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The Cochrane Database of Systematic... Nov 2020Basal cell carcinoma (BCC) is the commonest cancer affecting white-skinned individuals, and worldwide incidence is increasing. Although rarely fatal, BCC is associated... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Basal cell carcinoma (BCC) is the commonest cancer affecting white-skinned individuals, and worldwide incidence is increasing. Although rarely fatal, BCC is associated with significant morbidity and costs. First-line treatment is usually surgical excision, but alternatives are available. New published studies and the development of non-surgical treatments meant an update of our Cochrane Review (first published in 2003, and previously updated in 2007) was timely.
OBJECTIVES
To assess the effects of interventions for BCC in immunocompetent adults.
SEARCH METHODS
We updated our searches of the following databases to November 2019: Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and LILACS.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of interventions for BCC in immunocompetent adults with histologically-proven, primary BCC. Eligible comparators were placebo, active treatment, other treatments, or no treatment.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Primary outcome measures were recurrence at three years and five years (measured clinically) (we included recurrence data outside of these time points if there was no measurement at three or five years) and participant- and observer-rated good/excellent cosmetic outcome. Secondary outcomes included pain during and after treatment, early treatment failure within six months, and adverse effects (AEs). We used GRADE to assess evidence certainty for each outcome.
MAIN RESULTS
We included 52 RCTs (26 new) involving 6690 participants (median 89) in this update. All studies recruited from secondary care outpatient clinics. More males than females were included. Study duration ranged from six weeks to 10 years (average 13 months). Most studies (48/52) included only low-risk BCC (superficial (sBCC) and nodular (nBCC) histological subtypes). The majority of studies were at low or unclear risk of bias for most domains. Twenty-two studies were industry-funded: commercial sponsors conducted most of the studies assessing imiquimod, and just under half of the photodynamic therapy (PDT) studies. Overall, surgical interventions have the lowest recurrence rates. For high-risk facial BCC (high-risk histological subtype or located in the facial 'H-zone' or both), there may be slightly fewer recurrences with Mohs micrographic surgery (MMS) compared to surgical excision (SE) at three years (1.9% versus 2.9%, respectively) (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.16 to 2.64; 1 study, 331 participants; low-certainty evidence) and at five years (3.2% versus 5.2%, respectively) (RR 0.61, 95% CI 0.18 to 2.04; 1 study, 259 participants; low-certainty evidence). However, the 95% CI also includes the possibility of increased risk of recurrence and no difference between treatments. There may be little to no difference regarding improvement of cosmetic outcomes between MMS and SE, judged by participants and observers 18 months post-operatively (one study; low-certainty evidence); however, no raw data were available for this outcome. When comparing imiquimod and SE for nBCC or sBCC at low-risk sites, imiquimod probably results in more recurrences than SE at three years (16.4% versus 1.6%, respectively) (RR 10.30, 95% CI 3.22 to 32.94; 1 study, 401 participants; moderate-certainty evidence) and five years (17.5% versus 2.3%, respectively) (RR 7.73, 95% CI 2.81 to 21.3; 1 study, 383 participants; moderate-certainty evidence). There may be little to no difference in the number of participant-rated good/excellent cosmetic outcomes (RR 1.00, 95% CI 0.94 to 1.06; 1 study, 326 participants; low-certainty evidence). However, imiquimod may result in greater numbers of good/excellent cosmetic outcomes compared to SE when observer-rated (60.6% versus 35.6%, respectively) (RR 1.70, 95% CI 1.35 to 2.15; 1 study, 344 participants; low-certainty evidence). Both cosmetic outcomes were measured at three years. Based on one study of 347 participants with high- and low-risk primary BCC of the face, radiotherapy may result in more recurrences compared to SE under frozen section margin control at three years (5.2% versus 0%, respectively) (RR 19.11, 95% CI 1.12 to 325.78; low-certainty evidence) and at four years (6.4% versus 0.6%, respectively) (RR 11.06, 95% CI 1.44 to 84.77; low-certainty evidence). Radiotherapy probably results in a smaller number of good participant- (RR 0.76, 95% CI 0.63 to 0.91; 50.3% versus 66.1%, respectively) or observer-rated (RR 0.48, 95% CI 0.37 to 0.62; 28.9% versus 60.3%, respectively) good/excellent cosmetic outcomes compared to SE, when measured at four years, where dyspigmentation and telangiectasia can occur (both moderate-certainty evidence). Methyl-aminolevulinate (MAL)-PDT may result in more recurrences compared to SE at three years (36.4% versus 0%, respectively) (RR 26.47, 95% CI 1.63 to 429.92; 1 study; 68 participants with low-risk nBCC in the head and neck area; low-certainty evidence). There were no useable data for measurement at five years. MAL-PDT probably results in greater numbers of participant- (RR 1.18, 95% CI 1.09 to 1.27; 97.3% versus 82.5%) or observer-rated (RR 1.87, 95% CI 1.54 to 2.26; 87.1% versus 46.6%) good/excellent cosmetic outcomes at one year compared to SE (2 studies, 309 participants with low-risk nBCC and sBCC; moderate-certainty evidence). Based on moderate-certainty evidence (single low-risk sBCC), imiquimod probably results in fewer recurrences at three years compared to MAL-PDT (22.8% versus 51.6%, respectively) (RR 0.44, 95% CI 0.32 to 0.62; 277 participants) and five years (28.6% versus 68.6%, respectively) (RR 0.42, 95% CI 0.31 to 0.57; 228 participants). There is probably little to no difference in numbers of observer-rated good/excellent cosmetic outcomes at one year (RR 0.98, 95% CI 0.84 to 1.16; 370 participants). Participant-rated cosmetic outcomes were not measured for this comparison. AEs with surgical interventions include wound infections, graft necrosis and post-operative bleeding. Local AEs such as itching, weeping, pain and redness occur frequently with non-surgical interventions. Treatment-related AEs resulting in study modification or withdrawal occurred with imiquimod and MAL-PDT.
AUTHORS' CONCLUSIONS
Surgical interventions have the lowest recurrence rates, and there may be slightly fewer recurrences with MMS over SE for high-risk facial primary BCC (low-certainty evidence). Non-surgical treatments, when used for low-risk BCC, are less effective than surgical treatments, but recurrence rates are acceptable and cosmetic outcomes are probably superior. Of the non-surgical treatments, imiquimod has the best evidence to support its efficacy. Overall, evidence certainty was low to moderate. Priorities for future research include core outcome measures and studies with longer-term follow-up.
Topics: Adult; Aminolevulinic Acid; Antineoplastic Agents; Carcinoma, Basal Cell; Cryotherapy; Female; Humans; Imiquimod; Immunocompetence; Laser Therapy; Male; Mohs Surgery; Neoplasm Recurrence, Local; Photochemotherapy; Photosensitizing Agents; Radiotherapy; Randomized Controlled Trials as Topic; Skin Neoplasms; Treatment Outcome
PubMed: 33202063
DOI: 10.1002/14651858.CD003412.pub3 -
Acta Dermato-venereologica Jan 2021A systematic literature review was conducted to identify and qualitatively assess randomized controlled trials in immunocompetent patients ≥ 18 years with head-... (Meta-Analysis)
Meta-Analysis
A systematic literature review was conducted to identify and qualitatively assess randomized controlled trials in immunocompetent patients ≥ 18 years with head- region lesions of actinic keratoses who were treated with field-directed, lesion-directed and other therapies. Network meta-analysis was used to quantitatively evaluate field-directed therapies (5-fluorouracil formulations, diclofenac sodium, imiquimod, ingenol mebutate, 5-aminolevulinic acid or methyl aminolevulinate plus photodynamic therapy) using complete clearance or partial clearance of actinic keratoses lesions, and adverse event-related withdrawals as a proxy of acceptability. Of 2,863 references identified, 75 trials reported in 151 publications were included. In summary, comparative network meta-analysis evaluation showed that 5-fluorouracil formulations were the most efficacious interventions examined. 5-fluorouracil 4%, which was recently approved, showed a comparable efficacy profile to 5-fluorouracil 5%, and had satisfactory acceptability outcomes.
Topics: Diterpenes; Humans; Imiquimod; Keratosis, Actinic; Network Meta-Analysis; Photochemotherapy; Treatment Outcome
PubMed: 33170301
DOI: 10.2340/00015555-3690 -
BMC Oral Health Nov 2020Photodynamic therapy (PDT) is a new option for oral lichen planus (OLP) management; however, there are different opinions on the efficacy of PDT for OLP. The aim of this... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Photodynamic therapy (PDT) is a new option for oral lichen planus (OLP) management; however, there are different opinions on the efficacy of PDT for OLP. The aim of this study was to comprehensively assess the efficacy of PDT in the treatment of OLP and compare PDT with steroid therapy.
METHODS
A systematic review and meta-analysis were conducted to assess the curative effect of PDT. Five electronic databases were searched, PubMed, Web of Science, the Cochrane Library, Embase, and EBSCO up to 1 December, 2019. Random and fixed effects models for pooled estimates calculation were used and the Meta package of R was applied.
RESULTS
Pooled estimates revealed that, after PDT, the lesion size decreased by 1.53 cm (95% confidence interval (CI): 0.71-2.35) after PDT and the partial response (PR) was 0.77 (95% CI: 0.65-0.85). The visual analogue scale (VAS) score decreased by 3.82 (95% CI: 2.80-4.85) and the Thongprasom sign score decreased by 1.33 (95% CI: 0.56-2.10) after PDT. Subgroup analyses revealed that the 5-aminolevulinic acid (5-ALA) was more effective than methylene blue (MB), with a PR of 0.87 (95% CI: 0.80-0.91). The topical use of 5-ALA yielded a better response than gargling methylene blue. In terms of VAS, the diode laser showed a better clinical PR in the treatment of OLP. In terms of changes in lesion size, the efficacy of the semiconductor laser was higher than that of the diode laser. PDT had a similar efficacy to topical corticosteroids, as shown by pooled estimates of five randomised controlled trials with 139 lesions.
CONCLUSION
This systematic review indicates that PDT is an effective treatment modality for the management of OLP. PDT is as effective as topical corticosteroid in the treatment of OLP and could be used for cases resistant to steroids or when steroids are contraindicated.
Topics: Humans; Lasers, Semiconductor; Lichen Planus, Oral; Photochemotherapy; Treatment Outcome
PubMed: 33148217
DOI: 10.1186/s12903-020-01260-x -
The Cochrane Database of Systematic... Aug 2020Occupational lead exposure can lead to serious health effects that range from general symptoms (depression, generalised ache, and digestive signs, such as loss of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Occupational lead exposure can lead to serious health effects that range from general symptoms (depression, generalised ache, and digestive signs, such as loss of appetite, stomach ache, nausea, diarrhoea, and constipation) to chronic conditions (cerebrovascular and cardiovascular diseases, cognitive impairment, kidney disease, cancers, and infertility). Educational interventions may contribute to the prevention of lead uptake in workers exposed to lead, and it is important to assess their effectiveness.
OBJECTIVES
To assess the effect of educational interventions for preventing lead uptake in workers exposed to lead.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, CINAHL, and OSH UPDATE to 5 June 2020, with no language restrictions.
SELECTION CRITERIA
We sought randomised controlled trials (RCT), cluster-RCTs (cRCT), interrupted time series (ITS), controlled before-after studies (CBA) and uncontrolled before-after studies that examined the effects of an educational intervention aimed at preventing lead exposure and poisoning in workers who worked with lead, for which effectiveness was measured by lead levels in blood and urine, blood zinc protoporphyrin levels and urine aminolevulinic acid levels.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened the search results, assessed studies for eligibility, and extracted data using standard Cochrane methods. We used the ROBINS-I tool to assess the risk of bias, and GRADE methodology to assess the certainty of the evidence.
MAIN RESULTS
We did not find any RCT, cRCT, ITS or CBA studies that met our criteria. We included four uncontrolled before-after studies studies, conducted between 1982 and 2004. Blood lead levels Educational interventions may reduce blood lead levels, but the evidence is very uncertain. In the short-term after the educational intervention, blood lead levels may decrease (mean difference (MD) 9.17 µg/dL, 95% confidence interval (CI) 4.14 to 14.20; one study with high baseline blood lead level, 18 participants; very low-certainty evidence). In the medium-term, blood lead levels may decrease (MD 3.80 µg/dL, 95% CI 1.48 to 6.12; one study with high baseline blood lead level, 34 participants; very low-certainty evidence). In the long-term, blood lead levels may decrease when the baseline blood lead levels are high (MD 8.08 µg/dL; 95% CI 3.67 to 12.49; two studies, 69 participants; very low-certainty evidence), but not when the baseline blood lead levels are low (MD 1.10 µg/dL, 95% CI -0.11 to 2.31; one study, 52 participants, very low-certainty evidence). Urine lead levels In the long-term, urinary lead levels may decrease after the educational intervention, but the evidence is very uncertain (MD 42.43 µg/L, 95% CI 29.73 to 55.13; one study, 35 participants; very low-certainty evidence). Behaviour change The evidence is very uncertain about the effect of educational intervention on behaviour change. At medium-term follow-up after the educational intervention, very low-certainty evidence from one study (89 participants) found inconclusive results for washing before eating (risk ratio (RR) 1.71, 95% CI 0.42 to 6.91), washing before drinking (RR 1.37, 95% CI 0.61 to 3.06), and not smoking in the work area (RR 1.04, 95% CI 0.74 to 1.46). Very low-certainty evidence from one study (21 participants) suggested that employers may improve the provision of fit testing for all respirator users (RR 1.87, 95% CI 1.16 to 3.01), and prohibit eating, drinking, smoking, and other tobacco use in the work area (RR 4.25, 95% CI 1.72 to 10.51), however, the results were inconclusive for the adequate provision of protective clothing (RR 1.40, 95% CI 0.82 to 2.40). At long-term follow-up, very low-certainty evidence from one study (89 participants) suggested that workers may improve washing before drinking (RR 3.24, 95% CI 1.09 to 9.61), but results were inconclusive for washing before eating (RR 11.71, 95% CI 0.66 to 208.33), and for not smoking in the work area (RR 1.56, 95% CI 0.98 to 2.50). Very low-certainty evidence from one study (21 participants) suggested that employers may improve the provision of fit testing for all respirator users (RR 1.70, 95% CI 1.09 to 2.63), may provide adequate protective clothing (RR 2.80, 95% CI 1.23 to 6.37), and may prohibit eating, drinking, smoking, and other tobacco use in the work area (RR 2.13, 95% CI 1.19 to 3.81). Improved knowledge or awareness of the adverse health effects of lead The evidence is very uncertain about the effect of educational intervention on workers' knowledge. At medium-term follow-up, questionnaires found that workers' knowledge may improve (MD 5.20, 95% CI 3.29 to 7.11; one study, 34 participants; very low-certainty evidence). At long-term follow-up, there may be an improvement in workers' knowledge (MD 5.80, 95% CI 3.89 to 7.71; one study, 34 participants; very low-certainty evidence), but results were inconclusive for employers' knowledge (RR 1.67, 95% CI 0.74 to 3.75; one study, 21 participants; very low-certainty evidence). None of the studies measured the other outcomes of interest: blood zinc protoporphyrin levels, urine aminolevulinic acid levels, air lead levels, and harms. One study provided the costs of each component of the intervention.
AUTHORS' CONCLUSIONS
Educational interventions may prevent lead poisoning in workers with high baseline blood lead levels and urine lead levels but this is uncertain. Educational interventions may not prevent lead poisoning in workers with low baseline blood lead levels but this is uncertain.
PubMed: 35819457
DOI: 10.1002/14651858.CD013097.pub2 -
Dermatology Online Journal Mar 2020New treatment options for warts include intralesional wart injection with agents such as vitamin D, measles, mumps, and rubella (MMR) vaccine antigen, Bacillus...
BACKGROUND
New treatment options for warts include intralesional wart injection with agents such as vitamin D, measles, mumps, and rubella (MMR) vaccine antigen, Bacillus Calmette-Guerin (BCG) antigen, and candida antigen but there have been limited studies to compare their efficacies.
OBJECTIVE
The purpose of this systematic review is to compare the efficacy and safety of injectable agents used for the treatment of warts.
METHODS
A PubMed search included terms "intralesional wart therapy," "wart injection" and "verruca injection." Articles reviewed were published over 10 years.
RESULTS
A total of 43 articles were reviewed; 30 covered studies with more than 10 participants and 13 were case reports, case series, and reviews. In comparison studies intralesional agents have equal or superior efficacy (66%-94.9%) compared to first-line salicylic acid or cryotherapy (65.5-76.5%). One advantage of intralesional injections is the rate of complete resolution of distant warts.
LIMITATIONS
Each study varied in their agents, treatment interval, and treatment dose, making comparisons difficult.
CONCLUSIONS
Intralesional wart injections are safe, affordable, and efficacious treatments for warts. Physicians should consider intralesional injections for patients with refractory warts, multiple warts, or warts in sensitive areas.
Topics: Aminolevulinic Acid; Anti-Bacterial Agents; Antiviral Agents; BCG Vaccine; Bacterial Vaccines; Humans; Injections, Intralesional; Interferon-alpha; Mycobacterium; Tuberculin; Vitamin D; Warts
PubMed: 32609439
DOI: No ID Found -
Advanced Drug Delivery Reviews Jan 2020This review analyses physical drug delivery enhancement technologies with a focus on improving UV damaged skin, actinic keratoses and non-melanoma skin cancer treatment....
This review analyses physical drug delivery enhancement technologies with a focus on improving UV damaged skin, actinic keratoses and non-melanoma skin cancer treatment. In recent years, physical drug delivery enhancement has been shown to enhance cosmeceutical and skin cancer treatment efficacy, but there are pros and cons to each approach which we discuss in detail. Mechanisms of action, clinical efficacy, experimental design, outcomes in academic publications, clinical trial reports and patents are explored to evaluate each technology with a critical, translation focused lens. We conclude that the commercial success of cosmeceutical applications, e.g. microneedles, will drive further innovation in this arena that will impact how actinic keratoses and non-melanoma skin cancers are clinically managed.
Topics: Administration, Cutaneous; Clinical Trials as Topic; Cosmetic Techniques; Dermatologic Agents; Drug Delivery Systems; Humans; Iontophoresis; Keratosis, Actinic; Laser Therapy; Microinjections; Skin; Skin Aging; Skin Neoplasms; Ultrasonography; Ultraviolet Rays
PubMed: 32339593
DOI: 10.1016/j.addr.2020.04.008 -
European Urology Focus Jul 2021The main challenge in radical prostatectomy is complete excision of malignant tissue, while preserving continence and erectile function. Positive surgical margins (PSMs)... (Review)
Review
CONTEXT
The main challenge in radical prostatectomy is complete excision of malignant tissue, while preserving continence and erectile function. Positive surgical margins (PSMs) occur in up to 38% of cases, are associated with tumour recurrences, and may result in debilitating additional therapies. Despite surgical developments for prostate cancer (PCa), no technology is yet implemented to assess surgical margins of the entire prostatic surface intraoperatively.
OBJECTIVE
The aim of this systematic review is to provide an overview of novel imaging methods developed for intraoperative margin assessment in PCa surgery, which are compared with standard postoperative histopathology.
EVIDENCE ACQUISITION
A literature search of the last 10 yr was conducted in the Scopus, PubMed, and Embase (Ovid) databases. Eligible articles had to report the PSM rate according to their intraoperative margin assessment technology in comparison with standard histopathology.
EVIDENCE SYNTHESIS
The search resulted in 616 original articles, of which 11 were included for full-text review. The main technical developments in PCa margin assessment included optical coherence tomography, photodynamic diagnosis with 5-aminolevulinic acid, spectroscopy, and enhanced microscopy. These techniques are described and their main advantages, limitations, and applications in the clinical setting are discussed.
CONCLUSIONS
Several imaging methods are suggested in literature for the detection of positive margins during PCa surgery. Despite promising qualifications of the mentioned technologies, many struggle to find implementation in the clinic. Surgical conditions hampering the signal, long imaging times, and comparison with histopathology are mutual challenges. The next step towards reduction of PSMs in PCa surgery includes evaluation of these technologies in large clinical trials.
PATIENT SUMMARY
In this review, new technologies are reported that can assist the surgeon by detecting insufficient removal of all tumorous tissue during surgery, instead of the standard postoperative histopathological assessment. Currently, it is not clear whether these technologies improve the patient outcome directly; however, the review shows potential future implementations.
Topics: Humans; Male; Margins of Excision; Neoplasm Recurrence, Local; Prostate; Prostatectomy; Technology
PubMed: 32088139
DOI: 10.1016/j.euf.2020.02.004 -
BMJ Open Oct 2019To explore the diagnostic performance of image technique based transurethral resection for bladder cancer, with white light-guided cystoscopy (WLC) as the reference... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To explore the diagnostic performance of image technique based transurethral resection for bladder cancer, with white light-guided cystoscopy (WLC) as the reference standard.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
PubMed/MEDLINE, Web of Science, the Cochrane Library, Central Register of Controlled Trials and Embase from inception to 31 March 2018.
METHODS
Included studies reported the diagnostic performance of photodynamic diagnosis (PDD) with 5-aminolevulinic acid (5-ALA), PDD with hexaminolevulinic acid (HAL) or narrow band imaging (NBI), with WLC as the reference standard at the patient or lesion level. The studies' risk of bias (RoB) was assessed using Quality Assessment of Diagnostic Studies-2. Data were pooled using a random effect diagnostic meta-analysis, and subgroup analyses were performed.
RESULTS
Twenty-six studies comprising a total of 3979 patients were included in this diagnostic meta-analysis. Pooled sensitivity (SSY), specificity (SPY), diagnostic OR (DOR) and area under the receiver operating characteristic curve (AUROC) values were calculated per group for NBI, HAL and 5-ALA at the lesion or patient level. NBI showed significant diagnostic superiority compared with WLC at the lesion level (SSY 0.94, 95% CI 0.82 to 0.98; SPY 0.79, 95% CI 0.73 to 0.85; DOR 40.09, 95% CI 20.08 to 80.01; AUROC 0.88, 95% CI 0.85 to 0.91). NBI presented the highest DOR (358.71, 95% CI 44.50 to 2891.71) in the patient level. Subgroup analyses were performed on studies with low to moderate RoB and at least 100 patients at the lesion level. These results were consistent with those of the overall analysis.
CONCLUSIONS
Pooled data indicated that image technique based transurethral resection (NBI, HAL and 5-ALA) showed diagnostic superiority compared with WLC. Moreover, NBI is potentially the most promising diagnostic intervention, showing the best diagnostic performance outcomes. Further prognostic outcomes of novel imaging technologies compared with those WLC should be explored in addition to current diagnostic performance analysis.
Topics: Aminolevulinic Acid; Cystoscopy; Humans; Image Interpretation, Computer-Assisted; Narrow Band Imaging; Photosensitizing Agents; Urinary Bladder Neoplasms
PubMed: 31628123
DOI: 10.1136/bmjopen-2018-028173 -
Frontiers in Oncology 2019High-grade glioma (HGG) is associated with a dismal prognosis despite significant advances in adjuvant therapies, including chemotherapy, immunotherapy, and...
High-grade glioma (HGG) is associated with a dismal prognosis despite significant advances in adjuvant therapies, including chemotherapy, immunotherapy, and radiotherapy. Extent of resection continues to be the most important independent prognosticator of survival. This underlines the significance of increasing gross total resection (GTR) rates by using adjunctive intraoperative modalities to maximize resection with minimal neurological morbidity. 5-aminolevulinic acid (5-ALA) is the only US Food and Drug Administration-approved intraoperative optical agent used for fluorescence-guided surgical resection of gliomas. Despite several studies on the impact of intra-operative 5-ALA use on the extent of HGG resection, a clear picture of how such usage affects patient survival is still unavailable. A systematic review was conducted of all relevant studies assessing the GTR rate and survival outcomes [overall survival (OS) and progression-free survival (PFS)] in HGG. A meta-analysis of eligible studies was performed to assess the influence of 5-ALA-guided resection on improving GTR, OS, and PFS. GTR was defined as >95% resection. Of 23 eligible studies, 19 reporting GTR rates were included in the meta-analysis. The pooled cohort had 998 patients with HGG, including 796 with newly diagnosed cases. The pooled GTR rate among patients with 5-ALA-guided resection was 76.8% (95% confidence interval, 69.1-82.9%). A comparative subgroup analysis of 5-ALA-guided vs. conventional surgery (controlling for within-study covariates) showed a 26% higher GTR rate in the 5-ALA subgroup (odds ratio, 3.8; < 0.001). There were 11 studies eligible for survival outcome analysis, 4 of which reported PFS. The pooled mean difference in OS and PFS was 3 and 1 months, respectively, favoring 5-ALA vs. control ( < 0.001). This meta-analysis shows a significant increase in GTR rate with 5-ALA-guided surgical resection, with a higher weighted GTR rate (~76%) than the pivotal phase III study (~65%). Pooled analysis showed a small yet significant increase in survival measures associated with the use of 5-ALA. Despite the statistically significant results, the low level of evidence and heterogeneity across these studies make it difficult to conclusively report an independent association between 5-ALA use and survival outcomes in HGG. Additional randomized control studies are required to delineate the role of 5-ALA in survival outcomes in HGG.
PubMed: 31380272
DOI: 10.3389/fonc.2019.00620 -
International Journal of Oral Science Apr 2019With recent developments in photosensitizers and light delivery systems, topical 5-aminolevulinic acid-mediated photodynamic therapy (ALA-PDT) has become the fourth...
With recent developments in photosensitizers and light delivery systems, topical 5-aminolevulinic acid-mediated photodynamic therapy (ALA-PDT) has become the fourth alternative therapeutic approach in the management of oral leucoplakia (OLK) due to its minimally invasive nature, efficacy, and low risk of systemic side effects and disfigurement. This report presents step-by-step guidelines for applying topical ALA-PDT in the management of OLK based on both the clinical experience of the authors and a systematic review of the current literature. Studies using protocols with standardized parameters and randomized clinical trials at multiple centres with adequate sample sizes and both interim and long-term follow-ups are needed before universally applicable guidelines can be produced in this field.
Topics: Aminolevulinic Acid; Humans; Leukoplakia, Oral; Photochemotherapy; Photosensitizing Agents; Practice Guidelines as Topic
PubMed: 30971683
DOI: 10.1038/s41368-019-0047-0