Email this article Analysis of the efficacy and safety of eribulin therapy in patients with HR+/HER2- metastatic breast cancer pretreated with CDK4/6 inhibitors in real Russian practice
- Authors: Kolyadina I.V.1,2,3,4, Abidova N.R.5, Akopyan A.A.5, Antonova G.V.6, Arapova O.I.6, Bobrova E.A.7, Bolotina L.V.8, Valiakhmetova C.K.9, Vasilevskaya A.V.10, Vladimirova L.Y.11, Volkonskiy M.V.5, Ganshina I.P.2, Gudkova I.E.12, Dergunov A.S.13, Evstigneeva I.V.13, Egurenkova V.S.7, Emshanov A.V.14, Zhukova L.G.7, Zueva E.V.15, Karabina E.V.16, Kolokolov J.J.17, Kuzmicheva S.V.7, Kuchevskaya O.A.6, Luev I.A.5, Maistrenko K.S.6, Markizova E.V.6, Marfutov V.V.7, Medvedev S.P.18, Merzlikina Y.I.7, Nersesova T.A.15, Ovchinnikova E.G.19, Orlova S.A.9, Samaneva N.Y.11, Stativko O.A.15, Storozhakova A.E.11, Stroyakovskiy D.L.5, Sultanbaev A.V.9, Tekeeva A.I.20, Fadeeva N.V.21, Fedorova A.N.15, Shalaeva O.M.22, Shangina I.A.6, Shirokova O.N.23, Shumskikh A.R.24, Yakubova M.Z.10
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Affiliations:
- Russian Medical Academy of Continuous Professional Education
- Blokhin National Medical Research Center of Oncology
- Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology
- Moscow City Oncological Hospital №62
- City Clinical Hospital №40
- Loginov Moscow Clinical Research Center
- Hertsen Moscow Oncology Research Institute – branch of National Medical Research Radiological Centre
- Republican Clinical Oncological Dispensary
- Moscow Regional Oncological Dispensary
- National Medical Research Center of Oncology
- Troitsk City Hospital
- Tver Regional Clinical Oncological Dispensary
- Oncology Center
- City Clinical Oncological Hospital №1
- Tula Regional Oncological Dispensary
- Botkin City Clinical Hospital
- Treatment and Rehabilitation Center
- Nizhny Novgorod Regional Clinical Oncological Dispensary
- Medical Center for Rehabilitation
- Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
- Perm Regional Oncological Dispensary
- Sverdlovsk Regional Oncological Dispensary
- Orenburg Regional Clinical Oncological Dispensary
- Issue: Vol 23, No 1 (2021)
- Pages: 68-76
- Section: CLINICAL ONCOLOGY
- URL: https://journals.rcsi.science/1815-1434/article/view/70308
- DOI: https://doi.org/10.26442/18151434.2021.1.200769
- ID: 70308
Cite item
Abstract
Relevance. Data on the efficacy of endocrine and chemotherapy regimens in patients with hormone-resistant metastatic breast cancer (mBC) after progression with CDK4/6 inhibitors are limited; the search for an effective therapy regimen in this clinical situation is an urgent task of clinical oncology.
Aim. Evaluate the efficacy and safety of eribulin therapy in patients with HR+/HER2- mBC after progression with CDK4/6 inhibitors; compare the results of the Russian study and the EMPOWER observational study in the USA.
Materials and methods. The Russian observational study included 54 patients (pts) with HR+/HER2- mBC, who were treated with eribulin after CDK4/6 inhibitors in 24 Russian Cancer hospitals. The median age of pts was 56 years; 75.9% of them had recurrent BC, 24.1% – de novo BC stage IV; 51.9% of pts had progression with CDK4/6 inhibitors in the first 6 months of therapy (primary endocrine resistance); 48.1% of patients had progression in the period from 6 to 38 months; 89.1% had visceral site of metastases (liver MTS – 65.5%, lung MTS – 52.8%, brain MTS in 7.5%). Eribulin was used after anthracyclines and taxanes in 94.4% of cases. The efficacy and safety of eribulin therapy in patients with HR+/HER2- mBC after progression with CDK4/6 inhibitors was studied, as well as subgroup analysis according to age, sites of metastasis, and previously treatment options.
Results. Eribulin was prescribed in the standard regimen of 1.4 mg/m2 on days 1 and 8, the interval between cycles was 21 days, the number cyclys of chemotherapy was 1–44 (median – 8, the mean number of cycles – 10.5). With a median follow-up of 11.5 months (from 3 to 36 months), 30 patients (55.6%) continue therapy with eribulin at present; therapy was cancelled in 24 patients due to progression in 22 (40.7%) cases, and due to intolerable toxicity in 2 (3.7%) patients. The maximum response to eribulin therapy included partial response (in 11 cases, 24.4%), stable disease (in 30 cases, 66.7%) and progression in 4 (8.9%) patients. Median PFS with eribulin therapy was 10.0 months; the 6-month, 1-year, and 2-year PFS were 79.5%, 44.8% and 26.5%, respectively. Eribulin therapy was equally effective in different subgroups (p>0.05) and did not depend on the age of patients, the previously received treatment, the presence of visceral MTS and liver damage. The best response to chemotherapy with eribulin was observed in lung metastases: median PFS 24 months vs 9.1 months, p=0.056. The safety profile was favorable; adverse events were registered in 34.5% of patients, which required dose adjustment in 18.5% of cases. With a median follow-up of 11.5 months, 92.6% of patients remain alive.
Conclusion. Eribulin has demonstrated high efficacy and favorable safety profile in hormone-resistant HER2- mBC in patients with progression when receiving CDK4/6 inhibitor.
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##article.viewOnOriginalSite##About the authors
Irina V. Kolyadina
Russian Medical Academy of Continuous Professional Education; Blokhin National Medical Research Center of Oncology; Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology;
Author for correspondence.
Email: irinakolyadina@yandex.ru
ORCID iD: 0000-0002-1124-6802
D. Sci. (Med.), Prof.
Russian Federation, Moscow; Moscow; MoscowNatalia R. Abidova
Moscow City Oncological Hospital №62
Email: Vitt18@yandex.ru
oncologist
Russian Federation, MoscowArshak A. Akopyan
Moscow City Oncological Hospital №62
Email: arsh.akopian@gmail.com
oncologist
Russian Federation, MoscowGalina V. Antonova
City Clinical Hospital №40
Email: gal-antonova@mail.ru
oncologist
Russian Federation, MoscowOksana I. Arapova
City Clinical Hospital №40
Email: sno7@yandex.ru
oncologist
Russian Federation, MoscowElvira A. Bobrova
Loginov Moscow Clinical Research Center
Email: bobrovaelvira@yandex.ru
oncologist
Russian Federation, MoscowLarisa V. Bolotina
Hertsen Moscow Oncology Research Institute – branch of National Medical Research Radiological Centre
Email: lbolotina@yandex.ru
ORCID iD: 0000-0003-4879-2687
D. Sci. (Med.)
Russian Federation, MoscowChulpan K. Valiakhmetova
Republican Clinical Oncological Dispensary
Email: chvali@bk.ru
Cand. Sci. (Med.)
Russian Federation, UfaAnna V. Vasilevskaya
Moscow Regional Oncological Dispensary
Email: annavasilevs@rambler.ru
Department Head
Russian Federation, BalashikhaLyubov Y. Vladimirova
National Medical Research Center of Oncology
Email: lubovurievna@gmail.com
ORCID iD: 0000-0002-4822-5044
D. Sci. (Med.)
Russian Federation, Rostov-on-DonMikhail V. Volkonskiy
Moscow City Oncological Hospital №62
Email: mux19@yandex.ru
ORCID iD: 0000-0003-4060-5015
oncologist
Russian Federation, MoscowInna P. Ganshina
Blokhin National Medical Research Center of Oncology
Email: ganshinainna77@mail.ru
ORCID iD: 0000-0002-0105-9376
Cand. Sci. (Med.)
Russian Federation, MoscowIrina E. Gudkova
Troitsk City Hospital
Email: i.gudkova@list.ru
Department Head
Russian Federation, TroitskAlexandr S. Dergunov
Tver Regional Clinical Oncological Dispensary
Email: a.dergunov87@yandex.ru
Department Head
Russian Federation, TverIrina V. Evstigneeva
Tver Regional Clinical Oncological Dispensary
Email: irevst@yandex.ru
Department Head
Russian Federation, TverViktoria S. Egurenkova
Loginov Moscow Clinical Research Center
Email: DRAGON2699@yandex.ru
oncologist
Russian Federation, MoscowAleksei V. Emshanov
Oncology Center
Email: emshanov.alesha@yandex.ru
oncologist
Russian Federation, Rostov-on-DonLyudmila G. Zhukova
Loginov Moscow Clinical Research Center
Email: zhukova.lyudmila008@mail.ru
ORCID iD: 0000-0003-4848-6938
D. Sci. (Med.)
Russian Federation, MoscowElena V. Zueva
City Clinical Oncological Hospital №1
Email: elena.zyeva@yahoo.com
Cand. Sci. (Med.)
Russian Federation, MoscowElena V. Karabina
Tula Regional Oncological Dispensary
Email: kev-251@yandex.ru
oncologist
Russian Federation, TulaJames J. Kolokolov
Botkin City Clinical Hospital
Email: jamesstep@mail.ru
oncologist
Russian Federation, MoscowSvetlana V. Kuzmicheva
Loginov Moscow Clinical Research Center
Email: dr-kuzmicheva@yandex.ru
oncologist
Russian Federation, MoscowOlesya A. Kuchevskaya
City Clinical Hospital №40
Email: Olesya.kuchevskaya@mail.ru
Department Head
Russian Federation, MoscowIvan A. Luev
Moscow City Oncological Hospital №62
Email: torleyf@gmail.com
ORCID iD: 0000-0002-7694-0862
oncologist
Russian Federation, MoscowKsenia S. Maistrenko
City Clinical Hospital №40
Email: ksenimay94@gmail.com
oncologist
Russian Federation, MoscowElena V. Markizova
City Clinical Hospital №40
Email: marklenav@gmail.com
oncologist
Russian Federation, MoscowVasily V. Marfutov
Loginov Moscow Clinical Research Center
Email: v.marfutov@mknc.ru
oncologist
Russian Federation, MoscowSergey P. Medvedev
Treatment and Rehabilitation Center
Email: feelyou2017@mail.ru
oncologist
Russian Federation, MoscowYulia I. Merzlikina
Loginov Moscow Clinical Research Center
Email: anoma-lia@mail.ru
oncologist
Russian Federation, MoscowTatyana A. Nersesova
City Clinical Oncological Hospital №1
Email: dr.nersesova@gmail.com
oncologist
Russian Federation, MoscowElena G. Ovchinnikova
Nizhny Novgorod Regional Clinical Oncological Dispensary
Email: ego52@bk.ru
Cand. Sci. (Med.)
Russian Federation, Nizhny NovgorodSvetlana A. Orlova
Republican Clinical Oncological Dispensary
Email: lana.orlova_84@mail.ru
Department Head
Russian Federation, CheboksaryNatalia Y. Samaneva
National Medical Research Center of Oncology
Email: prettyfairy19@rambler.ru
ORCID iD: 0000-0003-0843-6012
oncologist
Russian Federation, Rostov-on-DonOlesya A. Stativko
City Clinical Oncological Hospital №1
Email: olesya_stativko@mail.ru
oncologist
Russian Federation, MoscowAnna E. Storozhakova
National Medical Research Center of Oncology
Email: maymur@list.ru
ORCID iD: 0000-0003-0965-0264
oncologist
Russian Federation, Rostov-on-DonDaniil L. Stroyakovskiy
Moscow City Oncological Hospital №62
Email: d.stroiakovski@icloud.com
ORCID iD: 0000-0003-1973-1092
Cand. Sci. (Med.)
Russian Federation, MoscowAlexander V. Sultanbaev
Republican Clinical Oncological Dispensary
Email: rkodrb@yandex.ru
ORCID iD: 0000-0003-0996-5995
Cand. Sci. (Med.)
Russian Federation, UfaAsiat I. Tekeeva
Medical Center for Rehabilitation
Email: tekeevaai@mail.ru
oncologist
Russian Federation, PodolskNatalia V. Fadeeva
Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
Email: 89048082445@mail.ru
Cand. Sci. (Med.)
Russian Federation, ChelyabinskAlina N. Fedorova
City Clinical Oncological Hospital №1
Email: fedorova_an89@mail.ru
oncologist
Russian Federation, MoscowOksana M. Shalaeva
Perm Regional Oncological Dispensary
Email: o.schalaeva@gmail.com
Department Head
Russian Federation, PermIrina A. Shangina
City Clinical Hospital №40
Email: shanginairina@mail.ru
oncologist
Russian Federation, MoscowOksana N. Shirokova
Sverdlovsk Regional Oncological Dispensary
Email: ons80@list.ru
Department Head
Russian Federation, SverdlovskAlisa R. Shumskikh
Orenburg Regional Clinical Oncological Dispensary
Email: a.tsugyleva@mail.ru
oncologist
Russian Federation, OrenburgMariam Z. Yakubova
Moscow Regional Oncological Dispensary
Email: yak9090@mail.ru
ORCID iD: 0000-0002-0417-7028
oncologist
Russian Federation, BalashikhaReferences
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