电邮这篇文章 Effectiveness and safety of empegfilgrastim (Extimia®) in patients with solid tumors receiving cytotoxic therapy: final results of the DEFENDOR study
- 作者: Snegovoy A.1, Kononenko I.1, Radiukova I.2, Orlova S.3, Sultanbaev A.4, Dubovichenko D.5, Dergunov A.6, Saidullaeva A.6, Repina N.7, Gronskaia I.8, Rossokha E.9, Starostina T.10, Akimova O.11, Vasil'eva I.12, Godzhieva Z.13, Garanina O.14, Gorchkhanova K.15, Machekhina I.16, Gracheva A.6, Danilova A.17, Dmitrakova T.14, Dmitriev V.18, Dmitrochenko M.19, Dylinova O.20, El'kova V.10, Zhelezniak A.21, Zubova I.19, Ivanov A.3, Kaleikina L.22, Komoza I.14, Korolev D.23, Lebedeva L.5, Lebedinets A.24, Mamedguseinova N.25, Miagkova V.25, Matiushina E.26, Narovenkova K.14, Nikolaeva V.27, Novikov D.6, Polonskaia G.6, Rebrina O.19, Safronova M.19, Semenova A.27, Semenova I.14, Skotnikov R.7, Solov'eva E.5, Tat'ianenko A.6, Teterich A.18, Timin V.26, Tolmacheva I.14, Tiugina I.28, Khodkevich A.14, Tsarakhova F.29, Chapko I.5, Shegurova M.21, Shakurova N.30, Shalina A.20, Shumilkina E.3, Iakuba D.6, Ibragimova T.31, Feoktistova P.31, Sorokina I.31,32, Berezina A.33, Kiseleva P.32, Mironenko O.33, Prosianikova O.32
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隶属关系:
- Lopatkin Scientific Research Institute of Urology – branch of the National Medical Research Radiological Centre
- Clinical Oncology Dispensary, Omsk
- Republican Clinical Oncology Dispensary, Cheboksary
- Republican Clinical Oncology Dispensary, Ufa
- Arkhangelsk Clinical Oncology Dispensary
- Tver Regional Clinical Oncology Dispensary
- Tula Regional Clinical Oncology Dispensary
- Saint Petersburg State University
- Altai Regional Oncology Dispensary
- Voronezh Regional Clinical Oncology Dispensary
- Ostoverkhov Kursk Oncology Scientific and Clinical Center
- Pskov Regional Clinical Oncology Dispensary
- Regional Oncology Dispensary, Vladikavkaz
- Briansk Regional Oncology Dispensary
- Republican Oncology Dispensary, Nazran
- Botkin Hospital
- City Clinic No. 106
- Belgorod Oncology Dispensary
- Smolensk Regional Oncology Clinical Dispensary
- Regional Clinical Oncology Hospital, Yaroslavl
- Nizhniy Novgorod Regional Clinical Oncology Dispensary
- Republican Oncology Dispensary, Saransk
- Primorsky Regional Oncology Dispensary
- Leningrad Regional Clinical Hospital
- Oncology Dispensary, Rostov-on-Don
- Komi Republican Oncology Dispensary
- Yakutsk Republican Oncology Dispensary
- Ivanovo Regional Oncology Dispensary
- Regional Oncology Dispensary
- Tomsk Regional Oncology Dispensary
- Loginov Moscow Clinical Scientific Center
- JSC "Biocad"
- Russian Academy of National Economy and Public Administration of the President of the Russian Federation
- 期: 卷 26, 编号 2 (2024)
- 页面: 159-171
- 栏目: Articles
- URL: https://journals.rcsi.science/1815-1434/article/view/260598
- DOI: https://doi.org/10.26442/18151434.2024.2.202829
- ID: 260598
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Aim. To evaluate the effectiveness and safety of Extimia® (empegfilgrastim, JSC "BIOCAD") in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia (FN) and infections caused by FN in patients with solid tumors receiving myelosuppressive therapy.
Materials and methods. The paper presents the final results of a multicenter prospective observational post-marketing study of the safety and effectiveness of Extimia® (empegfilgrastim) in patients with solid tumors receiving cytotoxic therapy. For the primary prevention of FN, all patients received empegfilgrastim at 7.5 mg subcutaneously once per course of chemotherapy (CT) 24 hours after the end of CT administration. The primary endpoint included an assessment of the relative dose-intensity (RDI) of the CT courses administered. The endpoints of interest included the assessment of the RDI of CT courses by nosology and CT regimen, the frequency of dose-limiting neutropenia, and the incidence of all adverse events (AEs) in patients who received at least one dose of the study medication, including serious AEs.
Results. From February 2021 to December 2022, 3218 patients with various malignancies were included in 41 study centers of the Russian Fede- ration. Of these, 3217 (99.97%) patients received at least one dose of the study drug, and 2663 (82.8%) patients were included in the RDI evaluation population according to the study protocol. The mean age in this group was 56.9 (18–84) years. RDI ≥85% was achieved in 2,415 (90.7%) patients. The mean RDI was 96.2%, with a median of 100%. FN risk factors were present in 1216 (45.7%) patients, with age ≥65 years being the most common risk factor at 761/2663 (28.6%). It should be noted that in patients younger than 65 years, the RDI was 91.5%, and in elderly patients (≥65 years) 88.7%. Dose-limiting neutropenia was reported in 19 (0.7%) patients. There were 74 cases of grade 3–4 AEs (according to CTCAE v.5) in 59 (1.8%) patients. The most common were neutropenia, anemia, and diarrhea in 19 (0.7%), 7 (0.2%), and 6 (0.2%) patients, respectively. Serious AEs were reported in 17 patients (0.5%).
Conclusion. Primary prophylaxis of FN with long-acting granulocyte colony-stimulating factor empegfilgrastim effectively maintains RDI in various nosological and therapeutic groups of patients with different CT regimens in real-world clinical practice.
作者简介
Anton Snegovoy
Lopatkin Scientific Research Institute of Urology – branch of the National Medical Research Radiological Centre
编辑信件的主要联系方式.
Email: drsneg@gmail.com
ORCID iD: 0000-0002-0170-5681
D. Sci. (Med.), Prof.
俄罗斯联邦, MoscowInessa Kononenko
Lopatkin Scientific Research Institute of Urology – branch of the National Medical Research Radiological Centre
Email: drsneg@gmail.com
ORCID iD: 0000-0002-7142-2986
Cand. Sci. (Med.)
俄罗斯联邦, MoscowIrina Radiukova
Clinical Oncology Dispensary, Omsk
Email: drsneg@gmail.com
Cand. Sci. (Med.)
俄罗斯联邦, OmskSvetlana Orlova
Republican Clinical Oncology Dispensary, Cheboksary
Email: drsneg@gmail.com
Head Department
俄罗斯联邦, CheboksaryAlexander Sultanbaev
Republican Clinical Oncology Dispensary, Ufa
Email: drsneg@gmail.com
ORCID iD: 0000-0003-0996-5995
Cand. Sci. (Med.)
俄罗斯联邦, UfaDaria Dubovichenko
Arkhangelsk Clinical Oncology Dispensary
Email: drsneg@gmail.com
Cand. Sci. (Med.)
俄罗斯联邦, ArkhangelskAleksandr Dergunov
Tver Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
Head Department
俄罗斯联邦, TverAleksandra Saidullaeva
Tver Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
Head Department
俄罗斯联邦, TverNadezhda Repina
Tula Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
Head Department
俄罗斯联邦, TulaIuliia Gronskaia
Saint Petersburg State University
Email: drsneg@gmail.com
ORCID iD: 0000-0002-1060-0806
oncologist
俄罗斯联邦, Saint PetersburgElena Rossokha
Altai Regional Oncology Dispensary
Email: drsneg@gmail.com
ORCID iD: 0000-0002-5303-3012
Cand. Sci. (Med.)
俄罗斯联邦, BarnaulTatiana Starostina
Voronezh Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, VoronezhOksana Akimova
Ostoverkhov Kursk Oncology Scientific and Clinical Center
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, KurskIuliia Vasil'eva
Pskov Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, PskovZarina Godzhieva
Regional Oncology Dispensary, Vladikavkaz
Email: drsneg@gmail.com
chemotherapist
俄罗斯联邦, VladikavkazOl'ga Garanina
Briansk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, BrianskKhava Gorchkhanova
Republican Oncology Dispensary, Nazran
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, NazranIuliia Machekhina
Botkin Hospital
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, MoscowAleksandra Gracheva
Tver Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, TverAnastasiia Danilova
City Clinic No. 106
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, Saint PetersburgTat'iana Dmitrakova
Briansk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, BrianskVadim Dmitriev
Belgorod Oncology Dispensary
Email: drsneg@gmail.com
D. Sci. (Med.)
俄罗斯联邦, BelgorodMarina Dmitrochenko
Smolensk Regional Oncology Clinical Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, SmolenskOlga Dylinova
Regional Clinical Oncology Hospital, Yaroslavl
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, YaroslavlViktoriia El'kova
Voronezh Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, VoronezhAlla Zhelezniak
Nizhniy Novgorod Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, Nizhniy NovgorodIrina Zubova
Smolensk Regional Oncology Clinical Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, SmolenskAleksandr Ivanov
Republican Clinical Oncology Dispensary, Cheboksary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, CheboksaryLiliia Kaleikina
Republican Oncology Dispensary, Saransk
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, SaranskIuliia Komoza
Briansk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, BrianskDmitrii Korolev
Primorsky Regional Oncology Dispensary
Email: drsneg@gmail.com
Head Department
俄罗斯联邦, VladivostokLiudmila Lebedeva
Arkhangelsk Clinical Oncology Dispensary
Email: drsneg@gmail.com
Cand. Sci. (Med.)
俄罗斯联邦, ArkhangelskAndrei Lebedinets
Leningrad Regional Clinical Hospital
Email: drsneg@gmail.com
Cand. Sci. (Med.)
俄罗斯联邦, Saint PetersburgNaira Mamedguseinova
Oncology Dispensary, Rostov-on-Don
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, Rostov-on-DonValeriia Miagkova
Oncology Dispensary, Rostov-on-Don
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, Rostov-on-DonElena Matiushina
Komi Republican Oncology Dispensary
Email: drsneg@gmail.com
Head Department
俄罗斯联邦, SyktyvkarKristina Narovenkova
Briansk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, BrianskValentina Nikolaeva
Yakutsk Republican Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, YakutskDenis Novikov
Tver Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, TverGalina Polonskaia
Tver Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, TverOlesia Rebrina
Smolensk Regional Oncology Clinical Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, SmolenskMariia Safronova
Smolensk Regional Oncology Clinical Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, SmolenskAnna Semenova
Yakutsk Republican Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, YakutskInessa Semenova
Briansk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, BrianskRoman Skotnikov
Tula Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, TulaEkaterina Solov'eva
Arkhangelsk Clinical Oncology Dispensary
Email: drsneg@gmail.com
Cand. Sci. (Med.)
俄罗斯联邦, ArkhangelskAnna Tat'ianenko
Tver Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, TverAntonina Teterich
Belgorod Oncology Dispensary
Email: drsneg@gmail.com
Head Department
俄罗斯联邦, BelgorodVladimir Timin
Komi Republican Oncology Dispensary
Email: drsneg@gmail.com
Head Department
俄罗斯联邦, SyktyvkarIrina Tolmacheva
Briansk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, BrianskIana Tiugina
Ivanovo Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, IvanovoAleksandra Khodkevich
Briansk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, BrianskFatima Tsarakhova
Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, VladikavkazIana Chapko
Arkhangelsk Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, ArkhangelskMargarita Shegurova
Nizhniy Novgorod Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, Nizhniy NovgorodNadezhda Shakurova
Tomsk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, TomskAnna Shalina
Regional Clinical Oncology Hospital, Yaroslavl
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, YaroslavlElena Shumilkina
Republican Clinical Oncology Dispensary, Cheboksary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, CheboksaryDaria Iakuba
Tver Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, TverTansylu Ibragimova
Loginov Moscow Clinical Scientific Center
Email: drsneg@gmail.com
oncologist
俄罗斯联邦, MoscowPolina Feoktistova
Loginov Moscow Clinical Scientific Center
Email: drsneg@gmail.com
ORCID iD: 0000-0002-0340-7119
Cand. Sci. (Med.)
俄罗斯联邦, MoscowIrina Sorokina
Loginov Moscow Clinical Scientific Center; JSC "Biocad"
Email: drsneg@gmail.com
Cand. Sci. (Biol.), Loginov Moscow Clinical Scientific Center, JSC "Biocad"
俄罗斯联邦, Moscow; Saint PetersburgAnna Berezina
Russian Academy of National Economy and Public Administration of the President of the Russian Federation
Email: drsneg@gmail.com
independent expert of research projects
俄罗斯联邦, MoscowPolina Kiseleva
JSC "Biocad"
Email: drsneg@gmail.com
technical support specialist
俄罗斯联邦, Saint PetersburgOlga Mironenko
Russian Academy of National Economy and Public Administration of the President of the Russian Federation
Email: drsneg@gmail.com
ORCID iD: 0000-0001-8952-8386
Cand. Sci. (Econ.)
俄罗斯联邦, MoscowOxana Prosianikova
JSC "Biocad"
Email: drsneg@gmail.com
ORCID iD: 0009-0005-3684-6301
Cand. Sci. (Med.)
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