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Cancer Medicine Jul 2023To assess the impact of primary-site surgery plus systemic therapy compared to systemic therapy alone on overall survival in common metastatic cancer types. (Meta-Analysis)
Meta-Analysis
PURPOSE
To assess the impact of primary-site surgery plus systemic therapy compared to systemic therapy alone on overall survival in common metastatic cancer types.
METHODS
Data sources included Embase, PubMed, and Web of Science (January 1, 1995-March 22, 2023). Randomized controlled trials were included that enrolled patients diagnosed with the 10 most common de novo metastatic cancer types in the Surveillance, Epidemiology, and End Results database and randomized patients to resection of the primary site and systemic therapy versus systemic treatment alone. Random-effects models were used to pool associations by cancer type.
RESULTS
Eight studies with 1774 patients evaluating the efficacy of surgery in breast, renal, stomach, and colorectal cancer were included. There was no statistically significant reduction in risk of all-cause mortality associated with surgical intervention for metastatic breast (HR = 0.94, 95% CI 0.63-1.40) or renal cancer (HR = 0.79, 95% CI 0.53-1.20), although results were heterogeneous (I = 73.7% and 80.6%, respectively). One study evaluating gastrectomy in metastatic stomach cancer found no benefit (HR = 1.09, 95% CI 0.78-1.52), while a small trial suggested that surgery and hyperthermic intraperitoneal chemotherapy might be beneficial for colorectal cancer with peritoneal metastasis (HR = 0.55, 95% CI 0.32-0.95).
CONCLUSIONS
Few randomized trials have evaluated cancer-directed surgery among patients with metastatic solid malignancies.
Topics: Humans; Stomach Neoplasms; Colorectal Neoplasms
PubMed: 37309837
DOI: 10.1002/cam4.6061 -
Oncology 2023Therapy-related leukemia is a term that describes the occurrence of leukemia following exposure to hematotoxins and radiation to emphasize the difference from leukemia... (Review)
Review
BACKGROUND
Therapy-related leukemia is a term that describes the occurrence of leukemia following exposure to hematotoxins and radiation to emphasize the difference from leukemia that arises de novo. Many agents and host factors contribute to this entity of leukemias. Therapy-related acute myeloid leukemia has an extensive literature review in contrast to therapy-related chronic myeloid leukemia (t-CML). Radioactive iodine (RAI), an established agent in the management of differentiated thyroid carcinomas, has raised concern due to its possible carcinogenic effects.
SUMMARY
In this article, we reviewed all the reports from the 1960s to date related to t-CML following RAI on Google Scholar and PubMed. We have identified 14 reports and found that most reports were for men under the age of 60 years with primary papillary thyroid carcinoma and mixed follicular-papillary thyroid carcinoma who developed t-CML mainly between 4 and 7 years after exposure to varying doses of I131. However, the mean dose was 287.78 millicuries (mCi). It was reported that a statistically significant increase in leukemia following RAI therapy (relative risk of 2.5 for I131 vs. no I131). Also, there was a linear relationship between the cumulative dose of I131 and the risk of leukemia. Doses higher than 100 mCi were associated with a greater risk of developing secondary leukemia, and most of the leukemias developed within the initial 10 years of exposure. The precise mechanism through which RAI provokes leukemia is largely unclear. A few mechanisms have been proposed.
KEY MESSAGES
Although the risk for t-CML appears to be low based on current reports and does not represent a contraindication to RAI therapy, it should not be disregarded. We suggest including it in the risk-benefit discussion before initiating this therapy. Long-term follow-up for patients is advisable for those who received doses over 100 mCi with a complete blood count, possibly yearly, for the first 10 years. The new onset of significant leukocytosis post RAI exposure should raise the suspicion for t-CML. Further studies are needed to establish or refute a causal relationship.
Topics: Male; Humans; Middle Aged; Thyroid Neoplasms; Iodine Radioisotopes; Thyroid Cancer, Papillary; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Risk Assessment
PubMed: 37231874
DOI: 10.1159/000530463 -
Cureus Apr 2023Sickle cell disease (SCD) is an inherited disorder that impairs red blood cells (RBCs) and disrupts the delivery of oxygen to tissues. There is currently no cure.... (Review)
Review
Sickle cell disease (SCD) is an inherited disorder that impairs red blood cells (RBCs) and disrupts the delivery of oxygen to tissues. There is currently no cure. Symptoms can appear as early as six months of age and include anemia, acute episodes of pain, swelling, infections, delayed growth, and vision problems. A growing number of therapies are being investigated for reducing these episodes of pain, also known as vaso-occlusive crises (VOCs). The research literature evidence, however, currently includes far more approaches that have not shown superiority versus placebo than ones that have been proven effective. The purpose of this systematic review is to evaluate the body of randomized controlled trials (RCTs) to determine the quality of support for and against the use of a variety of current and emerging therapies for treading SCD VOCs. Several important new papers have emerged since previous systematic reviews with similar objectives were published. This review was conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and focused on PubMed exclusively. Only RCTs were sought, and no other filters, except for a five-year historical timeline cut-off, were used. Of the 46 publications that were returned in response to the query, 18 were ultimately accepted as meeting the pre-established inclusion criteria. The Cochrane risk-of-bias tool was utilized as a quality assessment measure, and the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) framework was used to assess the certainty of the evidence. Among the included publications, five out of 18 featured positive results with superiority and statistical significance versus placebo for either reduction in pain score or number/duration of VOCs. The approaches featured therapies ranging from de novo molecules to currently available drugs approved for other indications to naturally occurring metabolites such as amino acids and vitamins. A single therapy, arginine, was supported for both clinical endpoints: pain score reduction and shortened VOC duration. Currently, two therapies are approved by the United States Food and Drug Administration (FDA) and are commercially available (crizanlizumab, ADAKVEO and L-glutamine, Endari). All other therapies are investigational only in nature. Several studies included measurement of biomarker endpoints as well as clinical outcomes. Generally, beneficial outcomes related to improving biomarker levels did not also translate into statistically significant reduction of pain scores or number/duration of VOCs. While measuring biomarkers may contribute to the understanding of pathophysiology, it does not appear to directly offer predictive value toward treatment success clinically. It can be concluded that there exists a specific opportunity to design, fund, and execute investigations that both compare emerging and existing therapies versus one another and compare combinational therapies versus placebo.
PubMed: 37223201
DOI: 10.7759/cureus.38014 -
Health Technology Assessment... May 2023Early evidence suggests that using radiofrequency ablation as an adjunct to standard care (i.e. endoscopic retrograde cholangiopancreatography with stenting) may improve... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Early evidence suggests that using radiofrequency ablation as an adjunct to standard care (i.e. endoscopic retrograde cholangiopancreatography with stenting) may improve outcomes in patients with malignant biliary obstruction.
OBJECTIVES
To assess the clinical effectiveness, cost-effectiveness and potential risks of endoscopic bipolar radiofrequency ablation for malignant biliary obstruction, and the value of future research.
DATA SOURCES
Seven bibliographic databases, three websites and seven trials registers were searched from 2008 until 21 January 2021.
REVIEW METHODS
The study inclusion criteria were as follows: patients with biliary obstruction caused by any form of unresectable malignancy; the intervention was reported as an endoscopic biliary radiofrequency ablation to ablate malignant tissue that obstructs the bile or pancreatic ducts, either to fit a stent (primary radiofrequency ablation) or to clear an obstructed stent (secondary radiofrequency ablation); the primary outcomes were survival, quality of life or procedure-related adverse events; and the study design was a controlled study, an observational study or a case report. Risk of bias was assessed using Cochrane tools. The primary analysis was meta-analysis of the hazard ratio of mortality. Subgroup analyses were planned according to the type of probe, the type of stent (i.e. metal or plastic) and cancer type. A de novo Markov model was developed to model cost and quality-of-life outcomes associated with radiofrequency ablation in patients with primary advanced bile duct cancer. Insufficient data were available for pancreatic cancer and secondary bile duct cancer. An NHS and Personal Social Services perspective was adopted for the analysis. A probabilistic analysis was conducted to estimate the incremental cost-effectiveness ratio for radiofrequency ablation and the probability that radiofrequency ablation was cost-effective at different thresholds. The population expected value of perfect information was estimated in total and for the effectiveness parameters.
RESULTS
Sixty-eight studies (1742 patients) were included in the systematic review. Four studies (336 participants) were combined in a meta-analysis, which showed that the pooled hazard ratio for mortality following primary radiofrequency ablation compared with a stent-only control was 0.34 (95% confidence interval 0.21 to 0.55). Little evidence relating to the impact on quality of life was found. There was no evidence to suggest an increased risk of cholangitis or pancreatitis, but radiofrequency ablation may be associated with an increase in cholecystitis. The results of the cost-effectiveness analysis were that the costs of radiofrequency ablation was £2659 and radiofrequency ablation produced 0.18 quality-adjusted life-years, which was more than no radiofrequency ablation on average. With an incremental cost-effectiveness ratio of £14,392 per quality-adjusted life-year, radiofrequency ablation was likely to be cost-effective at a threshold of £20,000 per quality-adjusted life-year across most scenario analyses, with moderate uncertainty. The source of the vast majority of decision uncertainty lay in the effect of radiofrequency ablation on stent patency.
LIMITATIONS
Only 6 of 18 comparative studies contributed to the survival meta-analysis, and few data were found concerning secondary radiofrequency ablation. The economic model and cost-effectiveness meta-analysis required simplification because of data limitations. Inconsistencies in standard reporting and study design were noted.
CONCLUSIONS
Primary radiofrequency ablation increases survival and is likely to be cost-effective. The evidence for the impact of secondary radiofrequency ablation on survival and of quality of life is limited. There was a lack of robust clinical effectiveness data and, therefore, more information is needed for this indication.
FUTURE WORK
Future work investigating radiofrequency ablation must collect quality-of-life data. High-quality randomised controlled trials in secondary radiofrequency ablation are needed, with appropriate outcomes recorded.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42020170233.
FUNDING
This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 27, No. 7. See the NIHR Journals Library website for further project information.
Topics: Humans; Bile Duct Neoplasms; Cholestasis; Cost-Benefit Analysis; Cost-Effectiveness Analysis; Observational Studies as Topic; Quality of Life
PubMed: 37212444
DOI: 10.3310/YYMN9802 -
Orthopedic Research and Reviews 2023The treatment of low-grade osteosarcomas is surgical resection with wide margins. In instances of dedifferentiation, a therapeutic paradigm similar to that of... (Review)
Review
The treatment of low-grade osteosarcomas is surgical resection with wide margins. In instances of dedifferentiation, a therapeutic paradigm similar to that of conventional high-grade osteosarcoma has not been adequately evaluated in these neoplasms. The main objective of this review was to define whether the addition of chemotherapy to surgical treatment has an impact on the survival of patients with dedifferentiated low-grade osteosarcomas. Secondary objectives were to observe the degree of histological response to neoadjuvant chemotherapy and to describe the percentage of de novo dedifferentiation. A systematic search of articles including dedifferentiated low-grade osteosarcomas, published between 1980 and 2022 was carried out in the PubMed, Cochrane and Scielo databases. A qualitative synthesis of the results was performed. Twenty-three articles comprising 117 patients were included. The survival of patients treated with surgery alone and surgery with chemotherapy was not statistically significant between the two groups. A good histological response was seen in 20% of specimens treated with neoadjuvant chemotherapy. De novo dedifferentiation was seen in approximately a fifth of low-grade osteosarcomas. The evidence available suggests that the addition of chemotherapy does not have an impact on the survival of patients with low-grade dedifferentiated osteosarcomas.
PubMed: 37143718
DOI: 10.2147/ORR.S404146 -
Vaccines Apr 2023Kidney transplant recipients (KTRs) who have a highly impaired immune response are in need of intensified and safe vaccination strategies to achieve seroconversion and... (Review)
Review
BACKGROUND
Kidney transplant recipients (KTRs) who have a highly impaired immune response are in need of intensified and safe vaccination strategies to achieve seroconversion and prevent severe disease.
METHODS
We searched the Web of Science Core Collection, the Cochrane COVID-19 Study Register and the WHO COVID-19 global literature on coronavirus disease from January 2020 to 22 July 2022 for prospective studies that assessed immunogenicity and efficacy after three or more SARS-CoV-2 vaccine doses.
RESULTS
In 37 studies on 3429 patients, de novo seroconversion after three and four vaccine doses ranged from 32 to 60% and 25 to 37%. Variant-specific neutralization was 59 to 70% for Delta and 12 to 52% for Omicron. Severe disease after infection was rarely reported but all concerned KTRs lacked immune responses after vaccination. Studies investigating the clinical course of COVID-19 found remarkably higher rates of severe disease than in the general population. Serious adverse events and acute graft rejections were very rare. Substantial heterogeneity between the studies limited their comparability and summary.
CONCLUSION
Additional SARS-CoV-2 vaccine doses are potent and safe in general terms as well as regarding transplant-specific outcomes whilst the Omicron wave remains a significant threat to KTRs without adequate immune responses.
PubMed: 37112775
DOI: 10.3390/vaccines11040863 -
Movement Disorders Clinical Practice Apr 2023Chromosome microarray analysis (CMA) can detect copy number variants (CNV) beyond the resolution of standard G-banded karyotyping. De novo or inherited microdeletions... (Review)
Review
BACKGROUND
Chromosome microarray analysis (CMA) can detect copy number variants (CNV) beyond the resolution of standard G-banded karyotyping. De novo or inherited microdeletions may cause autosomal dominant movement disorders.
OBJECTIVES
The purpose of this study was to analyze the clinical characteristics, associated features, and genetic information of children with deletions in known genes that cause movement disorders and to make recommendations regarding the diagnostic application of CMA.
METHODS
Clinical cases published in English were identified in scientific databases (PubMed, ClinVar, and DECIPHER) from January 1998 to July 2019 following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Cases with deletions or microdeletions greater than 300 kb were selected. Information collected included age, sex, movement disorders, associated features, and the size and location of the deletion. Duplications or microduplications were not included.
RESULTS
A total of 18.097 records were reviewed, and 171 individuals were identified. Ataxia (30.4%), stereotypies (23.9%), and dystonia (21%) were the most common movement disorders. A total of 16% of the patients demonstrated more than one movement disorder. The most common associated features were intellectual disability or developmental delay (78.9%) and facial dysmorphism (57.8%). The majority (77.7%) of microdeletions were smaller than 5 Mb. We find no correlation between movement disorders, their associated features, and the size of microdeletions.
CONCLUSIONS
Our results support the use of CMA as an investigational test in children with movement disorders. As the majority of identified articles were case reports and small case series (low quality), future efforts should focus on larger prospective studies to examine the causation of microdeletions in pediatric movement disorders.
PubMed: 37070051
DOI: 10.1002/mdc3.13711 -
Medicine Apr 2023Laparoscopic banded sleeve gastrectomy (LBSG) has been compared to laparoscopic sleeve gastrectomy (LSG) in terms of anthropometric results and postoperative... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Laparoscopic banded sleeve gastrectomy (LBSG) has been compared to laparoscopic sleeve gastrectomy (LSG) in terms of anthropometric results and postoperative complications, which are controversial. This systematic review and meta-analysis aimed to compare the safety and efficacy of LBSG and LSG.
METHODS
We performed a systematic review with meta-analysis according to preferred reporting items for systematic review and meta-analysis 2020 and assessing the methodological quality of systematic review 2 guidelines. We included studies that systematically searched electronic databases and compared LBSG with LSG conducted until August 10, 2021.
RESULTS
The literature search yielded 8 comparative studies. Seven hundred forty-three patients were included: 352 in the LBSG group and 391 in the LSG group. LBSG group allowed greater anthropometric parameters (body mass index [BMI] after 1 year (mean difference [MD] = -3.18; 95% CI [-5.45, -0.92], P = .006), %EWL after 1 year (MD = 8.02; 95% CI [1.22, 14.81], P = .02), and %EWL after 3 years (MD = 10.60; 95% CI [5.60, 15.69], P < .001) and similar results with LSG group in terms of operative time (MD = 1.23; 95% CI [-4.71, 7.17], P = .69), food intolerance (OR = 1.72; 95% CI [0.84, 3.49], P = .14), postoperative vomiting (OR = 2.10; 95% CI [0.69, 6.35], P = .19), and De novo GERD (OR = 0.65; 95% CI [0.34, 1.26], P = .2). Nevertheless, major postoperative complications did not differ between the 2 groups.
CONCLUSIONS
This systematic review and meta-analysis comparing LBSG and LSG concluded that banding sleeve gastrectomy (SG) may ensure a lower BMI and %EWL after 1 year of follow-up, and a significant reduction in %EWL after 3 years of follow-up. There is no evidence to support LBSG in vomiting, de novo GERD, food intolerance, or operative time.
Topics: Humans; Food Intolerance; Gastroplasty; Postoperative Complications; Gastrectomy; Postoperative Nausea and Vomiting; Gastroesophageal Reflux; Laparoscopy; Obesity, Morbid; Treatment Outcome; Retrospective Studies
PubMed: 37058050
DOI: 10.1097/MD.0000000000032982 -
Frontiers in Pediatrics 2023To systematically review, critically appraise the quality of recent clinical practice guidelines (CPGs) for neonatal hypoxic ischemic encephalopathy (HIE), and map their... (Review)
Review
Clinical practice guidelines for neonatal hypoxic-ischemic encephalopathy: A systematic review using the appraisal of guidelines for research and evaluation (AGREE) II instrument.
BACKGROUND AND OBJECTIVE
To systematically review, critically appraise the quality of recent clinical practice guidelines (CPGs) for neonatal hypoxic ischemic encephalopathy (HIE), and map their recommendations.
DATA SOURCES
CPG databases (GIN, ECRI, NICE, SIGN, DynaMed), Bibliographic databases (PubMed, Embase, CINAHL), and related specialized professional societies (e.g., AAP, CPS, BAPM, RCPCH, and SNS).
STUDY SELECTION
Original de-novo developed evidence-based CPGs for HIE, group authorship, Arabic or English languages, and international or national scope. The systematic review was drafted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement and Johnston et al methodological guide.
DATA EXTRACTION
Quality assessment of the included HIE CPGs by the Appraisal of Guidelines for REsearch & Evaluation II (AGREE II) Instrument and report their characteristics, AGREE II ratings, and recommendations.
DATA SYNTHESIS
Our search retrieved 2,489 citations, of which two recent HIE CPGs were eligible and appraised: Canadian Paediatric Society (CPS) and Queensland Maternity and Neonatal Services (QMN). The overall assessment of the QMN CPG was superior (83%). Domain 1 (Scope & Purpose) scored (47%, 63%), Domain 2 (Stakeholder Involvement) (72%, 39%), Domain 3 (Rigour of Development) (48%, 43%), Domain 4 (Clarity & Presentation) (100%, 96%), Domain 5 (Applicability) (59%, 9%), and Domain 6 (Editorial Independence) (67%, 17%) for the QMN and CPS CPGs respectively. All appraisers recommended the QMN CPG for use in practice.
CONCLUSION
The methodological quality of the QMN CPG was superior with the relevant recommendations for its use in neonatal practice.
LIMITATIONS
limited to Arabic and English languages.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=258291, identifier: CRD42021258291.
PubMed: 37033166
DOI: 10.3389/fped.2023.1092578 -
Scientific Reports Apr 2023Hepatitis B virus (HBV) has ten genotypes (A-J) and over 40 sub-genotypes based on the divergence of ≥ 8% and 4 to < 8% in the complete genome respectively.... (Meta-Analysis)
Meta-Analysis
Hepatitis B virus (HBV) has ten genotypes (A-J) and over 40 sub-genotypes based on the divergence of ≥ 8% and 4 to < 8% in the complete genome respectively. These genotypes and sub-genotypes influence the disease prognosis, response to therapy and route of viral transmission. Besides, infection with mixed genotypes and recombinant genotypes has also been reported. This study aimed at mapping the de novo genotypes and correlate them with the immigration trends in order to inform future research on the underlying reasons for the relative distribution of HBV genotypes from a large sample size pooled from many primary studies. Data was extracted from 59 full research articles obtained from Scopus, PubMed, EMBASE, Willy library, African Journal Online (AJOL) and Google Scholar. Studies that investigated the genotypes, sub-genotypes, mixed genotypes and recombinant were included. The Z-test and regression were used for the analysis. The study protocol is registered with PROSPERO under the registration number CRD42022300220. Overall, genotype E had the highest pooled prevalence significantly higher than all the other genotypes (P < 0.001). By region, genotype A posted the highest pooled prevalence in eastern and southern Africa, E in west Africa and D in north Africa (P < 0.0001). Regarding the emerging genotypes B and C on the African continent, genotype B was significantly higher in south Africa than C (P < 0.001). In contrast, genotype C was significantly higher in east Africa than west Africa (P < 0.0001). The A1 and D/E were the most diverse sub-genotypes and genotype mixtures respectively. Finally, we observed a general progressive decrease in the prevalence of predominant genotypes but a progressive increase in the less dominant by region. Historical and recent continental and intercontinental migrations can provide a plausible explanation for the HBV genotype distribution pattern on the African continent.
Topics: Humans; Hepatitis B virus; Africa, Northern; Genotype; Emigration and Immigration; Prognosis; Hepatitis B
PubMed: 37029173
DOI: 10.1038/s41598-023-32865-1