Prognostic Impact of Metastatic Sites in Patients with Biliary Tract Cancer Treated with Cisplatin, Gemcitabine, and Durvalumab.

BACKGROUND

Currently, data concerning the prognostic impact of metastatic sites in biliary tract cancers (BTC) are limited.

OBJECTIVE

The aim of the present study is to evaluate the prognostic impact of metastatic sites in patients with BTC treated with cisplatin-gemcitabine-durvalumab (CGD).

PATIENTS AND

METHODS

The study population comprised a large worldwide cohort of patients treated with CGD. The primary objectives were overall survival (OS) and progression-free survival (PFS) based on the location and number of metastatic sites.

RESULTS

A total of 666 patients with locally advanced (111) or metastatic (555) BTC treated with CGD were included in the study. None of the metastatic sites were shown to have a prognostic impact on OS at multivariate analysis. Patients with one to two metastatic sites had longer OS (hazard ratio [HR] 0.59; p = 0.005) and PFS (HR 0.73; p = 0.03) compared with those with three to five metastatic sites in the univariate analysis but not in the multivariate analysis. No statistically significant differences were observed in OS or PFS across different metastatic sites limited to a single organ. Patients with progressive disease (PD) on first-line CGD with a change in metastatic sites from baseline showed no statistically significant differences in OS2 (defined as the time from PD on first-line therapy to death for any cause) compared with those without a change in metastatic sites (HR 0.88; p = 0.60).

CONCLUSIONS

Our study did not show statistically significant differences in outcomes associated with location and number of metastatic sites in a large population of patients with BTC treated with CGD.