Randomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men With Metastatic Castration-Resistant Prostate Cancer

PURPOSE: Tasquinimod, a novel oral therapy targeting the tumor microenvironment, significantly improved progression-free survival (PFS) in a randomized, placebo-controlled phase II trial in men with metastatic castration-resistant prostate cancer (mCRPC). This phase III study was conducted to confirm the phase II results and to detect an overall survival (OS) benefit. PATIENTS AND METHODS: Men with chemotherapy-naïve mCRPC and evidence of bone metastases were assigned (2:1) to receive tasquinimod once per day or placebo until progression or toxicity. The primary end point was radiographic PFS (rPFS; time from random assignment to radiologic progression or death) per Prostate Cancer Working Group 2 criteria and RECIST 1.1. The study had 99.9% power to detect an rPFS hazard ratio (HR) of 0.6 with a two-sided alpha error of .05 and 80% power to detect a target HR of 0.8 for OS, the key secondary end point. RESULTS: In all, 1,245 patients were randomly assigned to either tasquinimod (n = 832) or placebo (n = 413) between March 2011 and December 2012 at 241 sites in 37 countries. Baseline characteristics were balanced between groups: median age, 71 years; Karnofsky performance status ≥ 90%, 77.3%; and visceral metastases, 21.1%. Estimated median rPFS by central review was 7.0 months (95% CI, 5.8 to 8.2 months) with tasquinimod and 4.4 months (95% CI, 3.5 to 5.5 months) with placebo (HR, 0.64; 95% CI, 0.54 to 0.75; P < .001). Median OS was 21.3 months (95% CI, 19.5 to 23.0 months) with tasquinimod and 24.0 months (95% CI, 21.4 to 26.9 months) with placebo (HR, 1.10; 95% CI, 0.94 to 1.28; P = .25). Grade ≥ 3 adverse events were more frequent with tasquinimod (42.8% v 33.6%), the most common being anemia, fatigue, and cancer pain. CONCLUSION: In chemotherapy-naïve men with mCRPC, tasquinimod significantly improved rPFS compared with placebo. However, no OS benefit was observed

Distance learning: opportunities and challenges in quarantine.

The urgent introduction of distance education into the learning process due to the COVID-19 pandemic has become a spontaneous experiment, requiring urgent decisions, effective mechanisms to implement into the educational process and analysis of ongoing educational process. The possibilities of modern digital technologies made it possible to quickly set up the information component of education and to controle student’s knowledge. A detailed analysis of the communication between the faculty members of the department among themselves and analysis of the features of teaching and self-education of students in the field of medical radiology and oncology based on answers and comments with using Google classroom, Socrative, Messenger Telegram, etc. was made. Issues of communicative interaction between faculty members and students, psychological aspects of distance communication, language of instruction, logistics of distance education and methodological problems are described in details. It has been suggested that distance education may be equally effective for theoretical subjects in full-time study form, but when studying clinical disciplines, the priority should be given to traditional methods of teaching, involving student's bedside training. Taking into account technical possibilities and high risk of development of extreme and emergency situations, it is suggested to introduce permanent readiness for distance education, to create all – Ukrainian distance imitation service of patients’ follow-up. The importance of using the state language in training as the basis for mastering the professional Ukrainian and English language as the basis for mastering international medical experience is indicated

Эффективность и безопасность эверолимуса у больных распространенным почечно-клеточным раком (результаты российского многоцентрового наблюдательного исследования)

Objective – to evaluate efficacy and safety of everolimus in Russian population of unselected patients with advanced renal cell carcinoma progressing after at least 1 line of anti-angiogenic targeted therapy.Materials and methods. In observational multicenter study CRAD001LRU03 from 17.01.2012 to 31.03.2015 in 43 centers 226 patients with advanced renal cell carcinoma with documented progression on the background or after at least 1 line of anti-angiogenic targeted therapy were included. The survey was conducted on all patients according to the practice, everolimus therapy was administered in accordance with instructions to the drug.Results. Objective response rate was 10 %, tumor control was achieved on 69.2 % of patients. Progression-free survival median – 7.8 months. Adverse events occurred in 44.7 % of patients, reached the III–IV severity of 9.3 %, were the reason for the cancellation of everolimus therapy in 2.2 % of cases. The most frequent complications of treatment were pneumonitis (n = 5 (2.2 %)) and anemia (n = 3 (1.3 %)).Conclusion. The observational study confirms efficacy and favorable safety profile of everolimus mTOR inhibitor in the Russian unselected patients with advanced renal cell carcinoma with progression or intolerable toxicity against background of anti-angiogenic therapy.Цель исследования – оценить эффективность и безопасность эверолимуса в российской популяции неотобранных больных распространенным раком почки, прогрессирующим после не менее 1 линии антиангиогенной таргетной терапии.Материалы и методы. В наблюдательное многоцентровое исследование CRAD001LRU03 с 17.01.2012 по 31.03.2015 в 43 центрах были включены 226 больных распространенным почечно-клеточным раком с доказанным прогрессированием на фоне или после не менее 1 линии антиангиогенной таргетной терапии. Обследование всех пациентов проводили согласно принятой в каждом центре практикой, терапию эверолимусом назначали в соответствии с инструкцией к препарату.Результаты. Частота объективных ответов составила 10 %, контроль над опухолью достигнут у 69,2 % больных. Медиана выживаемости без прогрессирования – 7,8 мес. Нежелательные явления развились у 44,7 % пациентов, достигли III–IV степени тяжести в 9,3 % и послужили причиной для отмены терапии эверолимусом в 2,2 % случаев. Наиболее частыми осложнениями лечения были пневмонит (n = 5 (2,2 %)) и анемия (n = 3 (1,3 %)).Заключение. Наблюдательное исследование подтвердило эффективность и благоприятный профиль безопасности ингибитора mTOR эверолимуса у неотобранных российских больных распространенным раком почки с прогрессированием или непереносимой токсичностью на фоне антиангиогенной таргетной терапии

Efficiency and safety of the everolimus in patients with the generalized renal cell carcinoma (multicentral observational study)

Objective – to evaluate efficacy and safety of everolimus in Russian population of unselected patients with advanced renal cell carcinoma progressing after at least 1 line of anti-angiogenic targeted therapy.Materials and methods. In observational multicenter study CRAD001LRU03 from 17.01.2012 to 31.03.2015 in 43 centers 226 patients with advanced renal cell carcinoma with documented progression on the background or after at least 1 line of anti-angiogenic targeted therapy were included. The survey was conducted on all patients according to the practice, everolimus therapy was administered in accordance with instructions to the drug.Results. Objective response rate was 10 %, tumor control was achieved on 69.2 % of patients. Progression-free survival median – 7.8 months. Adverse events occurred in 44.7 % of patients, reached the III–IV severity of 9.3 %, were the reason for the cancellation of everolimus therapy in 2.2 % of cases. The most frequent complications of treatment were pneumonitis (n = 5 (2.2 %)) and anemia (n = 3 (1.3 %)).Conclusion. The observational study confirms efficacy and favorable safety profile of everolimus mTOR inhibitor in the Russian unselected patients with advanced renal cell carcinoma with progression or intolerable toxicity against background of anti-angiogenic therapy

Randomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men With Metastatic Castration-Resistant Prostate Cancer

PURPOSE: Tasquinimod, a novel oral therapy targeting the tumor microenvironment, significantly improved progression-free survival (PFS) in a randomized, placebo-controlled phase II trial in men with metastatic castration-resistant prostate cancer (mCRPC). This phase III study was conducted to confirm the phase II results and to detect an overall survival (OS) benefit. PATIENTS AND METHODS: Men with chemotherapy-naïve mCRPC and evidence of bone metastases were assigned (2:1) to receive tasquinimod once per day or placebo until progression or toxicity. The primary end point was radiographic PFS (rPFS; time from random assignment to radiologic progression or death) per Prostate Cancer Working Group 2 criteria and RECIST 1.1. The study had 99.9% power to detect an rPFS hazard ratio (HR) of 0.6 with a two-sided alpha error of .05 and 80% power to detect a target HR of 0.8 for OS, the key secondary end point. RESULTS: In all, 1,245 patients were randomly assigned to either tasquinimod (n = 832) or placebo (n = 413) between March 2011 and December 2012 at 241 sites in 37 countries. Baseline characteristics were balanced between groups: median age, 71 years; Karnofsky performance status ≥ 90%, 77.3%; and visceral metastases, 21.1%. Estimated median rPFS by central review was 7.0 months (95% CI, 5.8 to 8.2 months) with tasquinimod and 4.4 months (95% CI, 3.5 to 5.5 months) with placebo (HR, 0.64; 95% CI, 0.54 to 0.75; P < .001). Median OS was 21.3 months (95% CI, 19.5 to 23.0 months) with tasquinimod and 24.0 months (95% CI, 21.4 to 26.9 months) with placebo (HR, 1.10; 95% CI, 0.94 to 1.28; P = .25). Grade ≥ 3 adverse events were more frequent with tasquinimod (42.8% v 33.6%), the most common being anemia, fatigue, and cancer pain. CONCLUSION: In chemotherapy-naïve men with mCRPC, tasquinimod significantly improved rPFS compared with placebo. However, no OS benefit was observed

Distance Learning: Opportunities and Challenges in Quarantine.

The urgent introduction of distance education into the learning process due to the COVID-19 pandemic has become a spontaneous experiment, requiring urgent decisions, effective mechanisms to implement into the educational process and analysis of ongoing educational process. The possibilities of modern digital technologies made it possible to quickly set up the information component of education and to controle student's knowledge. A detailed analysis of the communication between the faculty members of the department among themselves and analysis of the features of teaching and self-education of students in the field of medical radiology and oncology based on answers and comments with using Google classroom, Socrative, Messenger Telegram, etc. was made. Issues of communicative interaction between faculty members and students, psychological aspects of distance communication, language of instruction, logistics of distance education and methodological problems are described in details. It has been suggested that distance education may be equally effective for theoretical subjects in full-time study form, but when studying clinical disciplines, the priority should be given to traditional methods of teaching, involving student's bedside training. Taking into account technical possibilities and high risk of development of extreme and emergency situations, it is suggested to introduce permanent readiness for distance education, to create all – Ukrainian distance imitation service of patients' follow-up. The importance of using the state language in training as the basis for mastering the professional Ukrainian and English language as the basis for mastering International medical experience is indicated