Evaluation of the effectiveness of hematopoietic blood stem cell mobilization using empegfilgrastim (Extimia®, BIOCAD) in patients with lymphoproliferative diseases: the experience of several centers in the Russian Federation. A retrospective study

Ekaterina S. Nesterova; Нестерова Екатерина Сергеевна; Jana K. Mangasarova; Мангасарова Яна Константиновна; Madina O. Bagova; Багова Мадина Олеговна; Ekaterina A. Fastova; Фастова Екатерина Александровна; Aminat U. Magomedova; Магомедова Аминат Умарасхабовна; Oleg V. Margolin; Марголин Олег Викторович; Liliya G. Gorenkova; Горенкова Лилия Гамилевна; Runiza R. Abdurashidova; Абдурашидова Руниза Равильевна; Irina V. Galtseva; Гальцева Ирина Владимировна; Islam M. Nakastoev; Накастоев Ислам Мухарбекович; Vladimir S. Galuzyak; Галузяк Владимир Сидорович; Olga N. Baiteryakova; Байтерякова Ольга Николаевна; Alexandra A. Shcherbakova; Щербакова Александра Александровна; Maxim A. Telyashov; Теляшов Максим Александрович; Vadim K. Spitsyn; Спицын Вадим Константинович; David A. Sukhorukov; Сухоруков Давид Александрович; Eduard G. Gemdzhian; Гемджян Эдуард Георгиевич; Eugene E. Zvonkov; Звонков Евгений Евгеньевич; Galina D. Petrova; Петрова Галина Дмитриевна; Vladislav O. Sarzhevskiy; Саржевский Владислав Олегович; Nikita S. Shorokhov; Шорохов Никита Сергеевич; Sergey V. Voloshin; Волошин Сергей Владимирович; Sergey Yu. Linnikov; Линников Сергей Юрьевич; Maria V. Drozd; Дрозд Мария Владимировна; Polina I. Simashova; Симашова Полина Игоревна; Vasiliy P. Pop; Поп Василий Петрович; Oleg A. Rukavitsyn; Рукавицын Олег Анатольевич; Natalia V. Davydova; Давыдова Наталья Вячеславовна; Margarita Yu. Arushanyan; Арушанян Маргарита Юрьевна

doi:10.26442/18151434.2024.3.202989

Evaluation of the effectiveness of hematopoietic blood stem cell mobilization using empegfilgrastim (Extimia®, BIOCAD) in patients with lymphoproliferative diseases: the experience of several centers in the Russian Federation. A retrospective study

Authors: Nesterova E.S.¹, Mangasarova J.K.¹, Bagova M.O.¹, Fastova E.A.¹, Magomedova A.U.¹, Margolin O.V.¹, Gorenkova L.G.¹, Abdurashidova R.R.¹, Galtseva I.V.¹, Nakastoev I.M.¹, Galuzyak V.S.¹, Baiteryakova O.N.¹, Shcherbakova A.A.¹, Telyashov M.A.¹, Spitsyn V.K.¹, Sukhorukov D.A.¹, Gemdzhian E.G.¹, Zvonkov E.E.¹, Petrova G.D.², Sarzhevskiy V.O.³, Shorokhov N.S.³, Voloshin S.V.⁴, Linnikov S.Y.⁴, Drozd M.V.⁵, Simashova P.I.⁵, Pop V.P.⁵, Rukavitsyn O.A.⁵, Davydova N.V.⁵, Arushanyan M.Y.⁵
Affiliations:
1. National Medical Research Center for Hematology
2. Blokhin National Medical Research Center of Oncology
3. Pirogov National Medical and Surgical Center
4. Russian Research Institute of Hematology and Transfusiology
5. Burdenko Main Military Clinical Hospital
Issue: Vol 26, No 3 (2024)
Pages: 323-334
Section: Articles
URL: https://bakhtiniada.ru/1815-1434/article/view/275825
DOI: https://doi.org/10.26442/18151434.2024.3.202989
ID: 275825

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Abstract

Aim. To evaluate the effectiveness of autologous hematopoietic stem cell (HSC) mobilization with empegfilgrastim in patients with lymphoproliferative diseases (LPDs) and to identify prognostic factors affecting the effectiveness of mobilization.

Materials and methods. The paper analyzes the effectiveness of HSC mobilization with Extimia® by JSC "BIOCAD" (INN: empegfilgrastim) in patients with LPDs. The study included 89 patients with LPDs (Hodgkin's lymphoma, B- and T-cell lymphomas, plasma cell tumors) who were treated in 5 research centers of the Russian Federation (in Moscow and St. Petersburg). The median age of patients was 39 (18–67) years. In 26 (29%) patients, HSC mobilization was performed "in a stable state of hematopoiesis" using only pegylated granulocyte colony-stimulating factor (PEG-G-CSF), and in 63 (71%) patients after chemotherapy (CT). Empegfilgrastim was administered as a single dose of 7.5 mg subcutaneously in two regimens: 24 hours after the end of CT or at a random time.

Results. Two groups of patients were identified, analyzed, and compared: those with ineffective (n=23, 26%) and effective (n=66, 74%) HSC mobilization. Univariate and multivariate statistical analyses (binary logistic regression and multiple bidirectional binary logistic regression, respectively) were sequentially performed to determine the factors associated with ineffective mobilization. In a one-factor analysis, we studied the sex, age, diagnosis, bone/bone marrow involvement, the number of previous CT lines, the status of the disease (remission/no remission), the history of radiation therapy, the time interval from the administration of empegfilgrastim to the decision to perform leukapheresis, the mode of granulocytopoiesis stimulation ("in a stable state of hematopoiesis" or after CT), the leukocyte and platelet counts. The subsequent multifactorial analysis of the two selected parameters (diagnosis and time interval from drug administration to the decision to perform leukapheresis) showed the following statistically significant risk factors for ineffective mobilization: T-cell lymphoma; T-cell lymphoma versus other (combination) diagnoses (B-cell lymphoma, Hodgkin's lymphoma and plasma cell tumor): p=0.046, Wald test, odds ratio 4.18 (95% confidence interval 0.96–19.4). The time interval from the administration of empegfilgrastim to the first leukapheresis in the effective mobilization group depended on the diagnosis. The longest period was observed in patients with plasma cell tumors and the shortest in those with T-cell lymphomas: 10 (4–10) vs 5.5 (4–6) [p=0.01, Kruskal–Wallis test]. Empegfilgrastim proved equally effective for HSC mobilization both "on stable hematopoiesis" and after CT.

Conclusion. The results of the first multicenter experience with Extimia® by JSC "BIOCAD" (INN: empegfilgrastim) to mobilize autologous HSCs in LPD patients demonstrate its high efficacy with a favorable safety and tolerability profile: 74% (66/89) successful mobilizations after a single administration of a fixed dose of the drug.

Keywords

empegfilgrastim, pegylated colony-stimulating factor, autologous hematopoietic stem cell transplantation, hematopoietic stem cell mobilization, Extimia