Dataset Information

Effectiveness of Lomustine Combined With Bevacizumab in Glioblastoma: A Meta-Analysis.

ABSTRACT: Introduction: Despite surgical and chemotherapeutical treatment options, the prognosis for glioblastoma (GBM) remains poor. Some studies have found that using lomustine plus bevacizumab to treat GBM can prolong overall survival (OS) and progression-free survival (PFS). The aim of this study was to explore the efficacy of the two drugs in combination treatment of GBM using a meta-analysis of the existing literature to help settle the ongoing debate. Materials and Methods: PubMed, EMBASE, and the Cochrane Library were searched for the effectiveness of lomustine plus bevacizumab in GBM literature, updated on June 6, 2020. The main outcomes analyzed included PFS and OS; the effects of this drug combination on the 6-month PFS, which represents the percentage of patients who had PFS for 6 months, were also analyzed. All the data were pooled: OS and PFS with the mean difference (MD) and 6-month PFS with the risk ratio (RR). Because there were different control groups and dose groups, two subgroup analyses were run to ensure they were comparable. All statistical analyses were performed using the Review Manager Version 5.3 software. Results: Six clinical trials were identified which included 1,095 patients (treatment group: 516; control group: 579). The group treated with lomustine and bevacizumab showed an improvement in OS (MD =1.37; 95% CI, 0.49-2.25; p = 0.002), PFS (MD = 0.23; 95% CI, 0.13-0.34; p < 0.00001), and 6-month PFS (RR = 2.29; 95% CI, 1.43-3.65; p = 0.0005). Two subgroup analyses of the main outcome, OS, show that the results of Control group A (p = 0.01) and Dose group 2 (p = 0.003) are significantly different from those of the other control or dose groups. Conclusion: This study shows that lomustine and bevacizumab can effectively increase OS, PFS, and 6-month PFS in patients with GBM. The encouraging results of the lomustine and bevacizumab combination therapy for GBM should be studied in more clinical trials in the future.

SUBMITTER: Ren X

PROVIDER: S-EPMC7855027 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Effectiveness of Lomustine Combined With Bevacizumab in Glioblastoma: A Meta-Analysis.

Ren Xing X Ai Di D Li Tong T Xia Lei L Sun Lingzhi L

Frontiers in neurology 20210120

<b>Introduction:</b> Despite surgical and chemotherapeutical treatment options, the prognosis for glioblastoma (GBM) remains poor. Some studies have found that using lomustine plus bevacizumab to treat GBM can prolong overall survival (OS) and progression-free survival (PFS). The aim of this study was to explore the efficacy of the two drugs in combination treatment of GBM using a meta-analysis of the existing literature to help settle the ongoing debate. <b>Materials and Methods:</b> PubMed, EM ...[more]

PMID: 33551965

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Project description:BackgroundThe combination of galunisertib, a transforming growth factor (TGF)-? receptor (R)1 kinase inhibitor, and lomustine was found to have antitumor activity in murine models of glioblastoma.MethodsGalunisertib (300 mg/day) was given orally 14 days on/14 days off (intermittent dosing). Lomustine was given as approved. Patients were randomized in a 2:1:1 ratio to galunisertib + lomustine, galunisertib monotherapy, or placebo + lomustine. The primary objective was overall survival (OS); secondary objectives were safety, pharmacokinetics (PKs), and antitumor activity.ResultsOne hundred fifty-eight patients were randomized: galunisertib + lomustine (N = 79), galunisertib (N = 39), and placebo + lomustine (N = 40). Baseline characteristics were: male (64.6%), white (75.3%), median age 58 years, ECOG performance status (PS) 1 (63.3%), and primary glioblastoma (93.7%). The PKs of galunisertib were not altered with lomustine, and galunisertib had a median half-life of ?8 hours. Median OS in months (95% credible interval [CrI]) for galunisertib + lomustine was 6.7 (range: 5.3-8.5), 8.0 (range: 5.7-11.7) for galunisertib alone, and 7.5 (range: 5.6-10.3) for placebo + lomustine. There was no difference in OS for patients treated with galunisertib + lomustine compared with placebo + lomustine [P (HR < 1) = 26%]. Median progression-free survival of ?2 months was observed in all 3 arms. Among 8 patients with IDH1 mutation, 7 patients were treated with galunisertib (monotherapy or with lomustine); OS ranged from 4 to 17 months. Patients treated with galunisertib alone had fewer drug-related grade 3/4 adverse events (n = 34) compared with lomustine-treated patients (10% vs 26%). Baseline PS, post-discontinuation of bevacizumab, tumor size, and baseline levels of MDC/CCL22 were correlated with OS.ConclusionsGalunisertib + lomustine failed to demonstrate improved OS relative to placebo + lomustine. Efficacy outcomes were similar in all 3 arms.Clinical trial registrationNCT01582269, ClinicalTrials.gov.

Project description:BackgroundRecent studies showed inconsistent results of bevacizumab combined with chemotherapy vs single-agent therapy in terms of their safety and efficacy for the treatment of recurrent glioblastoma. Therefore, we performed a meta-analysis to explore the value of bevacizumab combined with chemotherapy and single-agent therapy in recurrent glioblastoma treatment.MethodsDatabases such as MEDLINE, Embase, and Cochrane Library were searched for randomized controlled trials (RCTs) related to the topic of bevacizumab combined with chemotherapy and single-agent therapy as treatments for recurrent glioblastoma from January 1980 to April 2018. Subsequent articles were then sorted, evaluated, and analyzed.ResultsWe pooled 1,169 patient cases from seven RCTs. Bevacizumab combined with chemotherapy showed a significantly improved progression-free survival (PFS) (HR=0.65; 95% CI 0.57-0.74; P<0.001) compared to single-agent therapy. In addition, the overall survival (OS) rate showed insignificant differences between the two groups (HR=0.96; 95% CI 0.83-1.12; P=0.622). Simultaneously, we found that bevacizumab combined with chemotherapy had a higher objective response rate (ORR) (OR=2.10; 95% CI 1.32-3.33; P=0.002), but also higher incidence of adverse events (AEs) (OR=1.85; 95% CI 1.26-2.71; P=0.002). However, in subgroup analysis, we found that AEs showed insignificant differences between the two treatment methods when bevacizumab was used as the single-agent therapy subgroup (P=0.058). In addition, in the subgroup with low corticosteroid use rate at baseline (N<50%), ORR (P=0.108) and AEs (P=0.134) showed insignificant differences between the two groups.ConclusionBevacizumab combined with chemotherapy can significantly improve PFS and ORR, but did not prolong OS in these studies, and can even lead to higher odds of AEs. In addition, bevacizumab may play a dominant role and corticosteroid may be an unfavorable factor in the combination therapy of recurrent glioblastoma.

Dataset Information

Effectiveness of Lomustine Combined With Bevacizumab in Glioblastoma: A Meta-Analysis.

Publications

Effectiveness of Lomustine Combined With Bevacizumab in Glioblastoma: A Meta-Analysis.

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