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 (Hodgkins 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 (2172) years, 13/40 (32.5%) patients belonged to the older age group (60 years). Patients had functional status on the ECOG scale of 02 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 35 degrees of severity; secondary endpoints: frequency of FN; frequency of severe infections (34 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 34 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.

The review presents the results of studies published in 2020 concerning the role of positron emission tomography (PET) in the diagnosis of different types of malignant lymphomas. The authors tried to highlight the current trends in the development of the PET method in case of Hodgkin lymphoma, diffuse large B-cell lymphoma, follicular lymphoma and multiple myeloma. The topic concerning the use of PET in immunotherapy is highlighted separately. There was also an emphasis on the interpretation of quantitative imaging biomarkers used in PET. The concept of PET-adapted approach in Hodgkin lymphoma, the predictive significance of PET before high-dose chemotherapy and autologous hematopoietic stem cell transplantation in patients with diffuse large B-cell lymphoma, predictive value of intermediate PET in case of follicular lymphoma, the application of methionine as PET tracer to diagnose tumor burden and to measure minimal residual disease in case of multiple myeloma, the variants of atypical tumor response to the immune checkpoint inhibitors therapy, PET in diagnosing immune-mediated adverse events are currently relevant for oncologists, hematologists, radiologists and discussed in this article. In the context of the topics the authors showed the results of PET imaging of Russian patients who had PET examination in the Bakulev National Medical Research Center for Cardiovascular Surgery.

Aim. To assess the long-term results of high-dose chemotherapy following autologous hematopoietic stem cell transplantation (autoHSCT) for multiple myeloma (MM) in the real setting and influence of different factors on the results. Materials and methods. From 2006 till 2018 in Pirogovs Center were performed 205 autoHSCT for patients with MM, aged between 3172 years (median 55). 55 (26.8%) autoHSCT were tandem. The study population consisted of 45% men and 55% women. Median follow up was 75 months. For the majority of patients autoHSCT was performed after achieving at least partial response according to the IMWG criteria. For less than 9% patients, autoHSCT was done for chemo refractory disease as a salvage therapy. Most of the patients 179 (87.4%) were treated using melphalan-based conditioning regimens (140 or 200 mg/m2). Initial staging according to ISS was done for less than 30% and to R-ISS less than 5% patients. No transplant-related mortality till D + 100 was registered. 186 patients were included in the final analysis. Results. The 5-year OS and PFS were 73% and 34%, respectively, that corresponds with international data. For patients, younger than 60, 5-year OS was 82%; for patients older than 60, it was 49% (p0.05). For tandem autoHSCT, 5-year PFS was 44%; for single autoHSCT 26% (p0.05). 5-year PFS after autoHSCT was significantly higher in patients with complete and stringent complete response after autoHSCT (44%) in comparison with the group with partial and very good partial response (77%). Sex, response before and after autoHSCT, immunomodulatory drugs in induction, number of prior lines of induction therapy, conditioning regimen and maintenance therapy had no influence on OS. PFS had the same tendencies, except tumor response after autoHSCT. Conclusion. In a real setting, we recommend tandem autoHSCT for all eligible patients with chemosensitive disease, despite the depth of response and induction therapy. Patients younger than 60 and patients with complete of greater response after autoHSCT, benefit from the autoHSCT most. Implementation of total cytogenetic testing according to the R-ISS is of a great value for further development of autoHSCT for MM in Russia.