Vol 25, No 6 (2023): Personalized oncology in real clinical practice

The article reflects practical aspects of the introduction of a new professional standard of oncologist. These are segreagation of competences according to the new labor functions, admission to professional retraining in oncology of doctors of new specialties, preparation of a new educational standard, as well as new requirements for work experience in the main specialty for retraining.

Randomized clinical trials (RCTs) are the “gold standard” of evidence-based medicine. However, it is no less evident that real practice presents many new and important questions that are difficult to answer in the RCT. To what extent does the real patient meet the criteria for inclusion in the study? What are the efficacy and safety of the drug in comorbid and elderly patients? How deviations from the treatment regimen affect safety, etc. The introduction of innovative oncology approaches is disproportionately faster than in other fields. That is why a balanced analysis of the effects of innovation in real-world practice is relevant. Regulatory authorities are aware of this and demonstrate a willingness to consider and actively support real-world evidence research as part of drug applications, which is a powerful incentive for developing this area. The purpose of the article is to analyze the regulatory approaches in the United States and Europe to real-world studies when considering drug applications and to discuss the experience of organizing an observational study of the effectiveness of individual drugs for the treatment of oncological diseases in Moscow as a unique example of interaction between regulatory authorities and the expert community of oncologists.

Modern antitumor therapy includes novel targeted and immunotherapeutic options specifically targeting tumor targets. However, many of these targets are also expressed in the constantly proliferating epidermis of the skin, leading to derangement of proliferation and differentiation of keratinocytes, inflammatory responses, skin barrier dysfunction, inhibition of antimicrobial peptides' synthesis, and toxic skin reactions. The article presents an overview of current data on microbiome disorders associated with toxic skin reactions. The potential mechanisms of skin microbiome changes inducing the occurrence and persistence of rashes during anticancer therapy are addressed.

Background. Primary hyperparathyroidism is a common endocrinological disease caused mainly by parathyroid adenoma. The main treatment method is surgery (parathyroidectomy). Therefore, the exact determination of adenoma localization is crucial.

Aim. To evaluate the current possibilities of multimodal diagnosis of parathyroid adenomas.

Materials and methods. A retrospective analysis of 49 patients with primary hyperparathyroidism aged 24 to 82 (median 57.9 years) was performed. Modern radionuclide and hybrid technologies were used for topical diagnosis and metabolic assessment of parathyroid adenomas: scanning, single-photon emission computed tomography, single-photon emission computed tomography combined with computed tomography, positron emission tomography combined with computed tomography with 18F-deoxyglucose and 18F-choline. The diagnosis of primary hyperparathyroidism was confirmed by a biochemical blood test: the level of parathyroid hormone and ionized and total calcium.

Results. The study included 43 (87.8%) females and 6 (12.2%) males. The female/male ratio was 7.2:1. Most cases (78.1%) were the hypercalcemic type of primary hyperparathyroidism, and the normocalcemic type was diagnosed in 21.9% of patients. The mean parathyroid hormone level was 145.43 pg/mL, exceeding the reference values by 2.2 times. Parathyroid hormone concentration in patients with primary hyperparathyroidism was 156.38 pg/mL, and mean ionized and total blood calcium levels were 1.43 and 3.04 mmol/L, respectively. The asymptomatic type occurred in 76.7% of patients. The symptomatic type of hyperparathyroidism had 23.3%, manifested with nephrolithiasis, pancreatitis, and bone lesions. Parathyroid adenomas were more often located in the left lobe (42.9%). In 77.6% of patients with primary hyperparathyroidism, solitary adenomas were detected. Ectopia of the parathyroid glands was detected in 16.3% of patients, with intrathyroidal location in the left lobe being the most common. Rare locations include the anterior and posterior mediastinum and the esophageal wall.

Conclusion. Modern diagnostic multimodal options based on radionuclide and hybrid technologies are crucial in the personalized treatment of primary hyperparathyroidism.