Intermediate assessment of the results of a clinical study of a neoadjuvant combined treatment of patients with high-risk and very high-risk prostate cancer
N.N. Buevich (1), S.A. Protsenko (1), A.K. Nosov (1), S.A. Reva (1, 2), A.S. Artemyeva (1), M.V. Berkut (1)
1) N.N. Petrov National Medical Research Center of Oncology, St. Petersburg, Russia;
2) Pavlov First St. Petersburg State Medical University, Clinic of Urology, St. Petersburg, Russia
Background. Prostate cancer is the leading medical and social problem of the male population. Thousands of men die from this pathology every year. The article reviews the results of various strategies for the treatment of high-risk and very high-risk prostate cancer, as well as the materials of authors’ own research. Objective. Improvement of the effectiveness of treatment of patients with high-risk and very high-risk prostate cancer.
Methods. Data on patients with patients with high-risk and very high-risk prostate cancer, who received treatment in the N.N. Petrov NMRCO from 2014 to 2018.
Results. In this article, we present the intermediate assessment of data of a group of patients (n=46) who received only combined treatment (neoadjuvant therapy with docetaxel+degarelix followed by radical prostatectomy). 28 patients (61%) received full treatment. In five patients, completion of the neoadjuvant therapy stage was not possible due to the progression of the disease (increase in PSA level after a previous pronounced decrease, n=2), the presence of comorbidities/adverse events (n=2), death by home accident (n=1). As a result of the use of neoadjuvant drug treatment, a statistically significant (p=0.004) decrease in the volume of the prostate gland and PSA level (p=0.008) was achieved. Assessment of the safety of neoadjuvant drug treatment of high-risk and very high-risk prostate cancer patients revealed an acceptable toxicity profile. The frequency of grade 3–4 hematological complications was 21% (n=6). Non-hematological adverse events developed in 43% (n=12) of patients, with grade 3–4 – in 7% (n=2). Given the prospective nature of the research, it is planned to continue trial until the solution of the tasks set (the evaluation of therapeutic pathomorphosis, molecular genetic markers).
Conclusion. Neoadjuvant therapy with docetaxel and degarelix is associated with improved results of treatment of patients with high-risk and very high-risk prostate cancer. The treatment regimen used showed an acceptable tolerability and toxicity profile.
Keywords: prostate cancer, high risk, survival, neoadjuvant therapy, docetaxel, radical prostatectomy
About the Autors
Corresponding author: Natalia N. Buevich, Oncologist, Postgraduate Student at the Scientific Department of Innovative Methods of Therapeutic Oncology and Rehabilitation, N.N. Petrov National Medical Research Center of Oncology, St. Petersburg, Russia; e-mail: email@example.com
Address: 68, Leningradskaya Street, Pesochny settlement, St. Petersburg 197758, Russian Federation