Department of Oncology, The First People's Hospital of Yuhang District, Hangzhou, China.
Department of Oncology, The First People's Hospital of Yuhang District, Hangzhou, China,
Oncol Res Treat. 2020;43(9):460-469. doi: 10.1159/000507093. Epub 2020 Jul 6.
Gemcitabine-cisplatin (GP) has been regarded as standard first-line chemotherapy for advanced biliary tract cancer (BTC). Fluoropyrimidine-cisplatin (FP) has also shown a survival benefit. However, the clinical choice between them is controversial.
We performed a meta-analysis to assess the efficacy and safety of the two chemotherapy regimens.
A total of 5 studies (2 randomized controlled trials, RCTs, and 3 retrospective studies) involving 727 patients were included. There were no statistically significant differences between the two groups in overall response rate, ORR (risk ratio, RR = 1.13, 95% confidence interval, CI, 0.80-1.58, p = 0.489), disease control rate, DCR (RR = 1.02, 95% CI 0.91-1.13, p = 0.751), progression-free survival/time to progression (hazard rate, HR = 0.95, 95% CI 0.86-1.05, p = 0.315) and overall survival (HR = 1.06, 95% CI 0.98-1.14, p = 0.125). As compared with GP, FP showed lower incidences of all grade 3/4 adverse events with statistical significance (p < 0.001). In a subgroup analysis of RCTs, no statistical differences were found between FP and GP in ORR (RR = 1.06; 95% CI 0.58-1.95; p = 0.842) and DCR (RR = 1.22; 95% CI 1.00-1.50; p = 0.056), but FP showed significantly lower incidences of all grade 3/4 adverse events compared with GP (p < 0.01). Some limitations of the meta-analysis are retrospective studies included, some end points within the trials missing rendering a pooled analysis of the two RCTs impossible and heterogeneous fluoropyrimidine combinations. All studies were performed in Asia which are not completely transferable to European patients.
With some limitations, the meta-analysis suggested that FP seems to be as effective as GP with a more favorable safety profile in first-line chemotherapy for Asian patients with advanced BTC.
吉西他滨-顺铂（GP）已被视为晚期胆道癌（BTC）的标准一线化疗药物。氟尿嘧啶-顺铂（FP）也显示出生存获益。然而，两者之间的临床选择仍存在争议。
我们进行了一项荟萃分析，以评估这两种化疗方案的疗效和安全性。
共纳入 5 项研究（2 项随机对照试验[RCT]和 3 项回顾性研究），共 727 例患者。两组患者在总缓解率（RR=1.13，95%置信区间[CI]为 0.80-1.58，p=0.489）、疾病控制率（RR=1.02，95%CI为 0.91-1.13，p=0.751）、无进展生存期/进展时间（风险比[HR]为 0.95，95%CI 为 0.86-1.05，p=0.315）和总生存期（HR 为 1.06，95%CI 为 0.98-1.14，p=0.125）方面均无统计学差异。与 GP 相比，FP 表现出较低的所有 3/4 级不良事件发生率，差异具有统计学意义（p<0.001）。在 RCT 的亚组分析中，FP 与 GP 在总缓解率（RR=1.06；95%CI 为 0.58-1.95；p=0.842）和疾病控制率（RR=1.22；95%CI 为 1.00-1.50；p=0.056）方面无统计学差异，但 FP 表现出所有 3/4 级不良事件发生率显著低于 GP（p<0.01）。荟萃分析存在一些局限性，包括纳入的回顾性研究、一些试验中缺失的终点数据，使得无法对 2 项 RCT 进行汇总分析，以及氟尿嘧啶组合存在异质性。所有研究均在亚洲进行，不完全适用于欧洲患者。
存在一定局限性的情况下，该荟萃分析表明，FP 似乎与 GP 一样有效，且在亚洲晚期 BTC 患者的一线化疗中具有更有利的安全性特征。
