Vol 22, No 2 (2020)

Hodgkin's lymphoma
Demina E.A., Tumyan G.S., Moiseeva T.N., Mikhailova N.B., Myakova N.V., Rumyantsev A.G., Maschan A.A., Kaplanov K.D., Shmakov R.G., Falaleeva N.A., Ptushkin V.V., Osmanov E.A., Poddubnaya I.V., Baikov V.V., Kovrigina A.M., Konovalov D.M., Trofimova O.P., Sotnikov V.M., Ilin N.V., Vinogradova Y.N., Nechesnyuk A.V., Parkhomenko R.A., Stefanov D.N., Nevolsky A.A., Ivanov S.A., Khaylova Z.V.

Clinical recommendations.

Journal of Modern Oncology. 2020;22(2):6-33
Follicular lymphoma
Babicheva L.G., Tumyan G.S., Osmanov E.A., Falaleeva N.A., Kravchenko S.K., Stefanov D.N., Poddubnaya I.V., Myakova N.V., Rumyantsev A.G., Maschan A.A., Ptushkin V.V., Baikov V.V., Kovrigina A.M., Krivolapov I.A., Konovalov D.M., Nevolsky A.A., Ivanov S.A., Khaylova Z.V., Gevorkian T.G.

Clinical recommendations.

Journal of Modern Oncology. 2020;22(2):34-51
Conference Proceedings
Therapy of Hodgkin lymphoma in Russia during the COVID-19 pandemic
Poddubnaya I.V., Baryakh E.A., Vorobyev V.I., Demina E.A., Zhukov N.V., Kaplanov K.D., Konstantinova T.S., Motorin D.V., Ptushkin V.V., Sarzhevsky V.O., Tumyan G.S.

Relevance. COVID-19 pandemic currently has a significant negative impact on the treatment of patients with oncological pathology, including patients with classic Hodgkin lymphoma. Generalized data on publications on the impact of concomitant pathology on the severity of infection show a significant increase in the risk of death from infection in male patients, aged >60 years, with the presence of ≥3 concomitant diseases, among which particularly negative role is played by diseases of the cardiovascular system, diabetes, oncology, chronic lung disease, immunodeficiency conditions. Particularly dangerous is the development of COVID-19 infection in an interval of less than 14 days from the course of antitumor therapy. At the same time, patients with Hodgkin lymphoma require immediate treatment, often associated with toxic, immunosuppressive therapy, frequent visits to the clinic, hospitalizations. International communities have not yet developed clear guidelines for the management of patients with Hodgkin’s lymphoma. Taking into account the understanding that the circulation of coronoviral infection will continue in the population, the Advisory board on the Problems of Hodgkin Lymphoma Therapy in the COVID-19 Pandemic is highly relevant.

Aim. To change and adapt current treatment approaches in the current epidemiological environment.

Results. The main directions of the impact of the COVID-19 pandemic on the treatment of patients with cancer pathology, including patients with classical Hodgkin lymphoma, were determined, key problems in the treatment of LC during the COVID-19 pandemic were identified, and measures aimed at reducing the risk for patients were developed. Existing approaches to first-line, relapse/refracturing cHL therapy, including salvage therapy, and auto/allo SCT during the COVID-19 pandemic, have been adapted.

Journal of Modern Oncology. 2020;22(2):52-55
New opportunities of systemic therapy of CD30-positive primary cutaneous T-cell lymphomas
Poddubnaya I.V., Ptushkin V.V., Belousova I.E., Gorenkova L.G., Kaplanov K.D., Karamova A.E., Kovrigina A.M., Kolomeitsev O.A., Konstantinova T.S., Kokhan M.M., Pospelova T.I.

Relevance. Cutaneous T-cell lymphomas (CTCL) are not common diseases which are associated with a decrease in quality of life. Currently available systemic therapy rarely provides a stable and long-termed response. In Russia, current CTCL therapy is a big issue due to the limited access to modern targeted therapy, an absence of a National CTCL registry, and the difficulties in morphological diagnosis of these rare diseases. Since June 17, 2019, a new indication of brentuximab vedotin as a new treatment option for patients with CD30+ CTCL after at least one line of previous systemic therapy was registered. Brentuximab vedotin is a conjugate of a CD30 directed monoclonal antibody and an antitumor agent. Brentuximab vedotin is a CD30-directed monoclonal antibody conjugated to an antitumor agent.

Aim. To identify the unresolved issues of current clinical practice and to adapt available approaches to the treatment and diagnosis of CD30 + CTCL given new therapeutic opportunities.

Results. The available approaches to the systemic CTCL therapy in Russia routine clinical practice have been discussed, the unresolved issues of therapy and diagnosis have been identified, the routing of patients with CD30 + CTCL in Russia has been discussed, the importance of CD30 testing has been established, the profiles of patients with CTCL for treatment with brentuximab vedotin have been determined.

Journal of Modern Oncology. 2020;22(2):79-81
Cancer patient management during the COVID-19 pandemic Training module. Version 2 from 30.04.2020
Poddubnaya I.V., Sychev D.A., Abuzarova G.R., Allakhverdiev A.K., Arkhiri P.P., Babicheva L.G., Baranova M.P., Volkova M.I., Ignatova A.V., Kashurnikov A.I., Kniazev R.I., Kolyadina I.V., Komarov I.G., Kriukov A.V., Levitskaia N.V., Liadov V.K., Malikhova O.A., Nered S.N., Orel N.F., Podviaznikov S.O., Sagaidak I.V., Sarmanaeva R.R., Stilidi I.S., Trofimova O.P., Tumian G.S., Kharitonova T.V.

The training module was developed by the staff of the department under the leadership of the head. Department of Academician of RAS, Professor I.V. Poddubnoy and Rector of FSBEI DPO RMANPO of the Ministry of Health of Russia, Corr. RAS, Professor D.A. Sychev.

Journal of Modern Oncology. 2020;22(2):56-73
Original Article
Maintenance oncohematological patients and new coronavirus infection: experience of the City Clinical Hospital №52
Baryakh E.A., Kochneva O.L., Misyurina E.N., Zhelnova E.I., Yatskov K.V., Zagrebneva A.I., Zyangirov R.R., Samsonova I.V., Poteshkina N.G., Lysenko M.A., Poddubnaya I.V.

Justification. Oncological diseases, along with diabetes, hypertension, cardiovascular and chronic obstructive pulmonary diseases, are associated with severe course and worst prognosis of the new coronavirus infection – COVID-19. Due to the limited number of the international studies and the lack of the domestic publications on the analysis of the course of COVID-19 in patients with oncohematological pathology and the patient management tactics, this work seems extremely topical.

Materials and methods. 24.04.2020–31.05.2020, 110 patients with oncohematological pathology associated with new coronavirus infection were observed on the basis of the hematology service of City Clinical Hospital №52: 59 women and 51 men, mean age 58 (18–90) years.

Results. Currently, 24 (22%) patients among 110 are continuing treatment. The outcome of the disease is observed in 86 (78%) patients: 50 (58%) patients were discharged from hospital with complete or partial resolution of pneumonia, 36 (42%) of the 86 patients died. The groups did not differ in gender. The median age was higher in the group of deceased patients (66 vs. 54 years in patients who had a favorable outcome after COVID-19). The somatic status ECOG 3–4 was an independent predictive factor determining the adverse outcome of the disease. The third part of the patients from the group with a fatal cases due to a severe condition in the debut of the disease immediately were hospitalized in the intensive care unit (ICU), 2 (6%) of them had died within the first day. Disposition, according to the nosology showed a significant predominance among patients with an adverse outcome associated with acute leukemia (18% vs 39%). Patients with resistant course of hemoblastosis accounted for 50% of deceased patients. Severe form of the course of COVID-19 infection was twice as frequently (46% vs 84%) among patients with an adverse outcome of the disease, that was associated with both the initial more severe group of patients (33% were hospitalized in the ICU), and less curability of pneumonia against the background of the adverse prognostic factors: the older age group, the predominance of patients with acute leukemia and resistant course of oncohematological diseases. Specific anticancer therapy and COVID-19 therapy were comparable in both groups.

Conclusions. Identification of new coronavirus infection against a backdrop of oncohematological disease is associated with a severe course of COVID-19 and high death rate – 42%. According to the preliminary obtained results, the adverse prognostic factors of COVID-19 in patients with oncohematological diseases include: elderly age, the poor somatic status (ECOG 3–4), relapse or progression of hemoblastosis and nosological affiliation to acute leukemia.

Journal of Modern Oncology. 2020;22(2):74-78
First-line therapy of indolent non-Hodgkin’s lymphoma in routine clinical practice
Babicheva L.G., Poddubnaya I.V.

The aim is to evaluate the efficacy of the first-line rituximab-containing therapy of B-cell lymphoproliferative diseases in Russian clinical practice between 2014 and 2017.

Materials and methods. In the post-authorisation multicenter study EQUILIBRIUM were included 1 thousand patients aged from 21 to 91 with B-cell non-Hodgkin’s lymphoma or chronic lymphatic leukemia who had received at least 4 cycles of rituximab-containing therapy using the drug Acellbia®. This article was devoted to the group of indolent non-Hodgkin’s lymphomas and included 253 patients: follicular lymphoma – 51% of cases, marginal zone lymphoma – 44% of patients, extremely rare were registered lymphoplasmacytic lymphoma and Waldenstrom macroglobulinemia – in 3% and in 2% of cases, respectively. The median age in patients with indolent non-Hodgkin’s lymphomas was 62 years (21–91 years). The vast majority of patients were diagnosed with stage III–IV – 190 (75%) of patients. More than 1/2 (53.4%) of patients in routine practice received R-CHOP therapy as a first-line. BR regimen was applied in 15.4% of cases, 14.2% of patients were treated with R-CVP/R-COP. We indicated rare use of rituximab as monotherapy in induction mode – only 4.4% of patients. And 2.4% of patients were treated with fludarabine-containing therapy.

Results. The final assessment of the effect was carried out after 6–8 cycles of treatment and as a result the overall effect was more than 90%: the frequency of complete remission was 61%, partial responses – 32.9%. The progression admitted only in 17 (6.7%) patients among 253 observed. With a median of 15 months, the median of overall survival and event-free survival was not achieved.

Conclusion. The use of the available and appropriate treatment according to the domestic clinical guidelines with the inclusion of the Russian biosimilar anti-CD20 monoclonal antibody – Acellbia®, demonstrates high direct efficacy and satisfactory long-term treatment results comparable to the retrospective analysis of the previous clinical studies of the original drug rituximab.

Journal of Modern Oncology. 2020;22(2):119-125
Biobanks in oncology: global experience and Russian reality
Kaprin A.D., Ivanov S.A., Petrov V.A., Dukhova N.N., Dvinskikh N.I., Falaleeva N.A., Grivtsova L.I.

One of the integral components of modern large-scale research projects in the field of medicine are biobanks. The main objective of this infrastructure is the professional collection of biological samples that can be studied with respect to a wide range of molecular biological parameters and will not lose their information value over a long storage period. These samples are made informative not only by correctly conducted preanalytical preparation at the stage of taking samples and placing them in storage, but also by detailed information support (the so-called annotated samples). The sample annotation is the fully collected personal, clinical and laboratory data about a patient. An important point of the biobank infrastructure is compliance with regulatory legal acts and ethical standards, including the procedure for signing an informed consent by a patient about voluntary donation of biological samples and the use of personal data. All this ensures the implementation of the main objective of creating biobanks – the wide and uninterrupted availability of collections of biological material for researchers and developers and compliance with specific scientific tasks. This review is devoted to biobanking issues, as well as to the description and analysis of the currently existing oncological biobank infrastructure, both globally and within the Russian Federation.

Journal of Modern Oncology. 2020;22(2):82-88
Accompanying therapy in oncohematological patients with secondary immunodeficiency
Babicheva L.G., Poddubnaya I.V.

Actuality. The inability of a person’s immune system to withstand foreign antigenic aggression is called immunodeficiency. More than 1/2 of all cases of secondary immunodeficiency (SID) in the world are occupied by hemoblastosis and, in a greater degree, the therapy, accompanied by the immunosuppression. Due to the expansion of the arsenal of new targeted drugs for the treatment of oncohematological diseases affecting different parts of the immune system, to increasingly frequent use of autologous and especially allogeneic hematopoietic cell transplantation, the prevalence and the frequency of SID are inexorably increasing. Timely diagnosis of SID should be the starting point of the management of oncohematological patients to reduce the incidence of infectious complications and, as a result, case fatality rate. Monitoring is based on assessing risk factors and identifying the category of patients requiring active preventive measures before they develop severe infection. Elimination of the main cause of SID development is the preferred option for the prevention of the infectious complications. However, in case of multiple myeloma, chronic lymphocytic leukemia and other oncohematological diseases, this option is often impossible. Therefore, active accompanying therapy is necessary for this category of patients, in particular immunoglobulin (Ig) replacement therapy. Main clinical communities are currently in the process of updating their guidelines and recommendations on using Ig replacement therapy in patients with hemoblastosis accompanied severe recurrent infections; after ineffective antibiotic treatment; with a proven inadequate specific antibody response; IgG<4 g/l. Numerous cohort, observational and randomized trials showed the significant reduction in the number of infectious complications in oncohematological patients on using long-term (not less than 10–12 months) intravenous Ig replacement therapy. The lack of attention of oncologists and hematologists to the early diagnosis and prevention of these conditions leads to the increase in the number of infectious complications with all the consequences such as worsen treatment results and increase mortality among oncohematological patients.

Conclusion. There is a real need to raise awareness among physicians and patients, to use screening and better management of the group of patients with increased risk of SID, and preventive use of intravenous Ig to reduce the incidence of infectious complications and active accompanying therapy aimed at reducing infection-related mortality.

Journal of Modern Oncology. 2020;22(2):89-97
Adjuvant targeted therapy for non-small cell lung cancer
Laktionov K.K., Kazakov A.M., Gordiev M.G., Kononets P.V., Akhmedov B.B., Maevskaia J.N.

Non-small cell lung cancer (NSCLC) is a heterogeneous group of diseases with a wide range of possible targeted activating mutations. In this regard, a lot of attention is paid to such treatment of patients with NSCLC as adjuvant targeted therapy after radical surgical treatment, nowadays. The active interest in this option is associated with several reasons: sufficient low efficacy of adjuvant chemotherapy, increased capabilities of molecular genetic methods to determine the activating mutations, extensive introduction of liquid biopsy into the clinical practice, as well as the results of the trials associated with the use of targeted therapy both in the treatment of advanced forms of NSCLC and in an adjuvant regimen. The results of such trials as SELECT, ADJUVANT/CTONG1104, ADAURA have shown the benefit of adjuvant targeted therapy in comparison with chemotherapy, placebo or historical control. The ability to identify circulating tumor DNA as a marker of minimal residual disease after surgical treatment, as well as the determination of the mutation profile using the minimally invasive method such as the fluid biopsy will allow achieving an even more personalized approach to the appointment of adjuvant therapy. All this makes the use of adjuvant targeted therapy a promising and effective treatment option.

Journal of Modern Oncology. 2020;22(2):104-107
Inhibin B in diagnosis and monitoring of granulosa-cell tumors of ovary
Lyubimova N.V., Beishembaev A.M., Timofeev Y.S., Zhordania K.I., Kushlinskii N.E.

Introduction. Granulosa cell tumors of ovary (GCTO) – rare type of malignant ovarian neoplasms formed from granulosa cells of the follicles capable to produce biologically active substances, including inhibin B. The purpose of this study is evaluation of clinical significance of inhibin B analysis in blood serum of patients with adult type of GCTO primary disease, relapse and during remission after treatment.

Materials and methods. The study included 134 patients with GCTO, 15 patients with benign ovarian tumors and 82 healthy women. Inhibin B was determined in blood serum with standard enzyme-linked immunosorbent assay Inhibin B Gen II ELISA (Beckman Coulter, USA) in the microplate format.

Results. The analysis data indicates a high sensitivity of inhibin B in the diagnosis of primary GCTO (92.3%) and in relapse (92.7%) with a specificity 100%. An increase of inhibin B before the clinical manifestation of relapse (for 2–12 months) confirms its significance as an effective biochemical marker for GCTO monitoring.

Conclusion. Inhibin B can be used as effective biochemical marker of primary and GCTO and its relapses.

Journal of Modern Oncology. 2020;22(2):116-118
Best Practice
Prospects of eribulin administration for patients with HR-positive HER2-negative metastatic breast cancer after progression on CDK4/6 Inhibitors: theoretical background and first experience
Kolyadina I.V., Ganshina I.P., Kuzmicheva S.V., Tekeeva A.I., Kolokolov J.D., Volkonskii M.V., Poddubnaya I.V.

Combining cyclin-dependent kinases 4 and 6 (CDK 4/6) inhibitors with endocrine therapies in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in the first and second lines has emerged as optimal treatment strategy and has implications related to clinical efficacy, rapid clinical response and manageable tolerability. However, approximately one in five women has progression during the first year, we have to make efforts to choose the treatments for hormone receptor-positive breast cancer. Potential treatment options include prospective chemotherapy drug eribulin, its efficacy has been demonstrated in various biological subtypes of metastatic breast cancer in patients pretreated with anthracyclines and taxanes. Data from EMPOWER study evaluating the use of eribulin in female patients with hormone positive HER2-negative metastatic breast cancer who received CDK 4/6 inhibitor therapy showed promising results. In the cohort eribulin was prescribed according to the FDA indications in the USA after at least three prior regimens with a prior anthracycline and a taxane overall response rate was 26.7%, clinical benefit rate was 54.1%, median progressive-free survival was not reached and 6-month progressive-free survival rates was 70.4%. Eribulin demonstrated a manageable tolerability profile, adverse event rates were similar to those in clinical trials and other observational studies. In this paper we present the analysis from Russia of five cases of luminal HER2-negative breast cancer who had progression after CDK 4/6 inhibitor therapy. All patients had visceral metastases, one of them had brain metastases. Eribulin was used according to prescribing information in Russia, in metastatic settings in patients pretreated with anthracyclines and taxanes in the second chemotherapy line (3 patients) and in the third line (2 patients). Four patients achieved stable disease, one patient had partial response. Duration of eribulin treatment response was from 8 to 22 months. Eribulin appeared to be well-tolerated, dose reduction was not noted. Data from EMPOWER (USA) and the first treatment results from Russia demonstrated eribulin may be a potential treatment option in hormone-positive breast cancer following prior CDK 4/6i therapy for disease control and to preserve quality of life.

Journal of Modern Oncology. 2020;22(2):98-103
Clinical Case
Clinical case of long-term use of osimertinib in the treatment of EGFR mutation-positive lung adenocarcinoma
Odintsova S.V., Sviridenko M.A., Cheremnykh A.O., Filippova E.A., Urtenova M.A., Orlov S.V.

This article reviews clinical case of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer and the usage of osimertinib for its treatment. Targeted drugs, EGFR tyrosine kinase inhibitors were approved for the treatment of non-small cell lung cancer more than 15 years ago*. Updated results of the large multicenter randomized FLAURA trial showed that osimertinib, a third-generation irreversible selective epidermal growth factor receptor tyrosine kinase inhibitor, was more effective than first-generation EGFR tyrosine kinase inhibitors, not only in terms of progression-free survival, but in terms of duration of response and overall survival. Furthermore, statistically and clinically significant benefit is achieved without deterioration of tolerance and quality of life. This article presents a clinical case of a woman who has taken part in this clinical trial. In light of the fact that this patient has been one of the first to receive this therapy in Russia, this experience appears to be interesting, because it allows assess the long-term results of the therapy: the achieved response duration is more than 50 months with good tolerance of therapy.

Journal of Modern Oncology. 2020;22(2):108-111
Clinical case of long-term use of durvalumab in the treatment of advanced small-cell lung cancer
Statsenko G.B., Kurakin V.I., Plokhotenko I.V.

Over the last few decades there was a little progress in the treatment of small cell lung cancer (SCLC). But now the approaches are changing with immune checkpoint inhibitors coming into clinical practice. Using a combination of immunotherapy with the standard chemotherapy in the first line of extensive stage small cell lung cancer (ES-SCLC) results in significant overall survival improvement, for the first time the median survival in these patients exceeded one year. Here we present a clinical case of ES-SCLC patient treated with durvalumab, a monoclonal antibody against PD-L1, in combination with etoposide and carboplatin in the CASPIAN clinical trial. In the CASPIAN trial more than 20% of patients treated with durvalumab stay alive more than two years. In the presented case we also reported durable control of the disease, the patient continued to receive durvalumab of more than two years with acceptable tolerability.

Journal of Modern Oncology. 2020;22(2):112-115

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