An Efficacy and Safety Comparison of Regorafenib and Nivolumab in Unresectable Hepatocellular Cancer Patients: A Systematic Review.

OBJECTIVE: This systematic review aimed to compare the efficacy and safety of regorafenib and nivolumab, two FDA-approved second-line treatments for unresectable Hepatocellular Carcinoma (HCC). METHODS: Literature comparing the efficacy and safety of regorafenib and nivolumab in unresectable HCC patients was systematically searched across seven databases, including: PubMed, SCOPUS, Cochrane Database of Systematic Reviews, ScienceDirect, EBSCOhost, EMBASE, and ProQuest, using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. The search was done on April 2nd, 2023. Study quality and risk of bias were assessed using the Agency for Healthcare Research and Quality (AHRQ) and ROBINS-1 tools. The selected studies were included in the qualitative data synthesis. RESULTS: Three trials found that HCC patients taking nivolumab had statistically insignificantly longer OS, TTP, and progression-free survival than those on regorafenib. Nivolumab increased ORR, with largely partial responses, and mixed DCR, with little statistical significance. All three studies showed that nivolumab had fewer side effects and improved tolerance. DISCUSSION: Three retrospective cohort studies with a total of 383 regorafenib-receiving cohorts and 230 nivolumab-receiving cohorts were included in the qualitative analysis. Nivolumab was found to be superior in regards of longer overall survival, longer time to progression, higher objective response rate, and lower adverse event occurrence. However, statistical significance was not achieved in most of the parameters. CONCLUSIONS: The use of nivolumab is preferable as the second-line systemic therapy for unresectable HCC. More high-quality studies are urgently needed to generate quantitative analysis, and to encourage the formation of guidelines for second-line systemic therapy.

SARS-CoV-2 RT-LAMP in saliva: enhancing the results via a combination of cooling and specimen dilution procedure.

Colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP) is a potential and relatively simple rapid diagnostics method for COVID-19 detection. This study aims to evaluate and optimize the RT-LAMP performance on saliva specimens based on a commercially available kit.Modifications on an established protocol (Protocol A) were used, including Proteinase K supplementation (Protocol B); pre-treatment using nuclease-free water and proteinase K (Protocol C); Saliva cooling (Protocol D); saliva dilution after pre-treatment (Protocol E); lastly a combination of saliva cooling and dilution (Protocol F). Protocol performances were evaluated by comparing success rates (SR), diagnostic accuracy (DA), sensitivity, specificity, and predictive values. Additionally, a correlation between the Ct value by RT-qPCR and RT-LAMP performance was analyzed.. A total of 106 specimens were used in this study. Protocols B and C showed 100% unreadable results, therefore were paused. Protocol F showed the highest SR (87.65%) compared to other protocols, with a slight compromise to DA (81.69%), sensitivity (57.14%), specificity (97.67%), PPV (94.12%), and NPV (77.78%). In the sub-analysis of the low Ct value group (Ct < 30), Protocol F demonstrated a higher success rate (86.57%) compared to protocol A (64.18%); increased 3.08% sensitivity and 2.42% NPV; comparable DA; minor reduction in specificity (A = 100%; F = 97.67%) and PPV (A = 100%; F = 92.31%). A combination of saliva cooling-dilution substantially increased the tested kit's success rate, despite a slight decrease in specificity and PPV. Findings confirmed the saliva cooling-dilution procedure was beneficial to the test's SR, sensitivity, and NPV in the low Ct value group. Supplementary Information: The online version contains supplementary material available at 10.1007/s13337-024-00870-1.