Interim results of a multicenter retrospective-prospective observational post-marketing study of Extimia® BIOCAD (INN: empegfilgrastim) to evaluate safety and efficacy in patients with lymphoproliferative diseases receiving cytotoxic therapy
- Authors: Nesterova E.S.1, Klitochenko T.Y.2,3, Glonina N.N.4, Fadeeva N.V.5, Sannikova T.A.6, Lyalina I.S.7, Shelekhova T.V.8, Sherstnev D.G.8, Voloshin S.V.9, Sarzhevskii V.O.10, Hofman A.A.11, Ichshanov D.G.12, Poddubnaya I.V.12
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Affiliations:
- National Medical Research Center for Hematology
- Volgograd State Medical University
- Volgograd Regional Clinical Oncological Dispensary
- Sergeev Regional Clinical Hospital №1
- Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
- Perm Regional Oncological Dispensary
- Sakhalin Regional Oncological Dispensary
- Razumovsky Saratov State Medical University
- Russian Research Institute of Hematology and Transfusiology
- Pirogov National Medical Surgical Center
- Altai Regional Oncological Dispensary
- Russian Medical Academy of Continuous Professional Education
- Issue: Vol 22, No 4 (2020)
- Pages: 77-84
- Section: CLINICAL ONCOLOGY
- URL: https://journals.rcsi.science/1815-1434/article/view/61160
- DOI: https://doi.org/10.26442/18151434.2020.4.200492
- ID: 61160
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Abstract
Aim. To assess the efficacy and safety of using the drug Extimia® BIOCAD (international nonproprietary name – INN: empegfilgrastim) in order to reduce the frequency and duration of neutropenia, the frequency of febrile neutropenia (FN) and infections manifested by FN in patients with lymphoproliferative diseases receiving myelosuppressive therapy.
Materials and methods. This publication presents the interim results of a multicenter retrospective – prospective observational post-marketing study of the safety and efficacy of the drug Extimia® BIOCAD (INN: empegfilgrastim) in patients with lymphoproliferative diseases receiving cytotoxic therapy (LEGERITY). The interim data analysis included 40 patients with lymphoproliferative diseases (Hodgkin’s lymphoma, diffuse large B-cell lymphoma, multiple myeloma, primary mediastinal large B-cell lymphoma, follicular lymphoma, chronic lymphocytic leukemia, splenic marginal zone lymphoma), who were treated in ten research centers of the Russian Federation (Moscow, St. Petersburg, regional clinics). The median age of patients was 48 (21–72) years, 13/40 (32.5%) patients belonged to the older age group (≥60 years). Patients had functional status on the ECOG scale of 0–2 and received at least 2 chemotherapy injections against the background of prophylaxis with empegfilgrastim. Empegfilgrastim was administered at a dose of 7.5 mg subcutaneously once 24 hours after the end of the administration of cytotoxic chemotherapeutic agents. Primary endpoint: frequency of neutropenia 3–5 degrees of severity; secondary endpoints: frequency of FN; frequency of severe infections (3–4 stages); frequency of antibiotic prescription; relative dose intensity of therapy of the conducted chemotherapy courses; the incidence of all adverse reactions in patients who received at least one dose of the study drug empegfilgrastim; the incidence of all serious adverse reactions in patients who received at least one dose of the study drug empegfilgrastim; the incidence of CTCAE 5.0 grade 3–4 HP in patients who received at least one dose of the study drug empegfilgrastim; discontinuation rate of study drug empegfilgrastim due to adverse reactions.
Results. The results of this study demonstrate that the incidence of neutropenia of 3 degree of severity after the 1st cycle of chemotherapy developed in 2/40 patients (5%) and as a result of high-dose therapy (R-DHAP). Neutropenia of any severity was reported in 5/40 patients (12.5%). Cases of FN development have not been registered. Severe infections (mucositis, enteropathy, pneumonia, etc.), as well as the use of antibacterial and antifungal drugs during 1 cycle of chemotherapy and in the inter-course period after 1 cycle of therapy were not recorded in any patient. The next course of myelosuppressive therapy was not delayed due to the development of neutropenia in any of the patients during the study. Adverse events, according to the researcher, associated with the use of empegfilgrastim, were registered in 2/40 patients (5%): moderate generalized pain syndrome (“diffuse” pain) of 1 severity and in one case – ossalgia of 2 severity. No serious adverse reactions were reported.
Conclusion. The results of the interim analysis of the study demonstrate the high efficacy of the first Russian original pegylated granulocyte colony-stimulating factor empegfilgrastim after a single administration of a fixed dose in the treatment of patients with aggressive and indolent lymphomas. The drug has a favorable tolerance profile in any age group of patients, especially in elderly patients. Administration of empegfilgrastim as a prophylaxis of neutropenia in patients with lymphoproliferative diseases receiving myelosuppressive therapy of varying intensity can reduce the burden on medical personnel, improve patient adherence to treatment, and contribute to the implementation of the therapeutic plan.
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##article.viewOnOriginalSite##About the authors
Ekaterina S. Nesterova
National Medical Research Center for Hematology
Author for correspondence.
Email: nest.ek@yandex.ru
ORCID iD: 0000-0002-6035-9547
Cand. Sci. (Med.)
Russian Federation, MoscowTatyana Yu. Klitochenko
Volgograd State Medical University; Volgograd Regional Clinical Oncological Dispensary
Email: vokod@volganet.ru
Cand. Sci. (Med.)
Russian Federation, VolgogradNatalya N. Glonina
Sergeev Regional Clinical Hospital №1
Email: khhemnatali@mail.ru
ORCID iD: 0000-0001-7340-7467
Department Head
Russian Federation, KhabarovskNatalya V. Fadeeva
Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
Email: onco74@chelonco.ru
ORCID iD: 0000-0001-7588-4929
Cand. Sci. (Med.)
Russian Federation, ChelyabinskTatyana A. Sannikova
Perm Regional Oncological Dispensary
Email: permcancer@yandex.ru
ORCID iD: 0000-0003-4243-5398
Department Head
Russian Federation, PermIrina S. Lyalina
Sakhalin Regional Oncological Dispensary
Email: sakhonco@mail.ru
hematologist
Russian Federation, Yuzhno-SakhalinskTatyana V. Shelekhova
Razumovsky Saratov State Medical University
Email: tshelexova@mail.ru
D. Sci (Med.), Prof.
Russian Federation, SaratovDmitrij G. Sherstnev
Razumovsky Saratov State Medical University
Email: sargem2006@mail.ru
ORCID iD: 0000-0002-2290-5180
Assistant
Russian Federation, SaratovSergey V. Voloshin
Russian Research Institute of Hematology and Transfusiology
Email: RRIHT@mail.ru
ORCID iD: 0000-0003-1784-0375
Cand. Sci. (Med.)
Russian Federation, Saint PetersburgVladislav O. Sarzhevskii
Pirogov National Medical Surgical Center
Email: info@pirogov-center.ru
ORCID iD: 0000-0001-7164-6595
D. Sci (Med.)
Russian Federation, MoscowAlina A. Hofman
Altai Regional Oncological Dispensary
Email: akod@akod22.ru
Head Day Hospital
Russian Federation, BarnaulDamir G. Ichshanov
Russian Medical Academy of Continuous Professional Education
Email: doctorichshanov@gmail.com
resident
Russian Federation, MoscowIrina V. Poddubnaya
Russian Medical Academy of Continuous Professional Education
Email: ivprectorat@inbox.ru
ORCID iD: 0000-0002-0995-1801
D. Sci (Med.), Prof., Acad. RAS
Russian Federation, MoscowReferences
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