Major Complications and Adverse Events Related to the Injection of the SpaceOAR Hydrogel System Before Radiotherapy for Prostate Cancer: Review of the Manufacturer and User Facility Device Experience Database

2019 ◽  
Vol 33 (10) ◽  
pp. 868-871 ◽  
Author(s):  
Alireza Aminsharifi ◽  
Srinath Kotamarti ◽  
David Silver ◽  
Ariel Schulman
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Major Complications ◽  
Cancer Review ◽  
User Facility ◽  
Spaceoar Hydrogel ◽  
Hydrogel System

Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Quality Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

scholarly journals Predictors of complications occurring after open and robot-assisted prostate cancer surgery: a retrospective evaluation of 1062 consecutive patients treated in a tertiary referral high volume center

2021 ◽  
Author(s):  
Antonio Benito Porcaro ◽  
Alessandro Tafuri ◽  
Riccardo Rizzetto ◽  
Nelia Amigoni ◽  
Marco Sebben ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Postoperative Complications ◽  
Radical Prostatectomy ◽  
Blood Loss ◽  
Open Approach ◽  
Intraoperative Blood Loss ◽  
Tertiary Referral ◽  
Robot Assisted ◽  
The Third ◽  
Major Complications

AbstractTo investigate factors associated with the risk of major complications after radical prostatectomy (RP) by the open (ORP) or robot-assisted (RARP) approach for prostate cancer (PCa) in a tertiary referral center. 1062 consecutive patients submitted to RP were prospectively collected. The following outcomes were addressed: (1) overall postoperative complications: subjects with Clavien-Dindo System (CD) one through five versus cases without any complication; (2) moderate to major postoperative complications: cases with CD < 2 vs.  ≥ 2, and 3) major post-operative complications: subjects with CDS CD ≥  3 vs.  < 3. The association of pre-operative and intra-operative factors with the risk of postoperative complications was assessed by the logistic regression model. Overall, complications occurred in 310 out of 1062 subjects (29.2%). Major complications occurred in 58 cases (5.5%). On multivariate analysis, major complications were predicted by PCa surgery and intraoperative estimated blood loss (EBL). ORP compared to RARP increased the risk of major CD complications from 2.8 to 19.3% (OR = 8283; p < 0.0001). Performing ePLND increased the risk of major complications from 2.4 to 7.4% (OR = 3090; p < 0.0001). Assessing intraoperative blood loss, the risk of major postoperative complications was increased by BL above the third quartile when compared to subjects with intraoperative blood loss up to the third quartile (10.2% vs. 4.6%; OR = 2239; 95%CI: 1233–4064). In the present cohort, radical prostatectomy showed major postoperative complications that were independently predicted by the open approach, extended lymph-node dissection, and excessive intraoperative blood loss.

scholarly journals Hypofractionated radiotherapy versus conventional radiotherapy in patients with intermediate- to high-risk localized prostate cancer: a meta-analysis of randomized controlled trials

BMC Cancer ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Wei Guo ◽  
Yun-Chuan Sun ◽  
Jian-Qiang Bi ◽  
Xin-Ying He ◽  
Li Xiao
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Localized Prostate Cancer ◽  
Hypofractionated Radiotherapy ◽  
Cancer Specific Survival ◽  
Conventional Radiotherapy ◽  
Results Of Treatment

Abstract Background Prostate cancer is one of the most common cancers in the world. The results of treatment after hypofractionated radiotherapy only have been reported from several small randomized clinical trials. Therefore, we conducted a meta-analysis to compare clinical outcomes of hypofractionated radiotherapy versus conventional radiotherapy in the treatment of intermediate- to high-risk localized prostate cancer. Methods Relevant studies were identified through searching related databases till August 2018. Hazard ratio (HR) or risk ratio (RR) with its corresponding 95% confidence interval (CI) was used as pooled statistics for all analyses. Results The meta-analysis results showed that overall survival (HR = 1.12, 95% CI: 0.93–1.35, p = 0.219) and prostate cancer-specific survival (HR = 1.29, 95% CI: 0.42–3.95, p = 0.661) were similar in two groups. The pooled data showed that biochemical failure was RR = 0.90, 95% CI: 0.76–1.07, p = 0.248. The incidence of acute adverse gastrointestinal events (grade ≥ 2) was higher in the hypofractionated radiotherapy (RR = 1.70, 95% CI: 1.12–2.56, p = 0.012); conversely, for late grade ≥ 2 gastrointestinal adverse events, a significant increase in the conventional radiotherapy was found (RR = 0.75, 95% CI: 0.61–0.91, p = 0.003). Acute (RR = 1.01, 95% CI: 0.89–1.15, p = 0.894) and late (RR = 0.98, 95% CI: 0.86–1.10, p = 0.692) genitourinary adverse events (grade ≥ 2) were similar for both treatment groups. Conclusion Results suggest that the efficacy and risk for adverse events are comparable for hypofractionated radiotherapy and conventional radiotherapy in the treatment of intermediate- to high-risk localized prostate cancer.

scholarly journals Adverse Events in Total Ankle Arthroplasty, Analysis of the FDA Medical and User Facility Device Experience Database

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0028
Author(s):  
Karim Mahmoud ◽  
Sreenivasulu Metikala ◽  
Kathryn O’Connor ◽  
Daniel Farber
Keyword(s):  
Adverse Events ◽  
Aseptic Loosening ◽  
Mandatory Reporting ◽  
Total Ankle Replacement ◽  
Total Ankle Arthroplasty ◽  
Ankle Arthritis ◽  
Ankle Arthroplasty ◽  
Ankle Replacement ◽  
Mode Of Failure ◽  
User Facility

Category: Ankle Arthritis Introduction/Purpose: Total ankle replacement has become a popular treatment option for end stage ankle arthritis. Most of the reports of adverse events following total ankle replacement have been from high volume institutions and are subject to either observational or selection bias as well as potential under-reporting as they do not include the experience of community and lower volume centers and surgeons. The FDA’s Medical and User Facility Device Experience (MAUDE) Database provides a more complete scope of adverse events due to the mandatory reporting requirements by the FDA of implant manufactures. We reviewed the database to identify the common modes of failure and complications of total ankle implants Methods: We retrospectively reviewed reports of the MAUDE database from November 2011 to September 2018 regarding all total ankle implants. Each device in the MAUDE database is classified with a 3-letter code, we identified the 2 codes assigned to total ankle arthroplasty devices, and manually searched the FDA’s published Device Classification list for adverse events. All events were reviewed and classified. Data related to patient age or sex, surgeon, medical center location are not available in the database Results: We identified 1000 adverse reports in the period between November 2011 and September 2018. After exclusion of duplicate reports for single events or reports irrelevant to total ankle arthroplasty, a total of 697 adverse event reports were noted. The most common mode of failure was aseptic loosening (21%), followed by infection (16%), alignment and mechanical issues (instability, malalignment, malposition, stiffness, impingement) (15%), implantation issues (pin, screw or drill breakage, alignment guide problems) (9%), polyethylene related problems (wear, displaced or fractured implants) (7%), bony and soft tissue overgrowth (6%), and peri-prosthetic fractures (5%). Conclusion: Our analysis reveals that the most reported mode of failure was aseptic loosening followed by infection. However, it is notable that there are a significant number of issues with implant alignment and mechanics, complications during implantation and polyethylene component failure that are under-reported in the literature. Knowledge of these adverse events may help surgeons avoid similar complications as well as lead to improvement in component implantation and design

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