ПЕРВИЧНО-МНОЖЕСТВЕННЫЕ ЗЛОКАЧЕСТВЕННЫЕ НОВООБРАЗОВАНИЯ С ПОРАЖЕНИЕМ МОЧЕПОЛОВЫХ ОРГАНОВ

The incidence of polyneoplasia was studied among the urban and rural populations of the Omsk Region. Urinary tract neoplasms constitute 10% of the total structure of cancer morbidity, these occurring twice more frequently in the urban population than in the rural one. Polyneoplasias involving the urinary tract are metachronous in 62.8%, synchronous in 35.2%, metachronous-and-synchronous in 1.2%, and synchronous-and-metachronous in 0.8%. Out of 253 patients with polyneoplasia involving the urinary tract, 176 (69.6%) died and 77 (30.4%) survived during 8 years.Изучена частота первично-множественного рака среди городского и сельского населения Омской области. Новообразования мочеполовых органов в общей структуре онкологической заболеваемости составляют 10%, причем среди городского населения они встречаются в 2 раза чаще, чем среди сельского. Первично-множественные злокачественные опухоли с поражением мочеполовых органов в 62,8% случаев являются метахронными, в 35,2% - синхронными, в 1,2% - метахронно-синхронными и в 0,8% - синхронно-метахронными. В течение 8 лет из 253 пациентов с первично-множественным раком с поражением мочеполовых органов умерло 176 человек (69,6%), живы 77 человек (30,4%)

Morphological prerequisites for the formation of fascial duplication in the elimination of damage to the anterior rectal wall during prostatectomy

Background Intraoperative rectal injury in prostatectomy patients is an uncommon but severe complication. Particular attention is paid to improving the results of healing damage to the anterior rectal wall during prostatectomy.Objective To study the morphological features of the parietal pelvic fascia and the rectal wall to substantiate the possibility of the formation of fascial duplication in the elimination of damage to the anterior rectal wall during prostatectomy.Material and Methods The authors carried out an intravital morphological analysis of the parietal pelvic fascia covering the levator rectum muscle and the anterior rectal wall in 10 men.Results The parietal pelvic fascia contains more powerful bundles of collagen fibers, which in certain areas are partially woven into the fibers of striated muscle tissue. The adventitia of the rectum is characterized by a looser arrangement of the interacting components of the formed connective and smooth muscle tissue. In the studied formations of the small pelvis, the thickness of collagen fibers separately and in the composition of bundles, as well as the cells of the differon and each fiber separately did not differ, which indicated the identity of their tinctorial properties in the compared zones.Conclusion Morphological analysis showed that when juxtaposing and touching the edges of the healing area of the surgical wound without tension, a stable and continuous scar of the fascial duplication is formed, which ensures reliable fusion of the stitched anatomical structures

Хирургическая техника стабилизации уретровезикального анастомоза для улучшения результатов раннего восстановления удержания мочи после позадилонной простатэктомии

Objective: to develop and substantiate the method of stabilization of urethrovesical anastomosis with retropubic prostatectomy to improve the results of early recovery of urinary retention.Materials and methods. 58 patients who had undergone radical prostatectomy were enrolled into the prospective study. The patient population was divided into two groups by the blinded randomization. The first control group consists of 29 men who underwent traditional routine surgical treatment. The second main group (29 patients) who underwent novel surgical treatment with making urethrocysteoanastomosis based on original method (Patent for invention № 2559588 from 14 Jul 2015 “Method of propylaxis of urinary incontinence after retropubic prostatectomy”).Results. At the moment of the hospital discharge the urine continence was achieved by the 20.7 % (n = 6) patients from the first group and 48.3 % (n = 14) patients from the second group. During the follow-up period in a month after surgery urine continence was maintained by the 37.9 % (n = 11) patients from the first group and 72.4 % (n = 23) patients from the second group, in three months after surgery — 62.0 % (n = 18) patients from the first group and 79.3 % (n = 23) patients from the second group. After the 6 months follow-up period 75.9 % (n = 22) patients from the first group and 86.2 % (n = 25) patients from the second group maintain urine continence. One-year follow-up period showed urine continence in 89.7 % (n = 26) patients from the first group and 93.1 % (n = 27) patients from the second group Conclusion. The surgical technique developed and introduced into clinical practice made it possible to stabilize urethrocysteoanastomosis, prevent or significantly shorten the incontinence period within the first year after retropubic prostatectomy, and improve the quality of life of patients.Цель исследования — разработать и обосновать способ стабилизации уретровезикального анастомоза при позадилонной простатэктомии для улучшения результатов раннего восстановления удержания мочи.Материалы и методы. В проспективное исследование включены данные 58 мужчин, которым выполнена позадилонная простатэктомия. Методом слепой рандомизации пациенты распределены на 2 группы: 1-я (контрольная) — 29 мужчин, которым проведено традиционное хирургическое лечение, 2-я (основная) — 29 пациентов, которым выполнено хирургическое лечение с формированием уретровезикального анастомоза по оригинальной методике (патент на изобретение №2559588 от 14.07.2015 «Способ профилактики недержания мочи после позадилонной простатэктомии»).Результаты. На момент выписки из стационара удерживали мочу 6 (20,7 %) мужчин 1-й группы и 14 (48,3 %) мужчин 2-й. При диспансерном динамическом наблюдении через 1 мес после операции удерживали мочу 11 (37,9 %) пациентов 1-й группы и 21 (72,4 %) пациент 2-й, через 3 мес — 18 (62,0 %) и 23 (79,3 %) мужчины соответственно. Континентными через 6 мес после операции были 22 (75,9 %) мужчины 1-й группы и 25 (86,2 %) мужчин 2-й, через 1 год — 26 (89,7 %) и 27 (93,1 %) пациентов соответственно.Заключение. Разработанный и внедренный в клиническую практику хирургический прием позволял стабилизировать уретроцистоанастомоз, предотвращал или значительно сокращал сроки недержания мочи в течение первого года после простатвезикулэктомии и способствовал улучшению качества жизни пациентов

Overall Survival with Adjuvant Pembrolizumab in Renal-Cell Carcinoma

BackgroundAdjuvant pembrolizumab therapy after surgery for renal-cell carcinoma was approved on the basis of a significant improvement in disease-free survival in the KEYNOTE-564 trial. Whether the results regarding overall survival from the third prespecified interim analysis of the trial would also favor pembrolizumab was uncertain.MethodsIn this phase 3, double-blind, placebo-controlled trial, we randomly assigned (in a 1:1 ratio) participants with clear-cell renal-cell carcinoma who had an increased risk of recurrence after surgery to receive pembrolizumab (at a dose of 200 mg) or placebo every 3 weeks for up to 17 cycles (approximately 1 year) or until recurrence, the occurrence of unacceptable toxic effects, or withdrawal of consent. A significant improvement in disease-free survival according to investigator assessment (the primary end point) was shown previously. Overall survival was the key secondary end point. Safety was a secondary end point.Download a PDF of the Research Summary.ResultsA total of 496 participants were assigned to receive pembrolizumab and 498 to receive placebo. As of September 15, 2023, the median follow-up was 57.2 months. The disease-free survival benefit was consistent with that in previous analyses (hazard ratio for recurrence or death, 0.72; 95% confidence interval [CI], 0.59 to 0.87). A significant improvement in overall survival was observed with pembrolizumab as compared with placebo (hazard ratio for death, 0.62; 95% CI, 0.44 to 0.87; P=0.005). The estimated overall survival at 48 months was 91.2% in the pembrolizumab group, as compared with 86.0% in the placebo group; the benefit was consistent across key subgroups. Pembrolizumab was associated with a higher incidence of serious adverse events of any cause (20.7%, vs. 11.5% with placebo) and of grade 3 or 4 adverse events related to pembrolizumab or placebo (18.6% vs. 1.2%). No deaths were attributed to pembrolizumab therapy.ConclusionsAdjuvant pembrolizumab was associated with a significant and clinically meaningful improvement in overall survival, as compared with placebo, among participants with clear-cell renal-cell carcinoma at increased risk for recurrence after surgery. (Funded by Merck Sharp and Dohme, a subsidiary of Merck; KEYNOTE-564 ClinicalTrials.gov number, NCT03142334.

Phase 3 CLEAR study in patients with advanced renal cell carcinoma: outcomes in subgroups for the lenvatinib-plus-pembrolizumab and sunitinib arms

IntroductionThe phase 3 CLEAR study demonstrated that lenvatinib plus pembrolizumab significantly improved efficacy versus sunitinib as first-line treatment for patients with advanced renal cell carcinoma (RCC). Prognostic features including presence and/or site of baseline metastases, prior nephrectomy, and sarcomatoid features have been associated with disease and treatment success. This subsequent analysis explores outcomes in patients with or without specific prognostic features.MethodsIn CLEAR, patients with clear cell RCC were randomly assigned (1:1:1) to receive either lenvatinib (20 mg/day) plus pembrolizumab (200 mg every 3 weeks), lenvatinib (18 mg/day) plus everolimus (5 mg/day), or sunitinib alone (50 mg/day, 4 weeks on, 2 weeks off). In this report, progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) were all assessed in the lenvatinib-plus-pembrolizumab and the sunitinib arms, based on baseline features: lung metastases, bone metastases, liver metastases, prior nephrectomy, and sarcomatoid histology.ResultsIn all the assessed subgroups, median PFS was longer with lenvatinib-plus-pembrolizumab than with sunitinib treatment, notably among patients with baseline bone metastases (HR 0.33, 95% CI 0.21–0.52) and patients with sarcomatoid features (HR 0.39, 95% CI 0.18–0.84). Median OS favored lenvatinib plus pembrolizumab over sunitinib irrespective of metastatic lesions at baseline, prior nephrectomy, and sarcomatoid features. Of interest, among patients with baseline bone metastases the HR for survival was 0.50 (95% CI 0.30–0.83) and among patients with sarcomatoid features the HR for survival was 0.91 (95% CI 0.32–2.58); though for many groups, median OS was not reached. ORR also favored lenvatinib plus pembrolizumab over sunitinib across all subgroups; similarly, complete responses also followed this pattern.ConclusionEfficacy outcomes improved following treatment with lenvatinib-plus-pembrolizumab versus sunitinib in patients with RCC—irrespective of the presence or absence of baseline lung metastases, baseline bone metastases, baseline liver metastases, prior nephrectomy, or sarcomatoid features. These findings corroborate those of the primary CLEAR study analysis in the overall population and support lenvatinib plus pembrolizumab as a standard of care in 1L treatment for patients with advanced RCC.Clinical trial registrationClinicalTrials.gov, identifier NCT0281186

Промежуточный анализ неинтервенционного исследования по изучению эпидемиологии и естественного течения неметастатического кастрационно-резистентного рака предстательной железы в России

Objective: to study the clinical and demographic profile of patients with non-metatstatic castration-resistant prostate cancer (nmCRPC) and clinical approaches to the treatment of nmCRPC in the context of daily medical practice before and after progression M1 stage.Materials and methods. The multicenter non-interventional epidemiological study is planned to include 200 patients with a documented diagnosis of nmCRPC from 2019 to 2020. The interim report has included data on 108 patients from 13 centers located in different regions of the Russian Federation. The median age of the patients was 73 (55—90) years.Results and conclusion. When the diagnosis of nmCRPC was made, the median prostate specific antigen was 8.23 (0.17—116.9) ng/ml, and the prostate specific antigen doubling time was 6 (1—50) months. When diagnosed nmCRPC, 86 patients (79.6 %) underwent a change of therapy, of which 42 % were prescribed modern regimens containing the new generation non-steroid antiandrogens (apalutamide, enzalutamide).Цель исследования — изучение клинического и Демографического профиля пациентов с неметастатическим кастрационно-рези-стентным раком предстательной железы (нмКРРПЖ) в России с оценкой времени прогрессирования до стадии M1 и клинических подходов к лечению нмКРРПЖ в условиях повседневной медицинской практики до и после прогрессирования до M1.Материалы и методы. В многоцентровое неинтервенционное эпидемиологическое исследование планируется включить 200 пациентов с подтвержденным диагнозом нмКРРПЖ в период с 2019 по 2020 г. В промежуточный анализ вошли данные 108 пациентов из 13 центров, расположенных в разных регионах России. МеДиана возраста пациентов составила 73 (55—90) года.Результаты и заключение. При постановке диагноза нмКРРПЖ медиана концентрации сывороточного простатического специфического антигена составляла 8,23 (0,17—116,9) нг/мл, время уДвоения простатического специфического антигена — 6 (1—50) мес. При Диагностике нмКРРПЖ 86 (79,6 %) пациентам была провеДена смена терапии, из них в 42 % случаев назначена современная терапия нестероиДными антианДрогенами нового поколения (апалутамиД, энзалутамиД)

Состояние онкологической помощи больным раком предстательной железы в Омской области в 2005-2010 гг.

Objective: to study the frequency and dynamics of morbidity and mortality in male population of Omsk region with prostate cancerfor the period from 2005 to 2010.Materials and methods. A retrospective analysis was carried out for the periodfrom 2005 to 2010 of the initial diagnosis of1840patients with prostate cancer and the causes of death of837men in the Omsk region. The contingents of patients with prostate cancer were studied depending on the geographic location, size and composition of the region’s population. The data of the updated base of the population cancer registry and the main reporting forms were used.Results. There was an increase in the absolute number of diagnosed patients with prostate cancer for the first time by an average of 9.9 % annually. The downward trend was in the number of patients with I—II tumor stage lesions. Stable high annual detection of patients was with stage III (more than 50 %). The advanced forms of prostate cancer accounted for up to 24.4 %. The absolute number of men registered had increased by 52.4 %. The annual mortality rate decreased by an average of 5.7 %. During the monitoring period the absolute number of dead patients increased by an average of 6.7 % annually.Conclusion. The development and regional implementation of the Program for the early diagnosis and screening of prostate cancer based on a set of simple and generally accessible methods is advisable.Цель исследования — изучить частоту и динамику заболеваемости раком предстательной железы и смертности от данной патологии среди мужского населения Омской области в период с 2005 по 2010 г.Материалы и методы. За период с 2005по 2010 г. проведен ретроспективный анализ первичной диагностики 1840 больных раком предстательной железы и причин смерти 837мужчин в Омской области. Изучены контингенты больных раком предстательной железы в зависимости от географического положения, численности и состава населения региона. Использовали данные уточненной базы популяционного ракового регистра и основные отчетные формы.Результаты. Отмечено увеличение абсолютного числа вновь выявленных больных раком предстательной железы в среднем на 9,9 % ежегодно. Наблюдалась тенденция к снижению числа больных с I—II стадиями опухолевого поражения. Отмечено стабильно высокое (более 50 %) ежегодное выявление пациентов с III стадией. Запущенные формы рака предстательной железы составляли до 24,4 %. На 52,4 % увеличилось абсолютное число мужчин, состоящих на учете. Показатель годичной летальности снизился в среднем на 5,7 %. За период наблюдения увеличилось абсолютное число умерших пациентов в среднем на 6,7 % ежегодно.Заключение. Целесообразны разработка и региональное внедрение Программы ранней диагностики и скрининга рака предстательной железы на основании комплекса простых и общедоступных методов

Эпидемиология и естественное течение неметастатического кастрационно-резистентного рака предстательной железы в российской популяции

Aim. To study the clinical and demographic profile of patients with non-metatstatic castration-resistant prostate cancer (nmCRPC) and clinical approaches to the treatment of nmCRPC in the context of daily medical practice before and after progression M1 stage.Materials and methods. The multicenter non-interventional epidemiological study were included 200 patients with a documented diagnosis of nmCRPC from 2019 to 2020. Each patient visited twice: start and after 6 months. Of the 200 patients included, 9 were excluded from the analysis presented in this article: 1 patient had no information on inclusi- on criteria, 1 patient did not meet the inclusion criteria, 7 patients did not attend visit 2. Thus, data are presented for 191 patients.Results and conclusion. The median age was 74.3 years (range 55 to 91). 72 % (137/191) had a disability group. The most common comorbidities were hypertension (n = 115) and hypercholesterolemia (n = 56). The median time from the diagnosis of prostate cancer to the development of castration resistance (diagnosis of nmCRPC) was 75 months. Prostate specific antigen (PSA) nadir (0.37 ng/ml on average) was achieved after 15 months of prostate cancer therapy (median time to reach PSA nadir). At the same time, PSA doubling time in most cases (47.6 %; 91/191) was less than 6 months, 18.8 % of persons (36/191) had PSA doubling time for more than 10 months.Цель исследования – изучение клинического и демографического профиля пациентов с неметастатическим кастрационно-резистентным раком предстательной железы (нмКРРПЖ) в России с оценкой времени прогрессирования до стадии M1 и клинических подходов к лечению нмКРРПЖ в условиях повседневной медицинской практики до и после прогрессирования до M1.Материалы и методы. В многоцентровое неинтервенционное эпидемиологическое исследование были включены 200 пациентов с подтвержденным диагнозом нмКРРПЖ в период с 2019 по 2020 г. В рамках исследования проведены 2 визита: в начале и через 6 мес. Из 200 пациентов 9 мужчин были исключены из анализа, представленного в настоящей статье: у 1 пациента отсутствовала информация о критериях включения, 1 пациент не соответствовал критериям включения, 7 пациентов не прошли визит 2. Таким образом, данные представлены для 191 пациента.Результаты и заключение. Средний возраст пациентов – 74,3 (55–91) года. У 72 % (137/191) пациентов имелась группа инвалидности. Наиболее распространенными сопутствующими заболеваниями были гипертензия (n = 115) и гиперхолестеринемия (n = 56). Медиана времени от диагностики рака предстательной железы до развития кастрационной резистентности (постановки диагноза нмКРРПЖ) составила 75 мес. Надир простатического специфичес кого антигена (ПСА) (в среднем 0,37 нг/мл) достигался через 15 мес терапии рака предстательной железы (медиана времени достижения надира ПСА). Время удвоения ПСА в большинстве случаев (47,6 %; 91/191) было менее 6 мес, у 18,8 % (36/191) пациентов зарегистрировано время удвоения ПСА более 10 мес