab vs paclitaxel alone for metastatic breast cancer. N Engl J Med 2007; 357 (26): 2666–76.
11. von Minckwitz G, Untch M, Blohmer JU et al. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol 2012; 30 (15): 1796–804.
12. Pivot XB, Li RK, Thomas ES et al. Activity of ixabepilone in oestrogen receptor-negative and oestrogen receptor-progesterone receptor-human epidermal growth factor receptor 2-negative metastatic breast cancer. Eur J Cancer 2009; 45 (17): 2940–6.
13. Bertucci F, Finetti P, Birnbaum D. Basal breast cancer: a complex and deadly molecular subtype. Curr Mol Med 2012; 12 (1): 96–110.
14. Robert NJ, Diéras V, Glaspy J et al. RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol 2011; 29 (10): 1252–60. http://doi:10.1200/ JCO.2010.28.0982
15. Miles DW, Diéras V, Cortés J et al. First-line bevacizumab in combination with chemotherapy for HER2-negative metastatic breast cancer: pooled and subgroup analyses of data from 2447 patients. Ann Oncol 2013.
16. Brufsky AM, Hurvitz S, Perez et al. RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2011; 29 (32): 4286–93.
2. Rossari JR, Metzger-Filho O, Paesmans M et al. Bevacizumab and breast cancer: a meta-analysis of first-line phase III studies and a critical reappraisal of available evidence. J Oncol 2012; 417 673.
3. Brufsky A, Valero V, Tiangco B et al. Second-line bevacizumab-containing therapy in patients with triple-negative breast cancer: subgroup analysis of the RIBBON-2 trial. Breast Cancer Res Treat 2012; 133 (3): 1067–75.
4. von Minckwitz G, Eidtmann H, Rezai M et al. Neoadjuvant chemotherapy and bevacizumab for HER2-negative breast cancer. N Engl J Med 2012; 366 (4): 299–309.
5. Lang I, Brodowicz T, Ryvo L et al. Central European Cooperative Oncology Group. Bevacizumab plus paclitaxel vs bevacizumab plus capecitabine as first-line treatment for HER2-negative metastatic breast cancer: interim efficacy results of the randomised, open-label, non-inferiority, phase 3 TURANDOT trial. Lancet Oncol 2013; 14 (2): 125–33.
6. Cortes J, Calvo V, Ramírez-Merino N et al. Adverse events risk associated with bevacizumab addition to breast cancer chemotherapy: a meta-analysis. Ann Oncol 2012; 23 (5): 1130–7.
7. Gray R, Bhattacharya S et al. Independent review of E2100: a phase III trial of bevacizumab plus paclitaxel vs paclitaxel in women with metastatic breast cancer. J Clin Oncol 2009; 27 (30): 4966–72. http://doi:10.1200/ JCO.2008.21.6630
8. Miles DW, Chan A, Dirix LY et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2010; 28 (20): 3239–47.
9. Croom KF, Dhillon S. Bevacizumab: a review of its use in combination with paclitaxel or capecitabine as first-line therapy for HER2-negative metastatic breast cancer. Drugs 2011; 71 (16): 2213–29.
10. Miller K, Wang M, Gralow J et al. Paclitaxel plus bevacizumab vs paclitaxel alone for metastatic breast cancer. N Engl J Med 2007; 357 (26): 2666–76.
11. von Minckwitz G, Untch M, Blohmer JU et al. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol 2012; 30 (15): 1796–804.
12. Pivot XB, Li RK, Thomas ES et al. Activity of ixabepilone in oestrogen receptor-negative and oestrogen receptor-progesterone receptor-human epidermal growth factor receptor 2-negative metastatic breast cancer. Eur J Cancer 2009; 45 (17): 2940–6.
13. Bertucci F, Finetti P, Birnbaum D. Basal breast cancer: a complex and deadly molecular subtype. Curr Mol Med 2012; 12 (1): 96–110.
14. Robert NJ, Diéras V, Glaspy J et al. RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol 2011; 29 (10): 1252–60. http://doi:10.1200/ JCO.2010.28.0982
15. Miles DW, Diéras V, Cortés J et al. First-line bevacizumab in combination with chemotherapy for HER2-negative metastatic breast cancer: pooled and subgroup analyses of data from 2447 patients. Ann Oncol 2013.
16. Brufsky AM, Hurvitz S, Perez et al. RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2011; 29 (32): 4286–93.
Авторы
Л.В.Манзюк, Е.И.Коваленко, Е.В.Артамонова, Л.И.Османова
ФГБУ РОНЦ им. Н.Н.Блохина РАМН, Москва
ФГБУ РОНЦ им. Н.Н.Блохина РАМН, Москва
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L.V.Manzyuk, E.I.Kovalenko, E.V.Artamonova, L.I.Osmanova
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