Comparison between Fluoropyrimidine-Cisplatin and Gemcitabine-Cisplatin as First-Line Chemotherapy for Advanced...

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.