The reasons for prescribing antitumor drugs beyond the registered indications in real clinical practice: A retrospective study

Aim. To study the reasons for prescribing antitumor drugs (ATDs) beyond the registered indications (BRIs) in real clinical practice. Materials and methods. The study was conducted at the Tula Regional Clinical Oncology Center. For 6 months of 2019, information was analyzed on 919 completed cases of treatment of 201 patients over the age of 18 who received antitumor drug therapy for morphologically verified solid malignant neoplasms in the inpatient department of the medical organization using a regional information system. Completed cases of treatment with ATDs were copied BRIs and in accordance with the registered indications. The analysis of the literature devoted to the study of the causes of the use of ATDs outside the registered indications has been carried out. The reasons for prescribing ATDs BRIs in real clinical practice were studied when analyzing completed cases of treatment of patients receiving appropriate therapy. Results. In 86.2% of cases, the main reason for the use of antitumor drug therapy BRIs is associated with the presence of antitumor agents in clinical guidelines and recommendations of professional communities. 11.6% of cases of prescribing antitumor agents BRIs were associated with burdened clinical situations: exhaustion of the possibilities of registered therapy; lack of treatment options for rare forms of neoplasms; lack of alternative options with contraindications to standard treatment methods. Other reasons for prescribing the above mentioned treatment were extremely rare and were situational in nature. Conclusion. In the vast majority of cases, the main reason for prescribing ATDs BRIs is the presence of these agents in clinical guidelines and recommendations of professional communities. The second most common cause is associated with burdened clinical situations. The information obtained indicates that the use of ATDs in cancer patients is an integral part of routine clinical practice and in the future can be used to improve the regulatory regulation of these prescriptions.