BackgroundThe purpose of this trial is to evaluate the safety and efficacy of ELENAGEN, a novel anticancer therapeutic DNA plasmid encoding p62/SQSTM1 protein, as an adjuvant to chemotherapy with gemcitabine (GEM) in patients with advanced platinum-resistant ovarian cancer.MethodsThis open-label prospective randomized study with two arms. GEM (1000 mg/m2) on days 1 and 8 every 3 weeks was administered in both arms: in the Chemo arm (n = 20), GEM was the only treatment, and in the ELENAGEN arm (n = 20), GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly). The primary endpoint was progression-free survival (PFS), and the secondary endpoint was safety. Antitumor activity was assessed by RECIST 1.1, and criteria safety was assessed according to NCI CTCAE version 5.0.ResultsAccording to the cutoff data, the median follow-up was 13.8 months. There were no serious adverse events related to ELENAGEN treatment. The median PFS was 2.8 and 7.2 months in the Chemo and ELENAGEN arms, respectively (p Log-Rank = 0.03). Notably, at the time of cutoff, 9 patients (45%) in the ELENAGEN arm did not progress, with the longest PFS recorded thus far being 24 months. Subgroup analysis of patients in both arms demonstrated high efficacy of ELENAGEN in patients with worse prognostic factors: high pretreatment levels of CA125 and progression after platinum-free interval <3 months.ConclusionsThe addition of ELENAGEN to gemcitabine is effective in patients with platinum-resistant ovarian cancer, including those with a worse prognosis.Clinical trial registrationhttps://www.clinicaltrials.gov/study/NCT05979298, identifier NCT05979298, 2023-08-07.
The study was made to evaluate the effect of interleukin-2 (IL-2) as part of the R-CHOP regimen on the rate of a complete metabolic response (CMR) using the data of interim positron emission tomography (PET/CT) and progression-free survival compared to the standard regimen in patients with diffuse B-cell lymphoma (DCLC). The data of 152 patients with biopsy-proven DCLC who were treated in the period 2015–2020 were included. Among them, 59 patients were included in the prospective group (R-CHOP + IL-2 in a total course dose of 5,000,000 IU). The control group consisting of 93 patients received standard R-CHOP therapy. PET/CT was performed after 4 courses of therapy, metabolic response was assessed using the Deauville scale, and Deauville 1-2 was classified as CMR. The rate of CMR in the R-CHOP+IL-2 group was 67.8 %, while in the control group it was 50.5 % (pχ² = 0.044). The 5-year progression-free survival (PFS) in the R-CHOP+IL-2 and R-CHOP groups was 80.7 and 64.5 %, respectively (p = 0.04). In the favorable and intermediate prognosis groups (IPI 0–3), PFS was not statistically significantly different depending on treatment. At high risk (IPI 4–5), the 5-year PFS in the R-CHOP + IL-2 and R-CHOP groups was 71.4 and 25.0 %, respectively (p = 0.02). Including IL-2 in the R-CHOP regimen in the first-line treatment of patients with DCLC increases the incidence of CMR according to 18-FDG PET/CT after 4 courses of chemoimmunotherapy and PFS in the high-risk group.
e17540 Background: We recently reported on the efficacy of the p62/SQTM1-encoding plasmid in patients with advanced, recurrent platinum-resistant ovarian cancer (PROC) receiving gemcitabine chemotherapy. Here we analyze the effects of baseline prognostic factors on efficacy. Methods: A prospective multicenter randomized study took place between 01/2020 and 08/2023. Cohort A (n=20) consisted of Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks and Cohort B (n=20) consisted of Gemcitabine (Gem) 1000 mg/m2 days 1,8 every 3 weeks plus p62-plasmid 2.5 mg i.m. weekly. We stratified the patients into subgroups according to their baseline CA-125 level (normal vs high), number of lines of chemo (1 vs 2-3) received by a platinum-sensitive ovarian cancer (PSOC) patient before they became PROC, platinum-free interval (PFI) (up to 3 mo vs more than 3 mo), and presence or absence of peritoneal effusion. Cox proportional hazards regression analysis was utilized to determine effect of progression free survival (PFS). Results: The median follow-up was 13.8 months (mos). The median PFS was 2.8 mos in Gem (Arm A) and 7.2 mos in Gem + Plasmid (Arm B) respectively (p = 0.03). The overall response rate (ORR) by RESIST 1.1 was higher in the Gem +Plasmid arm: partial response (PR) - 5.0% and 20.0%, stable disease (SD) - 40.0% and 60.0%, and disease control rate 41.2 and 80% in Chemo and Plasmid arms respectively). In cohort A, all patients have progressed, whereas in Cohort B (Gem +Plasmid) 9 patients (45%) remained progression-free with the longest duration of response being 30 mo. Overall survival cannot be assessed yet. Analyzing prognostic factors with Cox Proportional Hazards Regression Analysis identified that the following factors increase p62 sensitivity: initial high CA-125 level PFS 2.5 and 6.5 (p = 0.01) in Arm A vs B, 1 line chemo vs 2 or 3 lines for PSOC, PFS 2.3 and 7.1 (p = 0.008) in Arm A vs B, and presence of peritoneal effusion PFS 2.4 and 7.6 (p = 0.008) in Arm A vs B (Table ). Conclusions: We observed maximal effect on PFS when combining the p62-encoding plasmid with Gem in the patients with the most dismal prognosis PROC: rapid progression (relapse as PROC after the first line of treatment and/or short PFI), in patients with an initial high level of CA-125, and/or pleural effusion. [Table: see text]
The currently used prognostic factors for long-term results of standard treatment of diffuse large B-cell lymphoma (DLBCL) are not clear enough to predict outcomes. The prognostic significance of interim PET/CT in DLBCL remains controversial. The aim of this study is to determine the predictive value of interim 18 F-FDG PET/CT after first-line treatment in patients with DLBCL. One hundred-eighty patients with DLBCL underwent baseline and interim 18 F-FDG PET/CT scans after 4 cycles of R-CHOP during the period of 2015–2020 at the N. N. Alexandrov National Cancer Centre of Belarus. Interim 18 F-FDG PET/ CT findings were retrospectively correlated to the progression-free survival (PFS) using the Kaplan–Meier analysis. The metabolic response was assessed according Deauville criteria: PET-negative – Deauville 1–2, PET-positive – Deauville 3–5. The International prognostic index (IPI) was used for risk stratification. After 4 cycles of chemotherapy, PET-positive lesions were found in 76 patients and negative scans – in 104 patients. Survival analyses showed highly significant relationships between early interim 18 F-FDG PET/CT imaging and PFS (p < 0.001). For PET-negative patients, the 7-year PFS rate was 91.1 %, for PET-positive patients it is 41.2 %. 5-year PFS rates for PET-negative patients with IPI scores 0–1, 2–3 and 4–5 were 97.5, 93.4 and 66.7 %, respectively. For PET-positive patients, 5-year PFS rates in the same subgroups were 55.6, 50.6 and 23.1 %, respectively. Early interim 18 F-FDG PET/CT imaging is a predictor of PFS in DLBCL. An early assessment of chemotherapy response with 18 F-FDG PET/CT scans may provide useful information on selection of patients for escalated therapeutic strategies.
Objectives. To determine the risk factors for the development of secondary postmastectomy lymphedema in patients with locally advanced breast cancer. Material and methods. The study included patients with stages IIIB-IIIC of locally advanced breast cancer who underwent complex treatment with the use of a standard mastectomy (control group) and a developed surgical technique (main group), when the stage of axillary lymph node dissection was carried out with preventive removal of the clavicular part of the pectoralis major muscle and the sternum - clavicular fascia. Radiation and chemotherapy were similar in both groups. The frequency and severity of secondary postmastectomy edema of the upper limb and its relationship with comorbidities were assessed. Results. The results were evaluated in 90 patients of the main group and 86 patients of the control group, the follow up period was more than one year after the operation. The groups were comparable in terms of the main clinical and biological parameters. In the main group, 21 cases of secondary postmastectomy edema were revealed (23.3±4.5%), in the control group – 36 (41.9±5.3%, p=0.009). When assessing the effect of obesity on the incidence of lymphedema, development the data were obtained that indicated an increase of its frequency in patients with obesity (47.8±5.3%) when compared to patients with normal weight (16.3±4.0%, p<0.001). Similar data were obtained both among patients of the control (p<0.001) and main groups (p=0.005). Among obese patients who had been operated according to the standard technique, the edema of the upper limb developed significantly more often (58.7±7.3%) when compared with the main group (36.4±7.3%, p=0.034). Conclusions. A statistically significant influence on the development of postmastectomy lymphedema was exerted by such factors as the presence of obesity in patients (p<0.001) and the method of surgical intervention (p=0.011). According to the monovariant analysis, the developed technique of surgical intervention enables 2.4 times reduction in the incidence of lymphedema when compared to standard treatment (p=0.009).
Treatment of poorly-pigmented tumors of small sizes can be carried out using photodynamic therapy (PDT). The material for the analysis was data on 112 patients. We used data from the Belarusian Cancer Registry, medical records of patients with clinically diagnosed choroid melanoma (C69.3 according to ICD-10) for the period 2013–2021. The size and level of blood flow in the tumors were assessed using an ultrasound machine with a doppler attachment. PDT was carried out using a «UPL PDT» semiconductor laser (Lemt, Republic of Belarus, λ=661 nm) with a light spot diameter of 1 to 3 mm for 60 s per field with a light dose of 50 J/cm2. The entire surface of the tumor was exposed to the action, with the fields “tiled”, from the periphery to the top of the tumor, with overlapping fields. Tumor pigmentation was assessed visually. To evaluate the treatment outcome, the general group of patients was divided into three subgroups according to thickness and basal diameter. Group I – 40 (35.7%) patients, with an average tumor thickness of 1.4±0.2 mm, basal diameter – 5.8±1.5 mm. II – 51 (45.5%) patients, with an average tumor thickness of 2.3 ± 0.3 mm, basal diameter – 7.9 ± 1.5 mm. III – 21 (18.8%) patients. The mean value of the tumor thickness was 3.8±0.4 mm, the basal diameter was 9.8±1.4 mm. After PDT in the general group (n=112), 29 (25.9%) patients had complete tumor resorption, and 83 (74.1%) patients had stabilization. The eyeball was saved in 107 (95.5%) patients. Continued growth and relapse were recorded in 34 patients: 25 (22.3%) and 9 (8.0%), respectively. In 29 (85.3%) patients, the eyeball was preserved after treatment of relapse and continued growth. 5 (4.5%) enucleations were performed. Adjusted one-year cumulative survival was 100%, 3-year and 5-year 95.8±2.4%, 93.7±3.1%, respectively
Introduction. The initial detection of regional and/or distant metastases in patients with newly diagnosed prostate cancer (PCa) is important for the management and disease prognosis. Conventional diagnostic imaging methods have certain limitations and do not allow a comprehensive assessment of the tumor spread. In recent years the use of positron emission tomography combined with computed tomography (PET/CT) with ligands of the prostate-specific membrane antigen (PSMA) has been rapidly expanding in oncological practice. The aim of the study was to analyze the diagnostic performance of 18F-PSMA-1007 PET/CT for the detection of metastases in patients with newly diagnosed prostate cancer. Material and methods. The study included 52 patients with newly diagnosed high-risk PCa, who underwent 18F-PSMA-1007 PET/CT. In all patients, there were no regional and/or distant metastases according to results of conventional imaging methods (bone scan, computed (or magnetic resonance) tomography of the pelvis). The conclusion about the presence or absence of metastases was made based on pathomorphological verification (in 27 patients) or using all available imaging and clinical follow-up as a reference. Results. Of the 52 patients included in the analysis, 26 (50.0%) had PCa metastases. Of these, 25 (48.1% of total cases) patients had true positive 18F-PSMA-1007 PET/CT. False-positive findings occurred in 2 cases. The positive predictive value of the method was 96.1%. In a univariate analysis of factors associated with true-positive PET/CT results, only the T-stage and Gleason score demonstrated statistically significant predictive value (p<0.05). According to multivariate analysis, only the Gleason score was statistically significantly associated with true positive findings on 18F-PSMA-1007 PET/CT (p=0.03). The most unfavorable in terms of the risk of detecting metastases was the group of patients with a Gleason score 7 (4+3) -10 (metastasis rate was 62.2%). Conclusion. 18F-PSMA-1007 PET/CT is an informative method for the detection of metastases in patients with newly diagnosed high risk PCa. 18F-PSMA-1007 PET/CT may be recommended in patients with Gleason score 4+3 or higher due to the high probability of regional and/or distant metastases, which were not detected by conventional methods.
In the situation of biochemical recurrence (BCR) of prostate cancer (PCa) it is important to distinguish between local recurrence in the prostate bed and systemic disease progression. Conventional imaging modalities have a limited role, especially in patients with low prostate specific antigen (PSA) levels. In recent years, the role of positron emission tomography combined with computed tomography (PET/CT) with PSMA-labeled ligands has grown, but there is currently no consensus on the role and effectiveness of the method in detecting local recurrence of the disease. The aim of the study was to analyze the diagnostic performance of 18F-PSMA‐1007 PET/CT in detecting local recurrence of prostate cancer. The study included 57 patients with BCR after radical prostatectomy, who underwent PET/CT with 18F-PSMA-1007 and according to its results there were no distant and/or regional metastases. Local recurrence was clinically verified in 53 (93.0%) patients. The sensitivity of PET/CT in detecting local recurrence was 58.5 %, specificity ‒ 75.0, positive predictive value ‒ 96.9, negative predictive value ‒ 12.0 %. According to multivariate analysis, only PSA level was significantly associated with truepositive PET/CT findings (p = 0.02). According to multivariate analysis, PSA level is an independent predictive factor of 18F-PSMA‐1007 PET/CT sensitivity in detecting local recurrence (p < 0.05). In the subgroup of patients with a low PSA level sensitivity was only 20.0 %. Therefore, a negative PET/CT scan at PSA level <0.5 ng/ml is not a reason for delay the initiation of salvage radiation therapy.
Here we report the results of the second interim analysis of a randomized prospective multi-center clinical study aimed to evaluate safety and efficacy of p62/SQTM1-encoding plasmid applied as an adjuvant to chemotherapy in patients with advanced platinum-resistant ovarian cancer. P62 encoding plasmid acts as an classic anti-cancer DNA vaccine and it also lowers chronic inflammation thus rendering tumor cells more susceptible to immune response and chemotherapy. A prospective randomized study was started in 2020. Chemotherapy (Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks) was administered in both arms. In the Chemo arm (n = 20) it was the only treatment, and in the Plasmid arm (n = 20) the same chemo was supplemented with p62-plasmid (2.5 mg i.m. weekly). To data cut-off, the median follow-up was 11.1 months in Efficacy-Evaluable Set. The median progression-free survival (PFS) was 2.7 and 6.6 mo in Chemo and Plasmid arms respectively (p Log-Rank = 0.018). Noteworthy, as of today, 35% of patients in the plasmid group did not progress with the longest PFS recorded so far is 24 months. The tumor response was assessed according to the RECIST 1.1 criteria. No complete responses were observed in either group. The objective response rate was higher in the Plasmid arm: partial response (PR) - 5.0% and 20.0%, stable disease (SD) - 40.0% and 60.0%, disease progression - 55.0% and 20.0%, and disease control rate (PR and SD) - 45.0% and 85.0% in Chemo and Plasmid arms respectively (p = 0,001). One patient in the Plasmid arm underwent complete cytoreduction with no evidence of disease progression. No Grade 3-4 toxicities were observed in both arms. All adverse effects were managed by conventional medications. No treatment delays or interruptions due to plasmid-related adverse events were registered. The interim results of this study show that adding p62/SQSTM1-encoding plasmid to standard Gemcitabine chemotherapy for advanced platinum-resistant ovarian cancer is a novel treatment approach which is safe, well-tolerated and effective: it improves ORR, DCR, and PFS. The long-lasting PFS in some patients is typical for immunotherapeutic agents. The study is ongoing.
Введение. Первоначальное обнаружение регионарных и/или отдаленных метастазов у пациентов с впервые выявленным раком предстательной железы (РПЖ) важно для выбора тактики лечения и прогноза заболевания. Традиционные методы диагностической визуализации имеют определенные ограничения, а также не позволяют комплексно оценить распространенность опухолевого процесса. В последние годы в онкологической практике стремительно расширяется применение позитронноэмиссионной томографии, совмещенной с компьютерной томографией (ПЭТ/КТ), с использованием лигандов к простатическому специфическому мембранному антигену (prostate specific membrane antigen – PSMA). Цель исследования. Изучить диагностические возможности ПЭТ/КТ с 18F-PSMA-1007 в обнаружении метастатического поражения у пациентов с впервые выявленным РПЖ с высоким риском прогрессирования. Материал и методы. В исследование были включены 52 пациента с впервые выявленным РПЖ высокого риска прогрессирования, которым выполнена ПЭТ/КТ с 18F-PSMA-1007. У всех пациентов отсутствовали данные в пользу регионарных и/или отдаленных метастазов по результатам стандартных методов обследований (остеосцинтиграфия с использованием 99mTc-метилендифосфонатов, компьютерная (или магнитно-резонансная) томография таза). Окончательные выводы о наличии либо отсутствии метастазов делались на основании патоморфологической верификации (у 27 пациентов) либо данных обследований в динамике на фоне проводимой терапии. Результаты. Из 52 включенных в анализ пациентов у 26 (50,0%) имели место метастазы РПЖ. Из их числа у 25 (48,1% от общего числа случаев) пациентов получены истинно-положительные результаты ПЭТ/КТ с 18F-PSMA-1007. Ложно-положительные находки имели место в 2 случаях. Положительное предсказательное значение метода составило 96,1%. При проведении моновариантного анализа факторов, ассоциированных с истинно положительными результатами ПЭТ/КТ, только уровень степени местной распространенности и сумма Глисона продемонстрировали статистически значимое прогностическое значение (p<0,05). По данным мультивариантного анализа только сумма Глисона была статистически значимо ассоциирована с истинно-положительными находками при ПЭТ/КТ с 18F-PSMA-1007 (р=0,03). Наиболее неблагоприятной в отношении риска выявления метастазов была группа пациентов с суммой Глисона 7 (4+3)-10 (частота метастазов составила 62,2%). Заключение. ПЭТ/КТ с 18F-PSMA-1007 – информативный метод обнаружения метастатического поражения у пациентов с впервые выявленным РПЖ из группы высокого риска прогрессирования. Выполнение ПЭТ/КТ с 18F-PSMA-1007 может быть рекомендовано при значении суммы Глисона 4+3 и выше ввиду высокой вероятности наличия не определяемых стандартными методами регионарных и/или отдаленных метастазов.
Background. Surgical morbidities of radical cystectomy, which are, as a rule, complicated intraabdominal infections, appear to be the main causes of repeated surgeries and fatal outcomes. The elimination of the infection Indus and an-timicrobic therapy are the currently accepted standard of treatment for postoperative peritonitis in cancer urology, as well as in general surgery hospital. Objective: defining the most reasonable option of surgical aid for peritonitis developing after cystectomy. Materials and methods . In the time period from 2000 through 2014, 58 cancer patients with postoperative peritonitis developing after cystectomy received indoor treatment at N.N. Alexandrov Republican Research and Practical Center for Oncology and Medical Radiology. Their mean age was 64.9 years, the range 44-90 years, 53 (91.4 %) of them being male. Primary urinary bladder cancer was present in 51 (87.9 %) patients. Peritoneal infection was microbiologically verified in 57 (98.3 %) patients. Each case of fatal outcome was associated with ineffective treatment of peritonitis. Depending on the intraoperative findings (presence or absence of a hollow organ defect) and the surgical approach undertaken (obstructive resection or operation maintaining the continuity of the intestinal and/or urinary tract), the patients were stratified into three groups: group 1 (n = 28), group 2 (n = 20) and group 3 (n = 10). There were no significant differences in the basic parameters specifying peritoneal infection severity between the patients of groups 1 and 2 vs group 3 (p >0.05). Results. Overall mortality amounted to 25.9 %, 15 patients died. Among the 28 (48.3 %) patients (group 1) who underwent obstructive elimination of the peritonitis focus by means of urointestinal reservoir ablation, resection of small or large intestine with ileo- or colostomy, 6 patients died, mortality 21.4 %. In the 10 (17.2 %) patients (group 3) who succeeded in preserving the urinary conduit or continuity of the bowels by anastomosis defect closure, resection of enteroentero-anastomosis or urointestinal reservoir with repeated anastomosing or defect closure, mortality was higher (60 %) (p = 0.045); 6 patients died. Conclusion. The most effective option of surgical treatment of postoperative peritonitis developing after cystectomy is obstructive reoperation on the bowels and urinary tracts: compared with the intervention consisting in preserving the urinary conduit and/or continuity of the intestinal tract, this type of surgery caused a 2.8-fold lower mortality.
Enterobacteriaceae family microorganisms, specifically E. coli and K. pneumoniae isolates, are the most common activators of postoperative peritonitis in oncology. Many of these microorganisms produce extended-spectrum beta-lactamases (ESBL). The deemed resistance of ESBL-producing enterobacteria to all β-lactam antibiotics, except for carbapenems, leads to ineffectiveness of empiric antibiotic therapy. Purpose of the study: To define the risk factors of peritoneal contamination with ESBL-producing enterobacteria for choosing optimal empirical antibacterial therapy on the example of a specific cancer patient with postoperative peritonitis. Results: Independent risk factors of peritoneal contamination with ESBL-producing enterobacteria included “the administration of antibiotics for more than three days” (OR 106, 95% CI 21.0-537, p<0.001), “two or more relaparotomies” (OR 2.66, 95% CI 1.32-5.34, p =0.006), and “postoperative preventive antibiotic treatment” (OR 0.17, 95% CI 0.04-0.75, p =0.02). The obtained prognostic model allowed predicting the infection with ESBL-producing enterobacteria before establishing the postoperative peritonitis microbial etiology. The model sensitivity was 94.7%, overall predictive accuracy was 73.1. Conclusion: Prolonged administration of antibiotics (3rd-generation cephalosporins and/or fluoroquinolones) after cancer surgery to prevent surgical infections is the main independent risk factor of peritoneal contamination with ESBL- producing enterobacteria.
CMF (Cyclophosphamide 600mg/m2 + Methotrexate 40mg/m2 + Fluorouracil 600mg/m2, IV, day 1 and 8, every 4 weeks) remains a chemotherapeutic modality effective for metastatic triple-negative breast cancer (mTNBC). A plasmid encoding p62/SQTM1 reduces chronic inflammation, changes the tumor microenvironment, and increases the number of tumor-infiltrating lymphocytes. Dosing of the plasmid preserved the lives of 10 out of 11 dogs with breast cancer. In a human phase I/IIa trial, it demonstrated an excellent safety profile and limited cancer progression.
Here we report the first intermediate analysis of a randomized prospective multi-center clinical study aimed to evaluate safety and efficacy of p62/SQTM1-encoding plasmid applied as an adjuvant to chemotherapy in patients with advanced platinum-resistant ovarian cancer. Previously we reported that the p62-plasmid reduces chronic inflammation, changes the tumor microenvironment, and increases the number of tumor-infiltrating lymphocytes. In a phase I/IIa study in patients with refractory solid tumors, the plasmid demonstrated high degree of safety and preliminary indications of efficacy.
The objective of the study was to evaluate the results of Ruthenium-106 (106Ru) + Rhodium-106 (106Rh) brachytherapy in uveal melanoma (UM) patients.The data for the period 2001–2018 were taken from the Belarusian Cancer Registry and medical records of patients with clinically diagnosed uveal melanoma who received treatment at the N. N. Alexandrov National Cancer Centre of Belarus. A total of 383 patients were included in the study. 106Ru + 106Rh β-ophthalmic applicators were used for brachytherapy (BT). The calculated dose to the tumor apex was 120–130 Gy, while the reduced 100–110 Gy was administered to tumors close to the optic nerve. To analyze the treatment outcomes, patients were divided into three groups based on a basal diameter of a tumor.Out of a total 383 patients, complete tumor resolution was observed in 282 (73.6 %), tumor stabilization was present in 76 (19.8 %). Continued tumor growth and tumor relapse were observed in 34 (9.13 %) and 50 (13.05 %) patients, respectively. 59 (15.1 %) patients underwent enucleation. The metastatic disease developed in 47 (12.3 %) cases. BT adverse effects were observed in 21.3 % cases. The relapse-free survival in the group of patients with a basal tumor diameter of up to 9 mm was 76.0 ± 6.3 %, which was higher than that in the groups with a large basal diameter (p = 0.002). Over a 15-year follow-up period, almost half of the patients (52.2 ± 15.6 %) with a tumor base of more than 12 mm relapsed.Considering the high rates of the continued tumor growth during treatment in patients with a basal tumor diameter of more than 12 mm, combined therapy must be used in this group.
The existing standard methods for the diagnosis of prostate cancer (PCa) have reached their limit in the detection of early forms of the disease. Fairly recently a new promising modality of transrectal ultrasound (US) has appeared - shear wave elastography (SWE), allowing to approach the solution of this problem. Objectives. To increase the effectiveness of early diagnosis of PCa by evaluating the data of multiparametric magnetic resonance imaging (MRI), transrectal US with SWE (US-SWE) and systematic biopsy, supplemented by the target stage. Material and methods. The material for the study was 186 patients with suspected PCa who underwent the following diagnostic measures: determination of the level of prostate specific antigen (PSA) isoforms with the calculation of calculated values, multiparametric MRI, transrectal US-SWE, biopsy (n=164) with separate labeling (t=126) and histological examination. Results. Improved reporting system and terminology for data evaluation of transrectal US-SWE with final assessment categories of PCa possibility is presented. A new algorithm for early diagnosis of PCa using ultrasound elastography has been proposed. The incidence of PCa in the group of patients to whom the new diagnostic method [n=126] was applied made up 78/126 (61.9%), out of them GG (grade group of the International Society of Urological Pathology [ISUP]) ≥ 2 was in 39/126 (31.0%), which is better compared to the standard approach. Transrectal US-SWE allowed to identify additionally 13/78 (16.7%) PCa foci in the study group of 126 (10.3%) patients in whom PCa was not visualized on multiparametric MRI, of which GG ≥2 was in 6/13 (46.2%). PCa lesions revealed on transrectal US-SWE were localized mainly in the posterior zones (11/13 [84.6%]). Conclusions. The developed method of early diagnosis of PCa by means of ultrasound SWE is effective and suitable for applying in clinical practice.
Background. There is no unified approach to the management of patients with small choroid melanoma (CM) (thickness up to 3 mm, base diameter up to 10 mm). The study of the development of metastases in these patients is of great significance for choosing an appropriate treatment method.Purpose: to assess the incidence of metastatic disease in patients with small CM, who were treated with transpupillary thermotherapy (TTT), photodynamic therapy (PDT), and brachytherapy (BT).Material and Methods. The retrospective study included 149 patients with CM, who were treated at the National Cancer Center of Belarus from 2005 to 2018. All patients had tumors less than 10 mm in diameter, less than 3 mm in thickness, and had no signs of systemic progression before starting therapy. All tumors corresponded to stage T1N0M0 (American Joint Committee on Cancer (AJCC)). 44 patients were treated with PDT, 47 with TTT, and 58 with BT.Results. The median follow-up time was 154 months (12 years) in patients treated with brachytherapy, 128 months (10 years) in patients treated with TTT and 72 months (6 years) in patients treated with PDT. During the follow-up period, metastases were observed in 1 (2.3 %) patient after PDT and in 5 (10.6 %) patients after TTT. In patients treated with BT, systemic progression was not recorded during the follow-up period. All cases of metastatic disease were associated with local recurrence or continued growth of CM.Discussion. The 5-year metastasis-free survival after TTT was worse than after PDT (82 ± 8.0 % and 94 ± 6.0 %, respectively, p<0.0001). However, in some cases, preference can be given to laser treatment methods, allowing the patients to avoid post-radiation retinopathies. The lack of local control of the tumor can be considered a surrogate marker for the development of metastatic disease. Conclusion. The highest metastasis-free rates were observed after brachytherapy. Positron emission tomography is recommended for early detection of systemic progression of the disease. Key words: choroid melanoma, uveal melanoma, transpupillary thermotherapy, photodynamic therapy, brachytherapy, metastatic-free survival, organ-preserving treatment.>˂0.0001). However, in some cases, preference can be given to laser treatment methods, allowing the patients to avoid post-radiation retinopathies. The lack of local control of the tumor can be considered a surrogate marker for the development of metastatic disease.Conclusion. The highest metastasis-free rates were observed after brachytherapy. Positron emission tomography is recommended for early detection of systemic progression of the disease.