Индивидуальная оценка уровня простатического специфического антигена у больных раком предстательной железы после брахитерапии

The study covered 44 patients with localized and locally advanced prostate cancer (PC), who were followed up for at least 18 months after brachytherapy. A significant reduction in the level of prostatic specific antigen (PSA) in the blood of patients was observed 3 months after brachytherapy and tended to decrease further during a 12-month follow-up. It is the time after brachytherapy that may be considered as a criterion for a primary tumor response to the therapy. There were individual differences in the velocity and decrease rate of PSA levels during the therapy: in 30 (68.2%) patients, PSA values were in the range of 0.01—0.98 ng/ml (mean 0.39±0.31 ng/ml) while in 14 (31.8%) patients, those were 1.10—6.20 ng/ml (3.02±1.79 ng/ml). A certain correlation was found between the parameters of PSA (baseline PSA level, time course of changes, and kinetics of PSA levels) and the outcome of the disease. A more objective evaluation of the efficiency may be made after increasing the time of a follow-up and the number of patients after brachytherapy.

Зомета в терапии рака предстательной железы с метастатическим поражением костей на фоне андрогенной депривации (результаты Российского многоцентрового исследования)

Introduction: Hormonal therapy is the method of choice in treating disseminated prostate cancer. Chronic androgenic suppression causes a reduction in bone mineral density. The most common complications of bone metastases are pathological fractures, spinal cord compression, pain, etc.Methods: A multicenter study (11 clinics of Russia) assessing the efficacy of Zometa in preventing skeletal complications of bone metastases was conducted in 2004—2005. Zometa was administered intravenously at a dose of 4 mg every 3Р4 weeks with androgenic deprivation. Its objective effect was evaluated in 70 patients. Changes in bone mineral density were evaluated by densitometry.Results: Complete pain relief was achieved in 73% of the patients; after therapy 86% of the patients had 0—1 WHO activity status score, 97% of the patients had no bone complications. The level of bone resorption marker β-Cross-Laps decreased to the normal values in 51% of the patients.Conclusion: The study has provided an evidence of the efficacy of Zometa and the necessity of using this drug in complex therapy for bone metastases of prostate cancer.Introduction: Hormonal therapy is the method of choice in treating disseminated prostate cancer. Chronic androgenic suppression causes a reduction in bone mineral density. The most common complications of bone metastases are pathological fractures, spinal cord compression, pain, etc.Methods: A multicenter study (11 clinics of Russia) assessing the efficacy of Zometa in preventing skeletal complications of bone metastases was conducted in 2004—2005. Zometa was administered intravenously at a dose of 4 mg every 3Р4 weeks with androgenic deprivation. Its objective effect was evaluated in 70 patients. Changes in bone mineral density were evaluated by densitometry.Results: Complete pain relief was achieved in 73% of the patients; after therapy 86% of the patients had 0—1 WHO activity status score, 97% of the patients had no bone complications. The level of bone resorption marker β-Cross-Laps decreased to the normal values in 51% of the patients.Conclusion: The study has provided an evidence of the efficacy of Zometa and the necessity of using this drug in complex therapy for bone metastases of prostate cancer

Individual estimation of the level of prostatic specific antigen in patients with prostate cancer after brachytherapy

The study covered 44 patients with localized and locally advanced prostate cancer (PC), who were followed up for at least 18 months after brachytherapy. A significant reduction in the level of prostatic specific antigen (PSA) in the blood of patients was observed 3 months after brachytherapy and tended to decrease further during a 12-month follow-up. It is the time after brachytherapy that may be considered as a criterion for a primary tumor response to the therapy. There were individual differences in the velocity and decrease rate of PSA levels during the therapy: in 30 (68.2%) patients, PSA values were in the range of 0.01—0.98 ng/ml (mean 0.39±0.31 ng/ml) while in 14 (31.8%) patients, those were 1.10—6.20 ng/ml (3.02±1.79 ng/ml). A certain correlation was found between the parameters of PSA (baseline PSA level, time course of changes, and kinetics of PSA levels) and the outcome of the disease. A more objective evaluation of the efficiency may be made after increasing the time of a follow-up and the number of patients after brachytherapy

БЕЗОПАСНОСТЬ И ПЕРЕНОСИМОСТЬ ПРЕПАРАТА 6НР У ВЗРОСЛЫХ ВИЧ-ИНФИЦИРОВАННЫХ БОЛЬНЫХ, РАНЕЕ НЕ ПОЛУЧАВШИХ АРВТ

The safety, tolerance and potential therapeutic benefits of 6HP were assessed upon its use in treatment courses provided to ART-naïve adult HIV patients within the framework of Phase I randomized single-blinded trial 6HP-1-2013. Study group included 75 HIV patients referred to the third subclinical stage of HIV infection. The patients were randomized into five groups, each comprising 15 subjects. 6HP was administered per os twice daily at the dose 600 mg in Group 1 and 800 mg in Group 2 and once daily at the dose 1200 mg in Group 3, 1600 mg in Group 4, and 2000 mg in Group 5. Treatment courses lasted for 35 days. After they were completed, significant decreases in HIV RNA (log10 copies/mL) were found in all groups (p<0,05). The decreases were significantly more pronounced in Groups 2, 4, and 5 than in Group 1 (p<0,05). In all groups, CD4 cell counts medians were found to increase. Drug tolerance under the conditions of the above therapeutic regimen was estimated as good. No associations were found between the rates and severities of adverse events and the doses and administration regimens of 6HP. The adverse events were detected in 53,3% of patients. In 90% of the cases, the events were mild and did not necessitate an additional therapy. 6HP administration once daily combined with other ART drugs was recommended for further clinical studies.Целью исследования была оценка безопасности и переносимости препарата 6НР при курсовом приеме у взрослых больных с ВИЧ-инфекцией, ранее не получавших антиретровирусную терапию. Исследование 6НР-1-2013 - рандомизированное, простое слепое исследование I фазы по изучению безопасности и переносимости препарата 6НР с оценкой потенциальной терапевтической пользы при курсовом приеме у взрослых ВИЧ-инфицированных больных, ранее не получавших антиретровирусную терапию. В исследование было включено 75 больных с ВИЧ-инфекцией, у которых была установлена 3 субклиническая стадия ВИЧ-инфекции. Пациенты были рандомизированы в пять групп в соотношении 1:1:1:1:1 (по 15 человек в каждой группе). Пациенты группы 1 принимали препарат 6НР в суточной дозе 1200 мг (по 600 мг 2 раза в сутки); группы 2 - в суточной дозе 1600 мг (по 800 мг 2 раза в сутки); группы 3 - в суточной дозе 1200 мг однократно; группы 4 - в суточной дозе 1600 мг однократно; группы 5 - в суточной дозе 2000 мг однократно. Продолжительность курсового приема (монотерапия 6НР) составила 35 дней. После завершения исследования существенное снижение уровня РНК ВИЧ (logiü копий/мл) имело место во всех исследуемых группах (р<0,05). Снижение уровня вирусной нагрузки у пациентов групп: 2, 4 и 5 было достоверно больше, чем у пациентов группы 1 (р<0,05). Также у пациентов всех групп было обнаружено увеличение медианы количества CD4-лимфоцитов. При анализе безопасности было установлено, что при курсовом (5 недель) пероральном приеме больными с ВИЧ-инфекцией переносимость исследуемого препарата была хорошей. Не установлена связь частоты и степени тяжести тех или иных нежелательных явлений с суточной дозой и кратностью приема исследуемого препарата. Развитие побочных действий отметили у 53,3% больных, причем в 90% случаев нежелательные явления имели легкую степень тяжести, в большинстве случаев не были связаны с исследуемым препаратом и не требовали назначения дополнительной терапии. На основании результатов проведенного исследования препарат 6НР с однократным приемом в сутки был рекомендован для дальнейшего клинического изучения у больных с ВИЧ-инфекцией в составе схемы комбинированной антиретровирусной терапии

Zometa in therapy for bone metastases of prostate cancer during androgenic deprivation (Results of Russian multicenter study)

Introduction: Hormonal therapy is the method of choice in treating disseminated prostate cancer. Chronic androgenic suppression causes a reduction in bone mineral density. The most common complications of bone metastases are pathological fractures, spinal cord compression, pain, etc.Methods: A multicenter study (11 clinics of Russia) assessing the efficacy of Zometa in preventing skeletal complications of bone metastases was conducted in 2004—2005. Zometa was administered intravenously at a dose of 4 mg every 3Р4 weeks with androgenic deprivation. Its objective effect was evaluated in 70 patients. Changes in bone mineral density were evaluated by densitometry.Results: Complete pain relief was achieved in 73% of the patients; after therapy 86% of the patients had 0—1 WHO activity status score, 97% of the patients had no bone complications. The level of bone resorption marker β-Cross-Laps decreased to the normal values in 51% of the patients.Conclusion: The study has provided an evidence of the efficacy of Zometa and the necessity of using this drug in complex therapy for bone metastases of prostate cancer