Aim. The main objective of the prospective multicentre observational study is to describe adverse events occurred during treatment with aflibercept plus FOLFIRI therapy in real life practice. In despite of broad use of aflibercept in Federal oncological centers, this regimen is still perceived by healthcare professionals (HCPs) as having worse safety profile in comparison with other antiangiogenic agents. Taking into account limited experience of using aflibercept in Russia it s critically important to evaluate and document adverse events occurred with treatment in aflibercept plus FOLFIRI regimen in patients with metastatic colorectal cancer (mCRC) in real-life practice.
Methods. The physician selection was performed as a random process. Twenty sites with experience in treatment of mCRC patients were selected. The investigators were encouraged to enroll all patients meeting eligibility criteria in consecutive manner. Total number of included patients into the study patient was 101. Data were evaluable for 91 patients. 14 of 91 (15.4 %) patients didn ’t meet inclusion criteria and were excluded from the per protocol analysis: 10 patients didn ’t receive oxaliplatin within the last line of therapy preceding inclusion into the study and in 4 patients progression occurred more than 6 months after the end of adjuvant therapy.
Results. Overall, 265 treatment emergent adverse events (TEAEs) occurred in the 77 patients analysed per protocol. In total, 23 grade 3 and 5 grade 4 TEAEs were reported by 16 and 4 patients, respectively. The most common TEAEs were nausea (68 events in 31 [40.3 %j patients), diarrhea (43 events in 25 [32.5 %j patients), hypertension (36 in 20 [26.0 %] patients), neutropenia (29 events in J5 [J9.5 %] patients), asthenia (28 events in 12 [15.6 %]patients). Three cases of grade 1-2 stomatitis were reported in 2 (2.6 %) patients. And one patient reported grade 1 epistaxis during the study. There was no case of gastrointestinal perforation, fistula development, ulceration, arterial or venous thromboembolism. During this study seven serious adverse events were documented in 5 (6.5 %) patients of 77. The reason for treatment discontinuation in 5 (11.1 %) of 45 cases was adverse event. No death, classified as related to any component of therapy, was reported in this study.
Conclusion. This national (Russian) prospective multicentre non-interventional study conducted in patients with mCRC in daily practice suggests that aflibercept plus FOLFIRI has a manageable safety profile in line with VELOUR phase III study.
Introduction. Locally advanced pancreatic cancer (LAPC) is accompanied by a diverse clinical picture, one of the leading symptoms is chronic pain syndrome (CPS), which occurs in 30 % of patients in the early stages of the disease and in 80 % of patients with advanced pancreatic cancer. The basic method of treating CPS is analgesic therapy. However, the widespread use of painkillers is limited due to the short and incomplete analgesic effects, as well as side effects of painkillers. The use of chemoradiotherapy (CRT) contributes to the relief of CPS, however, it is accompanied by adverse events (AE) and a short analgesic effect.
Aim. The aim of the study was to evaluate the first experience of using of intra-arterial administration of a combination of gemcitabine at a dose of 1,000 mg/m2 and nano-stabilized paclitaxel at a dose of 125 mg/m2 in combination with conformal radiation therapy in patients with LAPC with CPS.
Materials and methods. A controlled open, single-center, non-randomized, retrospective study included 17 patients who received combined treatment - a single selective intra-arterial administration of gemcitabine at a dose of 1,000 mg/m2 and nano-stabilized paclitaxel at a dose of 125 mg/m2, followed by conformal radiation therapy with beam of 51 Gr in medium fractionation mode. The dynamics of CPS was assessed by the intensity, severity, localization and characteristics of the applied analgesic therapy using the BPi-SF-Russian-2001 questionnaire when the patient was admitted before treatment, on the 24th and 54th days of combination therapy.
Results. Complications associated with angiography and radiation therapy have not been reported. There were no pronounced (more than Grade 1) immediate and distant AEs of intra-arterial chemotherapy in patients. An analysis of CPS and its associated indicators showed a decrease in the severity of pain, which ultimately was an important component of the quality of life of patients. Significant decrease in CPS occurred on the 24th day before treatment. The analgesic effect was reliably maintained on the 54th day. The maximum analgesic effect of the combined treatment was noted on the 24th day. Thus, the duration of anesthesia was recorded up to 54 days. The analgesic effect significantly contributed to improving mood, the ability to contact with others, and also affected the quality and duration of sleep and the ability to enjoy life in patients of the study group.
Conclusion. The use of intra-arterial chemotherapy with gemcitabine and nano-stabilized paclitaxel in combination with radiation therapy can effectively affect on CPS and the quality of life in patients with LAPC.
The review presents the latest data on the development of a new direction of interdisciplinary integration of radiation and molecular biological technologies ‘omiсs', including high technologies in the field of genomics, transcriptomics, proteomics and metabo-lomics, which are the basis of systems biology and the future of medicine. The integration of medical imaging and advances in genetics have created a new direction of research - radiogenomics, which is a key step in the development of omhs-technologies. Radiogenomics - phenotype imaging, computer vision - is an interdisciplinary integration of visual radiology and biological systems that study biomedical imaging involving phenotypic and genotypic parameters that reflect the molecular and genotypic basis of tissue from which to predict patient risk and outcomes. Coupled with state-of-the-art analytical software, quantitative and qualitative imaging biomarkers bring unprecedented insight into complex tumor biology and contribute to a deeper understanding of cancer development and progression. Using the latest advances in digital, information and molecular biological technology, is an active convergence of specialties radiologist and genetics, giving the opportunity at the stage of studying medical images of the breast to obtain information about the biological characteristics of the tumor molecular subtype of cancer, determining prognosis, evaluating risk of recurrence, which is important for the choice of adequate tactics of individual monitoring and selection of medical benefits. Development of visual symptom medical images of the breast, characteristic for different molecular subtypes of cancer, will contribute to more accurate diagnosis of different manifestations of cancer, the choice of adequate treatment tactics that increase the duration and preservation of the high quality of a woman s life.
Drug treatment is an integral part of the complex approach for early and locally advanced breast cancer. The article considers the main goals and principles of neoadjuvant chemotherapy for different breast cancer subtypes, the relationship between complete pathomorpho-logical response and long-term results as well as approaches to the treatment of residual disease. A unified residual tumor assessment based on calculating the RCB-index after neoadjuvant chemotherapy allows to identify patient prognostic groups with different responses to treatment and, in turn, to plan additional therapy for them.
In the present work, the indicators of overall and disease-free survival of 85 patients with triple negative breast cancer (TNBC) depending on the receptor status of the tumor, as well as depending on the level of expression of androgen receptors in patients with AR+ TNBC (58.8 %; n = 50) were analyzed. The results suggest the prognostic value of androgen receptors on the surface of TNBC ’s cells.
Advanced well differentiated neuroendocrine tumors (NET) have poor sensitivity to chemotherapy. Approaches to the second and subsequent lines of treatment have not been developed to date Aranosa is a derivative of nitrosourea. it is close to streptozotocin in terms of its chemical structure, but it has a more favorable toxicity profile. Aranoza is actively studied in well differentiated NET. The drug was effective in the fourth line of treatment of the patient with NET and liver metastases.
This article describes a new affordable diagnostic method of neuroendocrine tumors, shows the basic information on it’s conduction and interpretation of the results. Scintigraphy of neuroendocrine tumors with 99mTc-Tectro-tyd is a new alternative and more affordable diagnostic method that allows you to determine tumor receptor status, assess the prevalence of the tumor process and plan therapy. This study may also be the first step in planning radionuclide therapy for patients with neuroendocrine tumors. Also there is a short review on teranostics.
This article presents the immediate results of the treatment of patients with locaiiy advanced cancer of the oropharyngeal region, using the new puncture cryodestruction technique and standard surgical treatment. The overall and one-year disease-free survival rates of patients with locally advanced cancer of the oropharyngeal region were evaluated. The analysis of disease progression data in the main and in the control groups was carried out.
Leiomyosarcoma (LMS) is a group of malignant mesenchymal tumors with variable behavior and prognosis. in general, 5-year overall survival rates for 64 %o, but in case of disseminated disease it decreases to 10-16 %. The main treatment modality that determines the prognosis is radical surgery. For the treatment of unresectable leiomyosarcoma, chemotherapy and targeted therapy are used. One of the alternative options for drug treatment with uterine leiomyosarcoma is hormone therapy. its use is possible with a positive status of estrogen and progesterone receptors in the tumor. The presence of steroid hormone receptor expression is a favorable prognostic factor. This article presents our own analysis of the frequency of expression of estrogen and progesterone receptors and the frequency of hormone therapy in leiomyosarcoma of different anatomic localization.
Introduction. The new COVID-19 pandemics is posing unprecedented challenges and threats to patients and healthcare systems worldwide. Patients with the worst outcomes and higher mortality are reported to include immunocompromized subjects, namely patients with comorbidities, elderly patients, and malnourished people.
Materials and methods. An analytical review of publications from recent years on the nutritional management of outpatient and hospital cancer patients in the context of the COVID-19 pandemics was conducted.
Results. The European Society for Clinical Nutrition and Metabolism (ESPEN) and the American Society for Parenteral and Enteral Nutrition (ASPEN) have published recommendations based on scientific and clinical evidence on nutrition as part of the treatment process in cancer patients, including those infected with COVID-19. Cancer patients are more likely to develop malnutrition than other patients, which is exacerbated by COVID-19 infection and is a factor in increased mortality. Cancer patients with COVID-19 represent a high-risk group for the development of malnutrition as a result of a combination of the infectious disease, tumor process and its management (chemotherapy, radiotherapy, targeted and immunotherapy). Oral nutritional support for cancer patients with malnutrition includes a fixed daily diet (breakfast, lunch and dinner) and fortified (functional) snack foods, as well as enteral nutrition or sip feeding. Enteral nutrition gives better clinical results than a diet without enteral nutrition - weight and BMI increase, the patient s physical and emotional self-assessment improves. Enteral feeding includes special mixtures of proteins, fats, carbohydrates, vitamins and trace elements. Energy and protein consumption targets (total diet + enteral nutrition) can be used to maintain or restore lean body mass (LBM) in cancer patients: 25-30 kcal/kg per day and 1.2-1.5 g of protein/kg per day. To maintain the immune system and achieve clinical benefits, it is advisable to include omega-3 fatty acids (EPA + DHA) as well as vitamin D. In ICU for patients in a serious condition it is advisable to combine enteral nutrition and parenteral nutrition (PN) with the use of three-in-one systems including an amino acid solution, fat emulsion with omega-3 fatty acids and glucose with added fat and water-soluble vitamins and trace elements.
Conclusions. Outpatient and hospitalized COVID-19-infected cancer patients with malnutrition or a risk of developing it should be provided with adequate nutritional support based on a balanced daily diet supplemented with enteral nutrition (high-energy protein mixtures with micronutrients, omega-3 fatty acids and vitamin D) and, if necessary, parenteral nutrition.
Three randomized phase III trials have now conclusively proven that exposure to a PD-1 inhibitor prolongs survival in recurrent/meta-static (R/M) HNSCC, and it is clear that such agents should be used in the management of all patients who do not have contraindications to their use. Two of these phase III randomized trials showed that the antiPD-1 antibodies nivolumab and pembrolizumab were superior to investigators' choice chemotherapy in second-line platinum-refractory R/M HNSCC. Recently, a third phase III randomized trial, KEYNOTE-048, showed that pembrolizumab with chemotherapy was superior to the EXTREME regimen (cis- or carboplatin, 5-fluoro-uracil [5-FU] and cetuximab) in all patients, and pembrolizumab monotherapy was superior in patients whose tumors express PD-L1 in first-line R/M HNSCC. Pembrolizumab is now approved by FDA as a monotherapy in PD-L1 expressing disease (combined positive score [CPS] ≥ 1) or in combination with chemotherapy for all patients with R/M HNSCC. Thus, PD-L1 biomarker testing will be routinely used in R/M HNSCC, and this employs a scoring system that incorporates immune cell staining, referred to as CPS. Additionally, for the 85 % of patients with PD-L1 (CPS ≥ 1), clinical judgment will guide the choice of pembrolizumab monotherapy or pembrolizumab plus chemotherapy, until more detailed clinical data are forthcoming to better inform this decision. In this article we discuss the clinical trials leading to these therapeutic advances and we will review initial results from clinical trials in previously untreated, locally advanced disease, and those using novel combinations of checkpoint inhibitors, co-stimulatory agonists, and therapeutic vaccines.
ISSN 2949-2807 (Online)