Outcomes of sorafenib treatment of advanced renal cell carcinoma according to International Metastatic Renal Cell Carcinoma Data Consortium risk criteria: analysis of Japanese real-world data from postmarketing all-patient surveillance of sorafenib

Aim: To assess sorafenib survival outcomes in renal cell carcinoma patients using standard International Metastatic Renal Cell Carcinoma Data Consortium (IMDC) risk criteria. Patients & methods: The authors restratified a real-world cohort of 3255 advanced renal cell carcinoma patients, obtained from Japanese sorafenib postmarketing surveillance, to assess survival outcomes using IMDC criteria; intermediate risk was subdivided into Int-1 and Int-2 (one and two risk factors, respectively). Results: Overall, 2225 (68%) IMDC-evaluable patients were reclassified as favorable (17%), intermediate (62%) and poor (21%) risk, with median progression-free survival of 10.4, 8.1 and 3.4 months, respectively. Int-1 (36%) and Int-2 (26%) subgroups had median progression-free survival of 10.1 and 6.0 months, respectively. Sorafenib had acceptable safety/tolerability. Conclusion: Sorafenib effectiveness was promising for IMDC intermediate risk, particularly Int-1, warranting further investigation.

Immediate results of surgical treatment of high and intermediate risk pulmonary embolism in elderly and senile patients

The aim of the study: is to analyze the immediate results of surgical treatment of high-and intermediate-risk PE in a group of elderly and senile patients. Material and methods. The study included 43 patients operated on for high-and intermediate-risk pulmonary embolism between 2008 and 2019. In the general group of patients, the number of women prevailed and amounted to 67.4%. The average age was 65.4 ± 4.23 years old. The Miller index in the general group was 29.1 ± 1.42. The Geneva Index was 8.4 ± 1.12. The average pressure in the pulmonary artery at the time of operation was 54 ± 1.4 mm Hg, and the peak pressure was 68 ± 3.43 mm Hg. Results. 5 patients died at the hospital stage. Thus, the hospital survival rate of patients was 88.4%. Among nonlethal complications, cardiovascular and respiratory failure prevailed. According to the statement, the calculated pressure gradient in the pulmonary artery was 29.0 ± 3.1 mm Hg. Conclusion. Surgical treatment is a highly eff ective and reliable method of treatment in the group of older patients.

Shear Wave Elastography and Thyroid Imaging Reporting and Data System (TIRADS) for the Risk Stratification of Thyroid Nodules—Results of a Prospective Study

Purpose: To compare the diagnostic performance of thyroid imaging reporting and data system (TIRADS) in combination with shear wave elastography (SWE) for the assessment of thyroid nodules. Methods: A prospective study was conducted with the following inclusion criteria: preoperative B-mode ultrasound (US) including TIRADS classification (Kwak-TIRADS, EU-TIRADS), quantitative SWE and available histological results. Results: Out of 43 patients, 61 thyroid nodules were detected; 10 nodules were found to be thyroid cancer (7 PTC, 1 FTC, 2 HüCC) and 51 were benign. According to Kwak-TIRADS the majority of benign nodules (47 out of 51, 92.2%) were classified in the low-risk- and intermediate-risk class, four nodules were classified as high-risk (7.8%). When using EU-TIRADS, the benign nodules were distributed almost equally across all risk classes, 21 (41.2%) nodules were classified in the low-risk class, 16 (31.4%) in the intermediate-risk class and 14 (27.4%) in the high-risk class. In contrast, most of the malignant nodules (eight out of ten) were classified as high-risk on EU-TIRADS. One carcinoma was classified as low-risk and one as intermediate-risk nodule. For SWE, ROC analysis showed an optimal cutoff of 18.5 kPa to distinguish malignant and benign nodules (sensitivity 80.0%, specificity 49.0%, PPV 23.5% and NPV 92.6%). The addition of elastography resulted in an increase of accuracy from 65.6% to 82.0% when using Kwak-TIRADS and from 49.2% to 72.1% when using EU-TIRADS. Conclusion: Our data demonstrate that the combination of TIRADS and SWE seems to be superior for the risk stratification of thyroid nodules than each method by itself. However, verification of these results in a larger patient population is mandatory.

Significance of upfront cytoreductive nephrectomy stratified by IMDC risk for metastatic renal cell carcinoma in targeted therapy era – a multi-institutional retrospective study

Background This retrospective multicenter study aimed to evaluate the survival benefit of upfront cytoreductive nephrectomy (CN) in metastatic renal cell carcinoma (RCC) patients stratified by International Metastatic RCC Database Consortium (IMDC) risk criteria. Methods We reviewed the medical records in the Michinoku Database between 2008 and 2019. Patients who received upfront CN, systemic therapy without CN (no CN) and CN after drug therapy (deferred CN) were analyzed. To exclude selection bias due to patient characteristics, baseline clinical data were adjusted by inverse probability of treatment weighting (IPTW). Overall survival (OS) was compared between upfront CN and non-upfront CN (no CN plus deferred CN). Associations between time-varying covariates including systemic therapies and OS stratified by IMDC risk criteria were analyzed by IPTW-adjusted Cox regression method. Results Of 259 patients who fulfilled the selection criteria, 107 were classified in upfront CN and 152 in non-upfront CN group. After IPTW-adjusted analysis, upfront CN showed survival benefit compared to non-upfront CN in patients with IMDC intermediate risk (median OS: 52.5 versus 31.3 months, p < 0.01) and in patients with IMDC poor risk (27.2 versus 11.4 months, p < 0.01). In IPTW-adjusted Cox regression analysis of time-varying covariates, upfront CN was independently associated with OS benefit in patients with IMDC intermediate risk (hazard ratio 0.52, 95% confidence interval 0.29–0.93, p = 0.03) and in patients with IMDC poor risk (0.26, 0.11–0.59, p < 0.01). Conclusions Upfront CN may confer survival benefit in RCC patients with IMDC intermediate and poor risk.

Laboratory risk indicator for necrotizing fasciitis: an objective scoring system as a tool for early diagnosis of necrotizing fasciitis

Background: Necrotizing soft tissue infections are often fatal, characterized by extensive necrosis of the subcutaneous tissues and fascia. The mortality of 30-40% reflects the inadequacy of early recognition of necrotizing soft tissue infections. This study emphasizes on the search for a tool that reliably and rapidly identifies patients with NF. An objective of current study was to validate the LRINEC score as a tool for early distinguishing of necrotizing fasciitis from other soft tissue infections.Methods: Prospective clinical study analysis of outcome of sixty of patients with soft tissue infections were evaluated based on LRINEC. Based on their LRINEC score, the patients were categorized as low, intermediate and high risk for the onset of necrotizing fasciitis.Results: A total of 60 patients with soft tissue infections were prospectively evaluated and categorized on the basis of LRINEC score 45 patients in low risk category, 7 in Intermediate risk and 8 patients in high risk group. In terms of outcome, all cases (including positive tissue diagnosis cases) in low risk and intermediate risk groups and 2 cases in high risk group were improved with surgical debridement/fasciotomy. The cutoff of LRINEC ≥6 has better sensitivity and specificity in identifying the risk of the patient.Conclusions: LRINEC scoring system has a better positive predictive value in identifying the onset and risk strategizing of necrotizing fasciitis.

Iodine-125 brachytherapy and robotic stereotactic radiotherapy — treatment options for patients with localized prostate cancer

Introduction. Modern radiological treatment options for patients with localized prostate cancer (PCa) have several advantages and allow achieving high rates of biochemical control.Purpose of the study. To compare immediate, proximate, and long-term results of low-dose Iodine-125 brachytherapy (I-125 BT) and robotic stereotactic radiotherapy (SBRT) in patients with localized low- and intermediate-risk PCa.Materials and methods. The study included 296 patients with localized low- and intermediate-risk PCa. I-125 BT and SBRT were performed in 208 and 88 patients, respectively. All patients with an intermediate-risk PCa were prescribed neoadjuvant androgen-deprivation therapy (NADT) with luteinizing hormone-releasing hormone analogues (LHRH) for 4-6 months. Only radiation treatment was used for low-risk PCa. As a result, two groups and four subgroups of patients were formed depending on the treatment method. The immediate, proximate, and long-term results of radiation treatment methods were studied in groups and subgroups.Results. No complications were recorded during brachytherapy I-125. Radiation cystitis grade 1 and radiation rectitis grade 1 were diagnosed after SBRT in 16.6% and 4.0% of cases, respectively. In the only I-125 BT subgroup, the PSA level during the year decreased from 8.3 to 1.1 ng/ml, in the SBRT subgroup — from 7.5 to 0.8 ng/ml. In the case of combined treatment, PSA decreased from 1.2 to 0.93 ng/ml and from 4.5 to 0.5 ng/ml, respectively. Changes in prostate volume, residual volume, and urinary quality (I-PSS) were comparable in all subgroups. Five-year cancer-specific survival and overall survival in the group of patients after SBRT was 100%, after I-125 BT — more than 90%.Conclusion. Radiation treatment options for patients with localized PCa are safe. Conducting NADT does not significantly reduce the prostate volume and does not affect the indicators of urodynamics. High rates of cancer-specific five-year survival rate testify to the effectiveness of the evaluated treatment options.