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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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1. Title Title of document Efficacy and safety of eribulin in HER2-negative metastatic breast cancer: the results of long-term experience in real clinical practice in Russia
2. Creator Author's name, affiliation, country Vera A Gorbunova; N.N.Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation
2. Creator Author's name, affiliation, country Irina V Kolyadina; N.N.Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation
2. Creator Author's name, affiliation, country Elena I Kovalenko; N.N.Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation
2. Creator Author's name, affiliation, country Liudmila V Manziuk; N.N.Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation
2. Creator Author's name, affiliation, country Elena V Artamonova; N.N.Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation
2. Creator Author's name, affiliation, country Liudmila G Zhukova; A.S.Loginov Moscow Clinical Scientific Practical Center of the Department of Health of Moscow
2. Creator Author's name, affiliation, country Larisa V Bolotina; 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
2. Creator Author's name, affiliation, country Tat'iana Iu Semiglazova; N.N.Petrov National Medical Research Center of Oncology
2. Creator Author's name, affiliation, country Aleksei G Manikhas; City Clinical Oncology Dispensary
2. Creator Author's name, affiliation, country Natal'ia A Raevskaia; City Clinical Oncology Dispensary
2. Creator Author's name, affiliation, country Il'ia M Itkin; City Clinical Oncology Dispensary
2. Creator Author's name, affiliation, country Dmitrii V Filonenko; Moscow City Oncology Hospital №62 of the Department of Health of Moscow
2. Creator Author's name, affiliation, country Larisa A Zhilyaeva; Kursk Regional Clinical Oncology Center
2. Creator Author's name, affiliation, country Viktor E Gol'dberg; Research Institute of Oncology of the Tomsk National Research Medical Center of the Russian Academy of Sciences
2. Creator Author's name, affiliation, country Natal'ia O Popova; Research Institute of Oncology of the Tomsk National Research Medical Center of the Russian Academy of Sciences
2. Creator Author's name, affiliation, country Dmitrii M Ponomarenko; Regional Oncology Center
2. Creator Author's name, affiliation, country Valentina E Shikina; Moscow Regional Oncological Dispensary
2. Creator Author's name, affiliation, country Irina R Suslova; Oncologic Dispensary №4
2. Creator Author's name, affiliation, country Olga V Romanchuk; Oncologic Dispensary №4
2. Creator Author's name, affiliation, country Dmitrii V Kozlov; Diagnostic Clinical Center №1
2. Creator Author's name, affiliation, country Ali-Dzarakhmat S Rzaev; Diagnostic Clinical Center №1
2. Creator Author's name, affiliation, country Vasilii V Marfutov; A.S.Loginov Moscow Clinical Scientific Practical Center
2. Creator Author's name, affiliation, country Irina I Andreiashkina; A.S.Loginov Moscow Clinical Scientific Practical Center
2. Creator Author's name, affiliation, country Liubov' I Vladimirova; Rostov Research Institute of Oncology
2. Creator Author's name, affiliation, country Irina S Mitashok; Rostov Research Institute of Oncology
2. Creator Author's name, affiliation, country Natal'ia M Tikhanovskaia; Rostov Research Institute of Oncology
2. Creator Author's name, affiliation, country Elena V Karabina; Tula Regional Oncologic Dispensary
2. Creator Author's name, affiliation, country Guzel' Z Mukhametshina; Republican Clinical Oncology Dispensary
2. Creator Author's name, affiliation, country Al'fiia I Khasanova; Republican Clinical Oncology Dispensary
2. Creator Author's name, affiliation, country Sufiia Z Safina; Republican Clinical Oncology Dispensary
2. Creator Author's name, affiliation, country Mikhail V Shaidorov; N.N.Blokhin National Medical Research Center of Oncology
2. Creator Author's name, affiliation, country Dmitrii A Morozov; N.N.Blokhin National Medical Research Center of Oncology
2. Creator Author's name, affiliation, country Elena P Prokof'eva; Penza Regional Oncology Center
2. Creator Author's name, affiliation, country Liudmila V Kramskaia; D.D.Pletnev City Clinical Hospital, a separate division "Oncological Dispensary"
2. Creator Author's name, affiliation, country Tat'iana V Karandeeva; D.D.Pletnev City Clinical Hospital, a separate division "Oncological Dispensary"
2. Creator Author's name, affiliation, country Irina V Evstigneeva; Tver Regional Clinical Oncology Dispensary
2. Creator Author's name, affiliation, country Elena G Ovchinnikova; Nizhny Novgorod Regional Clinical Oncology Dispensary
2. Creator Author's name, affiliation, country Tat'iana P Klement'eva; Nizhny Novgorod Regional Clinical Oncology Dispensary
2. Creator Author's name, affiliation, country Olga V Khrupalo; Diagnostic Clinical Center №1
2. Creator Author's name, affiliation, country Elena V Tiuvinova; City Polyclinic №201
2. Creator Author's name, affiliation, country Viktor M Sherstnev; Oncologic Dispensary №5
2. Creator Author's name, affiliation, country Igor' S Chernov; Oncologic Dispensary №5
2. Creator Author's name, affiliation, country Dzheims Dzh Kolokolov; City Polyclinic №195
2. Creator Author's name, affiliation, country Elena A Gaisina; "Medical City"
2. Creator Author's name, affiliation, country Natal'ia V Levchenko; Saint Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care
2. Creator Author's name, affiliation, country Viacheslav A Chubenko; Saint Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care
2. Creator Author's name, affiliation, country Anton Iu Povyshev; District Clinical Hospital
2. Creator Author's name, affiliation, country Inna V Iudina; Clinical Oncologic Dispensary
2. Creator Author's name, affiliation, country Liudmila V Vorotilina; Clinical Oncologic Dispensary
2. Creator Author's name, affiliation, country Tat'iana V Andreeva; Smolensk Regional Oncological Dispensary
2. Creator Author's name, affiliation, country Garnik S Tumanian; Primorsky Regional Oncology Center
2. Creator Author's name, affiliation, country Anton E Koziakov; Novosibirsk Regional Clinical Oncologic Dispensary
2. Creator Author's name, affiliation, country Liudmila A Gil'mutdinova; Regional Clinical Center of Oncology
2. Creator Author's name, affiliation, country Mikhail A Osipov; Leningrad Regional Oncological Dispensary
2. Creator Author's name, affiliation, country Alina S Shatokhina; Clinical Oncology Dispensary №1
2. Creator Author's name, affiliation, country Alena A Vazhenina; Medical Center "Sunrise Clinic"
2. Creator Author's name, affiliation, country Angelina S Chichkanova; Privolzhskii District Medical Center
2. Creator Author's name, affiliation, country Vladimir I Vladimirov; Pyatigorsk Interdistrict Oncologic Dispensary
2. Creator Author's name, affiliation, country Aleksandr N Ivanov; Republican Clinical Oncologic Dispensary
2. Creator Author's name, affiliation, country Anna S Belokhvostova; Republican Oncology Center
2. Creator Author's name, affiliation, country Elena M Cherniakova; Republican Oncology Center
2. Creator Author's name, affiliation, country Elena A Tul'china; Bryansk Regional Oncological Center
2. Creator Author's name, affiliation, country Svetlana A Maklashova; Bryansk Regional Oncological Center
2. Creator Author's name, affiliation, country Oksana N Shkodenko; Stavropol Regional Clinical Oncology Dispensary
2. Creator Author's name, affiliation, country Iuliia V Kostalanova; Samara Regional Clinical Oncology Dispensary
2. Creator Author's name, affiliation, country Anna V Tarasova; Tolyatti City Clinical Hospital №5
2. Creator Author's name, affiliation, country Evgeniia S Kuz'mina; Salekhard District Clinical Hospital
3. Subject Discipline(s)
3. Subject Keyword(s) metastatic breast cancer; chemotherapy; eribulin; the Russian experience with eribulin
4. Description 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.
5. Publisher Organizing agency, location LLC Obyedinennaya Redaktsiya
6. Contributor Sponsor(s)
7. Date (DD-MM-YYYY) 15.03.2019
8. Type Status & genre Peer-reviewed Article
8. Type Type Research Article
9. Format File format
10. Identifier Uniform Resource Identifier https://modernonco.orscience.ru/1815-1434/article/view/33502
10. Identifier Digital Object Identifier (DOI) 10.26442/18151434.2019.1.190250
11. Source Title; vol., no. (year) Journal of Modern Oncology; Vol 21, No 1 (2019)
12. Language English=en ru
13. Relation Supp. Files
14. Coverage Geo-spatial location, chronological period, research sample (gender, age, etc.)
15. Rights Copyright and permissions Copyright (c) 2019 Consilium Medicum
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