The National Registry of treatment regimens in patients with metastatic castration-resistant prostate cancer in the Russian Federation

Background. In Russia in 2018, prostate cancer in 40.4 % of patients was detected in stages III–IV, which requires combined and complex treatment, including hormone therapy. In the course of treatment, the tumor inevitably acquires the features of castration resistance. Currently, there are several drugs for the treatment of metastatic castration-resistant prostate cancer (mCRPC), however, there are still no standards for the optimal drug choice in patients with mCRPC, data on adverse events, duration and quality of life of patients. The study objective is describe treatment regimens for patients with mCRPC who are receiving chemotherapy/hormone therapy as the 1st and 2nd line of therapy, describe the characteristics of patients and diseases, justify the choice of therapy, describe the response of a tumor to the treatment, the types of disease progression during chemotherapy and hormone therapy, reasons for the discontinuation of treatment, treatment sequence, assessment of the overall and progression-free survival. Materials and methods. The study included and analyzed 341 patients from 41 medical institutions in Russia. The total follow-up for each patient was up to 24 months, except of the cases of death of a patient or withdrawal from the observation. Results. At the time of the initial diagnosis of prostate cancer in 198 patients (58.1 %) stage IV cancer was detected. The Gleason index of 8–10 points was determined in 118 (40.5 %) patients. The median prostatic specific antigen level (min–max) was 42.1 ng/ml (0.075– 11 743 ng/ml). Medical castration was underwent in 304 (89.1 %) patients. Duration of androgen deprivation therapy <6 months – 26 (7.6 %) patients, ≥6 months <24 months – 138 (40.5 %), ≥24 months – 142 (41.6 %), not performed – 33 (9.7 %). Localization of metastases to regional lymph nodes was detected in 101 (29.8 %) patients, bones – 293 (86.4 %), liver – 12 (3.5 %), lung – 24 (7.1 %), brain – 3 (0.9 %), other localizations – 29 (8.6 %). At the end of the observation period, 158/341 (46 %) of the patients were alive, 97/341 (28.4 %) patients died and 73/341 (21.4 %) of the patients were lost for follow-up. The results of treatment using 1st line therapy were evaluated in 317 patients. The treatment was interrupted in 163/317 (51.4 %) cases. The main reason for the cessation of treatment (131/163, 80.3 %) was the progression of the disease. The 2nd line therapy was started in 124 patients. Treatment using the 2nd line therapy was discontinued in 62 patients (50.8 %). The reason for the cessation of the treatment in 41 patients (68.3 %) was the progression of the disease, in 11 patients (17.7 %) – the decision of the patient, in 1 patient (1.6 %) – non-hematological toxicity, in 11 patients (17.7 %) – other reasons. Conclusion. This study shows the epidemiological patterns of mCRPC, the approaches to treating the disease and the results in real clinical practice during the diagnosis and treatment of mCRPC in the Russian Federation. In the Russian patient’s population, the detection of prostate cancer remains at a high level in stage IV in which a patient has distant metastases (58.1 % of patients), while the high frequency of prostate cancer metastasis in bones is confirmed (86.4 % of patients). Long-term drug treatment of mCRPC is possible in the minority of patients, of all patients who start 1st line chemotherapy, the 2nd line of therapy is started only in 36.4 % of patients.