Abstract

TolsotogoSt., Saint Petersburg 197022, RussiaBackground.Prostate cancer (PCa) of a high and very high risk is a potentially fatal disease that requires an active multimodal approach, including the use of neoadjuvant drug treatment. As option for this treatment is neoadjuvant chemohormonal therapy (NCHT) followed by radical prostatectomy (RPE). However, data on the oncological results of treatment of such patients are still limited and the role of neoadjuvant therapy in the treatment of high and very high-risk PCa remains not fully understood.Objective:toassesstheoncologicalresultsoftreatmentpatientswithlocalizedandlocallyadvancedPCaofhighandveryhighriskafterNCHT.Materials and methods.This was a prospective randomized study: patients with PCa of high and very high-risk groups (prostate specific antigen levels (PSA) >20 ng/ml and/or Gleason score³8and/or clinical stage >T2c) were treated with RPE only (group RPE; n = 35) or NCHT followed by RPE (NCHT/RPE group; n = 36). The neoadjuvant course included the intravenous administration of docetaxel once every 21 days (75 mg/m2 up to 6 cycles) and the antagonist of the gonadotropin releasing hormone degarelix according to the standard scheme (6 subcutaneous injections every 28 days). After a follow-up examination evaluating the result of the neoadjuvant regimen, patients underwent RPE with extanded lymphadenectomy.Results.A mean follow-up was 37.08 ± 20.46 months. A statistically significant reduction of prostate specific antigen >50 % post-chemohormonal therapy was observed in all 36 cases. Lower postoperative stage was noticed in 38.5 % in NCHT/RPE group compared with 2.7 % in RPE group. Similarly, positive surgical margin rate was higher in group without neoadjuvant therapy – 40 and 25 % (RPE group). Cancerspecific survival was 97.2 % in NCHT/RPE group and 87.56 % in the RP group (p = 0.037), cancer specific survival rate – 91.4 % and97.2 % respectively (log-rank test p = 0.22). At the same time, no statistically significant differences were obtained in 3-year recurrence free survival between groups: 38.8 % in NCHT/RPE group versus 43.6 % in the RPE group (log-rank test p = 0.36).Conclusion.Conducting NCHT before RPE is a safe and effective strategy in patients with PCa of high and very high risk groups and could improve oncological results.

Highlights

  • This was a prospective randomized study: patients with Prostate cancer (PCa) of high and very high-risk groups (prostate specific antigen levels (PSA) >20 ng / ml and / or Gleason score ≥8 and / or clinical stage >T2c) were treated with radical prostatectomy (RPE) only or neoadjuvant chemohormonal therapy (NCHT) followed by RPE (NCHT / RPE group; n = 36)

  • The neoadjuvant course included the intravenous administration of docetaxel once every 21 days (75 mg / m2 up to 6 cycles) and the antagonist of the gonadotropin releasing hormone degarelix according to the standard scheme (6 subcutaneous injections every 28 days)

  • After a follow-up examination evaluating the result of the neoadjuvant regimen, patients underwent RPE with extanded lymphadenectomy

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Summary

Background

Prostate cancer (PCa) of a high and very high risk is a potentially fatal disease that requires an active multimodal approach, including the use of neoadjuvant drug treatment. As option for this treatment is neoadjuvant chemohormonal therapy (NCHT) followed by radical prostatectomy (RPE). A. et al Oncological results of neoadjuvant chemohormonal therapy in patients with high and very high-risk prostate cancer. Цель исследования – оценить онкологические результаты лечения пациентов с локализованным и местно-распространенным РПЖ высокого и очень высокого риска после НХГТ. В настоящий анализ проспективного рандомизированного исследования включены результаты лечения 82 пациентов с диагнозом РПЖ высокого риска за период с марта 2014 г.

Характеристика Characteristic
Findings
Периоперационные показатели Perioperative parameters

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