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Medicina (Kaunas, Lithuania) Mar 2024: An extracellular vesicle is part of a class of submicron particles derived from cells, mediating cellular crosstalk through microRNA (miRNA). MiRNA is a group of RNA...
: An extracellular vesicle is part of a class of submicron particles derived from cells, mediating cellular crosstalk through microRNA (miRNA). MiRNA is a group of RNA molecules, each of which consists of 15-22 nucleotides and post-transcriptionally modulates gene expression. The complementary mRNAs-onto which the miRNAs hybridize-are involved in processes such as implantation, tumor suppression, proliferation, angiogenesis, and metastasis that define the entire tumor microenvironment. The endometrial biopsy is a standard technique used to recognize cellular atypia, but other non-invasive markers may reduce patient discomfort during the use of invasive methods. The present study aims to examine the distribution and the regulation of the differentially expressed miRNAs (DEMs) and EV-derived substances in women with endometrial cancer. : We systematically searched the PubMed, EMBASE, Scopus, Cochrane Library, and ScienceDirect databases in April 2023, adopted the string "Endometrial Neoplasms AND Exosomes", and followed the recommendations in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. We selected all the studies that included patients with endometrial cancer and that described the regulation of miRNA molecules in that context. The differences in molecule expression between patients and controls were evaluated as significant when the proteins had a fold change of ±1.5. : Seventeen records fulfilled the inclusion criteria: a total of 371 patients and 273 controls were analyzed. The upregulated molecules that had the widest delta between endometrial cancer patients and controls-relative expression ≥ 1 > 3 log2(ratio)-were miR-20b-5p, miR-204-5p, miR-15a-5p, and miR-320a. In particular, miR-20b-5p and miR-204-5p were extracted from both serum and endometrial specimens, whereas miR-15a-5p was only isolated from plasma, and miR-320a was only extracted from the endometrial specimens. In parallel, the most downregulated miRNA in the endometrial cancer patients compared to the healthy subjects was miR-320a, which was found in the endometrial specimens. : Although their epigenetic regulation remains unknown, these upregulated molecules derived from EVs are feasible markers for the early detection of endometrial cancer. The modulation of these miRNA molecules should be assessed during different treatments or if recurrence develops in response to a targeted treatment modality.
Topics: Female; Humans; Embryo Implantation; Endometrial Neoplasms; Endometrium; Epigenesis, Genetic; MicroRNAs; Tumor Microenvironment
PubMed: 38541212
DOI: 10.3390/medicina60030486 -
Journal of Affective Disorders Jul 2024Intravenous (IV) racemic ketamine and intranasal (IN) esketamine have demonstrated rapid antidepressant effects in treatment-resistant depression (TRD). This systematic... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Intravenous (IV) racemic ketamine and intranasal (IN) esketamine have demonstrated rapid antidepressant effects in treatment-resistant depression (TRD). This systematic review aims to evaluate the efficacy and safety of ketamine and esketamine at various dosages for depression.
METHODS
We included randomized controlled trials (RCTs) with parallel group dose comparison of ketamine and esketamine for depression/TRD. Ovid Medline, Embase, PsycINFO, Scopus and Cochrane databases were searched. Standardized mean differences were calculated using Hedges'-g to complete random effects meta-analysis. The efficacy outcomes were changes in depression outcomes for IV ketamine and IN esketamine respectively. Safety was assessed by reported adverse effects.
RESULTS
A random effects meta-analysis of studies (n = 12) showed efficacy in reducing depression symptoms with IV ketamine (Hedges'g = 1.52 [0.98-2.22], Z = 4.23, p < 0.001) and IN esketamine (Hedges' g = 0.31 [0.18-0.44], Z = 4.53, P < 0.001) compared to control/placebo. Treatment response was observed at IV ketamine doses ≤0.2 mg/kg, >0.2-0.5 mg/kg and > 0.5 mg/kg. Higher IV ketamine doses (>0.5 mg/kg) did not lead to greater treatment response. Esketamine doses of 56-84 mg were superior to 28 mg dose.
LIMITATIONS
Overall quality of evidence was low and limited by small number of studies. Publication bias was high.
CONCLUSIONS
This meta-analysis suggests that IV ketamine may be efficacious at doses as low as 0.2 mg/kg, with increasing dose response at 0.5 mg/kg, without demonstrable increased benefit at 1 mg/kg, based on a small number of studies. Efficacy for IN esketamine increases with doses above 28 mg with best response being found between 56 and 84 mg for reducing depressive symptoms.
Topics: Ketamine; Humans; Administration, Intranasal; Depressive Disorder, Major; Antidepressive Agents; Depressive Disorder, Treatment-Resistant; Administration, Intravenous; Treatment Outcome; Dose-Response Relationship, Drug; Randomized Controlled Trials as Topic
PubMed: 38537759
DOI: 10.1016/j.jad.2024.03.137 -
Gynecological Endocrinology : the... Dec 2024To synthesize the primary evidence on the efficacy and safety of visnadine on symptoms of sexual dysfunction (SD) in heterosexual women.
OBJECTIVE
To synthesize the primary evidence on the efficacy and safety of visnadine on symptoms of sexual dysfunction (SD) in heterosexual women.
METHODS
We conducted a systematic review of randomized clinical trials (RCTs) with a primary search without language restriction in PubMed/Medline, Scopus, Embase, Web of Science, Cochrane Library, and international clinical trial registries. Trials reporting the use of visnadine by any route in women with SD were eligible. We performed screening, data extraction, and risk of bias assessment in a double-blind approach. The primary outcomes were the Female Sexual Function Index (FSFI) and its domains. Secondary outcomes were safety, arousal, lubrication, pleasure, orgasm, negative sensations, duration, and overall satisfaction.
RESULTS
Initially, 242 records were retrieved. We selected nine papers for full-text reading and finally included two RCTs: one with a parallel design and one with a crossover design with a total of 96 patients. One study compared visnadine aerosol with a placebo, while the other compared different frequencies of visnadine aerosol use. Visnadine use showed a statistically significant improvement ( < 0.05) in overall FSFI scores, regardless of the frequency of use. A meta-analysis was not possible due to the high clinical and methodological heterogeneity between available studies.
CONCLUSION
RCTs regarding the use of visnadine for the Female SD are scarce and methodologically limited. This preliminary evidence shows visnadine as a potentially effective and safe option to alleviate some of the clinical symptoms of SD in heterosexual women. However, future better-designed randomized studies with larger sample numbers are required.
Topics: Female; Humans; Heterosexuality; Randomized Controlled Trials as Topic; Sexual Dysfunction, Physiological; Aerosols; Chromans
PubMed: 38528806
DOI: 10.1080/09513590.2024.2328619 -
Journal of Orthopaedic Translation Mar 2024Reliable animal models are critical for preclinical research and should closely mimic the disease. With respect to route of infection, pathogenic agent, disease... (Review)
Review
BACKGROUND
Reliable animal models are critical for preclinical research and should closely mimic the disease. With respect to route of infection, pathogenic agent, disease progression, clinical signs, and histopathological changes. Sheep have similar bone micro- and macrostructure as well as comparable biomechanical characteristics to humans. Their use in bone research is established, however their use in bone infection research is limited. This systematic review will summarise the key features of the available bone infection models using sheep, providing a reference for further development, validation, and application.
METHOD
This systematic review was designed according to the PRISMA guidelines and registered with PROSPERO. Quality was assessed using SYRICLE's risk of bias tool adapted for animal studies. PubMed, MEDLINE, Web of Science and EMBASE were searched until March 2022.1921 articles were screened by two independent reviewers, and 25 were included for analysis.
RESULTS
Models have been developed in nine different breeds. was used in the majority of models, typically inoculating 10 colony forming units in tibial or femoral cortical defects. Infection was established with either planktonic or biofilm adherent bacteria, with or without foreign material implanted. Most studies used both radiological and microbiological analyses to confirm osteomyelitis.
CONCLUSIONS
There is convincing evidence supporting the use of sheep in bone infection models of clinical disease. The majority of sheep studied demonstrated convincing osteomyelitis and tolerated the infection with minimal complications. Furthermore, the advantages of comparable biology and biomechanics may increase the success for translating results to successful therapies.
THE TRANSLATIONAL POTENTIAL OF THIS ARTICLE
In the realm of preclinical research, the translation to viable clinical therapies is often perilous, and the quest for reliable and representative animal models remains paramount. This systematic review accentuates the largely untapped potential of sheep as large animal models, especially in bone infection research. The anatomical and biomechanical parallels between sheep and human bone structures position sheep as an invaluable asset for studying osteomyelitis and periprosthetic joint infection. This comprehensive exploration of the literature demonstrates the robustness and translational promise of these models. Furthermore, this article underscores the potential applicability for sheep in developing effective therapeutic strategies for human bone infections.
PubMed: 38524868
DOI: 10.1016/j.jot.2024.02.002 -
Clinical Implant Dentistry and Related... Mar 2024The present study aimed to systematically review the studies comparing the accuracy of intraoral scan (IOS) and conventional implant impressions (CI) in completely... (Review)
Review
OBJECTIVES
The present study aimed to systematically review the studies comparing the accuracy of intraoral scan (IOS) and conventional implant impressions (CI) in completely edentulous patients.
MATERIALS AND METHODS
Electronic searches were performed in PubMed, Embase and Cochrane CENTRAL up to December 1, 2023. Clinical studies and in vitro studies reporting the accuracy of digital full arch impressions were included. The primary outcome is the 3-dimensional deviations between the study reference models. A risk of bias assessment was performed for clinical studies. A stratified meta-analysis and a single-armed meta-analysis were conducted.
RESULTS
A total of 49 studies were included, with 8 clinical studies and 41 in vitro studies. For comparison between IOS and conventional impressions, studies were categorized into two groups based on the different measurement methods employed: RMS and CMM. In studies using RMS, the result favored the IOS in the unparalleled situation with the mean difference of -99.29 μm (95% CI: [-141.38, -57.19], I = 81%), while the result was opposite with the mean difference of 13.62 μm (95% CI: [10.97, 16.28], I = 26%) when implants were paralleled. For different brands of IOS, the accuracy ranged from 76.11 μm (95% CI: [42.36, 109.86]) to 158.63 μm (95% CI: [-14.68, 331.93]).
CONCLUSIONS
Accuracy of intraoral scan is clinically acceptable in edentulous arches, especially for unparalleled implants. More clinical studies are needed to verify the present finding.
PubMed: 38517307
DOI: 10.1111/cid.13321 -
The Cochrane Database of Systematic... Mar 2024Depression is common amongst older people residing in long-term care (LTC) facilities. Currently, most residents treated for depression are prescribed antidepressant... (Review)
Review
BACKGROUND
Depression is common amongst older people residing in long-term care (LTC) facilities. Currently, most residents treated for depression are prescribed antidepressant medications, despite the potential availability of psychological therapies that are suitable for older people and a preference amongst many older people for non-pharmacological treatment approaches.
OBJECTIVES
To assess the effect of psychological therapies for depression in older people living in LTC settings, in comparison with treatment as usual, waiting list control, and non-specific attentional control; and to compare the effectiveness of different types of psychological therapies in this setting.
SEARCH METHODS
We searched the Cochrane Common Mental Disorders Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, five other databases, five grey literature sources, and two trial registers. We performed reference checking and citation searching, and contacted study authors to identify additional studies. The latest search was 31 October 2021.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and cluster-RCTs of any type of psychological therapy for the treatment of depression in adults aged 65 years and over residing in a LTC facility.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened titles/abstracts and full-text manuscripts for inclusion. Two review authors independently performed data extraction and risk of bias assessments using the Cochrane RoB 1 tool. We contacted study authors for additional information where required. Primary outcomes were level of depressive symptomatology and treatment non-acceptability; secondary outcomes included depression remission, quality of life or psychological well-being, and level of anxious symptomatology. We used Review Manager 5 to conduct meta-analyses, using pairwise random-effects models. For continuous data, we calculated standardized mean differences and 95% confidence intervals (CIs), using endpoint data, and for dichotomous data, we used odds ratios and 95% CIs. We used GRADE to assess the certainty of the evidence.
MAIN RESULTS
We included 19 RCTs with 873 participants; 16 parallel group RCTs and three cluster-RCTs. Most studies compared psychological therapy (typically including elements of cognitive behavioural therapy, behavioural therapy, reminiscence therapy, or a combination of these) to treatment as usual or to a condition controlling for the effects of attention. We found very low-certainty evidence that psychological therapies were more effective than non-therapy control conditions in reducing symptoms of depression, with a large effect size at end-of-intervention (SMD -1.04, 95% CI -1.49 to -0.58; 18 RCTs, 644 participants) and at short-term (up to three months) follow-up (SMD -1.03, 95% CI -1.49 to -0.56; 16 RCTs, 512 participants). In addition, very low-certainty evidence from a single study with 82 participants indicated that psychological therapy was associated with a greater reduction in the number of participants presenting with major depressive disorder compared to treatment as usual control, at end-of-intervention and short-term follow-up. However, given the limited data on the effect of psychological therapies on remission of major depressive disorder, caution is advised in interpreting this result. Participants receiving psychological therapy were more likely to drop out of the trial than participants receiving a non-therapy control (odds ratio 3.44, 95% CI 1.19 to 9.93), which may indicate higher treatment non-acceptability. However, analyses were restricted due to limited dropout case data and imprecise reporting, and the finding should be interpreted with caution. There was very low-certainty evidence that psychological therapy was more effective than non-therapy control conditions in improving quality of life and psychological well-being at short-term follow-up, with a medium effect size (SMD 0.51, 95% CI 0.19 to 0.82; 5 RCTs, 170 participants), but the effect size was small at postintervention (SMD 0.40, 95% CI -0.02 to 0.82; 6 RCTs, 195 participants). There was very low-certainty evidence of no effect of psychological therapy on anxiety symptoms postintervention (SMD -0.68, 95% CI -2.50 to 1.14; 2 RCTs, 115 participants), although results lacked precision, and there was insufficient data to determine short-term outcomes.
AUTHORS' CONCLUSIONS
This systematic review suggests that cognitive behavioural therapy, behavioural therapy, and reminiscence therapy may reduce depressive symptoms compared with usual care for LTC residents, but the evidence is very uncertain. Psychological therapies may also improve quality of life and psychological well-being amongst depressed LTC residents in the short term, but may have no effect on symptoms of anxiety in depressed LTC residents, compared to control conditions. However, the evidence for these effects is very uncertain, limiting our confidence in the findings. The evidence could be strengthened by better reporting and higher-quality RCTs of psychological therapies in LTC, including trials with larger samples, reporting results separately for those with and without cognitive impairment and dementia, and longer-term outcomes to determine when effects wane.
Topics: Humans; Aged; Depression; Long-Term Care; Psychotherapy; Cognitive Behavioral Therapy; Behavior Therapy; Quality of Life
PubMed: 38501686
DOI: 10.1002/14651858.CD013059.pub2 -
Digestive Diseases and Sciences May 2024Infliximab and vedolizumab are widely used to treat Crohn's disease (CD) and ulcerative colitis (UC). (Meta-Analysis)
Meta-Analysis Comparative Study
Comparative Efficacy of Subcutaneous and Intravenous Infliximab and Vedolizumab for Maintenance Treatment of TNF-naive Adult Patients with Inflammatory Bowel Disease: A Systematic Literature Review and Network Meta-analysis.
BACKGROUND
Infliximab and vedolizumab are widely used to treat Crohn's disease (CD) and ulcerative colitis (UC).
AIMS
This systematic review and network meta-analysis evaluated comparative efficacy of various regimens for intravenous or subcutaneous infliximab and vedolizumab during maintenance treatment in CD and UC.
METHODS
Parallel-group randomized controlled trials (RCTs) were identified by a systematic literature review (CRD42022383401) and included if they evaluated therapeutics of interest for maintenance treatment of adults with moderate-to-severe luminal CD or UC and assessed clinical remission between Weeks 30 and 60. Clinical remission rates in CD or UC and mucosal healing rates in UC were analyzed in a Bayesian network meta-analysis model. Endoscopic outcomes in CD were synthesized by proportional meta-analysis.
RESULTS
Overall, 13 RCTs were included in the analyses. All vedolizumab studies randomized induction responders to maintenance treatment; infliximab studies used a treat-through design. Subcutaneous infliximab 120 mg every 2 weeks had the highest odds ratio (OR) [95% credible interval] versus placebo for clinical remission during the maintenance phase (CD: 5.90 [1.90-18.2]; UC: 5.45 [1.94-15.3]), with surface under the cumulative ranking curve (SUCRA) values of 0.91 and 0.82, respectively. For mucosal healing in UC, subcutaneous infliximab 120 mg every 2 weeks showed the highest OR (4.90 [1.63-14.1]), with SUCRA value of 0.73, followed by intravenous vedolizumab 300 mg every 4 weeks (SUCRA value, 0.70). Endoscopic outcomes in CD were better with subcutaneous infliximab 120 mg every 2 weeks than intravenous infliximab 5 mg/kg every 8 weeks.
CONCLUSIONS
Subcutaneous infliximab showed a favorable efficacy profile for achieving clinical remission and endoscopic outcomes during maintenance treatment in CD or UC.
Topics: Humans; Infliximab; Antibodies, Monoclonal, Humanized; Injections, Subcutaneous; Gastrointestinal Agents; Colitis, Ulcerative; Crohn Disease; Administration, Intravenous; Treatment Outcome; Adult; Randomized Controlled Trials as Topic; Remission Induction; Network Meta-Analysis; Maintenance Chemotherapy
PubMed: 38499736
DOI: 10.1007/s10620-023-08252-1 -
Critical Care Medicine Jul 2024To conduct a systematic review and meta-analysis assessing whether the use of antipsychotic medications in critically ill adult patients with delirium impacts... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To conduct a systematic review and meta-analysis assessing whether the use of antipsychotic medications in critically ill adult patients with delirium impacts patient-important outcomes.
DATA SOURCES
A medical librarian searched Ovid MEDLINE, EMBASE, APA PsycInfo, and Wiley's Cochrane Library as well as clinicaltrials.gov and the World Health Organization International Clinical Trials Registry Platform up to November 2023.
STUDY SELECTION
Independently and in duplicate, reviewers screened abstracts and titles for eligibility, then full text of qualifying studies. We included parallel-group randomized controlled trials (RCTs) that included critically ill adult patients with delirium. The intervention group was required to receive antipsychotic medications at any dose, whereas the control group received usual care or placebo.
DATA EXTRACTION
Reviewers extracted data independently and in duplicate using a piloted abstraction form. Statistical analyses were conducted using RevMan software (version 5.4).
DATA SYNTHESIS
Five RCTs ( n = 1750) met eligibility criteria. The use of antipsychotic medications compared with placebo did not increase the number of delirium- or coma-free days (mean difference 0.90 d; 95% CI, -0.32 to 2.12; moderate certainty), nor did it result in a difference in mortality, duration of mechanical ventilation, ICU, or hospital length of stay. The use of antipsychotics did not result in an increased risk of adverse events (risk ratio 1.27; 95% CI, 0.71-2.30; high certainty). Subgroup analysis of typical versus atypical antipsychotics did not identify any subgroup effect for any outcome.
CONCLUSIONS
In conclusion, our systematic review and meta-analysis demonstrated with moderate certainty that there is no difference in delirium- or coma-free days when delirious critically ill adults are treated with antipsychotic medications. Further studies in the subset of patients with hyperactive delirium may be of benefit.
Topics: Humans; Delirium; Antipsychotic Agents; Critical Illness; Randomized Controlled Trials as Topic
PubMed: 38488422
DOI: 10.1097/CCM.0000000000006251 -
Journal of Clinical Nursing Jul 2024To synthesise evidence from studies that explored the impact of electronic and self-rostering systems to schedule staff on healthcare organisations and healthcare... (Review)
Review
AIM
To synthesise evidence from studies that explored the impact of electronic and self-rostering systems to schedule staff on healthcare organisations and healthcare workers.
DESIGN
Mixed-method systematic review.
METHODS
Studies were screened by two independent reviewers and data were extracted using standardised data extraction tables. The quality of studies was assessed, and parallel-results convergent synthesis was conducted.
DATA SOURCES
Academic Search Complete, CINAHL, ERIC, MEDLINE, PsycINFO and PsycARTICLES were searched on January 3, 2023.
RESULTS
Eighteen studies were included (10 quantitative descriptive studies, seven non-randomised studies and one qualitative study). Studies examined two rostering interventions including self-rostering (n = 12) and electronic rostering (n = 6). It was found that the implementation of electronic and self-rostering systems for staff scheduling impacted positively on both, healthcare workers and healthcare organisations. Benefits included enhanced roster efficiency, staff satisfaction, greater control and empowerment, improved work-life balance, higher staff retention and reduced turnover, decreased absence rates and enhanced healthcare efficiency. However, self-rostering was found to be less equitable than fixed rostering, was associated with increased overtime, and correlated with a higher frequency of staff requests for shift changes.
CONCLUSION
The impact of electronic and self-rostering systems to schedule staff on healthcare organisations and healthcare workers' outcomes was predominantly positive. Further randomised controlled trials and longitudinal studies are warranted to evaluate the long-term impact of various rostering systems, including electronic and self-rostering systems.
IMPLICATIONS FOR HEALTHCARE
Rostering is a multifaceted responsibility for healthcare administrators, impacting patient care quality, workforce planning and healthcare expenditure.
IMPACT
Given that healthcare staffing costs constitute a substantial portion of global healthcare expenditure, efficient and strategic resource management, inclusive of healthcare staff rostering, is imperative.
REPORTING METHOD
The 27-item Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) checklist.
PATIENT OR PUBLIC CONTRIBUTION
No Patient or Public Contribution.
Topics: Humans; Health Personnel; Personnel Staffing and Scheduling; Job Satisfaction
PubMed: 38481071
DOI: 10.1111/jocn.17114 -
The Cochrane Database of Systematic... Mar 2024New strategies in immunotherapy with specific antigens that trigger an anti-tumour immune response in people with lung cancer open the possibility of developing... (Review)
Review
BACKGROUND
New strategies in immunotherapy with specific antigens that trigger an anti-tumour immune response in people with lung cancer open the possibility of developing therapeutic vaccines aimed at boosting the adaptive immune response against cancer cells.
OBJECTIVES
To evaluate the effectiveness and safety of different types of therapeutic vaccines for people with advanced non-small cell lung cancer.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, Wanfang Data, and China Journal Net (CNKI) up to 22 August 2023.
SELECTION CRITERIA
We included parallel-group, randomised controlled trials evaluating a therapeutic cancer vaccine, alone or in combination with other treatments, in adults (> 18 years) with advanced non-small cell lung cancer (NSCLC), whatever the line of treatment.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Our primary outcomes were overall survival, progression-free survival, and serious adverse events; secondary outcomes were three- and five-year survival rates and health-related quality of life.
MAIN RESULTS
We included 10 studies with 2177 participants. The outcome analyses included only 2045 participants (1401 men and 644 women). The certainty of the evidence varied by vaccine and outcome, and ranged from moderate to very low. We report only the results for primary outcomes here. TG4010 The addition of the vector-based vaccine, TG4010, to chemotherapy, compared with chemotherapy alone in first-line treatment, may result in little to no difference in overall survival (hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.65 to 1.05; 2 studies, 370 participants; low-certainty evidence). It may increase progression-free survival slightly (HR 0.74, 95% CI 0.55 to 0.99; 1 study, 222 participants; low-certainty evidence). It may result in little to no difference in the proportion of participants with at least one serious treatment-related adverse event, but the evidence is very uncertain (risk ratio (RR) 0.70, 95% CI 0.23 to 2.19; 2 studies, 362 participants; very low-certainty evidence). Epidermal growth factor vaccine Epidermal growth factor vaccine, compared to best supportive care as switch maintenance treatment after first-line chemotherapy, may result in little to no difference in overall survival (HR 0.82, 95% CI 0.66 to 1.02; 1 study, 378 participants; low-certainty evidence), and in the proportion of participants with at least one serious treatment-related adverse event (RR 1.32, 95% CI 0.88 to 1.98; 2 studies, 458 participants; low-certainty evidence). hTERT (vx-001) The hTERT (vx-001) vaccine compared to placebo as maintenance treatment after first-line chemotherapy may result in little to no difference in overall survival (HR 0.97, 95% CI 0.70 to 1.34; 1 study, 190 participants). Racotumomab Racotumomab compared to placebo as a switch maintenance treatment post-chemotherapy was assessed in one study with 176 participants. It may increase overall survival (HR 0.63, 95% CI 0.46 to 0.87). It may make little to no difference in progression-free survival (HR 0.73, 95% CI 0.53 to 1.00) and in the proportion of people with at least one serious treatment-related adverse event (RR 1.03, 95% CI 0.15 to 7.18). Racotumomab versus docetaxel as switch maintenance therapy post-chemotherapy was assessed in one study with 145 participants. The study did not report hazard rates on overall survival or progression-free survival time, but the difference in median survival times was very small - less than one month. Racotumomab may result in little to no difference in the proportion of people with at least one serious treatment-related adverse event compared with docetaxel (RR 0.89, 95% CI 0.44 to 1.83). Personalised peptide vaccine Personalised peptide vaccine plus docetaxel compared to docetaxel plus placebo post-chemotherapy treatment may result in little to no difference in overall survival (HR 0.80, 95% CI 0.42 to 1.52) and progression-free survival (HR 0.78, 95% CI 0.43 to 1.42). OSE2101 The OSE2101 vaccine compared with chemotherapy, after chemotherapy or immunotherapy, was assessed in one study with 219 participants. It may result in little to no difference in overall survival (HR 0.86, 95% CI 0.62 to 1.19). It may result in a small difference in the proportion of people with at least one serious treatment-related adverse event (RR 0.95, 95% CI 0.91 to 0.99). SRL172 The SRL172 vaccine of killed Mycobacterium vaccae, added to chemotherapy, compared to chemotherapy alone, may result in no difference in overall survival, and may increase the proportion of people with at least one serious treatment-related adverse event (RR 2.07, 95% CI 1.76 to 2.43; 351 participants).
AUTHORS' CONCLUSIONS
Adding a vaccine resulted in no differences in overall survival, except for racotumomab, which showed some improvement compared to placebo, but the difference in median survival time was very small (1.4 months) and the study only included 176 participants. Regarding progression-free survival, we observed no differences between the compared treatments, except for TG4010, which may increase progression-free survival slightly. There were no differences between the compared treatments in serious treatment-related adverse events, except for SRL172 (killed Mycobacterium vaccae) added to chemotherapy, which was associated with an increase in the proportion of participants with at least one serious treatment-related adverse event, and OSE2101, which may decrease slightly the proportion of people having at least one serious treatment-related adverse event. These conclusions should be interpreted cautiously, as the very low- to moderate-certainty evidence prevents drawing solid conclusions: many vaccines were evaluated in a single study with small numbers of participants and events.
Topics: Adult; Female; Humans; Male; Carcinoma, Non-Small-Cell Lung; Docetaxel; EGF Family of Proteins; Lung Neoplasms; Mycobacteriaceae; Quality of Life; Vaccines; Randomized Controlled Trials as Topic
PubMed: 38470132
DOI: 10.1002/14651858.CD013377.pub2