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

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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.

作者简介

Ekaterina Nesterova

National Medical Research Center for Hematology

编辑信件的主要联系方式.
Email: nest.ek@yandex.ru
ORCID iD: 0000-0002-6035-9547

Cand. Sci. (Med.)

俄罗斯联邦, Moscow

Aleksandra Saydullaeva

Tver Regional Clinical Oncological Dispensary

Email: nest.ek@yandex.ru

Department Head, Tver Regional Clinical Oncological Dispensary

俄罗斯联邦, Tver

Dmitry Sherstnev

Razumovsky Saratov State Medical University

Email: nest.ek@yandex.ru
ORCID iD: 0000-0002-2290-5180

Assistant

俄罗斯联邦, Saratov

Tatiana Shelekhova

Razumovsky Saratov State Medical University

Email: nest.ek@yandex.ru
ORCID iD: 0000-0002-4737-7695

D. Sci. (Med.), Prof., Razumovsky Saratov State Medical University

俄罗斯联邦, Saratov

Tatiana Klitochenko

Volgograd State Medical University; Volgograd Regional Clinical Oncological Dispensary;Clinic „Sova”

Email: nest.ek@yandex.ru

Cand. Sci. (Med.), Volgograd State Medical University, Volgograd Regional Clinical Oncological Dispensary, Clinic „Sova”

 

俄罗斯联邦, Volgograd; Volgograd; Volgograd

Gulnara Khusainova

Sigal Republican Clinical Oncological Dispensary

Email: nest.ek@yandex.ru
ORCID iD: 0000-0003-1916-9925

Cand. Sci. (Med.)

俄罗斯联邦, Kazan

Irina Lysenko

National Medical Research Center for Oncology

Email: nest.ek@yandex.ru
ORCID iD: 0000-0003-4457-3815

D. Sci. (Med.)

俄罗斯联邦, Rostov-on-Don

Irina Lyalina

Sakhalin Regional Oncological Dispensary

Email: nest.ek@yandex.ru

oncologist

俄罗斯联邦, Yuzhno-Sakhalinsk

Marina Demchenkova

Regional Oncological Dispensary

Email: nest.ek@yandex.ru

oncologist

俄罗斯联邦, Irkutsk

Svetlana Orlova

Republican Clinical Oncological Dispensary

Email: nest.ek@yandex.ru

Department Head

俄罗斯联邦, Cheboksary

Andrei Proydakov

Komi Republican Oncological Dispensary

Email: nest.ek@yandex.ru

Department Head

俄罗斯联邦, Syktyvkar

Мadina Betrozova

Oncological Dispensary

Email: nest.ek@yandex.ru

Department Head

俄罗斯联邦, Nalchik

Natalia Fadeeva

Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine

Email: nest.ek@yandex.ru

Cand. Sci. (Med.)

俄罗斯联邦, Chelyabinsk

Alina Gofman

Altai Regional Oncological Dispensary

Email: nest.ek@yandex.ru

oncologist

俄罗斯联邦, Barnaul

Yana Marchenko

Stavropol Regional Clinical Oncological Dispensary

Email: nest.ek@yandex.ru
ORCID iD: 0000-0003-3231-5421

Cand. Sci. (Med.)

俄罗斯联邦, Stavropol

Sergey Voloshin

Russian Research Institute of Hematology and Transfusiology; Kirov Military Medical Academy

Email: nest.ek@yandex.ru
ORCID iD: 0000-0003-1784-0375

Cand. Sci. (Med.), Assoc. Prof.

俄罗斯联邦, Saint Petersburg; Saint Petersburg

Elena Pashneva

Volgograd Regional Clinical Oncological Dispensary

Email: nest.ek@yandex.ru

Department Head

俄罗斯联邦, Volgograd

Vladislav Sarzhevskiy

Pirogov National Medical and Surgical Center

Email: vladsar100@gmail.com
ORCID iD: 0000-0001-7164-6595

D. Sci. (Med.), Prof.

俄罗斯联邦, Moscow

Alina Babicheva

Pirogov Russian National Research Medical University

Email: a.babicheva2@mail.ru
ORCID iD: 0009-0004-6696-2365

Student, Pirogov Russian National Research Medical University

俄罗斯联邦, Moscow

Irina Bondareva

People’s Friendship University of Russia (RUDN University)

Email: i_bondareva@yahoo.com
ORCID iD: 0000-0002-8436-8931

D. Sci. (Biol.)

俄罗斯联邦, Moscow

Natalia Glonina

Sergeyev Regional Clinical Hospital №1

Email: khhemnatali@mail.ru
ORCID iD: 0000-0001-7340-7467

Department Head

俄罗斯联邦, Khabarovsk

Damir Ishchanov

Russian Medical Academy of Continuous Professional Education

Email: nest.ek@yandex.ru

oncologist

俄罗斯联邦, Moscow

Irina Poddubnaya

Russian Medical Academy of Continuous Professional Education

Email: ivprectorat@inbox.ru
ORCID iD: 0000-0002-0995-1801

D. Sci. (Med.), Prof., Acad. RAS

俄罗斯联邦, Moscow

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