Efficacy of Photodynamic Therapy for the Treatment of Bowen’s Disease: A Meta-Analysis of Randomized Controlled Trials

Dermatology ◽  
2021 ◽  
pp. 1-9
Author(s):  
Wen-Li Xue ◽  
Jia-Qi Ruan ◽  
Hong-Ye Liu ◽  
Hong-Xia He
Keyword(s):  
Photodynamic Therapy ◽  
Response Rate ◽  
Complete Response Rate ◽  
Meta Analysis ◽  
Complete Response ◽  
Risk Of Bias ◽  
Bowen’S Disease ◽  
Bowen's Disease ◽  
Randomized Controlled ◽  
Significant Difference

<b><i>Background:</i></b> Photodynamic therapy is an established treatment option for Bowen’s disease. Our meta-analysis was aimed at evaluating the efficacy and recurrence of photodynamic therapy or other topical treatments (5-fluorouracil, cryotherapy) and of photodynamic therapy alone or in combination with other therapies (ablative fractional CO<sub>2</sub> laser or plum-blossom needle) for the treatment of Bowen’s disease. <b><i>Methods:</i></b> Trials that met our inclusion criteria were identified from PubMed, EMBASE, Web of Science, and Cochrane Library databases, and meta-analyses were conducted with RevMan V.5.4. The risk of bias was estimated with the Cochrane Collaboration’s risk of bias tools. Complete response rate, recurrence, pain/visual analogue scale score, cosmetic outcome, and adverse events were considered as outcomes. <b><i>Results:</i></b> Of the 2,439 records initially retrieved, 8 randomized controlled trials were included in this meta-analysis. According to our analyses, photodynamic therapy exhibited a significantly higher complete response rate (RR = 1.36, 95% CI [1.01, 1.84], <i>I</i><sup>2</sup> = 86%, <i>p</i> = 0.04), less recurrence (RR = 0.53, 95% CI [0.30, 0.95], <i>I</i><sup>2</sup> = 0%, <i>p</i> = 0.03), and better cosmetic outcome (RR = 1.34, 95% CI [1.15, 1.56], <i>I</i><sup>2</sup> = 0%, <i>p</i> = 0.0002) compared with other treatments. Moreover, there was a significant difference between the complete response rate of photodynamic therapy combined with ablative fractional CO<sub>2</sub> laser and that of photodynamic therapy (RR = 1.85, 95% CI [1.38, 2.49], <i>I</i><sup>2</sup> = 0%, <i>p</i> &#x3c; 0.0001). Photodynamic therapy combined with ablative fractional CO<sub>2</sub> laser or plum-blossom needle also showed significantly less recurrence (RR = 0.21, 95% CI [0.09, 0.51], <i>I</i><sup>2</sup> = 0%, <i>p</i> = 0.0005) and a lower visual analogue scale score (RR = 0.51, 95% CI [0.06, 0.96], <i>I</i><sup>2</sup> = 0%, <i>p</i> = 0.03) than photodynamic therapy alone. However, there was no significant difference in the complete response rate between photodynamic therapy combined with ablative continuous CO<sub>2</sub> laser and photodynamic therapy combined with ablative fractional CO<sub>2</sub> laser (RR = 1.00, 95% CI [0.54, 1.86], <i>I</i><sup>2</sup> not applicable, <i>p</i> = 1.00). <b><i>Conclusions:</i></b> This meta-analysis shows that photodynamic therapy can be used in the treatment of Bowen’s disease with better efficacy, less recurrence, and better cosmetic outcomes than cryotherapy and 5-FU. Some methods, including ablative fractional CO<sub>2</sub> laser, can be applied in combination with photodynamic therapy to improve efficacy. However, which laser-assisted photodynamic therapy scheme has the most advantages in the treatment of Bowen’s disease warrants further exploration.

scholarly journals Ablation Therapy Combined with EGFR TKIs in the Treatment of Advanced Non-Small Cell Lung Cancer: A Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Lu-Zhen Li ◽  
Jia-Ming Wu ◽  
Ting Chen ◽  
Liang-Chen Zhao ◽  
Juan-Na Zhuang ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Response Rate ◽  
Complete Response Rate ◽  
Meta Analysis ◽  
Complete Response ◽  
Small Cell ◽  
Small Cell Lung ◽  
Ablation Therapy ◽  
Randomized Controlled ◽  
Egfr Tkis

Objective. Systematically evaluate the efficacy of physical ablation combined with TKI in the treatment of advanced non-small cell lung cancer (NSCLC). Methods. We performed a comprehensive search of databases including OVID, PubMed, EMBASE, the Cochrane Library, and three Chinese databases (China National Knowledge Infrastructure, Wanfang Database, and Chongqing Weipu Database). The aim was to identify randomized controlled trials (RCT) investigating physical ablation as the treatment for advanced NSCLC. We also evaluated the methodological quality of the included studies and summarized the data extracted for meta-analysis with Review Manager 5.3. Results. A total of 9 studies, including 752 patients, were evaluable. The meta-analysis results show that the complete response rate (CRR) (RR: 2.23, 95% CI: 1. 46 to 3.40, P 0.01), partial response rate (PRR) (RR: −2.25, 95% CI: 1.41 to 3.59, P 0.01), and disease control rate (DCR) (RR: −2.80, 95% CI: 1.64 to 4.80, P < 0.01) of patients with advanced NSCLC who received physical ablation combined with TKI therapy were higher than those who did not receive physical ablation therapy. The control groups from seven of the studies had a total of 606 patients with targeted therapies and chemotherapy. The complete response rate was (CRR) (RR: 2.48, 2.4895% CI: 1.55 to 2.47, P 0.01), partial response rate (PRR) (RR: −1.66, 95% CI: 1.20 to 2.31, P < 0.01), and disease control rate (DCR) (RR: −2.68, 95% CI: 1.41 to 5.06, P < 0.01) for patients with advanced NSCLC who had received physical ablation combined with targeted therapies and chemotherapy, compared to patients who had not received physical ablation therapy. This difference was statistically significant. Above all, these results showed that the clinical efficacy of physical ablation combined EGFR-TKIs therapy (regardless of whether it was combined with chemotherapy) was better than that of EGFR-TKIs therapy alone. Conclusion. Physical ablation combined with TKI treatment in patients with advanced NSCLC can improve efficacy.

scholarly journals A New Light-Emitting, Fabric-Based Device for Photodynamic Therapy of Actinic Keratosis: Protocol for a Randomized, Controlled, Multicenter, Intra-Individual, Phase II Noninferiority Study (the Phosistos Study) (Preprint)

2018 ◽  
Author(s):  
Anne-Sophie Vignion-Dewalle ◽  
Henry Abi Rached ◽  
Elise Thecua ◽  
Fabienne Lecomte ◽  
Pascal Deleporte ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Phase Ii ◽  
Actinic Keratosis ◽  
Response Rate ◽  
Complete Response Rate ◽  
Red Light ◽  
Complete Response ◽  
Light Emitting ◽  
Randomized Controlled ◽  
Individual Phase

BACKGROUND Actinic keratosis (AK) is a common early in situ skin carcinoma caused by long-term sun exposure and usually develops on sun-exposed skin areas. Left untreated, AK may progress to squamous cell carcinoma. To prevent such risk, most clinicians routinely treat AK. Therapy options for AK include cryotherapy, topical treatments, curettage, excision surgery, and photodynamic therapy (PDT). OBJECTIVE The aim of this study is to assess the noninferiority, in terms of efficacy at 3 months, of a PDT protocol involving a new light-emitting device (PDT using the Phosistos protocol [P-PDT]) compared with the conventional protocol (PDT using the conventional protocol [C-PDT]) in the treatment of AK. METHODS In this randomized, controlled, multicenter, intra-individual, phase II noninferiority clinical study, subjects with AK of the forehead and scalp are treated with P-PDT on one area and with C-PDT on the contralateral area. In both areas, lesions are prepared and methyl aminolevulinate (MAL) is applied. Thirty minutes after MAL application, the P-PDT area is exposed to red light at low irradiance (1.3 mW/cm2) for 2.5 hours so that a light dose of 12 J/cm2 is achieved. In the control area (C-PDT area), a 37 J/cm2 red light irradiation is performed 3 hours after MAL application. Recurrent AK at 3 months is retreated. The primary end point is the lesion complete response rate at 3 months. Secondary end points include pain scores at 1 day, local tolerance at 7 days, lesion complete response rate at 6 months, cosmetic outcome at 3 and 6 months, and patient-reported quality of life and satisfaction throughout the study. A total of 45 patients needs to be recruited. RESULTS Clinical investigations are complete: 46 patients were treated with P-PDT on one area (n=285 AK) and with C-PDT on the contralateral area (n=285 AK). Data analysis is ongoing, and statistical results will be available in the first half of 2019. CONCLUSIONS In case of noninferiority in efficacy and superiority in tolerability of P-PDT compared with C-PDT, P-PDT could become the treatment of choice for AK. CLINICALTRIAL ClinicalTrials.gov NCT03076892; https://clinicaltrials.gov/ct2/show/NCT03076892 (Archived by WebCite at http://www.webcitation.org/779qqVKek) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12990

scholarly journals Safety and Efficacy Analysis of Selinexor-Based Treatment in Multiple Myeloma, a Meta-Analysis Based on Prospective Clinical Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Yali Tao ◽  
Hui Zhou ◽  
Ting Niu
Keyword(s):  
Multiple Myeloma ◽  
Partial Response ◽  
Adverse Events ◽  
Response Rate ◽  
Complete Response Rate ◽  
Meta Analysis ◽  
Complete Response ◽  
Cochrane Central Register ◽  
Safety And Efficacy ◽  
Grade 3

Background: Selinexor (SEL) is an orally bioavailable, highly-selective, and slowly-reversible small molecule that inhibits Exportin 1. Preclinical studies showed that SEL had synergistic antimyeloma activity with glucocorticoids, proteasome inhibitors (PIs) and immunomodulators. The combination of selinexor and dexamethasone (DEX) has been approved in the United States for patients with penta-refractory multiple myeloma in July 2019. This meta-analysis aimed to investigate the safety and efficacy of selinexor based treatment in Multiple myeloma.Methods: We systematically searched the Medline (PubMed), Embase, Web of Science, Cochrane Central Register of Controlled Trials Library databases and ClinicalTrials.gov. Outcome measures of efficacy included overall response rate (ORR), clinical benefit rate (CBR), stringent complete response rate (sCR), complete response rate (CR), very good partial response (VGPR), partial response rate (PR), minimal response (MR), rate of stable disease (SDR), rate of progressive disease (PDR) and median progression-free survival (mPFS). Safety was evaluated by the incidences of all grade adverse events and Grade≥3 adverse events. The subgroup analysis was conducted to analyze the difference in different combination treatment regimens (SEL + DEX + PIs vs SEL + DEX).Results: We included six studies with 477 patients. The pooled ORR, CBR, sCR, CR, VGPR, PR, MR, SDR, and PDR were 43% (18–67%), 55% (32–78%), 5% (−2–13%), 7% (4–11%), 14% (5–24%), 23% (15–31%), 11% (8–14%), 26% (14–38%) and 14% (4–23%), respectively. SEL + DEX + PIs treatment had higher ORR (54 vs 24%, p = 0.01), CBR (66 vs 37%, p = 0.01), sCR (10 vs 2%, p = 0.0008), and VGPR (23 vs 5%, p &lt; 0.00001) compared to SEL + DEX treatment, and lower PDR (4 vs 23%, p &lt; 0.00001) and SDR (17 vs 37%, p = 0.0006). The pooled incidences of any grade and grade≥3 were 45 and 30% in hematological AEs, and in non-hematological AEs were 40 and 30%, respectively. The most common all grade (68%) and grade≥3 (54%) hematological AE were both thrombocytopenia. Fatigue was the most common all grade (62%) and grade≥3 (16%) non-hematological AE. Compared to SEL + DEX treatment, SEL + DEX + PIs treatment had lower incidences of hyponatremia (39 vs 12%, p &lt; 0.00001), nausea (72 vs 52%, p &lt; 0.00001), vomiting (41 vs 23%, p &lt; 0.0001), and weight loss (42 vs 17%, p = 0.03) in all grade AEs. Meanwhile, SEL + DEX + PIs treatment had lower incidences of anemia (36 vs 16%, p = 0.02), fatigue (20 vs 13%, p = 0.04), hyponatremia (22 vs 5%, p &lt; 0.0001) than SEL + DEX treatment in grade≥3 AEs.Conclusion: Our meta-analysis revealed that selinexor-based regimens could offer reasonable efficacy and tolerable adverse events in patients with multiple myeloma. SEL + DEX + PIs treatments had higher efficacy and lower toxicities than SEL + DEX.

scholarly journals Mapping the preclinical to clinical evidence and development trajectory of the oncolytic virus talimogene laherparepvec (T-VEC): a systematic review

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e029475 ◽  
Author(s):  
Manoj Lalu ◽  
Garvin J Leung ◽  
Yuan Yi Dong ◽  
Joshua Montroy ◽  
Claire Butler ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Studies ◽  
Clinical Evidence ◽  
Response Rate ◽  
Complete Response Rate ◽  
Complete Response ◽  
Risk Of Bias ◽  
Preclinical Studies ◽  
Talimogene Laherparepvec ◽  
Development Trajectory

ObjectiveThis study aimed to conduct a systematic review of preclinical and clinical evidence to chart the successful trajectory of talimogene laherparepvec (T-VEC) from the bench to the clinic.DesignThis study was a systematic review. The primary outcome of interest was the efficacy of treatment, determined by complete response. Abstract and full-text selection as well as data extraction were done by two independent reviewers. The Cochrane risk of bias tool was used to assess the risk of bias in studies.SettingEmbase, Embase Classic and OvidMedline were searched from inception until May 2016 to assess its development trajectory to approval in 2015.ParticipantsPreclinical and clinical controlled comparison studies, as well as observational studies.InterventionsT-VEC for the treatment of any malignancy.Results8852 records were screened and five preclinical (n=150 animals) and seven clinical studies (n=589 patients) were included. We saw large decreases in T-VEC’s efficacy as studies moved from the laboratory to patients, and as studies became more methodologically rigorous. Preclinical studies reported complete regression rates up to 100% for injected tumours and 80% for contralateral tumours, while the highest degree of efficacy seen in the clinical setting was a 24% complete response rate, with one study experiencing a complete response rate of 0%. We were unable to reliably assess safety due to the lack of reporting, as well as the heterogeneity seen in adverse event definitions. All preclinical studies had high or unclear risk of bias, and all clinical studies were at a high risk of bias in at least one domain.ConclusionsOur findings illustrate that even successful biotherapeutics may not demonstrate a clear translational road map. This emphasises the need to consider increasing rigour and transparency along the translational pathway.PROSPERO registration numberCRD42016043541.

scholarly journals Efficacy and Safety of the Combination Treatment of Rituximab and Dexamethasone for Adults with Primary Immune Thrombocytopenia (ITP): A Meta-Analysis

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Jia Wang ◽  
Ya Li ◽  
Chong Wang ◽  
Yayue Zhang ◽  
Chong Gao ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Combination Treatment ◽  
Immune Thrombocytopenia ◽  
Response Rate ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Primary Immune Thrombocytopenia

Objective.To conduct a meta-analysis, assessing the efficacy and safety of the combination treatment of dexamethasone and rituximab for adults with ITP (primary immune thrombocytopenia).Methods.Randomized controlled trials that compared rituximab and dexamethasone combination treatment to dexamethasone monotherapy in the treatment of adults with ITP were collected by searching Pubmed, Embase, Cochrane, China National Knowledge (CNKI), Wanfang database, and Sino Med. We conducted pooled analyses on OR (overall response) rate, CR (complete response) rate, PR (partial response) rate, SR (sustained response) rate, R (relapse) rate, change in Treg cell count (mean [SD]), and AE (adverse event). GRADE pro scale was used to assess the quality of the evidence. Publication bias was assessed with Egger’s test method.Results.A total of 11 randomized controlled trials were eligible for inclusion. The overall efficacy estimates favored combination arm in terms of OR rate at month 3, CR rate at week 4 and month 3, SR rate, and Treg cell count at week 2. Subgroup analysis showed that females obtained a higher OR rate than males did at week 4. No significant difference was found in pooled analysis of relapse rate between combination arm and monotherapy arm. The comparison of serious AE and other AEs showed no significant difference either. A total of 19 outcomes were assessed by GRADE pro software, of which 79% (15/19) was scaled as moderate-to-high level. Publication bias existed in studies on OR at week 4 (P=0.025), CR at week 4 (P=0.017), infection (P=0.006), and rash (P=0.028) of the AEs.Conclusion.Dexamethasone combined with rituximab can provide a better long-term response in the treatment of adults with ITP and will not increase the risk of adverse effects.

scholarly journals Is reiki or prayer effective in relieving pain during hospitalization for cesarean? A systematic review and meta-analysis of randomized controlled trials

2017 ◽  
Vol 135 (2) ◽  
pp. 123-132 ◽  
Author(s):  
Guilherme Augusto Rago Ferraz ◽  
Meline Rosseto Kron Rodrigues ◽  
Silvana Andrea Molina Lima ◽  
Marcelo Aparecido Ferraz Lima ◽  
Gabriela Lopes Maia ◽  
...  
Keyword(s):  
Systematic Review ◽  
High Risk ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Spiritual Healing ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Section Design

ABSTRACT CONTEXT AND OBJECTIVE: This systematic review compared reiki and prayer with drug use for relieving pain during hospitalization for cesarean, given that the popularity of integrative medicine and spiritual healing has been increasing. It had the aim of evaluating whether reiki or prayer is effective in relieving pain during cesarean section. DESIGN AND SETTING: Systematic review with meta-analysis conducted at Botucatu Medical School, UNESP, São Paulo, Brazil. METHODS: The following databases were searched up to March 2016: MEDLINE, Embase, LILACS and CENTRAL. Randomized controlled trials published in English or Portuguese were included in the review. Two reviewers independently screened eligible articles, extracted data and assessed the risk of bias. A GRADE table was produced to evaluate the risk of bias. RESULTS: There was evidence with a high risk of bias showing a statistically significant decrease in pain score through use of reiki and prayer, in relation to the protocol group: mean difference = -1.68; 95% confidence interval: -1.92 to -1.43; P < 0.00001; I2 = 92%. Furthermore, there was no statistically significant difference in heart rate or systolic or diastolic blood pressure. CONCLUSION: Evidence with a high risk of bias suggested that reiki and prayer meditation might be associated with pain reduction.

scholarly journals Treatment of cutaneous lichen planus with ALA-mediated topical photodynamic therapy

2015 ◽  
Vol 08 (01) ◽  
pp. 1540004 ◽  
Author(s):  
Zhi-Xia Fan ◽  
Ling-Lin Zhang ◽  
Hong-Wei Wang ◽  
Pei-Ru Wang ◽  
Zheng Huang ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Side Effects ◽  
Lichen Planus ◽  
Clinical Assessment ◽  
Response Rate ◽  
Aminolevulinic Acid ◽  
Complete Response Rate ◽  
Complete Response ◽  
Chinese Patients

Purpose: To evaluate the effectiveness of topical 5-aminolevulinic acid (ALA)-mediated photodynamic therapy (PDT) for the treatment of cutaneous lichen planus (LP). Methods: A total of 17 symptomatic LP lesions in 7 Chinese patients were assessed. ALA cream (10%) was applied topically to LP lesions for 3 h. The lesions were irradiated with a 635 nm diode laser at the dose level of 100 J/cm2. The treatment was repeated at two-week intervals. Clinical assessment was conducted before each treatment. Follow-up was performed once a month for up to six months. Results: Lesions showed significant improvement after one to four courses of treatments. Complete response was achieved in 13 lesions (five patients) and partial remission in four lesions (two patients). The complete response rate was 71%. There was no significant side effects except the feeling of pain that most patients could tolerate. Follow-up of five patients who achieved complete response showed no signs of recurrence. Conclusion: Topical ALA PDT is effective in the treatment of cutaneous LP.

Dose-Dense Sequential Chemotherapy With Epirubicin and Paclitaxel Versus the Combination, as First-Line Chemotherapy, in Advanced Breast Cancer: A Randomized Study Conducted by the Hellenic Cooperative Oncology Group

2001 ◽  
Vol 19 (8) ◽  
pp. 2232-2239 ◽  
Author(s):  
George Fountzilas ◽  
Christos Papadimitriou ◽  
Urania Dafni ◽  
Dimitrios Bafaloukos ◽  
Dimosthenis Skarlos ◽  
...  
Keyword(s):  
Overall Response Rate ◽  
Response Rate ◽  
Complete Response Rate ◽  
Complete Response ◽  
First Line ◽  
Significant Difference ◽  
Group A ◽  
Dose Dense ◽  
Group B ◽  
Line Chemotherapy

PURPOSE: To compare the efficacy of two different schedules of epirubicin and paclitaxel, as first-line chemotherapy, in patients with advanced breast cancer (ABC). PATIENTS AND METHODS: From October 1997 until May 1999, 183 eligible patients with ABC entered the study. Chemotherapy in group A (93 patients) consisted of four cycles of epirubicin at a dose of 110 mg/m2 followed by four cycles of paclitaxel at a dose of 225 mg/m2 in a 3-hour infusion. All cycles were repeated every 2 weeks with granulocyte colony-stimulating factor support. The therapeutic regimen in group B (90 patients) consisted of epirubicin (80 mg/m2) immediately followed by paclitaxel (175 mg/m2 in a 3-hour infusion) every 3 weeks for six cycles. RESULTS: In total, 79 patients (85%) in group A and 72 patients (80%) in group B completed treatment. The median relative dose-intensity of epirubicin was 0.96 in both groups, and that of paclitaxel was 0.96 and 0.97 in groups A and B, respectively. The complete response rate was higher in group A (21.5% v 9% P = .02). Nevertheless, there was no significant difference in the overall response rate between the two groups (55% v 42%, P = .10). Severe neutropenia was more frequently observed with concurrent treatment. After a median follow-up of 16.5 months, median time to progression was 10 months in group A and 8.5 months in group B (P = .27), and median survival was 21.5 and 20 months, respectively (P = .17). CONCLUSION: The present study failed to demonstrate a significant difference in overall response rate between dose-dense sequential administration of epirubicin and paclitaxel compared with the combination of the two drugs given on the same day, even though the sequential treatment resulted in a significantly higher complete response rate.

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