Efficacy and safety of eribulin in HER2-negative metastatic breast cancer: the results of long-term experience in real clinical practice in Russia

Vera A Gorbunova; Горбунова Вера Андреевна; Irina V Kolyadina; Колядина Ирина Владимировна; Elena I Kovalenko; Коваленко Елена Игоревна; Liudmila V Manziuk; Манзюк Людмила Валентиновна; Elena V Artamonova; Артамонова Елена Владимировна; Liudmila G Zhukova; Жукова Людмила Григорьевна; Larisa V Bolotina; Болотина Лариса Владимировна; Tat'iana Iu Semiglazova; Семиглазова Татьяна Юрьевна; Aleksei G Manikhas; Манихас Алексей Георгиевич; Natal'ia A Raevskaia; Раевская Наталья Александровна; Il'ia M Itkin; Иткин Илья Михайлович; Dmitrii V Filonenko; Филоненко Дмитрий Владимирович; Larisa A Zhilyaeva; Жиляева Лариса Анатольевна; Viktor E Gol'dberg; Гольдберг Виктор Евгеньевич; Natal'ia O Popova; Попова Наталья Олеговна; Dmitrii M Ponomarenko; Пономаренко Дмитрий Михайлович; Valentina E Shikina; Шикина Валентина Евгеньевна; Irina R Suslova; Суслова Ирина Рудольфовна; Olga V Romanchuk; Романчук Ольга Викторовна; Dmitrii V Kozlov; Козлов Дмитрий Владимирович; Ali-Dzarakhmat S Rzaev; Рзаев Али-Дзарахмат Салманович; Vasilii V Marfutov; Марфутов Василий Васильевич; Irina I Andreiashkina; Андреяшкина Ирина Ивановна; Liubov' I Vladimirova; Владимирова Любовь Юрьевна; Irina S Mitashok; Миташок Ирина Степановна; Natal'ia M Tikhanovskaia; Тихановская Наталья Михайловна; Elena V Karabina; Карабина Елена Владимировна; Guzel' Z Mukhametshina; Мухаметшина Гузель Зиннуровна; Al'fiia I Khasanova; Хасанова Альфия Ирековна; Sufiia Z Safina; Сафина Суфия Зыевна; Mikhail V Shaidorov; Шайдоров Михаил Владимирови; Dmitrii A Morozov; Морозов Дмитрий Александрович; Elena P Prokof'eva; Прокофьева Елена Павловна; Liudmila V Kramskaia; Крамская Людмила Викторовна; Tat'iana V Karandeeva; Карандеева Татьяна Вадимовна; Irina V Evstigneeva; Евстигнеева Ирина Владимировна; Elena G Ovchinnikova; Овчинникова Елена Георгиевна; Tat'iana P Klement'eva; Клементьева Татьяна Павловна; Olga V Khrupalo; Хрупало Ольга Владимировна; Elena V Tiuvinova; Тювинова Елена Вячеславовна; Viktor M Sherstnev; Шерстнев Виктор Михайлович; Igor' S Chernov; Чернов Игорь Софрониеви; Dzheims Dzh Kolokolov; Колоколов Джеймс Джексонович; Elena A Gaisina; Гайсина Елена Александровна; Natal'ia V Levchenko; Левченко Наталья Валерьевна; Viacheslav A Chubenko; Чубенко Вячеслав Андреевич; Anton Iu Povyshev; Повышев Антон Юрьевич; Inna V Iudina; Юдина Инна Викторовна; Liudmila V Vorotilina; Воротилина Людмила Викторовна; Tat'iana V Andreeva; Андреева Татьяна Вячеславовна; Garnik S Tumanian; Туманян Гарник Сасунович; Anton E Koziakov; Козяков Антон Евгеньевич; Liudmila A Gil'mutdinova; Гильмутдинова Людмила Алексеевна; Mikhail A Osipov; Осипов Михаил Анатольевич; Alina S Shatokhina; Шатохина Алина Станиславовна; Alena A Vazhenina; Важенина Алена Александровна; Angelina S Chichkanova; Чичканова Ангелина Семеновна; Vladimir I Vladimirov; Владимиров Владимир Иванович; Aleksandr N Ivanov; Иванов Александр Николаевич; Anna S Belokhvostova; Белохвостова Анна Сергеевна; Elena M Cherniakova; Чернякова Елена Михайловна; Elena A Tul'china; Тульчина Елена Анатольевна; Svetlana A Maklashova; Маклашова Светлана Александровна; Oksana N Shkodenko; Шкоденко Оксана Николаевна; Iuliia V Kostalanova; Косталанова Юлия Владимировна; Anna V Tarasova; Тарасова Анна Владимировна; Evgeniia S Kuz'mina; Кузьмина Евгения Сергеевна

doi:10.26442/18151434.2019.1.190250

Efficacy and safety of eribulin in HER2-negative metastatic breast cancer: the results of long-term experience in real clinical practice in Russia

Authors: Gorbunova V.A¹, Kolyadina I.V¹, Kovalenko E.I¹, Manziuk L.V¹, Artamonova E.V¹, Zhukova L.G², Bolotina L.V³, Semiglazova T.I.⁴, Manikhas A.G⁵, Raevskaia N.A⁵, Itkin I.M⁵, Filonenko D.V⁶, Zhilyaeva L.A⁷, Gol'dberg V.E⁸, Popova N.O⁸, Ponomarenko D.M⁹, Shikina V.E¹⁰, Suslova I.R¹¹, Romanchuk O.V¹¹, Kozlov D.V¹², Rzaev A.S¹², Marfutov V.V¹³, Andreiashkina I.I¹³, Vladimirova L.I¹⁴, Mitashok I.S¹⁴, Tikhanovskaia N.M¹⁴, Karabina E.V¹⁵, Mukhametshina G.Z¹⁶, Khasanova A.I¹⁶, Safina S.Z¹⁶, Shaidorov M.V¹⁷, Morozov D.A¹⁷, Prokof'eva E.P¹⁸, Kramskaia L.V¹⁹, Karandeeva T.V¹⁹, Evstigneeva I.V²⁰, Ovchinnikova E.G²¹, Klement'eva T.P²¹, Khrupalo O.V¹², Tiuvinova E.V²², Sherstnev V.M²³, Chernov I.S²³, Kolokolov D.D.²⁴, Gaisina E.A²⁵, Levchenko N.V²⁶, Chubenko V.A²⁶, Povyshev A.I.²⁷, Iudina I.V²⁸, Vorotilina L.V²⁸, Andreeva T.V²⁹, Tumanian G.S³⁰, Koziakov A.E³¹, Gil'mutdinova L.A³², Osipov M.A³³, Shatokhina A.S³⁴, Vazhenina A.A³⁵, Chichkanova A.S³⁶, Vladimirov V.I³⁷, Ivanov A.N³⁸, Belokhvostova A.S³⁹, Cherniakova E.M³⁹, Tul'china E.A⁴⁰, Maklashova S.A⁴⁰, Shkodenko O.N⁴¹, Kostalanova I.V⁴², Tarasova A.V⁴³, Kuz'mina E.S⁴⁴
Affiliations:
1. N.N.Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation
2. A.S.Loginov Moscow Clinical Scientific Practical Center of the Department of Health of Moscow
3. P.A.Herzen Moscow Research Institute of Oncology - branch of the National Medical Research Radiological Center of the Ministry of Health of the Russian Federation
4. N.N.Petrov National Medical Research Center of Oncology
5. City Clinical Oncology Dispensary
6. Moscow City Oncology Hospital №62 of the Department of Health of Moscow
7. Kursk Regional Clinical Oncology Center
8. Research Institute of Oncology of the Tomsk National Research Medical Center of the Russian Academy of Sciences
9. Regional Oncology Center
10. Moscow Regional Oncological Dispensary
11. Oncologic Dispensary №4
12. Diagnostic Clinical Center №1
13. A.S.Loginov Moscow Clinical Scientific Practical Center
14. Rostov Research Institute of Oncology
15. Tula Regional Oncologic Dispensary
16. Republican Clinical Oncology Dispensary
17. N.N.Blokhin National Medical Research Center of Oncology
18. Penza Regional Oncology Center
19. D.D.Pletnev City Clinical Hospital, a separate division "Oncological Dispensary"
20. Tver Regional Clinical Oncology Dispensary
21. Nizhny Novgorod Regional Clinical Oncology Dispensary
22. City Polyclinic №201
23. Oncologic Dispensary №5
24. City Polyclinic №195
25. "Medical City"
26. Saint Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care
27. District Clinical Hospital
28. Clinical Oncologic Dispensary
29. Smolensk Regional Oncological Dispensary
30. Primorsky Regional Oncology Center
31. Novosibirsk Regional Clinical Oncologic Dispensary
32. Regional Clinical Center of Oncology
33. Leningrad Regional Oncological Dispensary
34. Clinical Oncology Dispensary №1
35. Medical Center "Sunrise Clinic"
36. Privolzhskii District Medical Center
37. Pyatigorsk Interdistrict Oncologic Dispensary
38. Republican Clinical Oncologic Dispensary
39. Republican Oncology Center
40. Bryansk Regional Oncological Center
41. Stavropol Regional Clinical Oncology Dispensary
42. Samara Regional Clinical Oncology Dispensary
43. Tolyatti City Clinical Hospital №5
44. Salekhard District Clinical Hospital
Issue: Vol 21, No 1 (2019)
Pages: 12-23
Section: Articles
URL: https://journals.rcsi.science/1815-1434/article/view/33502
DOI: https://doi.org/10.26442/18151434.2019.1.190250
ID: 33502

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Abstract

Aim. The aim of the study is to examine the efficacy and safety of eribulin in HER2-negative metastatic breast cancer (BC) in Russian clinical practice. Materials and methods. The analysis included 459 patients with advanced BC from 44 federal and municipal medical clinics in Russia and received at least 2 courses of treatment with eribulin in accordance with the registered indications for drug. The average age of women was 56 years (between 29 and 81 years), 83% of patients had HER2-negative tumor subtype (49.9% - luminal BC and 33.1% - triple-negative BC) HER2-positive biological tumor subtype was registered in 17% of patients. Visceral metastases were diagnosed in 73% of patients and three-zone and multiple zone metastases were diagnosed in 41.6% of cases. The median number of prior lines of therapy in patients with disseminated disease was 2; anthracycline and taxane chemotherapy was applied in 94.3% of patients, and 38.1% of patients were recived CT plus capecitabine. Standard treatment regimen with eribulin was cotinuing (1.4 mg/m² as a 2-5-minute intravenous infusion administrated on days 1, 8 of a 21-day cycle) until disease progression, unacceptable toxic effects, or impossibility of the drug administration for any other reason. We estimated the efficacy and safety of treatment with eribulin in Russian patients with HER2-negative BC. Results. Objective response rate was achieved in 20.5% of cases, complete response rate was in 3.2%, partial - 17.3%, and the stable disease rate was marked in 52.7% of women, and in 19.7% of these cases was prolonged more than 6 months. The frequency of objective response was higher in luminal BC group compared with triple-negative BC: 23.5% vs 15.8%; tumor growth control 76.9% vs. 67.8%, respectively; p<0.05. Median progression-free survival was 4.83 months (5.17 months - luminal BC and 4.0 months - triple-negative BC). On application of eribulin in first-, second- and third-line treatment we achived maximum efficiency: the frequency of objective response rate was 24.2%, tumor growth control - 82.2%, median progression-free survival - 5.07 months; any data were achived on drug application in fourth-line and further lines of treatment: 15.4%, 58.6% and 4.27 months, respectively; p<0.05. We showed the group of women with "special response" to eribulin (72 cases, 19%) associated with the high efficacy of therapy, regardless of biological subtypes and metastases localization: objective response rate - 48.6%, long-term stable disease rate - 51.4%. The safety profile of eribulin was acceptable; the dose reduction to 1.1 mg/m² was required only in 14.2% of patients and after the reduction eribulin therapy was continued without moderate adverse events. Conclusions. Efficacy and safety of eribulin therapy in Russian patients completely confirm the results of earlier randomized studies. The combination of efficiency in tumors with different biological subtypes and a safety profile makes eribulin the therapeutic option of appling in patients with advanced anthracycline-and taxan-resistant BC.

Keywords

metastatic breast cancer, chemotherapy, eribulin, the Russian experience with eribulin

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Efficacy and safety of eribulin in HER2-negative metastatic breast cancer: the results of long-term experience in real clinical practice in Russia

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