Comparison between Fluoropyrimidine-Cisplatin and Gemcitabine-Cisplatin as First-Line Chemotherapy for Advanced Biliary Tract Cancer: A Meta-Analysis.

BACKGROUND

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.

METHODS

We performed a meta-analysis to assess the efficacy and safety of the two chemotherapy regimens.

RESULTS

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.

CONCLUSION

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.