Analysis of the regional clinical use of CDK4/6 inhibitor ribociclib as a mechanism of integration of a research approach in drug provision

Abstract

Introduction. Implementation of data from registration studies into clinical practice often presents a number of problems due to the heterogeneity of the patient population, the lack of uniformity of thinking among clinicians, and organizational difficulties. Using the example of studying the algorithm for prescribing ribociclib in a cohort of patients from one region in modern realities and the possibilities of drug provision, we have shown the main controversial points in the implementation of the results of clinical trials in the daily practice of an oncologist.Aim. The purpose of this study was to analyze our own preliminary results of the treatment of patients with hormone-receptorpositive Her-2-negative metastatic breast cancer using ribociclib in the routine practice of prescribing CDK4/6 inhibitors outside of clinical trials, taking into account the peculiarities of regional drug supply.Materials and methods. A retrospective analysis of the results of treatment of patients (n = 56) who took ribociclib in terms of combined hormone therapy for metastatic hormone-dependent Her-2 negative breast cancer in the practice of oncologists in the Krasnodar Territory from 2019 to 2022 was carried out.Results. At the time of data collection and analysis, with a total follow-up time of 29 months, the median overall survival was not achieved, 52 patients (92.9%) were alive and continued to follow up. The median progression-free survival was also not reached: disease progression was recorded in 19 patients (33.9%), 37 patients (66.1%) continued treatment. A total of 14 out of 56 patients (25.1%) received ribociclib therapy in combination with drugs for endocrine therapy in the first and second lines. The best results were demonstrated by patients with a high level of expression of progesterone receptors in the tumor (p = 0.005), a low level of Ki67 proliferative activity index (p = 0.035), without metastatic visceral lesions (p = 0.034), who received the minimum number of lines of therapy before the appointment of ribociclib (p = 0.029). The results of the clinical part of the study became available due to the timely optimization of regional drug supply processes with the creation and constant monitoring by clinicians of a stable cohort of patients in the form of updated registers.Conclusions. The introduction of the experience and knowledge of clinical oncologists into the process of drug supply management and its optimization, taking into account the understanding of data on drug efficacy and toxicity, is a promising direction and requires further discussion.