Amifostine reduces side effects and improves complete response rate during radiotherapy: Results of a meta-analysis

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.

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Optimized duration of antituberculosis treatment for managing female genital tuberculosis: real-world experience from a high prevalence region in Eastern China

10.21203/rs.3.rs-55589/v3 ◽

2020 ◽

Author(s):

Jian Sun ◽

Wenjie Wang ◽

Jing Ding ◽

Yusheng Cheng ◽

Yunfeng Zhou ◽

...

Keyword(s):

Side Effects ◽

Response Rate ◽

Complete Response Rate ◽

Complete Response ◽

Single Side ◽

Female Genital Tuberculosis ◽

Group A ◽

Intent To Treat ◽

Group B ◽

Female Genital

Abstract Background Duration of antituberculosis therapy (ATT) for managing female genital tuberculosis (FGTB) is controversial with the intermittent regimen no more advocated. We therefore conducted a prospective, real-world research to compare 6 months and 9 months of ATT.Methods Between 2012 and 2018, 109 drug-susceptible patients newly diagnosed with FGTB and/or tuberculous peritonitis (genital, 13; peritoneal, 34; mixed, 62) received naïve treatment for 9-12 months and further 18-month follow-up. Data on disease features at baseline and long-term outcome (intent-to-treat) were compared between group A (aged 18-35 yr) and group B (aged 36-81 yr). Efficacy and side effects of treatment were compared within each group 6 months and 9 months from ATT initiation (per-protocol), respectively. Results In contrast to group B at baseline, group A had more clinical evidence predicting active tuberculosis (P < 0.05), severer performance of genital lesions and pelvic adhensions (P < 0.05), more signs of active pulmonary tuberculosis (P < 0.01), and less performance of only TBP (P < 0.01). Intent-to-treat analysis showed higher incidence of overall single side effects and poor compliance in group B (P < 0.05), and similar recurrence rate between 2 groups. Per-protocol analysis showed increased complete response rate (P < 0.01) and similar incidence of side effects (P > 0.05) in group A, similar complete response rate (P > 0.05) and increased incidence of overall single side effects (P < 0.05) in group B at 9-month duration.Conclusions Younger females with FGTB had a greater risk of systemic infection of tuberculosis compared to older ones. Nine-month ATT using daily therapy proved to be beneficial for younger patients at reproductive age. Six-month option was suitable for older patients for reducing side effects and poor compliance in the duration of treatment.

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

Frontiers in Pharmacology ◽

10.3389/fphar.2021.758992 ◽

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 < 0.00001) compared to SEL + DEX treatment, and lower PDR (4 vs 23%, p < 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 < 0.00001), nausea (72 vs 52%, p < 0.00001), vomiting (41 vs 23%, p < 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 < 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.

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Optimized duration of antituberculosis treatment for managing female genital tuberculosis: real-world experience from a high prevalence region in Eastern China

10.21203/rs.3.rs-55589/v1 ◽

2020 ◽

Author(s):

Jianghua Yang ◽

Jian Sun ◽

Wenjie Wang ◽

Jing Ding ◽

Yusheng Cheng ◽

...

Keyword(s):

Side Effects ◽

Response Rate ◽

Complete Response Rate ◽

Complete Response ◽

Single Side ◽

Female Genital Tuberculosis ◽

Group A ◽

Intent To Treat ◽

Group B ◽

Female Genital

Abstract Background Duration of antituberculosis therapy (ATT) for managing female genital tuberculosis (FGTB) is controversial with the intermittent regimen no more advocated. We therefore conducted a prospective, real-world research to compare 6 months and 9 months of ATT. Methods Between 2012 and 2018, 109 drug-susceptible patients newly diagnosed with FGTB and/or tuberculous peritonitis (genital, 13; peritoneal, 34; mixed, 62) received naïve treatment for 9–12 months and further 18-month follow-up. Data on disease features at baseline and long-term outcome (intent-to-treat) were compared between group A (aged 15–35 years) and group B (aged ≥ 36 years). Efficacy and side effects of treatment were compared within each group 6 months and 9 months from ATT initiation (per-protocol), respectively. Results In contrast to group B at baseline, group A had more clinical evidence predicting active tuberculosis (P < 0.05), severer performance of genital lesions and pelvic adhensions (P < 0.05), more signs of active pulmonary tuberculosis (P < 0.01), and less performance of only TBP (P < 0.01). Intent-to-treat analysis showed higher incidence of overall single side effects and poor compliance in group B (P < 0.05), and similar recurrence rate between 2 groups. Per-protocol analysis showed increased complete response rate (P < 0.01) and similar incidence of side effects (P > 0.05) in group A, similar complete response rate (P > 0.05) and increased incidence of overall single side effects (P < 0.05) in group B at 9-mo duration. Conclusions Younger females with FGTB had a greater risk of systemic infection of TB compared to older ones. Nine-month ATT using daily therapy proved to be beneficial for younger patients at reproductive age. Six-month option was suitable for older patients for improving the side effects and poor compliance in the duration of treatment.

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

Dermatology ◽

10.1159/000519319 ◽

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

Background: 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 CO2 laser or plum-blossom needle) for the treatment of Bowen’s disease. Methods: 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. Results: 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], I2 = 86%, p = 0.04), less recurrence (RR = 0.53, 95% CI [0.30, 0.95], I2 = 0%, p = 0.03), and better cosmetic outcome (RR = 1.34, 95% CI [1.15, 1.56], I2 = 0%, p = 0.0002) compared with other treatments. Moreover, there was a significant difference between the complete response rate of photodynamic therapy combined with ablative fractional CO2 laser and that of photodynamic therapy (RR = 1.85, 95% CI [1.38, 2.49], I2 = 0%, p < 0.0001). Photodynamic therapy combined with ablative fractional CO2 laser or plum-blossom needle also showed significantly less recurrence (RR = 0.21, 95% CI [0.09, 0.51], I2 = 0%, p = 0.0005) and a lower visual analogue scale score (RR = 0.51, 95% CI [0.06, 0.96], I2 = 0%, p = 0.03) than photodynamic therapy alone. However, there was no significant difference in the complete response rate between photodynamic therapy combined with ablative continuous CO2 laser and photodynamic therapy combined with ablative fractional CO2 laser (RR = 1.00, 95% CI [0.54, 1.86], I2 not applicable, p = 1.00). Conclusions: 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 CO2 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.

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

Journal of Innovative Optical Health Sciences ◽

10.1142/s1793545815400040 ◽

2015 ◽

Vol 08 (01) ◽

pp. 1540004 ◽

Cited By ~ 2

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.

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Combining cellular immunotherapy was an optional choice for unresectable advanced HCC: a systematic review and meta-analysis

10.21203/rs.3.rs-16730/v1 ◽

2020 ◽

Author(s):

Jing Wang ◽

Lingxin Feng ◽

Linwei Zhang

Keyword(s):

Overall Survival ◽

Subgroup Analysis ◽

Response Rate ◽

Complete Response Rate ◽

Meta Analysis ◽

Complete Response ◽

Cochrane Library ◽

Cellular Immunotherapy ◽

Advanced Hepatocellular Carcinoma ◽

Advanced Hcc

Abstract Background The efficacy of cellular immunotherapy in advanced hepatocellular carcinoma (HCC) was controversial. This study was conducted to compare the effectiveness of combining cellular immunotherapy with that of incurable treatment alone. Methods The Ovid Medline, Embase, Cochrane Library and Pubmed were systematically searched due to January 8th 2020. The keywords include “immunotherapy”, “HCC” and study type. Treatment response was evaluated and progression-free survival (PFS) and overall survival (OS) were calculated using hazard ratio (HR) and 95% confidence interval (CI). Results A total of 19 studies with 1,275 patients were included in the meta-analysis. The median complete response rate (CR) was 19% in combining cellular immunotherapy comparing to 9% in the control group (RR=0.55, P=0.003). No significant difference was found in partial response and stable disease (RR=1.06 and 0.78, P>0.05, respectively). The progression disease rate was higher in the non-cellular immunotherapy group (31%) compared to the cellular immunotherapy group (RR=2.20, P=0.002). Patients treating with cellular immunotherapy had a better OS and PFS compared to those without cellular immunotherapy (HR=0.52 and 0.63, P<0.001). In the subgroup analysis, the only CIK infusion therapy and combined DC with CIK perfusion therapy patients had a better OS (HR=0.52 and 0.49, P<0.001 and P=0.002, respectively). Conclusion Our results suggested that combining use of cellular immunotherapy in advanced HCC could increase the complete response rate, and thereafter extend the progression-free and overall survival rate. Subgroup analysis suggested that combining use of CIK and DC or using CIK alone could provide the benefit in survival outcome.

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Investigating the Efficacy and Safety of Thalidomide for Treating Patients With ß-Thalassemia: A Meta-Analysis

Frontiers in Pharmacology ◽

10.3389/fphar.2021.814302 ◽

2022 ◽

Vol 12 ◽

Author(s):

Yanfei Lu ◽

Zhenbin Wei ◽

Gaohui Yang ◽

Yongrong Lai ◽

Rongrong Liu

Keyword(s):

Blood Transfusion ◽

Confidence Interval ◽

Odds Ratio ◽

Overall Response Rate ◽

Response Rate ◽

Complete Response Rate ◽

Meta Analysis ◽

Globin Gene ◽

Complete Response ◽

Efficacy And Safety

At present, the main therapies for ß-thalassemia patients include regular blood transfusion and iron chelation, associating with a number of limitations. Thalidomide, a fetal hemoglobin (HbF) inducer that promotes γ-globin gene expression, has been reported to be effective for ß-thalassemia. Thus, this meta-analysis was conducted to assess the efficacy and safety of thalidomide for treating patients with ß-thalassemia. We searched the related studies from eight databases published from inception until December 1, 2021. The R 4.0.5 language programming was used to perform meta-analysis. After screening of retrieved articles, 12 articles were included that enrolled a total of 451 patients. The Cochrane Collaboration risk assessment tool was used to evaluate the quality and the bias risk of the randomized controlled trials (RCTs), and non randomized trials were assessed using Newcastle-Ottawa Scale (NOS). After treatment with thalidomide, the pooled overall response rate (ORR) was 85% (95% confidence interval (CI): 80–90%), and the pooled complete response rate (CRR) was 54% (95% confidence interval: 31–76%). Compared with the placebo group, the thalidomide group had higher odds of overall response rate (odds ratio = 20.4; 95% CI: 6.75–61.64) and complete response rate (odds ratio = 20.4; 95% CI: 6.75–61.64). A statistically significant increase in hemoglobin level and HbF level after treatment, while there was no statistically significant difference in adult hemoglobin (HbA) level, spleen size, and serum ferritin. According to the results of ORR and CRR, transfusion-dependent thalassemia (TDT) patients showed remarkable efficacy of thalidomide, 83 and 52% respectively. So we analyzed 30 transfusion-dependent thalassemia patients from three studies and found that the most frequent ß-globin gene mutations were CD41-42 (-TCTT), while response to thalidomide did not show any statistically significant relationship with XmnI polymorphism or CD41-42 (-TCTT) mutation. About 30% of patients experienced mild adverse effects of thalidomide. Collectively, thalidomide is a relatively safe and effective therapy to reduce the blood transfusion requirements and to increase Hb level in patients with ß-thalassemia.

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Olanzapine 5mg vs 10mg for the Prophylaxis of Chemotherapy-Induced Nausea and Vomiting – A Network Meta-Analysis

10.21203/rs.3.rs-318837/v1 ◽

2021 ◽

Author(s):

Ronald Chow ◽

Rudolph M Navari ◽

Bryan Terry ◽

Carlo DeAngelis ◽

Elizabeth Prsic

Keyword(s):

Response Rate ◽

Complete Response Rate ◽

Meta Analysis ◽

Complete Response ◽

Nausea And Vomiting ◽

Published Data ◽

General Activity ◽

Inadequate Information ◽

Likelihood Model ◽

Evaluation Of Data

Abstract Introduction: Olanzapine administered at a 10mg dosage for prophylaxis of chemotherapy-induced nausea and vomiting may be associated with fatigue, drowsiness and reduced general activity. Therefore, a 5mg dose may be preferred, to reduce the occurrence of adverse events. The aim of this study was to conduct a network meta-analysis, and report on the efficacy of olanzapine administered at 5mg, relative to when administered at 10 mg. Methods: We used previously-published data from the systematic review by Chow et al which identified 17 adult trials which used 10mg doses, 3 which used 5mg doses, and 1 which used a mix of 5 and 10mg doses. A multivariate network meta-analysis using a restricted maximum likelihood model was used. Results: The complete response rate in the acute phase is not statistically different, between 5mg and 10mg doses of olanzapine – RR 0.97, 95% CI: 0.83 – 1.13. Additionally, in the overall phase, 5mg olanzapine is similarly as efficacious as 10mg olanzapine – RR 0.95, 95% CI: 0.56 – 1.60. Evaluation of data demonstrated that there was inadequate information to compare the toxicities of the two doses. Conclusion: Our analyses support individual published trials, and the rationale for future trials to compare 5mg to 10mg olanzapine regimens in head-to-head comparisons.

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Role of Different Frontline Regimens in Achieving Complete Response in Follicular Lymphoma: A Meta-Analysis of CR Rate and Its Relation to Hazard Rate for Disease Progression.

Blood ◽

10.1182/blood.v108.11.2754.2754 ◽

2006 ◽

Vol 108 (11) ◽

pp. 2754-2754 ◽

Cited By ~ 2

Author(s):

M. Wayne Saville ◽

John P. Leonard ◽

John D. Hainsworth ◽

Mitchell R. Smith ◽

Mohamed Darif ◽

...

Keyword(s):

Disease Progression ◽

Response Rate ◽

Complete Response Rate ◽

Meta Analysis ◽

Random Effect ◽

Single Agent ◽

Complete Response ◽

Time To Event ◽

Effect Model ◽

Event Rates

Abstract There are limited data on the relative efficacy of initial therapies for follicular NHL, in part due to the large sample size and prolonged follow-up required for comparative trials of induction regimens, and now complicated by the use of maintenance rituximab. To gain perspective in the comparison of different induction regimens (separate from rituximab maintenance), we performed a meta-analysis of trials in frontline indolent NHL, focusing on the clinical outcome measure of complete response rate (CRR) and its relation to disease progression. A literature search of clinical trials in untreated follicular NHL published from 2001–2006 was performed on Medline, Embase, Current Contents, and Biosis. Baseline characteristics, ORRs, CRRs, and time-to-event rates (TTP, PFS, EFS) were extracted. Studies were included only if they reported follicular-specific data. Therapies were induction and/or consolidation therapy, excluding trials with rituximab maintenance. Treatment categories were chemotherapy combinations without fludarabine (CHEMO); rituximab as a single-agent or in combination with chemotherapy (R±CHEMO); fludarabine as a single-agent or in combination (FLU); and ibritumomab tiuxetan or tositumomab as single agents or in combination (RIT). The Kruskal-Wallis test was used to compare baseline characteristics. CRRs were analyzed using the fixed effect model (Mantel-Haenszel) and the random effect model (DerSimonain and Laird). Reported time-to-event rates required a conversion to a standard monthly event rate (HR), assuming an exponential distribution. The Pearson correlation (rho) between the CRR and HR was estimated. 32 treatments from 25 publications with 2421 patients met the inclusion criteria—8 CHEMO, 13 R±CHEMO, 5 FLU and 6 RIT. Only median age and disease stage were consistently reported. Median age and proportion of stage 3–4 disease did not differ between treatment groups. Heterogeneity among the treatments was analyzed using an analog of ANOVA. There was a significant difference in CRRs between CHEMO, R±CHEMO, FLU and RIT (P=0.03). Random effect estimation showed a CRR of 37% with CHEMO (95% CI: 18%–57%), 53% with R±CHEMO (34%–71%), 68% with FLU (49%–87%), and 79% with RIT (73%–85%) (fig 1). There was a highly significant linear correlation between the CRR and HR for disease progression with all treatments (rho= −0.79; 95% CI: −0.57 to −0.91; P<0.001). Despite dissimilarities in therapy and patient populations, and heterogeneity of ORRs and CRRs within treatment groupings, significant differences in CRRs persist. The analysis suggests that a higher CRR is correlated with a lower hazard of disease progression. These data support the selection of regimens that achieve high CRRs for future trials of initial therapy and could provide an additional basis for the design of long-term therapeutic strategies. Figure 1: Complete Response Rate by region strategy Figure 1:. Complete Response Rate by region strategy

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