Immunotherapy is becoming an increasingly popular cancer treatment method due to its high specificity and potential to be more effective than traditional approaches. The problem of the use of concomitant rehabilitation measures remains in the highlight, as they can help reduce unwanted side effects of the main treatment and improve the overall quality of life of patients. Purpose of the study. To expand the comparative analysis of the quality of life of patients diagnosed with melanoma and receiving immunotherapy, as well as the overall response rate during treatment with the use of accompanying rehabilitation magnetotherapy. Materials and methods. The study included 128 patients diagnosed with melanoma and receiving immunotherapy with pembrolizumab or nivolumab. The patients of the study group (n = 67) underwent a course of immunotherapy and an accompanying course of rehabilitation magnetotherapy. The patients in the control group underwent a course of immunotherapy without accompanying rehabilitation magnetotherapy. Treatment efficacy was assessed according to iRECIST 1.1 criteria. The EORTC QLQ-C30 questionnaire was used to study the quality of life. The degree of adverse events was assessed according to CTCAE 5.0 criteria. Results. The objective response rate in the study group (70.1 %) was higher than in the control group (65.6 %). Stabilization was the most frequent response to systemic treatment in most cases: 41.8 % in the study group and 49.2 % in the control group. In the study group, the improvement in the overall quality of life was more noticeable and amounted to 9.6 %, while in the control group, the improvement was at the level of 6.2 % (Т = 0.4, р = 0.023). Improvement in the general level of health was noted by 10.9 % in the study group and by 5.4 % in the control group (Т = 0.43, р = 0.015). Conclusion. The use of accompanying rehabilitation magnetotherapy during the course of immunotherapy led to an improvement in the overall quality of life of patients and a decrease in treatment side effects. Further research in this area is needed in order to determine the potential of magnetotherapy as an additional rehabilitation method.
In this paper, the previously obtained results on recognition of ionograms using deep learning are expanded to predict the parameters of the ionosphere. After the ionospheric parameters have been identified on the ionogram using deep learning in real time, we can predict the parameters for some time ahead on the basis of the new data obtained Examples of predicting the ionosphere parameters using an artificial recurrent neural network architecture long short-term memory are given. The place of the block for predicting the parameters of the ionosphere in the system for analyzing ionospheric data using deep learning methods is shown.
Aim. To evaluate the efficacy and safety profile of the pembrolizumab biosimilar, Pembroria, in patients with advanced lung cancer in routine clinical practice. Materials and methods. The patients eligible for pembrolizumab therapy based on standard clinical indications and without contraindications participated in the multicenter, multicohort, post-marketing, prospective, non-interventional study. The primary endpoint was the best objective response rate (ORR) assessed within six months of treatment initiation. This report presents interim analysis for patients with non-squamous non-small cell lung cancer (nsNSCLC) and squamous non-small cell lung cancer (sNSCLC) using Fleming’s two-stage single-arm design (stages g1 and g2). Thresholds for hypothesis testing and sample size determination were based on established literature benchmarks. Results Non-squamous NSCLC. Stage g1 enrolled 20 patients with a median age of 64 years. The follow-up period for assessing the best objective response was 2.57 months. An objective response was achieved in 55% (11/20) of patients, meeting predefined efficacy criteria at stage g1. Squamous NSCLC. Stage g1 included 23 patients and based on the results of stage g1, the study proceeded to stage g2 with the enrollment of an additional 23 patients in stage g2, yielding a total of 46 participants with a median age of 66 years. An ORR of 47.8% (22/46) was observed, confirming efficacy of the pembrolisumab biosimilar at stage g2. The median follow-up period to the objective response assessment was 2.88 months. Across the six-month follow-up period, nine adverse events (AEs) were reported among seven patients (8.4%) in the NSCLC cohort. Four AEs were considered therapy-related and classified as Grade 2 per CTCAE v5.0. No AEs Grade 4/5 were recorded. Conclusion. In the NSCLC cohort, the pembrolizumab biosimilar (Pembroria) has demonstrated an ORR comparable to that of the reference pembrolizumab reported in clinical trials for both nsNSCLC and sNSCLC, regardless of PD-L1 expression levels or pembrolizumab treatment regimens. These findings support the real-world efficacy and safety of Pembroria in a diverse patient population.
e16077 Background: Alofanib (RPT835) is a first-in-class allosteric inhibitor that induces conformational changes in the extracellular domain of FGFR2. Here, we present the final results of the phase Ib clinical study (RPT835GC1B) of alofanib. Methods: Patients with metastatic gastric adenocarcinoma resistant to standard therapy with measurable disease were eligible. The dose finding part used a 3+3 design, starting with a dose level of 50 mg/m2, intravenously, 5 days on, 2 days off. Five dose levels were foreseen. Primary endpoint was maximum tolerated dose (MTD). Secondary endpoints included toxicity, PK, objective response rate (ORR), overall survival (OS), and progression-free survival (PFS). Results: 21 patients were enrolled. 4 (19.1%), 14 (66.7%), 9 (43%), 3 (14.3%), and 12 (57%) patients had ECOG PS 2, ≥2 metastatic sites, liver metastases, bone metastases, and 3-6 lines previous therapy, respectively. The MTD has not been reached and dose of 350 mg/m2 has been declared as recommended phase II dose. With median follow-up of 13.0 months 15 (71.4%) patients had any grade treatment related adverse events (TRAE). Grade 3-4 TRAE occurred in 6 (28.6%) patients. Two (9.5%) patients discontinued treatment due to grade 3 diarrhea and grade 4 reactions immediately after injections. There were no treatment-related deaths in the study. One partial response (5.26%) with a duration of 18.53 months was identified. Disease control rate (DCR) was 68.4% and median duration of stable disease was 4.91 months. Median PFS was 3.63 (95% CI 1.58–5.68) months. Median OS was 7.0 (3.82–10.18) months. 6-month OS rate was 57.1%. OS was almost 2 times better in patients with DCR (median 10.05 vs. 5.9 months) and without bone metastases (8.6 vs. 3.1). Only one patient (4.8%) had FGFR2 amplification (time to death was 7 months). PK parameters linearly changed depending on the dose level, but no correlation with efficacy was found. Table summarizes rate of TRAE and DCR in dose cohorts. Conclusions: Alofanib was feasible and showed early signals of efficacy in heavily-pretreated patients with metastatic gastric cancer. A phase 2 randomized trial is planned. Clinical trial information: NCT04071184. [Table: see text]
BACKGROUND: The data available today show the positive impact of increased physical activity on the patient’s condition, helping not only to improve physical health, but also psycho-emotional state, reducing stress and anxiety. Comprehensive rehabilitation programs can significantly improve the overall well-being of cancer patients and contribute to their return to an active social life. AIM: To study the effect of increased physical activity in the form of physical therapy on the overall result of antitumor treatment, the level of quality of life of patients with non-small cell lung cancer receiving immunotherapy both alone and in combination with cytostatics. MATERIALS AND METHODS: The study involved 56 patients who were divided into two groups: main (n=30) and control (n=26). The study included patients with ECOG status 1–3. In both groups, patients received standard antitumor therapy ― immunotherapy with pembrolizumab 400 mg every 42 days or 200 mg every 21 days as monotherapy, or in combination with cytotoxic therapy (carboplatin plus paclitaxel or pemetrexed). In addition to drug treatment, patients from the main group also regularly engaged in therapeutic exercises with an instructor. RESULTS: From the presented data and visualization it is clear that after treatment with the addition of physical education, the average level of quality of life in patients increased, the results highlight the significant positive impact of the rehabilitation program on the quality of life of cancer patients, reducing stress levels and improving functional indicators. CONCLUSION: The study shows that regular practice of therapeutic exercises can improve stress levels and improve emotional well-being, help reduce fatigue and reduce general weakness. A reduction in symptoms of depression and anxiety has been clearly demonstrated. Exercise therapy leads to increased muscle strength, which is especially important for recovery from intensive cancer treatments.
To analyze the quality of life in patients receiving immunotherapy and overall response rate in case of additional magnetotherapy.The study included 3 cohorts of patients (n=48) with various disseminated malignancies (melanoma, lung cancer, kidney cancer) who received immunotherapy. In the study groups, all patients additionally took courses of rehabilitation based on magnetotherapy. In the control cohorts, patients underwent courses of immunotherapy without additional magnetic therapy. Treatment efficacy was assessed according to iRECIST 1.1 criteria. The Russian version of the EORTC QLQ-C30 questionnaire was used to study the quality of life. We analyzed adverse events using the CTCAE 5.0 criteria.In patients with melanoma, the most common response to systemic treatment was stabilization (41.7% in the study group and 30.8% in the control group). The objective response rate was higher in the study group (33.3% vs. 23.1%). There was also significant improvement in the quality of life after treatment in the study group (by 23.5%). In the control group, the indicator worsened by 4.8%. Overall health improved by 12.8% in the study group and 10.3% in the control group. In patients with lung cancer, response to systemic treatment with stabilization was achieved in 33.3% of patients in the study group and 20% of patients in the control group. The objective response rate was 33.3% and 20%, respectively. Analysis of the study group revealed improvement of overall health by 9.6% and overall quality of life by 38.6%. In the control group, overall health improved by 4.8% and quality of life remained the same. In patients with kidney cancer, the objective response rate was 40% and 42.9%, respectively. Disease stabilization was achieved in 40% and 28.6% of patients, respectively. Overall health improved by 16.7% and 6.3%, overall quality of life - by 19% and 9.1%, respectively.Magnetic therapy during the course of immunotherapy improved the overall quality of life and reduced severity of adverse events. Further study of magnetotherapy as an accompanying rehabilitation technique is required.Иммунотерапия является быстро развивающимся направлением лечения рака, благодаря более высокой специфичности и потенциально большей эффективности, чем традиционные методы. Остается актуальным вопрос использования сопроводительных реабилитационных процедур, позволяющих снизить степень нежелательных явлений на фоне основного лечения, а также улучшить общее качество жизни пациентов.Провести сравнительный анализ общего качества жизни пациентов, получающих иммунотерапию, а также частоту общего ответа при использовании сопроводительной реабилитационной магнитотерапии.В исследование были включены 3 когорты пациентов (48 пациентов) с различными диссеминированными злокачественными образованиями (меланома, рак легкого, рак почки), получающих иммунотерапию, которые были разделены на группы исследования и контроля. В исследуемых группах все пациенты дополнительно проходили курсы реабилитационных программ, основанных на магнитотерапии. Пациенты контрольных групп получали курсы иммунотерапии без дополнительной магнитотерапии. Оценку эффективности лечения проводили в соответствии с критериями iRECIST 1.1. Для изучения качества жизни была использована русская версия опросника EORTC QLQ-C30. Степень нежелательных явлений оценивали по критериям CTCAE 5.0.В когорте пациентов с меланомой самым частым ответом на системное лечение являлась стабилизация (41,7% в исследуемой группе и 30,8% в группе контроля). Частота объективного ответа была выше в исследуемой группе и составила 33,3% (23,1% в группе контроля). В исследуемой группе также зарегистрировано значительное улучшение качества жизни на фоне лечения — на 23,5% (в группе контроля ухудшение показателя на 4,8%), общего состояния здоровья — на 12,8% (в группе контроля улучшение на 10,3%). В когорте пациентов с раком легкого ответ на системное лечение в виде стабилизации был достигнут у 33,3% пациентов в исследуемой группе и у 20% пациентов в группе контроля. Частота объективного ответа в исследуемой группе составила 33,3% (в контрольной группе — 20%). Результаты опроса пациентов в исследуемой группе показали улучшение общего состояния здоровья на 9,6%, а общего качества жизни — на 38,6%. В контрольной группе улучшение общего состояния здоровья составило 4,8%, а показатели общего качества жизни остались на прежнем уровне. В когорте пациентов с раком почки частота объективного ответа составила 40 и 42,9% в исследуемой и контрольной группах соответственно. Стабилизация заболевания была достигнута у 40 и 28,6% пациентов соответственно. Улучшение общего состояния здоровья составило 16,7 и 6,3%, общего качества жизни — 19 и 9,1% в исследуемой и контрольной группах соответственно.Результаты применения магнитотерапии во время курса иммунотерапии показали положительные изменения общего качества жизни пациентов, а также снижение степени нежелательных явлений на фоне проводимого лечения. Требуется дальнейшее исследование магнитотерапии в качестве сопроводительной реабилитационной методики.
