Use of docetaxel in low- and high-burden metastatic hormone-sensitive prostate cancer: A systematic review and assessment of subgroup analyses

2021 ◽  
Vol 27 (7) ◽  
pp. 1743-1750
Author(s):  
Manuel David Gil-Sierra ◽  
Emilio Jesus Alegre-del Rey ◽  
Catalina Alarcon de la Lastra-Romero ◽  
Marina Sánchez-Hidalgo
Keyword(s):  
Prostate Cancer ◽  
Systematic Review ◽  
Clinical Trials ◽  
Metastatic Disease ◽  
Subgroup Analysis ◽  
Randomised Clinical Trial ◽  
Randomised Clinical Trials ◽  
High Burden ◽  
Subgroup Analyses ◽  
Hormone Sensitive

Background Use of docetaxel in low- and high-burden metastatic hormone-sensitive prostate cancer presents considerable controversy. There is literature suggesting lack of benefit for low-volume of metastases. Objective The study aims to develop a systematic review and methodological assessment of subset analysis about use of docetaxel in metastatic hormone-sensitive prostate cancer regarding volume of metastatic disease. Methods A systematic review in the Pubmed® database was conducted up to 25 September 2020. A reference tracking was also developed. Randomised clinical trials with subgroup analysis according volume of metastatic disease for overall survival were selected. Two methodologies were used. One of them considered statistical interaction of subsets ( p(i) < 0.1), pre-specification, biological plausibility and consistency among subset results of similar randomised clinical trials. The second methodology was a two-part validated tool: preliminary questions to discard subset analysis without minimal relevance and a checklist The checklist provides recommendations for applicability of subgroup analysis in clinical practice. Results A total of 31 results were found in systematic reviews in the Pubmed® database. One result was identified in the reference tracking. Of the total of 32 results, four randomised clinical trials were included in the study. About first methodology, statistical interaction among subgroups was obtained in one randomised clinical trial. Subgroup analysis was pre-specified in two randomised clinical trials. Biological plausibility was reasonable. No external consistency among results of subgroup analyses in randomised clinical trials was observed. Preliminary questions of second methodology rejected applicability of subgroup analysis in three randomised clinical trials. A ‘null’ recommendation for applicability of subset results was obtained in the remaining randomised clinical trial. Conclusions Patients with low- and high-burden metastatic hormone-sensitive prostate cancer would benefit from docetaxel therapy. No consistent differences for overall survival were observed in subgroup analyses regarding volume of metastatic disease.

scholarly journals A systematic review of subgroup analyses in randomised clinical trials in cardiovascular disease

2021 ◽  
pp. 174077452098486
Author(s):  
Korbinian J Brand ◽  
Alexander Hapfelmeier ◽  
Bernhard Haller
Keyword(s):  
Systematic Review ◽  
Cardiovascular Disease ◽  
Clinical Trials ◽  
England Journal ◽  
New England ◽  
Statistical Significance ◽  
Randomised Clinical Trials ◽  
Primary Analysis ◽  
Subgroup Analyses ◽  
Trial Protocols

Background: Subgroup analyses are frequently used to assess heterogeneity of treatment effects in randomised clinical trials. Inconsistent, improper and incomplete implementation, reporting and interpretation have been identified as ongoing challenges. Further, subgroup analyses were frequently criticised because of unreliable or potentially misleading results. More recently, recommendations and guidelines have been provided to improve the reporting of data in this regard. Methods: This systematic review was based on a literature search within the digital archives of three selected medical journals, The New England Journal of Medicine, The Lancet and Circulation. We reviewed articles of randomised clinical trials in the domain of cardiovascular disease which were published in 2015 and 2016. We screened and evaluated the selected articles for the mode of implementation and reporting of subgroup analyses. Results: We were able to identify a total of 130 eligible publications of randomised clinical trials. In 89/130 (68%) articles, results of at least one subgroup analysis were presented. This was dependent on the considered journal (p < 0.001), the number of included patients (p < 0.001) and the lack of statistical significance of a trial’s primary analysis (p < 0.001). The number of reported subgroup analyses ranged from 1 to 101 (median = 13). We were able to comprehend the specification time of reported subgroup analyses for 71/89 (80%) articles, with 55/89 (62%) articles presenting exclusively pre-specified analyses. This information was not always traceable on the basis of provided trial protocols and often did not include the pre-definition of cut-off values for the categorization of subgroups. The use of interaction tests was reported in 84/89 (94%) articles, with 36/89 (40%) articles reporting heterogeneity of the treatment effect for at least one primary or secondary trial outcome. Subgroup analyses were reported more frequently for larger randomised clinical trials, and if primary analyses did not reach statistical significance. Information about the implementation of subgroup analyses was reported most consistently for articles from The New England Journal of Medicine, since it was also traceable on the basis of provided trial protocols. We were able to comprehend whether subgroup analyses were pre-specified in a majority of the reviewed publications. Even though results of multiple subgroup analyses were reported for most published trials, a corresponding adjustment for multiple testing was rarely considered. Conclusion: Compared to previous reviews in this context, we observed improvements in the reporting of subgroup analyses of cardiovascular randomised clinical trials. Nonetheless, critical shortcomings, such as inconsistent reporting of the implementation and insufficient pre-specification, persist.

Dietary supplements and prostate cancer: a systematic review of double-blind, placebo-controlled randomised clinical trials

Maturitas ◽  
2013 ◽  
Vol 75 (2) ◽  
pp. 125-130 ◽  
Author(s):  
Paul Posadzki ◽  
Myeong Soo Lee ◽  
Igho Onakpoya ◽  
Hye Won Lee ◽  
Byong Seob Ko ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Systematic Review ◽  
Clinical Trials ◽  
Dietary Supplements ◽  
Randomised Clinical Trials ◽  
Double Blind ◽  
Double Blind Placebo

DNA damage repair gene mutation testing and genetic counseling in men with/without prostate cancer: a systematic review

2020 ◽  
Author(s):  
Nigel Armstrong ◽  
Ruben GW Quek ◽  
Steve Ryder ◽  
Janine Ross ◽  
Titas Buksnys ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Systematic Review ◽  
At Risk ◽  
Dna Damage ◽  
Clinical Trials ◽  
Genetic Counseling ◽  
Mutation Screening ◽  
Dna Damage Repair ◽  
Mutation Testing ◽  
Damage Repair

Background: Ongoing clinical trials are investigating poly(ADP-ribose) polymerase (PARP) inhibitors to target the DNA damage repair (DDR) pathway in prostate cancer. DDR mutation screening will guide treatment strategy and assess eligibility for clinical trials. Materials & methods: This systematic review estimated the rate of DDR mutation testing or genetic counseling among men with or at risk of prostate cancer. Results: From 6856 records, one study fulfilled the inclusion criteria and described men undiagnosed with prostate cancer with a family history of BRCA1/2 mutation who received DDR mutation testing. Conclusion: With only one study included in this first systematic review of DDR mutation testing or genetic counseling in men with or at risk of prostate cancer, more research is warranted.

Anthroposophical Medicine: A systematic review of randomised clinical trials

2004 ◽  
Vol 116 (11-12) ◽  
pp. 407-408 ◽  
Author(s):  
Gunver S. Kienle ◽  
Harald J. Hamre ◽  
Helmm Kiene
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomised Clinical Trials ◽  
Anthroposophical Medicine

scholarly journals Diagnostic Role of 18F-PSMA-1007 PET/CT in Prostate Cancer Staging: A Systematic Review

Diagnostics ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 552
Author(s):  
Salam Awenat ◽  
Arnoldo Piccardo ◽  
Patricia Carvoeiras ◽  
Giovanni Signore ◽  
Luca Giovanella ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Systematic Review ◽  
Diagnostic Accuracy ◽  
Metastatic Disease ◽  
Cancer Staging ◽  
Relevant Information ◽  
Cochrane Library ◽  
Number Of Patients ◽  
Pet Ct

Background: The use of prostate-specific membrane antigen (PSMA)-targeted agents for staging prostate cancer (PCa) patients using positron emission tomography/computed tomography (PET/CT) is increasing worldwide. We performed a systematic review on the role of 18F-PSMA-1007 PET/CT in PCa staging to provide evidence-based data in this setting. Methods: A comprehensive computer literature search of PubMed/MEDLINE and Cochrane Library databases for studies using 18F-PSMA-1007 PET/CT in PCa staging was performed until 31 December 2020. Eligible articles were selected and relevant information was extracted from the original articles by two authors independently. Results: Eight articles (369 patients) evaluating the role of 18F-PSMA-1007 PET/CT in PCa staging were selected. These studies were quite heterogeneous, but, overall, they demonstrated a good diagnostic accuracy of 18F-PSMA-1007 PET/CT in detecting PCa lesions at staging. Overall, higher primary PCa aggressiveness was associated with higher 18F-PSMA-1007 uptake. When compared with other radiological and scintigraphic imaging methods, 18F-PSMA-1007 PET/CT had superior sensitivity in detecting metastatic disease and the highest inter-reader agreement. 18F-PSMA-1007 PET/CT showed similar results in terms of diagnostic accuracy for PCa staging compared with PET/CT with other PSMA-targeted tracers. Dual imaging with multi-parametric magnetic resonance imaging and 18F-PSMA-1007 PET/CT may improve staging of primary PCa. Notably, 18F-PSMA-1007-PET/CT may detect metastatic disease in a significant number of patients with negative standard imaging. Conclusions: 18F-PSMA-1007 PET/CT demonstrated a good accuracy in PCa staging, with similar results compared with other PSMA-targeted radiopharmaceuticals. This method could substitute bone scintigraphy and conventional abdominal imaging for PCa staging. Prospective multicentric studies are needed to confirm these findings.

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