■随着新型抗血管生成药物的开发和指南建议的不断发展,抗血管生成药物在卵巢癌(OC)中的疗效和安全性尚不清楚.因此,我们进行了一项荟萃分析,以评估抗血管生成药物单药治疗和联合治疗对OC的疗效和安全性.
■对多个数据库进行了详尽的文献综述,包括PubMed,Embase,WebofScience,还有Cochrane,涵盖2024年4月6日之前的所有相关随机对照试验(RCT)。疗效结果的评估包括无进展生存期(PFS),总生存期(OS),和客观反应率(ORR)。通过任何等级不良事件(AE)和≥3级AE的发生来评估安全性。数据的综合涉及危险比(HR)的计算,相对风险(RR),及其相应的95%置信区间(CI)和预测区间(PI)。试验序贯分析采用TSAv0.9.5.10Beta软件,STATA12.0和R软件4.3.1。
■在此荟萃分析中,包括35项RCT,总共涵盖16199个科目。总体分析表明,抗血管生成药物联合治疗显着改善了PFS(HR[95%CI]=0.678[0.606-0.759],95%PI:0.415-1.108),OS(HR[95%CI]=0.917[0.870-0.966],95%PI:0.851-0.984),和ORR(RR[95%CI]=1.441[1.287-1.614],95%PI:1.032-2.014),但也增加了≥3级不良事件的发生率(RR[95%CI]=1.137[1.099-1.177],95%PI:1.011-1.252)。该分析未证实抗血管生成单一疗法相对于安慰剂在PFS方面的任何益处(HR[95%CI]=0.956[0.709-1.288],95%PI:0.345-2.645)和OS(HR[95%CI]=1.039[0.921-1.173],95%PI:0.824-1.331)。然而,观察到使用抗血管生成药物的单一疗法确实会增加任何级别的不良事件的发生率(RR[95%CI]=1.072[1.036-1.109],95%PI:0.709-1.592)。
■我们的研究证实了PFS,操作系统,抗血管生成药物联合治疗对OC患者的ORR益处。随着更多的RCT变得可用,抗血管生成单一疗法的功效结果需要进一步评估。临床医生在临床环境中施用抗血管生成剂时应警惕AE。
UNASSIGNED: As the development of novel anti-angiogenic drugs and the continuous evolution of guideline recommendations, the efficacy and safety of anti-angiogenic agents in ovarian cancer (OC) remains unclear. Consequently, a meta-analysis was carried out to assess the efficacy and safety of anti-angiogenic drug monotherapy and combination therapy for OC.
UNASSIGNED: An exhaustive literature review was performed across multiple databases, including PubMed, Embase, Web of Science, and Cochrane, encompassing all relevant randomized controlled trials (RCTs) up until 6 April 2024. The evaluation of efficacy outcomes incorporated progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). Safety was assessed through the occurrence of any grade adverse events (AEs) and grade ≥3 AEs. Synthesis of the data involved the calculation of hazard ratios (HRs), relative risks (RRs), and their corresponding 95% confidence intervals (CIs) and prediction intervals (PIs). Trial sequential analysis was executed employing TSA v0.9.5.10 Beta software, STATA 12.0, and R software 4.3.1.
UNASSIGNED: In this meta-analysis, 35 RCTs were included, encompassing 16,199 subjects in total. The overall analysis indicated that anti-angiogenic drug combination therapy significantly improved PFS (HR [95% CI] = 0.678 [0.606-0.759], 95% PI: 0.415-1.108), OS (HR [95% CI] = 0.917 [0.870-0.966], 95% PI: 0.851-0.984), and ORR (RR [95% CI] = 1.441 [1.287-1.614], 95% PI: 1.032-2.014), but also increased the incidence of grade ≥3 AEs (RR [95% CI] = 1.137 [1.099-1.177], 95% PI: 1.011-1.252). The analysis did not corroborate any benefit of anti-angiogenic monotherapy over placebo concerning PFS (HR [95% CI] = 0.956 [0.709-1.288], 95% PI: 0.345-2.645) and OS (HR [95% CI] = 1.039 [0.921-1.173], 95% PI: 0.824-1.331). However, it was observed that monotherapy with anti-angiogenic drugs did increase the incidence of any grade AEs (RR [95% CI] = 1.072 [1.036-1.109], 95% PI: 0.709-1.592).
UNASSIGNED: Our study confirmed the PFS, OS, and ORR benefits of anti-angiogenic drug combination therapy for OC patients. The efficacy results of anti-angiogenic monotherapy necessitates further evaluation as more RCTs become available. Clinicians should be vigilant of AEs when administering anti-angiogenic agents in a clinical setting.