Cancer UrologyCancer UrologyОнкоурология1726-97761996-1812Publishing House ABV Press39710.17650/1726-9776-2014-10-4-52-61PROSTATE CANCERРАК ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫResults of a unicenter randomized study of the safety and efficiency of docetaxel chemotherapy before radical prostatectomy in patients with intermediate- and high-risk prostate cancer: An 11.4-year follow-upИсследование безопасности и эффективности химиотерапии доцетакселом перед радикальной простатэктомией у больных раком предст ательной железы промежуточного и высокого риска (наблюдение в течение 11,4 года)NosovA. K.НосовА. К.
Russian Federation
PetrovS. B.ПетровС. Б.
Russian Federation
RevaS. A.РеваС. А.
Russian Federation
sgreva79@mail.ruMamizhevE. M.МамижевЭ. М.
Russian Federation
NovikovR. V.НовиковР. В.
Russian Federation
VelievE. I.ВелиевЕ. И.
Russian Federation
MoiseenkoV. M.МоисеенкоВ. М.
Russian Federation
Department of Urologic Oncology, N.N. Petrov Research Institute of Oncology, Ministry of Health of RussiaОтделение онкоурологии ФГБУ «НИИ онкологии Н.Н. Петрова» Минздрава России68, Leningradskaya St., Pesochnyi Settlement, Saint Petersburg 197758197758 Санкт-Петербург, пос. Песочный, ул. Ленинградская, 68Department of Urology and Operative Andrology, Russian Medical Academy of Postgraduate Education, Ministry of Health of Russiaкафедра урологии и оперативной андрологии РМАПО Минздрава России2/1, Barrikadnaya St., Moscow 125993125993 Москва, ул. Баррикадная, 2/1Saint Petersburg Clinical Research-Practical Center for Specialized Medical (Oncology) CaresГБУЗ «Санкт-Петербургский клинический научно-практический центр специализированных видов медицинской помощи (онкологический)»68a, Leningradskaya St., Pesochnyi Settlement, Saint Petersburg 197758, RussiaРоссия, 197758 Санкт-Петербург, пос. Песочный, ул. Ленинградская, 68а3012201410452610112201401122014https://oncourology.abvpress.ru/oncur/article/view/397

Objective. Our retrospective study is aimed to assess safety, pathological response rate, and long-term oncologic outcomes of radical prostatectomy after neoadjuvant chemotherapy for intermediate- to high-risk PCa.

Materials and methods. Forty-four patients were involved in this study, with a 11.4-year follow-up period, on average. We assessed the RPE results in patients with intermediate and high risk of prostate cancer (PSA>10 ng/ml, Gleason score 7 and more, or clinical stage cT2c and more) after weekly treatment with docetaxel (36 mg/m2 for up to 6 cycles, 21 patients) and compared them with those in the second cohort (23 patients) who met oncologic inclusion criteria but received radical prostatectomy only. The long-term oncologic outcomes in both groups of the patients are reported.

Results. Toxicity has been mostly grade 1-2 in intensity and grade 3 and more complication rate does not exceed 10%. A statistically significant of more than 50% reduction in PSA level (pre- vs. post-chemotherapy) was observed in 52.4% cases. During the 11.4-year follow-up period, improvement in cancer-specific survival (CSS) was noted in 90% of patients from the neoadjuvant chemotherapy group, as compared with 60.9% in radical prostatectomy only group. The biochemical recurrence-free survival (BCR) was 68.5 % and 37.7 %, and the overall survival (OS) was 75.5 % and 54.6 % in the combined treatment group and surgery only group, respectively. However, the differences in BCR and OS were not statistically significant.

Conclusion. The use of neoadjuvant chemotherapy represents a safe and practicable treatment strategy resulting in reduced prostate volume and PSA level. Neoadjuvant docetaxel chemotherapy followed by radical prostatectomy was associated with higher observed BCR and OS, as compared with a surgical treatment only group. A statistically significant improvement of CSS is found in the combined treatment group. Therefore, the benefits of this treatment modality need to be validated for feasible implementation in the modern standard practices of prostate cancer treatment.

Цель исследования – оценка безопасности, частоты патоморфологических изменений и длительных онкологических результатов при проведении радикальной простатэктомии (РПЭ) после неоадъювантной химиотерапии (НХТ) у больных раком предстательной железы (РПЖ) промежуточного и высокого риска.

Материалы и методы. Нами проведен анализ результатов лечения 44 больных РПЖ, проводимого в период с 1998 по 2003 г. при средней длительности наблюдения 11,4 года. Мы оценили результаты РПЭ у больных РПЖ промежуточного и высокого риска (сТ2с–T3a и/или уровень простатспецифического антигена (ПСА) ≥ 10 нг/мл и/или сумма баллов по шкале Глисона ≥ 7) после еженедельного введения доцетаксела (в дозе 36 мг/м2, 6 циклов) и сравнили результаты с группой, в которой проводилось толькохирургическое лечение (n = 23). Критерием эффективности лечения были безрецидивная выживаемость (БРВ), раковоспецифическая (скорригированная) выживаемость (РСВ) и общая выживаемость (ОВ) в течение периода наблюдения 11,4 года.

Результаты. Среди развившихся осложнений химиотерапии преобладала токсичность I–II степени, а частота III степени токсичности не превышала 10 %. Статистически значимое более чем на 50 % уменьшение уровня ПСА отмечено в 52,4 % случаев. При наблюдении 11,4 года РСВ составила 90 % в группе НХТ и 60,9 % в группе хирургического лечения (p = 0,042). БРВ составила 68,5 и 37,7 %, а ОВ – 75,5 и 54,6 % в группах комбинированного лечения и только оперативного лечения соответственно.Однако в отличие от РСВ различия в БРВ (p = 0,25) и ОВ (p = 0,09) не были статистически достоверны.

Заключение. Использование НХТ представляет собой безопасный и эффективный метод лечения, приводящий к уменьшению объема предстательной железы и снижению уровня ПСА. НХТ с последующей РПЭ ассоциируется с более высокой БРВ и ОВ по сравнению с пациентами, перенесшими только хирургическое лечение. Отмечено статистически значимое улучшение РСВ в группе комбинированного лечения.

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