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Результаты первого ретроспективного анализа данных по применению эрибулина у пациенток с метастатическим раком молочной железы в условиях реальной клинической практики в России
Результаты первого ретроспективного анализа данных по применению эрибулина у пациенток с метастатическим раком молочной железы в условиях реальной клинической практики в России
Болотина Л.В., Манзюк Л.В., Горбунова В.А. и др. Результаты первого ретроспективного анализа данных по применению эрибулина у пациенток с метастатическим раком молочной железы в условиях реальной клинической практики в России. Современная Онкология. 2016; 18 (3): 27–32.
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Аннотация
В статье представлен обобщенный опыт применения эрибулина в реальной клинической практике онкологических учреждений Российской Федерации при метастатическом раке молочной железы. Проанализирована эффективность препарата при различных подтипах опухоли, выделены группы больных в зависимости от локализации метастазов, у которых эрибулин оказался максимально эффективным. Описаны токсические реакции, а также оценена возможность комбинации препарата с другими противоопухолевыми средствами.
Ключевые слова: метастатический рак молочной железы, эрибулин.
Key words: metastatic breast cancer, eribulin.
Ключевые слова: метастатический рак молочной железы, эрибулин.
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Key words: metastatic breast cancer, eribulin.
Полный текст
Список литературы
1. Инструкция по медицинскому применению препарата Халавен® (РУ ЛП-001782 от 28.07.2012, с изменениями от 28.07.2016). / Instruktsiia po meditsinskomu primeneniiu preparata Khalaven® (RU LP-001782 ot 28.07.2012, s izmeneniiami ot 28.07.2016). [in Russian]
2. Towle MJ, Salvato KA, Wels BF et al. Eribulin induces irreversible mitotic blockade: implications of cell-based pharmacodynamics for in vivo efficacy under intermittent dosing conditions. Cancer Res 2011; 71 (2): 496–505.
3. Funahashi et al. Eribulin mesylate reduces tumor microenvironment abnormality by vascular remodeling in preclinical human breast cancer models. Cancer Sciens 2014; 105 (10): 1334–42.
4. Ueda S, Saeki T, Takeuchi H et al. In vivo imaging of eribulin-induced reoxygenation in advanced breast cancer patients: a comparison to bevacizumab. Br J Cancer 2016.
5. Partridge AH et al. Chemo- and Targeted Therapy for Women with HER2 Negative (or unknown) Advanced Breast Cancer. J Clin Oncol 2014; 32: 3307–29.
6. Advanced Breast Cancer Third International Consensus Conference; 5–7 November 2015: Lisbon, Portugal.
7. Cortes J, O’Shaughnessy J, Loesch D et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a Phase 3 open-label randomised study. Lancet 2011; 377 (9769): 914–23.
8. Kaufman PA, Cortes J, Awada A et al. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and taxan. J Clin Oncol 2015; 33 (6): 594–601.
9. Twelves C, Awada A, Cortes J et al. Subgroup Analyses from a Phase 3, Open-Label, Randomized Study of Eribulin Mesylate Versus Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer. Breast Cancer: Basic Clin Res 2016: 10 77–84.
10. Pivot X, Marmé F., Koenigsberg R et al. Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy. Ann Oncol 2016; 27: 1525–31.
11. Fornier MN. Approved agents for metastatic breast cancer. Semin Oncol 2011; 38 (Suppl. 2): S3–S10.
12. Cortes J, Vahdat L, Blum JL 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 (25): 3922–8.
13. Van Persijn van Meerten EL, Gelderblom H, Bloem JL. RECIST revised: implications for the radiologist. A review article on the modi ed RECIST guideline. Eur Radiol 2010; 20 (6): 1456–67.
14. Blum JL, Twelves CJ, Dutcus C et al. Impact of the number of prior chemotherapy regimens on overall survival (OS) among subjects with locally recurrent or MBC treated with eribulin mesylate: results from the Phase III EMBRACE study. Presented at the 33rd Annual San Antonio Breast Cancer Symposium (SABCS), December 8–12, 2010; San Antonio, TX. USA. P6–13–01.
15. Twelves C et al. Efficacy and safety of eribulin in combination with capecitabine in patients with metastatic breast cancer: an open-label, phase 2 dose-confirmation study. Presented at SABCS 2014. Abstract. P3–13–04.
16. Wilks S, Puhalla S, O'Shaughnessy J et al. Phase 2, multicenter, singlearm study of eribulin mesylate with trastuzumab as firstLine therapy for locally recurrent or metastatic HER2positive breast cancer. Clin Breast Cancer 2014; 14: 405–12.
2. Towle MJ, Salvato KA, Wels BF et al. Eribulin induces irreversible mitotic blockade: implications of cell-based pharmacodynamics for in vivo efficacy under intermittent dosing conditions. Cancer Res 2011; 71 (2): 496–505.
3. Funahashi et al. Eribulin mesylate reduces tumor microenvironment abnormality by vascular remodeling in preclinical human breast cancer models. Cancer Sciens 2014; 105 (10): 1334–42.
4. Ueda S, Saeki T, Takeuchi H et al. In vivo imaging of eribulin-induced reoxygenation in advanced breast cancer patients: a comparison to bevacizumab. Br J Cancer 2016.
5. Partridge AH et al. Chemo- and Targeted Therapy for Women with HER2 Negative (or unknown) Advanced Breast Cancer. J Clin Oncol 2014; 32: 3307–29.
6. Advanced Breast Cancer Third International Consensus Conference; 5–7 November 2015: Lisbon, Portugal.
7. Cortes J, O’Shaughnessy J, Loesch D et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a Phase 3 open-label randomised study. Lancet 2011; 377 (9769): 914–23.
8. Kaufman PA, Cortes J, Awada A et al. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and taxan. J Clin Oncol 2015; 33 (6): 594–601.
9. Twelves C, Awada A, Cortes J et al. Subgroup Analyses from a Phase 3, Open-Label, Randomized Study of Eribulin Mesylate Versus Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer. Breast Cancer: Basic Clin Res 2016: 10 77–84.
10. Pivot X, Marmé F., Koenigsberg R et al. Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy. Ann Oncol 2016; 27: 1525–31.
11. Fornier MN. Approved agents for metastatic breast cancer. Semin Oncol 2011; 38 (Suppl. 2): S3–S10.
12. Cortes J, Vahdat L, Blum JL 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 (25): 3922–8.
13. Van Persijn van Meerten EL, Gelderblom H, Bloem JL. RECIST revised: implications for the radiologist. A review article on the modi ed RECIST guideline. Eur Radiol 2010; 20 (6): 1456–67.
14. Blum JL, Twelves CJ, Dutcus C et al. Impact of the number of prior chemotherapy regimens on overall survival (OS) among subjects with locally recurrent or MBC treated with eribulin mesylate: results from the Phase III EMBRACE study. Presented at the 33rd Annual San Antonio Breast Cancer Symposium (SABCS), December 8–12, 2010; San Antonio, TX. USA. P6–13–01.
15. Twelves C et al. Efficacy and safety of eribulin in combination with capecitabine in patients with metastatic breast cancer: an open-label, phase 2 dose-confirmation study. Presented at SABCS 2014. Abstract. P3–13–04.
16. Wilks S, Puhalla S, O'Shaughnessy J et al. Phase 2, multicenter, singlearm study of eribulin mesylate with trastuzumab as firstLine therapy for locally recurrent or metastatic HER2positive breast cancer. Clin Breast Cancer 2014; 14: 405–12.
2. Towle MJ, Salvato KA, Wels BF et al. Eribulin induces irreversible mitotic blockade: implications of cell-based pharmacodynamics for in vivo efficacy under intermittent dosing conditions. Cancer Res 2011; 71 (2): 496–505.
3. Funahashi et al. Eribulin mesylate reduces tumor microenvironment abnormality by vascular remodeling in preclinical human breast cancer models. Cancer Sciens 2014; 105 (10): 1334–42.
4. Ueda S, Saeki T, Takeuchi H et al. In vivo imaging of eribulin-induced reoxygenation in advanced breast cancer patients: a comparison to bevacizumab. Br J Cancer 2016.
5. Partridge AH et al. Chemo- and Targeted Therapy for Women with HER2 Negative (or unknown) Advanced Breast Cancer. J Clin Oncol 2014; 32: 3307–29.
6. Advanced Breast Cancer Third International Consensus Conference; 5–7 November 2015: Lisbon, Portugal.
7. Cortes J, O’Shaughnessy J, Loesch D et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a Phase 3 open-label randomised study. Lancet 2011; 377 (9769): 914–23.
8. Kaufman PA, Cortes J, Awada A et al. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and taxan. J Clin Oncol 2015; 33 (6): 594–601.
9. Twelves C, Awada A, Cortes J et al. Subgroup Analyses from a Phase 3, Open-Label, Randomized Study of Eribulin Mesylate Versus Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer. Breast Cancer: Basic Clin Res 2016: 10 77–84.
10. Pivot X, Marmé F., Koenigsberg R et al. Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy. Ann Oncol 2016; 27: 1525–31.
11. Fornier MN. Approved agents for metastatic breast cancer. Semin Oncol 2011; 38 (Suppl. 2): S3–S10.
12. Cortes J, Vahdat L, Blum JL 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 (25): 3922–8.
13. Van Persijn van Meerten EL, Gelderblom H, Bloem JL. RECIST revised: implications for the radiologist. A review article on the modi ed RECIST guideline. Eur Radiol 2010; 20 (6): 1456–67.
14. Blum JL, Twelves CJ, Dutcus C et al. Impact of the number of prior chemotherapy regimens on overall survival (OS) among subjects with locally recurrent or MBC treated with eribulin mesylate: results from the Phase III EMBRACE study. Presented at the 33rd Annual San Antonio Breast Cancer Symposium (SABCS), December 8–12, 2010; San Antonio, TX. USA. P6–13–01.
15. Twelves C et al. Efficacy and safety of eribulin in combination with capecitabine in patients with metastatic breast cancer: an open-label, phase 2 dose-confirmation study. Presented at SABCS 2014. Abstract. P3–13–04.
16. Wilks S, Puhalla S, O'Shaughnessy J et al. Phase 2, multicenter, singlearm study of eribulin mesylate with trastuzumab as firstLine therapy for locally recurrent or metastatic HER2positive breast cancer. Clin Breast Cancer 2014; 14: 405–12.
________________________________________________
2. Towle MJ, Salvato KA, Wels BF et al. Eribulin induces irreversible mitotic blockade: implications of cell-based pharmacodynamics for in vivo efficacy under intermittent dosing conditions. Cancer Res 2011; 71 (2): 496–505.
3. Funahashi et al. Eribulin mesylate reduces tumor microenvironment abnormality by vascular remodeling in preclinical human breast cancer models. Cancer Sciens 2014; 105 (10): 1334–42.
4. Ueda S, Saeki T, Takeuchi H et al. In vivo imaging of eribulin-induced reoxygenation in advanced breast cancer patients: a comparison to bevacizumab. Br J Cancer 2016.
5. Partridge AH et al. Chemo- and Targeted Therapy for Women with HER2 Negative (or unknown) Advanced Breast Cancer. J Clin Oncol 2014; 32: 3307–29.
6. Advanced Breast Cancer Third International Consensus Conference; 5–7 November 2015: Lisbon, Portugal.
7. Cortes J, O’Shaughnessy J, Loesch D et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a Phase 3 open-label randomised study. Lancet 2011; 377 (9769): 914–23.
8. Kaufman PA, Cortes J, Awada A et al. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and taxan. J Clin Oncol 2015; 33 (6): 594–601.
9. Twelves C, Awada A, Cortes J et al. Subgroup Analyses from a Phase 3, Open-Label, Randomized Study of Eribulin Mesylate Versus Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer. Breast Cancer: Basic Clin Res 2016: 10 77–84.
10. Pivot X, Marmé F., Koenigsberg R et al. Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy. Ann Oncol 2016; 27: 1525–31.
11. Fornier MN. Approved agents for metastatic breast cancer. Semin Oncol 2011; 38 (Suppl. 2): S3–S10.
12. Cortes J, Vahdat L, Blum JL 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 (25): 3922–8.
13. Van Persijn van Meerten EL, Gelderblom H, Bloem JL. RECIST revised: implications for the radiologist. A review article on the modi ed RECIST guideline. Eur Radiol 2010; 20 (6): 1456–67.
14. Blum JL, Twelves CJ, Dutcus C et al. Impact of the number of prior chemotherapy regimens on overall survival (OS) among subjects with locally recurrent or MBC treated with eribulin mesylate: results from the Phase III EMBRACE study. Presented at the 33rd Annual San Antonio Breast Cancer Symposium (SABCS), December 8–12, 2010; San Antonio, TX. USA. P6–13–01.
15. Twelves C et al. Efficacy and safety of eribulin in combination with capecitabine in patients with metastatic breast cancer: an open-label, phase 2 dose-confirmation study. Presented at SABCS 2014. Abstract. P3–13–04.
16. Wilks S, Puhalla S, O'Shaughnessy J et al. Phase 2, multicenter, singlearm study of eribulin mesylate with trastuzumab as firstLine therapy for locally recurrent or metastatic HER2positive breast cancer. Clin Breast Cancer 2014; 14: 405–12.
Авторы
Л.В.Болотина*1, Л.В.Манзюк2, В.А.Горбунова2, Е.И.Коваленко2, Г.З.Мухаметшина3, А.И.Хасанова3, Л.Ю.Владимирова4, И.С.Миташок4, Е.П.Прокофьева5, И.В.Евстигнеева6, И.И.Андреяшкина7, Н.А.Абрамова4, И.Л.Попова4, Е.В.Карабина8, А.А.Тетерич9, Е.А.Гайсина10, В.А.Чубенко11, С.В.Лимарева2, Н.М.Тихановская4, А.Э.Сторожакова4, Н.Ю.Саманева4, Я.В.Светицкая4, Т.А.Снежко4, Е.А.Калабанова4
1 ФГБУ Московский научно-исследовательский онкологический институт им. П.А.Герцена ФГБУ Национальный медицинский исследовательский радиологический центр Минздрава России. 125284, Россия, Москва, 2-й Боткинский пр., д. 3;
2 ФГБУ Российский онкологический научный центр им. Н.Н.Блохина Минздрава России; 115478, Россия, Москва, Каширское ш., д. 23;
3 ГАУЗ Республиканский клинический онкологический диспансер Минздрава Республики Татарстан. 420029, Россия, Казань, ул. Сибирский тракт, д. 29;
4 ФГБУ Ростовский научно-исследовательский онкологический институт Минздрава России. 344000, Россия, Ростов-на-Дону, ул. 14-я линия, д. 63;
5 ГБУЗ Областной онкологический диспансер. 440002, Россия, Пенза, пр-т Строителей, д. 37А;
6 ГБУЗ ТО Тверской областной клинический онкологический диспансер. 170008, Россия, Тверь, ул. 15 лет Октября, д. 57/37;
7 ГУЗ Областной онкологический диспансер №2. 410053, Россия, Саратов, Смирновское ущелье, д. 1;
8 ГУЗ Тульский областной онкологический диспансер. 300040, Россия, Тула, ул. Плеханова, д. 201а;
9 ОГБУЗ Белгородский онкологический диспансер. 308010, Россия, Белгород, ул. Куйбышева, д. 1;
10 ГАУЗ ТО МКМЦ Медицинский город. 625041, Россия, Тюмень, ул. Барнаульская, д. 32;
11 ГБУЗ Санкт-Петербургский клинический научно-практический центр специализированных видов медицинской помощи (онкологический). 197758, Россия, Санкт-Петербург, пос. Песочный, Ленинградская ул., д. 68А
*lbolotina@yandex.ru
1 P.A.Herzen Moscow Research Institute of Oncology of National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation. 125284, Russian Federation, Moscow, 2-i Botkinskii pr., d. 3;
2 N.N.Blokhin Russian Cancer Research Center of the Ministry of Health of the Russian Federation. 115478, Russian Federation, Moscow, Kashirskoe sh., d. 23;
3 Tatarstan Regional Clinical Cancer Center. 420029, Russian Federation, Kazan, ul. Sibirskii trakt, d. 29;
4 Rostov Research Institute of Oncology. 344000, Russian Federation, Rostov-on-Don, ul. 14-ia Liniia, d. 63;
5 SFHI Penza Regional Oncology Dispensary. 440002, Russian Federation, Penza, pr-t Stroiteley, d. 37A;
6 Tver Regional Clinical Oncology Dispensary. 170008, Russian Federation, Tver, ul. 15 let Oktiabria, d. 57/37;
7 Saratov Regional Oncology Dispensary No.2.; 410053, Russian Federation, Saratov, Smirnovskoe ushhelye, d. 1;
8 Tula Regional Oncology Dispensary. 300040, Russian Federation, Tula, ul. Plehanova, d. 201a;
9 Belgorod Regional Oncology Dispensary. 308010, Russian Federation, Belgorod, ul. Kuibysheva, d. 1;
10 State Autonomous institution of public Health «Multidisciplinary Clinical Medical Center «Medical Town». 625041, Russian Federation, Tiumen, ul. Barnaul'skaia, d. 32
11 SFHI St. Petersburg Clinical Research and Practical Center of Specialized Types of Medical Care (Oncologic).197758, Russian Federation, St. Petersburg, pos. Pesochnyj, Leningradskaja ul., d. 68A
*lbolotina@yandex.ru
1 ФГБУ Московский научно-исследовательский онкологический институт им. П.А.Герцена ФГБУ Национальный медицинский исследовательский радиологический центр Минздрава России. 125284, Россия, Москва, 2-й Боткинский пр., д. 3;
2 ФГБУ Российский онкологический научный центр им. Н.Н.Блохина Минздрава России; 115478, Россия, Москва, Каширское ш., д. 23;
3 ГАУЗ Республиканский клинический онкологический диспансер Минздрава Республики Татарстан. 420029, Россия, Казань, ул. Сибирский тракт, д. 29;
4 ФГБУ Ростовский научно-исследовательский онкологический институт Минздрава России. 344000, Россия, Ростов-на-Дону, ул. 14-я линия, д. 63;
5 ГБУЗ Областной онкологический диспансер. 440002, Россия, Пенза, пр-т Строителей, д. 37А;
6 ГБУЗ ТО Тверской областной клинический онкологический диспансер. 170008, Россия, Тверь, ул. 15 лет Октября, д. 57/37;
7 ГУЗ Областной онкологический диспансер №2. 410053, Россия, Саратов, Смирновское ущелье, д. 1;
8 ГУЗ Тульский областной онкологический диспансер. 300040, Россия, Тула, ул. Плеханова, д. 201а;
9 ОГБУЗ Белгородский онкологический диспансер. 308010, Россия, Белгород, ул. Куйбышева, д. 1;
10 ГАУЗ ТО МКМЦ Медицинский город. 625041, Россия, Тюмень, ул. Барнаульская, д. 32;
11 ГБУЗ Санкт-Петербургский клинический научно-практический центр специализированных видов медицинской помощи (онкологический). 197758, Россия, Санкт-Петербург, пос. Песочный, Ленинградская ул., д. 68А
*lbolotina@yandex.ru
________________________________________________
1 P.A.Herzen Moscow Research Institute of Oncology of National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation. 125284, Russian Federation, Moscow, 2-i Botkinskii pr., d. 3;
2 N.N.Blokhin Russian Cancer Research Center of the Ministry of Health of the Russian Federation. 115478, Russian Federation, Moscow, Kashirskoe sh., d. 23;
3 Tatarstan Regional Clinical Cancer Center. 420029, Russian Federation, Kazan, ul. Sibirskii trakt, d. 29;
4 Rostov Research Institute of Oncology. 344000, Russian Federation, Rostov-on-Don, ul. 14-ia Liniia, d. 63;
5 SFHI Penza Regional Oncology Dispensary. 440002, Russian Federation, Penza, pr-t Stroiteley, d. 37A;
6 Tver Regional Clinical Oncology Dispensary. 170008, Russian Federation, Tver, ul. 15 let Oktiabria, d. 57/37;
7 Saratov Regional Oncology Dispensary No.2.; 410053, Russian Federation, Saratov, Smirnovskoe ushhelye, d. 1;
8 Tula Regional Oncology Dispensary. 300040, Russian Federation, Tula, ul. Plehanova, d. 201a;
9 Belgorod Regional Oncology Dispensary. 308010, Russian Federation, Belgorod, ul. Kuibysheva, d. 1;
10 State Autonomous institution of public Health «Multidisciplinary Clinical Medical Center «Medical Town». 625041, Russian Federation, Tiumen, ul. Barnaul'skaia, d. 32
11 SFHI St. Petersburg Clinical Research and Practical Center of Specialized Types of Medical Care (Oncologic).197758, Russian Federation, St. Petersburg, pos. Pesochnyj, Leningradskaja ul., d. 68A
*lbolotina@yandex.ru
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