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The Cochrane Database of Systematic... Feb 2021Glaucoma is the leading cause of irreversible blindness. Minimally invasive surgical techniques, such as ab interno trabecular bypass surgery, have been introduced to...
BACKGROUND
Glaucoma is the leading cause of irreversible blindness. Minimally invasive surgical techniques, such as ab interno trabecular bypass surgery, have been introduced to prevent glaucoma from progressing. OBJECTIVES: In light of the potential benefits for people with open-angle glaucoma and the widespread uptake of the technique, it is important to critically evaluate the evidence for whether treatment with ab interno trabecular bypass surgery with Trabectome is both efficacious and safe.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2020, Issue 7); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 17 July 2020.
SELECTION CRITERIA
We searched for randomised controlled trials (RCTs) of ab interno trabecular bypass surgery with Trabectome compared to other surgical treatments (other minimally invasive glaucoma device techniques, trabeculectomy), laser treatment, or medical treatment. We also included trials in which these devices were combined with phacoemulsification compared to phacoemulsification in combination with other glaucoma surgery or alone.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. Our primary outcome was proportion of participants who were medication-free (not using eye drops). Secondary outcomes included mean change in intraocular pressure (IOP), proportion of participants who required further glaucoma surgery, mean change in quality of life, proportion of participants who achieved an IOP of 21 mmHg or less, 17 mmHg or less, or 14 mmHg or less and rate of visual field progression. Adverse effects were the proportion of participants experiencing intra- and postoperative complications. All outcomes were measured in the short term (6 to 18 months), medium term (18 to 36 months), and long term (36 months or longer).
MAIN RESULTS
In this update, we included one RCT which had previously been identified as an ongoing study in our 2016 publication. This trial was a single-centre, single-surgeon RCT set in Canada with 19 participants. Participants were adults who had open-angle glaucoma, open angles, and had inadequately controlled IOP that required surgical intervention. The study was terminated before the intended sample size was reached 'due to slow recruitment and increasing lack of clinical equipoise over time'. This reduced the power of the study to detect clinically important effects. We assessed the trial as being at high risk of attrition, reporting, and other potential sources of biases. The risks of performance and detection bias are unclear. The intervention group of 10 people had Trabectome ab interno trabeculotomy combined with cataract extraction (phaco-AIT) and the comparator group of 9 people had trabeculectomy with mitomycin C combined with cataract extraction (phaco-Trab), one of whom was lost to follow-up. Seven of 10 participants in the phaco-AIT group and 4 of 8 in the phaco-Trab group were medication-free (not using drops) at 12 months (odds ratio (OR) 2.33, 95% confidence interval (CI) 0.34 to 16.2; very low-certainty evidence). At 12 months, the mean change in IOP was worse for phaco-AIT than for phaco-Trab, but this evidence was very uncertain (mean difference (MD) 3.70 mmHg, 95% CI -1.44 to 8.84; very low-certainty evidence) in the phaco-AIT group, as was the difference in the mean number of IOP-lowering drops taken per day (MD -0.41, 95% CI -1.22 to 0.40; very low-certainty evidence). Only one participant in the phaco-AIT group required further glaucoma surgery. The study protocol declared that quality of life and visual field progression were measured, but they were not reported All 8 participants with complete data in the phaco-Trab group and 8 of 10 in the phaco-AIT had at least one early or late postoperative complication (e.g. day 1 IOP spike, hypotony, choroidal effusion, bleb leak or encapsulation, uveitis, or peripheral anterior synechiae). The evidence was very low-certainty due to high risk of bias for several domains for this study and for large imprecision of all estimates. We also identified one ongoing study, identified from the International Clinical Trials Registry Platform (ICTRP): a multicentre, open, RCT comparing Trabectome to ab interno trabeculectomy using microhook. The study investigators plan to recruit 120 adults between 20 and 90 years of age. The primary outcome is duration of treatment success. Secondary outcomes include postoperative IOP, number of anti-glaucoma medications, and adverse events.
AUTHORS' CONCLUSIONS
There is currently no high-quality evidence for the outcomes of ab interno trabecular bypass surgery with Trabectome for open-angle glaucoma. Properly designed RCTs are needed to assess the long-term efficacy and safety of this technique.
Topics: Bias; Glaucoma, Open-Angle; Humans; Phacoemulsification; Randomized Controlled Trials as Topic; Trabecular Meshwork; Trabeculectomy
PubMed: 33580495
DOI: 10.1002/14651858.CD011693.pub3 -
Cancer Medicine Nov 2020Intravesical instillation therapy is the mainstay of prophylaxis of tumor recurrence and progression in non-muscle-invasive bladder cancer. However, there is no study... (Meta-Analysis)
Meta-Analysis
Intravesical instillation therapy is the mainstay of prophylaxis of tumor recurrence and progression in non-muscle-invasive bladder cancer. However, there is no study evaluating the superiority of monotherapy. The aim of this study is to compare the efficacy of preventing recurrence and progression of intravesical monotherapies via network meta-analysis (NMA) of randomized controlled trials. Database searches were conducted on Embase, Ovid Medline, Web of Science, ScienceDirect, Cochrane Library, and ClinicalTrials.com from the time of establishment to February 6, 2020. The monotherapies included Bacille Calmette-Guérin (BCG), mitomycin C (MMC), interferon (IFN), adriamycin, epirubicin, gemcitabine (GEM), and thiotepa (THP). A Bayesian consistency network model was generated under a random-effects model. The superiority of therapy was identified based on the surface under the cumulative ranking curve (SUCRA). Fifty-seven studies with 12462 patients are included. NMA shows that GEM (SUCRA = 0.92), BCG (SUCRA = 0.82), and IFN (SUCRA = 0.78) are the top three effective drugs to reduce recurrence. GEM (SUCRA = 0.87) is the most effective therapy to prevent progress, followed by BCG, MMC, THP, and IFN with similar efficacy. Subgroup analysis of pairwise meta-analysis and NMA was performed on publication year, trial initiation year, study origin, center involvement, sample size, drug schedule, tumor characteristics, and trial quality to address confounding factors, which suggests the robustness of the results with stable effect sizes. Network meta-regression also indicates consistent rank by analyzing year, sample size, and quality. Compared with BCG, GEM is also a promising therapy with favorable efficacy to reduce tumor recurrence and progression. IFN and MMC could be alternative therapies for BCG with slightly inferior efficacy in recurrence prevention and similar efficacy in progression prevention. However, the results of this study should be treated with caution since most of the included studies are of moderate to high risk of bias.
Topics: Administration, Intravesical; Antineoplastic Agents; Clinical Trials as Topic; Disease Progression; Humans; Neoplasm Metastasis; Neoplasm Recurrence, Local; Network Meta-Analysis; Progression-Free Survival; Risk Assessment; Risk Factors; Time Factors; Urinary Bladder Neoplasms
PubMed: 33040478
DOI: 10.1002/cam4.3513 -
British Journal of Cancer Sep 2014Peritoneal carcinomatosis (PC) of colorectal cancer (CRC) origin is associated with poor outcome. This systematic review evaluates the available evidence about adjuvant... (Review)
Review
BACKGROUND
Peritoneal carcinomatosis (PC) of colorectal cancer (CRC) origin is associated with poor outcome. This systematic review evaluates the available evidence about adjuvant (hyperthermic) intraperitoneal chemotherapy ((H)IPEC) to prevent the development of PC.
METHODS
A systematic search of literature was conducted in August 2013 in PubMed, Embase, and the Cochrane database for studies on (H)IPEC to prevent PC in patients who underwent curative surgery for primary CRC.
RESULTS
Seven comparative studies and five cohort studies were selected. Treatment schedules varied between repeated fluoropyrimidine-based IPEC administration in the ambulatory setting to intra-operative (H)IPEC procedures using mitomycin-C or oxaliplatin. The reported rates of major complications related to adjuvant (H)IPEC was low. Four out of five evaluable comparative studies reported a significant difference in the incidence of PC in favour of (H)IPEC. All three comparative studies reporting on survival after intra-operative (H)IPEC showed a significant survival benefit in favour of the experimental arm. Substantial heterogeneity in patient selection, treatment protocols, and treatment effect evaluation among studies was observed.
CONCLUSIONS
The currently available evidence about adjuvant (H)IPEC in high-risk CRC is limited and subject to bias, but points towards improved oncological outcome and supports further randomised studies.
Topics: Ambulatory Care; Antineoplastic Combined Chemotherapy Protocols; Carcinoma; Chemotherapy, Adjuvant; Chemotherapy, Cancer, Regional Perfusion; Colorectal Neoplasms; Humans; Hyperthermia, Induced; Infusions, Parenteral; Intraoperative Care; Peritoneal Neoplasms; Survival Rate
PubMed: 25025964
DOI: 10.1038/bjc.2014.369 -
Medical Archives (Sarajevo, Bosnia and... Jun 2022Bladder cancer is still a burden on the world of oncology medicine, which every year affects about 3.4 million people globally with 430,000 new cases per year. It is the... (Meta-Analysis)
Meta-Analysis
Comparison Between Intravesical Chemotherapy Epirubicin and Mitomycin-C after TURB vs TURB Alone With Recurrence Rate of Non-Muscle Invasive Bladder Cancer: Meta-Analysis.
BACKGROUND
Bladder cancer is still a burden on the world of oncology medicine, which every year affects about 3.4 million people globally with 430,000 new cases per year. It is the fourth most common cancer in men and eighth most common women malignancy in the world. This makes bladder cancer a "silent killer" and it needs appropriate treatment planning. Single immediate instillation of chemotherapy after transurethral resection of the bladder (TURB) is recommended by EAU guideline, but its use remains a controversy.
OBJECTIVE
Study aimed to analyze benefit of intravesical chemotherapy following TURB in terms of recurrency of non-muscle invasive bladder cancer (NMIBC).
METHODS
Systematic review and meta-analysis of randomized controlled trials comparing the efficacy of a single instillation after TURB with TURB alone in NMIBC (pTa-pT1) patients was conducted. Studies searched throughout Medline, PubMed, Embase, and Cochrane in December 2018. Keywords were intravesical chemotherapy, combination, transurethral resection, bladder cancer. Inclusion criteria were RCT studies, subjects in study were treated single immediate chemotherapy instillation after TURB compared to TURB alone in patient with pTa-pT1 urothelial carcinoma of the bladder. Trials with additional treatment prior to first reccurence were not eligible. Studies using recurrence rate as dependent variable. From 361 studies, in total 11 studies were eligible for this meta-analysis.
RESULTS
From those 11 studies, it is shown that intravesical chemotherapy using Epirubicin and Mitomycin-C following TURB showed significant decrease of recurrence rate of bladder cancer even to progression of the disease compared to TURB alone (p<0.05) with pooled Risk Ratio were 0.69 and pooled heterogeneity (I) were 26.6%.
CONCLUSION
This meta-analysis study showed that combination therapy of intravesical chemotherapy after TURB is superior to TURB alone in showing the recurrence rate of NMIBC.
Topics: Administration, Intravesical; Carcinoma, Transitional Cell; Epirubicin; Female; Humans; Male; Mitomycin; Neoplasm Recurrence, Local; Randomized Controlled Trials as Topic; Urinary Bladder Neoplasms
PubMed: 36200115
DOI: 10.5455/medarh.2022.76.198-201 -
The Cochrane Database of Systematic... Apr 2020Nasolacrimal duct obstruction (NLDO) is a condition that results in the overflow of tears (epiphora) or infection of the nasolacrimal sac (dacryocystitis). The etiology... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Nasolacrimal duct obstruction (NLDO) is a condition that results in the overflow of tears (epiphora) or infection of the nasolacrimal sac (dacryocystitis). The etiology of acquired NLDO is multifactorial and is not fully understood. Dacryocystorhinostomy (DCR) is the surgical correction of NLDO, which aims to establish a new drainage pathway between the lacrimal sac and the nose. The success of DCR is variable; the most common cause of failure is fibrosis and stenosis of the surgical ostium. Antimetabolites such as mitomycin-C (MMC) and 5-fluorouracil (5-FU) have been shown to be safe and effective in reducing fibrosis and improving clinical outcomes in other ophthalmic surgery settings (e.g. glaucoma and cornea surgery). Application of antimetabolites at the time of DCR has been studied, but the utility of these treatments remains uncertain.
OBJECTIVES
Primary objective: To determine if adjuvant treatment with antimetabolites improves functional success in the setting of DCR compared to DCR alone. Secondary objectives: To determine if anatomic success of DCR is increased with the use of antimetabolites, and if the surgical ostium is larger in participants treated with antimetabolites.
SEARCH METHODS
We searched the Cochrane Register for Controlled Trials (CENTRAL) (which contains the Cochrane Eye and Vision Trials Register) (2019, Issue 9), Ovid MEDLINE, Embase.com, PubMed, LILACS (Latin American and Caribbean Health Sciences Literature database), ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic searches. We last searched the electronic databases on 6 September 2019.
SELECTION CRITERIA
We only included randomized controlled trials. Eligible studies were those that compared the administration of antimetabolites of any dose and concentration versus placebo or another active treatment in participants with NLDO undergoing primary DCR and reoperation. We only included studies that had enrolled adults 18 years or older. We also included studies that used silicone intubation as part of the DCR procedure.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Two review authors independently screened the search results, assessed risk of bias, and extracted data from the included studies using an electronic data collection form.
MAIN RESULTS
We included 31 studies in the review, of which 23 (1309 participants) provided data relating to our primary and secondary outcomes. Many of the 23 studies evaluated functional success, while others also assessed our secondary outcomes of anatomic success or ostium size, or both. Study characteristics Participant characteristics varied across studies, with the age of participants ranging from 30 to 70 years. Participants were predominantly women. These demographics correspond to those most frequently affected by nasolacrimal duct obstruction. Almost all of the studies utilized MMC as the antimetabolite, with only one using 5-FU. We assessed most trials as at unclear risk of bias for most domains. Conflicts of interest were not frequently reported, although the antimetabolites used are generic medications, and studies were not likely to be conducted for financial interest. Findings Twenty studies provided data on the primary outcome of functional success, of which 7 (356 participants) provided data at 6 months and 14 (909 participants) provided data beyond 6 months. At six months, the results showed no evidence of effect of antimetabolite on functional success (risk ratio (RR) 1.12, 95% confidence interval (CI) 0.98 to 1.29; low-certainty evidence). Beyond six months, the results favored the antimetabolite group (RR 1.15, 95% CI 1.07 to 1.25; moderate-certainty evidence). Fourteen studies reported data on the secondary outcome of anatomic success, of which 4 (306 participants) reported data at 6 months and 12 (831 participants) provided data beyond 6 months. Results at six months showed no evidence of effect of antimetabolite on anatomic success (RR 1.02, 95% CI 0.95 to 1.11; low-certainty evidence). Beyond six months, participants in the antimetabolite group were more likely to achieve anatomic success than those receiving DCR alone (RR 1.09, 95% CI 1.04 to 1.15; moderate-certainty evidence). At six months and beyond six months follow-up, two studies reported mean change in ostium size. We did not conduct meta-analysis for the various follow-up periods due to clinical, methodological, and statistical heterogeneity. However, point estimates from these studies at six months consistently favored participants in the antimetabolite group (low-certainty evidence). Beyond six months, while point estimates from one study favored participants in the antimetabolite group, estimates from another study showed no evidence of a difference between the two groups. The certainty of evidence at both time points was low. Adverse events Adverse events were rare. One study reported that one participant in the MMC group experienced delayed wound healing. Other studies reported no significant adverse events related to the application of antimetabolites.
AUTHORS' CONCLUSIONS
There is moderate-certainty evidence that application of antimetabolites at the time of DCR increases functional and anatomic success of DCR when patients are followed for more than six months after surgery, but no evidence of a difference at six months, low-certainty of evidence. There is low-certainty evidence that combining antimetabolite with DCR increases the size of the lacrimal ostium at six months. However, beyond six months, the evidence remain uncertain. Adverse effects of the application of antimetabolites were minimal.
Topics: Antimetabolites; Chemotherapy, Adjuvant; Combined Modality Therapy; Dacryocystorhinostomy; Female; Follow-Up Studies; Humans; Lacrimal Duct Obstruction; Male; Mitomycin; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome
PubMed: 32259290
DOI: 10.1002/14651858.CD012309.pub2 -
Acta Ophthalmologica Sep 2021To evaluate the anti-haze effect and visual outcome after intraoperative mitomycin C (MMC) use during photorefractive keratectomy (PRK) in myopia or myopic astigmatism... (Meta-Analysis)
Meta-Analysis
PURPOSE
To evaluate the anti-haze effect and visual outcome after intraoperative mitomycin C (MMC) use during photorefractive keratectomy (PRK) in myopia or myopic astigmatism patients.
METHODS
We searched in PubMed, EMBASE, Cochrane Library and Google Scholar comprehensively to obtain studies comparing the clinical effects after PRK with and without MMC published until February 2020. Meta-analysis of primary outcome (corneal haze rate) and secondary outcomes [predictability, efficacy, safety and corneal endothelial cell density (ECD)] were conducted. We used trial sequential analysis (TSA) in an effort to collect firm evidence supporting our conclusion.
RESULTS
Of the included 11 randomized controlled trials, five cohort and one case-control studies, 3536 eyes (2232 and 1304 in the MMC and control groups, respectively) were enrolled for meta-analysis. The TSA disclosed strong evidence of decline in corneal haze rate in the MMC group compared with that of the control group. In the subgroup analysis of duration, MMC seemed to reduce corneal haze rate in early-onset and late-onset haze. Predictability of refraction and visual acuity were greater in the MMC groups, not significantly though. The proportion of patients losing at least two lines of best corrected visual acuity postoperatively in the MMC groups was lower than that in the control groups. The corneal postoperative ECD showed no significant difference between the MMC and control groups.
CONCLUSION
Our meta-analysis revealed that MMC is an important anti-haze agent in PRK for reducing both early- and late-onset haze and can also help improving predictability of refraction and subjective postoperative visual acuity.
Topics: Corneal Opacity; Cross-Linking Reagents; Humans; Mitomycin; Myopia; Photorefractive Keratectomy; Postoperative Complications; Refraction, Ocular; Visual Acuity
PubMed: 33326173
DOI: 10.1111/aos.14704 -
Medicine Jun 2019To evaluate the efficacy and safety of trabeculectomy (Trab) with mitomycin-C (MMC) versus Trab with implant. (Meta-Analysis)
Meta-Analysis
AIM
To evaluate the efficacy and safety of trabeculectomy (Trab) with mitomycin-C (MMC) versus Trab with implant.
METHODS
Studies published in different languages were retrieved by systematically searching Embase, PubMed, Cochrane library, China Biology Medicine disc, and Google Scholar from 1966 to April 2018, as well as manually examining the references of the original articles. The outcome measures of efficacy covered intraocular pressure, glaucoma medications reductions, and success rate. Safety evaluation was measured by relative ratio of complications.
RESULTS
A total of 11 studies involving 443 participants were covered in this meta-analysis. The weighted mean difference (WMD) in the percentage of intraocular pressure (IOP) reduction (IOPR%) comparing Ologen group with MMC group was -3.69 (95% CI: -6.70 to -0.68) at 1 month, -2.69 (-5.17 to -0.21) at 3 months, -3.67 (-6.09 to -1.25)at 6 months, -3.24 (-6.08 to -0.41) at 12 months, 1.24 (-9.43 to 11.90) at 24 months, and 1.10 (-10.11 to 12.31) at 60 months, which showed that there was statistically significant difference at 1,3, 6, and12 months after the surgery. A significantly higher incidence of postsurgery hypotony (0.64 (95% Cl: 0.42 to 0.98)) and suture lysis (0.30 (95% CI: 0.10-0.93)) was observed in MMC group. However, there was no significant difference in the reduction in glaucoma medications, success rate, and incidence of other complications.Trab with 0.2 mg/mL MMC presented higher rates of complete success compared with Trab with 0.4 mg/mL MMC (P = .01).
CONCLUSION
Trab with MMC was associated with a higher IOP-lowering efficacy and a higher incidence of postsurgery hypotony and suture lysis in contrast to that of Trab with Ologen.
Topics: Collagen; Glycosaminoglycans; Humans; Mitomycin; Prostheses and Implants; Trabeculectomy
PubMed: 31232951
DOI: 10.1097/MD.0000000000016094 -
The Cochrane Database of Systematic... Jan 2020People with urothelial carcinoma of the bladder are at risk for recurrence and progression following transurethral resection of a bladder tumour (TURBT). Mitomycin C... (Meta-Analysis)
Meta-Analysis
BACKGROUND
People with urothelial carcinoma of the bladder are at risk for recurrence and progression following transurethral resection of a bladder tumour (TURBT). Mitomycin C (MMC) and Bacillus Calmette-Guérin (BCG) are commonly used, competing forms of intravesical therapy for intermediate- or high-risk non-muscle invasive (Ta and T1) urothelial bladder cancer but their relative merits are somewhat uncertain.
OBJECTIVES
To assess the effects of BCG intravesical therapy compared to MMC intravesical therapy for treating intermediate- and high-risk Ta and T1 bladder cancer in adults.
SEARCH METHODS
We performed a systematic literature search in multiple databases (CENTRAL, MEDLINE, Embase, Web of Science, Scopus, LILACS), as well as in two clinical trial registries. We searched reference lists of relevant publications and abstract proceedings. We applied no language restrictions. The latest search was conducted in September 2019.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that compared intravesical BCG with intravesical MMC therapy for non-muscle invasive urothelial bladder cancer.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened the literature, extracted data, assessed risk of bias and rated the quality of evidence according to GRADE per outcome. In the meta-analyses, we used the random-effects model.
MAIN RESULTS
We identified 12 RCTs comparing BCG versus MMC in participants with intermediate- and high-risk non-muscle invasive bladder tumours (published from 1995 to 2013). In total, 2932 participants were randomised. Time to death from any cause: BCG may make little or no difference on time to death from any cause compared to MMC (hazard ratio (HR) 0.97, 95% confidence interval (CI) 0.79 to 1.20; participants = 1132, studies = 5; 567 participants in the BCG arm and 565 in the MMC arm; low-certainty evidence). This corresponds to 6 fewer deaths (40 fewer to 36 more) per 1000 participants treated with BCG at five years. We downgraded the certainty of the evidence two levels due to study limitations and imprecision. Serious adverse effects: 12/577 participants treated with BCG experienced serious non-fatal adverse effects compared to 4/447 participants in the MMC group. The pooled risk ratio (RR) is 2.31 (95% CI 0.82 to 6.52; participants = 1024, studies = 5; low-certainty evidence). Therefore, BCG may increase the risk for serious adverse effects compared to MMC. This corresponds to nine more serious adverse effects (one fewer to 37 more) with BCG. We downgraded the certainty of the evidence two levels due to study limitations and imprecision. Time to recurrence: BCG may reduce the time to recurrence compared to MMC (HR 0.88, 95% CI 0.71 to 1.09; participants = 2616, studies = 11, 1273 participants in the BCG arm and 1343 in the MMC arm; low-certainty evidence). This corresponds to 41 fewer recurrences (104 fewer to 29 more) with BCG at five years. We downgraded the certainty of the evidence two levels due to study limitations, imprecision and inconsistency. Time to progression: BCG may make little or no difference on time to progression compared to MMC (HR 0.96, 95% CI 0.73 to 1.26; participants = 1622, studies = 6; 804 participants in the BCG arm and 818 in the MMC arm; low-certainty evidence). This corresponds to four fewer progressions (29 fewer to 27 more) with BCG at five years. We downgraded the certainty of the evidence two levels due to study limitations and imprecision. Quality of life: we found very limited data for this outcomes and were unable to estimate an effect size.
AUTHORS' CONCLUSIONS
Based on our findings, BCG may reduce the risk of recurrence over time although the Confidence Intervals include the possibility of no difference. It may have no effect on either the risk of progression or risk of death from any cause over time. BCG may cause more serious adverse events although the Confidence Intervals once again include the possibility of no difference. We were unable to determine the impact on quality of life. The certainty of the evidence was consistently low, due to concerns that include possible selection bias, performance bias, given the lack of blinding in these studies, and imprecision.
Topics: Administration, Intravesical; Antibiotics, Antineoplastic; BCG Vaccine; Carcinoma, Transitional Cell; Humans; Mitomycin; Randomized Controlled Trials as Topic; Treatment Outcome; Urinary Bladder Neoplasms
PubMed: 31912907
DOI: 10.1002/14651858.CD011935.pub2 -
The Cochrane Database of Systematic... Apr 2019Glaucoma affects more than 70 million people worldwide, with about 10% being bilaterally blind, making it the leading cause of irreversible blindness globally. In...
BACKGROUND
Glaucoma affects more than 70 million people worldwide, with about 10% being bilaterally blind, making it the leading cause of irreversible blindness globally. In patients with advanced glaucoma or those who have failed medical treatment without achieving adequate intraocular pressure (IOP) control, trabeculectomy (glaucoma filtration surgery where an ostium is created into the anterior chamber from underneath a partial thickness scleral flap to allow for aqueous flow out of the anterior chamber intointo the subconjunctival space forming a filtering bleb) and aqueous shunt surgery for more complex and refractory cases remain the mainstay therapies. Proliferation of fibrous tissue around an implanted aqueous shunt may block the diffusion of aqueous humour. Mitomycin C (MMC) is one of two commonly used adjunct antifibrotic agents used during aqueous shunt surgery to prevent proliferation of fibrous tissue. However, the effectiveness and safety of the use of intraoperative MMC during aqueous shunt surgery has not been established.
OBJECTIVES
To evaluate the effectiveness and safety of MMC versus no MMC used during aqueous shunt surgery for reducing IOP in primary and secondary glaucoma.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2018, Issue 2); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Sciences Literature Database (LILACS); ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 13 February 2018.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) in which one group of participants received MMC during aqueous shunt surgery and another group did not. We did not exclude studies based on outcomes.
DATA COLLECTION AND ANALYSIS
Two review authors independently reviewed titles and abstracts from the literature searches. We obtained full-text reports of potentially relevant studies and assessed them for inclusion. Two review authors independently extracted data related to study characteristics, risk of bias, and outcomes. We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We included five RCTs, with a total of 333 eyes with glaucoma randomized, and identified two ongoing trials. All included trials examined the effect of MMC versus no MMC when used during aqueous shunt surgery for glaucoma. The trials included participants with different types of uncontrolled glaucoma. One study was conducted in China, one in Saudi Arabia, two in the USA, and one study was a multicenter study conducted in Brazil, Canada, Scotland, and USA. We assessed all trials as having overall unclear risk of bias due to incomplete reporting of study methods and outcomes; two of the five trials were reported only as conference abstracts.None of the included trials reported mean decrease from baseline in IOP; however, all five trials reported mean IOP at 12 months post-surgery. At 12 months, the effect of MMC on mean IOP compared with no MMC was unclear based on a meta-analysis of trials (mean difference -0.12 mmHg, 95% CI -2.16 to 2.41; low-certainty evidence). Two trial did not report sufficient information to include in meta-analysis, but reported that mean IOP was lower in the MMC group compared with the no MMC group at 12 months.None of the included trials reported mean change from baseline in visual acuity; however, one trial reported lower mean LogMAR values (better vision) in the MMC group than in the no MMC group at 12 months post-surgery. None of the included studies reported the proportion of participants with stable best-corrected visual acuity. Three trials reported that loss of vision was not significantly different between groups (no data available for meta-analysis).None of the included studies reported the proportion of participants with a postoperative hypertensive phase, which is defined as IOP > 21 mmHg within 3 months after surgery. Two trials reported adverse events (choroidal effusion, corneal edema, flat anterior chamber, and retinal detachment); however, due to small numbers of events and sample sizes, no clear difference between MMC and placebo groups was observed.
AUTHORS' CONCLUSIONS
We found insufficient evidence in this review to suggest MMC provides any postoperative benefit for glaucoma patients who undergo aqueous shunt surgery. Data across all five included trials were sparse and the reporting of study methods required to assess bias was inadequate. Future RCTs of this intervention should report methods in sufficient detail to permit assessment of potential bias and estimate target sample sizes based on clinically meaningful effect sizes.
Topics: Glaucoma; Glaucoma Drainage Implants; Humans; Mitomycin; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 30999387
DOI: 10.1002/14651858.CD011875.pub2 -
Frontiers in Pharmacology 2020The introduction of cytoreductive surgery (CRS) followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with either oxaliplatin or mitomycin C for patients with...
Genetic Variants in DNA Repair Pathways as Potential Biomarkers in Predicting Treatment Outcome of Intraperitoneal Chemotherapy in Patients With Colorectal Peritoneal Metastasis: A Systematic Review.
BACKGROUND
The introduction of cytoreductive surgery (CRS) followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with either oxaliplatin or mitomycin C for patients with colorectal peritoneal metastasis (CPM) has resulted in a major increase in overall survival. Nonetheless, despite critical patient selection, the majority of patients will develop recurrent disease within one year following CRS + HIPEC. Therefore, improvement of patient and treatment selection is needed and may be achieved by the incorporation of genetic biomarkers. This systematic review aims to provide an overview of genetic biomarkers in the DNA repair pathway that are potentially predictive for treatment outcome of patients with colorectal peritoneal metastases treated with CRS + HIPEC with oxaliplatin or mitomycin C.
METHODS
A systematic review was conducted according to the PRISMA guidelines. Given the limited number of genetic association studies of intraperitoneal mitomycin C and oxaliplatin in patients with CPM, we expanded the review and extrapolated the data from biomarker studies conducted in colorectal cancer patients treated with systemic mitomycin C- and oxaliplatin-based chemotherapy.
RESULTS
In total, 43 papers were included in this review. No study reported potential pharmacogenomic biomarkers in patients with colorectal cancer undergoing mitomycin C-based chemotherapy. For oxaliplatin-based chemotherapy, a total of 26 genetic biomarkers within 14 genes were identified that were significantly associated with treatment outcome. The most promising genetic biomarkers were rs11615, rs1043953, rs13181, rs17655, rs3783819/rs973063/rs4151330, MMR status, ATM protein expression, tandem repeat D17S5, and rs2233678.
CONCLUSION
Several genetic biomarkers have proven predictive value for the treatment outcome of systemically administered oxaliplatin. By extrapolation, these genetic biomarkers may also be predictive for the efficacy of intraperitoneal oxaliplatin. This should be the subject of further investigation.
PubMed: 33117169
DOI: 10.3389/fphar.2020.577968