Effectiveness and safety of empegfilgrastim (Extimia®, BIOCAD) in patients with lymphoproliferative diseases receiving cytotoxic therapy: results of LEGERITY, a multicenter retrospective-and-prospective observational post-marketing study
Aim. To evaluate the effectiveness and safety of Extimia® BIOCAD (international non-proprietary name: empegfilgrastim) to reduce the incidence and duration of neutropenia, the incidence of febrile neutropenia (FN) and infections associated with FN in patients with lymphoproliferative diseases receiv...
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| Format: | Article |
| Language: | Russian |
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IP Habib O.N.
2023-12-01
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| Series: | Современная онкология |
| Subjects: | |
| Online Access: | https://modernonco.orscience.ru/1815-1434/article/viewFile/627191/142914 |
| _version_ | 1797290154916839424 |
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| author | Ekaterina S. Nesterova Aleksandra F. Saydullaeva Dmitry G. Sherstnev Tatiana V. Shelekhova Tatiana Yu. Klitochenko Gulnara N. Khusainova Irina B. Lysenko Irina S. Lyalina Marina V. Demchenkova Svetlana A. Orlova Andrei V. Proydakov Мadina V. Betrozova Natalia V. Fadeeva Alina A. Gofman Yana M. Marchenko Sergey V. Voloshin Elena A. Pashneva Vladislav O. Sarzhevskiy Alina R. Babicheva Irina B. Bondareva Natalia N. Glonina Damir G. Ishchanov Irina V. Poddubnaya |
| author_facet | Ekaterina S. Nesterova Aleksandra F. Saydullaeva Dmitry G. Sherstnev Tatiana V. Shelekhova Tatiana Yu. Klitochenko Gulnara N. Khusainova Irina B. Lysenko Irina S. Lyalina Marina V. Demchenkova Svetlana A. Orlova Andrei V. Proydakov Мadina V. Betrozova Natalia V. Fadeeva Alina A. Gofman Yana M. Marchenko Sergey V. Voloshin Elena A. Pashneva Vladislav O. Sarzhevskiy Alina R. Babicheva Irina B. Bondareva Natalia N. Glonina Damir G. Ishchanov Irina V. Poddubnaya |
| author_sort | Ekaterina S. Nesterova |
| collection | DOAJ |
| description | Aim. To evaluate the effectiveness and safety of Extimia® BIOCAD (international non-proprietary name: empegfilgrastim) to reduce the incidence and duration of neutropenia, the incidence of febrile neutropenia (FN) and infections associated with FN in patients with lymphoproliferative diseases receiving myelosuppressive therapy.
Materials and methods. The paper presents the results of a multicenter retrospective-and-prospective observational post-marketing study of the safety and effectiveness of Extimia® BIOCAD (international non-proprietary name: empegfilgrastim) in patients with lymphoproliferative diseases receiving cytotoxic therapy. Initially, the study was defined as retrospective-and-prospective. However, only 2 of 671 (0.3%) patients were included retrospectively. Thus, the study is based on the evaluation of prospectively collected data. The analysis describes the characteristics and treatment of 671 patients diagnosed with lymphoma who received one or more cycles of chemotherapy in the LEGERITY study. The endpoints of interest included the incidence of grade 3–4 neutropenia, FN, and grade 3–4 infectious complications, the frequency of antibiotic therapy, and the incidence of all adverse reactions in patients who received at least one dose of the study medication.
Results. A total of 671 patients were enrolled in the study, the majority having B-cell non-Hodgkin lymphoma (428/671, 64%) and Hodgkin lymphoma (211/671, 31%). The mean age was 54 years (18–84); 35% (236/671) of patients were elderly (over 60). The number of injections of empegfilgrastim for the entire observation period was 3093 (n=671). Adverse events were reported in 57/3093 (1.8%) cases. The most common adverse events were mild to moderate ossalgia and myalgia (27/671, 4%), back pain, and arthralgia (12/671, 1.8%), which did not require drug therapy. Two patients developed serious adverse reactions – CTCAE v.5 grade 4 hypotension events. 529 (78.8%) patients received at least 4 courses of chemotherapy. FN was reported in 14 (2.6%) patients and did not require antimicrobial therapy.
Conclusion. The final analysis results confirm the high clinical efficacy and safety of the Russian original pegylated granulocyte colony-stimulating factor empegfilgrastim (Extimia®) in patients with indolent and aggressive lymphomas. The data obtained from real-world clinical practice demonstrate a favorable safety and tolerability profile of empegfilgrastim in all age groups, including the elderly population. |
| first_indexed | 2024-03-07T19:16:21Z |
| format | Article |
| id | doaj.art-a4488d8f4b30472c91384c6204fc8dbe |
| institution | Directory Open Access Journal |
| issn | 1815-1434 1815-1442 |
| language | Russian |
| last_indexed | 2024-03-07T19:16:21Z |
| publishDate | 2023-12-01 |
| publisher | IP Habib O.N. |
| record_format | Article |
| series | Современная онкология |
| spelling | doaj.art-a4488d8f4b30472c91384c6204fc8dbe2024-02-29T13:31:29ZrusIP Habib O.N.Современная онкология1815-14341815-14422023-12-0125442243110.26442/18151434.2023.4.20253979541Effectiveness and safety of empegfilgrastim (Extimia®, BIOCAD) in patients with lymphoproliferative diseases receiving cytotoxic therapy: results of LEGERITY, a multicenter retrospective-and-prospective observational post-marketing studyEkaterina S. Nesterova0https://orcid.org/0000-0002-6035-9547Aleksandra F. Saydullaeva1Dmitry G. Sherstnev2https://orcid.org/0000-0002-2290-5180Tatiana V. Shelekhova3https://orcid.org/0000-0002-4737-7695Tatiana Yu. Klitochenko4Gulnara N. Khusainova5https://orcid.org/0000-0003-1916-9925Irina B. Lysenko6https://orcid.org/0000-0003-4457-3815Irina S. Lyalina7Marina V. Demchenkova8Svetlana A. Orlova9Andrei V. Proydakov10Мadina V. Betrozova11Natalia V. Fadeeva12Alina A. Gofman13Yana M. Marchenko14https://orcid.org/0000-0003-3231-5421Sergey V. Voloshin15https://orcid.org/0000-0003-1784-0375Elena A. Pashneva16Vladislav O. Sarzhevskiy17https://orcid.org/0000-0001-7164-6595Alina R. Babicheva18https://orcid.org/0009-0004-6696-2365Irina B. Bondareva19https://orcid.org/0000-0002-8436-8931Natalia N. Glonina20https://orcid.org/0000-0001-7340-7467Damir G. Ishchanov21Irina V. Poddubnaya22https://orcid.org/0000-0002-0995-1801National Medical Research Center for HematologyTver Regional Clinical Oncological DispensaryRazumovsky Saratov State Medical UniversityRazumovsky Saratov State Medical UniversityVolgograd State Medical UniversitySigal Republican Clinical Oncological DispensaryNational Medical Research Center for OncologySakhalin Regional Oncological DispensaryRegional Oncological DispensaryRepublican Clinical Oncological DispensaryKomi Republican Oncological DispensaryOncological DispensaryChelyabinsk Regional Clinical Center for Oncology and Nuclear MedicineAltai Regional Oncological DispensaryStavropol Regional Clinical Oncological DispensaryRussian Research Institute of Hematology and TransfusiologyVolgograd Regional Clinical Oncological DispensaryPirogov National Medical and Surgical CenterPirogov Russian National Research Medical UniversityPeople’s Friendship University of Russia (RUDN University)Sergeyev Regional Clinical Hospital №1Russian Medical Academy of Continuous Professional EducationRussian Medical Academy of Continuous Professional EducationAim. To evaluate the effectiveness and safety of Extimia® BIOCAD (international non-proprietary name: empegfilgrastim) to reduce the incidence and duration of neutropenia, the incidence of febrile neutropenia (FN) and infections associated with FN in patients with lymphoproliferative diseases receiving myelosuppressive therapy. Materials and methods. The paper presents the results of a multicenter retrospective-and-prospective observational post-marketing study of the safety and effectiveness of Extimia® BIOCAD (international non-proprietary name: empegfilgrastim) in patients with lymphoproliferative diseases receiving cytotoxic therapy. Initially, the study was defined as retrospective-and-prospective. However, only 2 of 671 (0.3%) patients were included retrospectively. Thus, the study is based on the evaluation of prospectively collected data. The analysis describes the characteristics and treatment of 671 patients diagnosed with lymphoma who received one or more cycles of chemotherapy in the LEGERITY study. The endpoints of interest included the incidence of grade 3–4 neutropenia, FN, and grade 3–4 infectious complications, the frequency of antibiotic therapy, and the incidence of all adverse reactions in patients who received at least one dose of the study medication. Results. A total of 671 patients were enrolled in the study, the majority having B-cell non-Hodgkin lymphoma (428/671, 64%) and Hodgkin lymphoma (211/671, 31%). The mean age was 54 years (18–84); 35% (236/671) of patients were elderly (over 60). The number of injections of empegfilgrastim for the entire observation period was 3093 (n=671). Adverse events were reported in 57/3093 (1.8%) cases. The most common adverse events were mild to moderate ossalgia and myalgia (27/671, 4%), back pain, and arthralgia (12/671, 1.8%), which did not require drug therapy. Two patients developed serious adverse reactions – CTCAE v.5 grade 4 hypotension events. 529 (78.8%) patients received at least 4 courses of chemotherapy. FN was reported in 14 (2.6%) patients and did not require antimicrobial therapy. Conclusion. The final analysis results confirm the high clinical efficacy and safety of the Russian original pegylated granulocyte colony-stimulating factor empegfilgrastim (Extimia®) in patients with indolent and aggressive lymphomas. The data obtained from real-world clinical practice demonstrate a favorable safety and tolerability profile of empegfilgrastim in all age groups, including the elderly population.https://modernonco.orscience.ru/1815-1434/article/viewFile/627191/142914non-hodgkin's lymphomaempegfilgrastimpegylated colony-stimulating factorclinical practiceprevention of neutropenia |
| spellingShingle | Ekaterina S. Nesterova Aleksandra F. Saydullaeva Dmitry G. Sherstnev Tatiana V. Shelekhova Tatiana Yu. Klitochenko Gulnara N. Khusainova Irina B. Lysenko Irina S. Lyalina Marina V. Demchenkova Svetlana A. Orlova Andrei V. Proydakov Мadina V. Betrozova Natalia V. Fadeeva Alina A. Gofman Yana M. Marchenko Sergey V. Voloshin Elena A. Pashneva Vladislav O. Sarzhevskiy Alina R. Babicheva Irina B. Bondareva Natalia N. Glonina Damir G. Ishchanov Irina V. Poddubnaya Effectiveness and safety of empegfilgrastim (Extimia®, BIOCAD) in patients with lymphoproliferative diseases receiving cytotoxic therapy: results of LEGERITY, a multicenter retrospective-and-prospective observational post-marketing study Современная онкология non-hodgkin's lymphoma empegfilgrastim pegylated colony-stimulating factor clinical practice prevention of neutropenia |
| title | Effectiveness and safety of empegfilgrastim (Extimia®, BIOCAD) in patients with lymphoproliferative diseases receiving cytotoxic therapy: results of LEGERITY, a multicenter retrospective-and-prospective observational post-marketing study |
| title_full | Effectiveness and safety of empegfilgrastim (Extimia®, BIOCAD) in patients with lymphoproliferative diseases receiving cytotoxic therapy: results of LEGERITY, a multicenter retrospective-and-prospective observational post-marketing study |
| title_fullStr | Effectiveness and safety of empegfilgrastim (Extimia®, BIOCAD) in patients with lymphoproliferative diseases receiving cytotoxic therapy: results of LEGERITY, a multicenter retrospective-and-prospective observational post-marketing study |
| title_full_unstemmed | Effectiveness and safety of empegfilgrastim (Extimia®, BIOCAD) in patients with lymphoproliferative diseases receiving cytotoxic therapy: results of LEGERITY, a multicenter retrospective-and-prospective observational post-marketing study |
| title_short | Effectiveness and safety of empegfilgrastim (Extimia®, BIOCAD) in patients with lymphoproliferative diseases receiving cytotoxic therapy: results of LEGERITY, a multicenter retrospective-and-prospective observational post-marketing study |
| title_sort | effectiveness and safety of empegfilgrastim extimia r biocad in patients with lymphoproliferative diseases receiving cytotoxic therapy results of legerity a multicenter retrospective and prospective observational post marketing study |
| topic | non-hodgkin's lymphoma empegfilgrastim pegylated colony-stimulating factor clinical practice prevention of neutropenia |
| url | https://modernonco.orscience.ru/1815-1434/article/viewFile/627191/142914 |
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