77P - A new prognostic index for patients with advanced BTC treated with cisplatin, gemcitabine and durvalumab

Background

This study aims to identify a new prognostic index for patients with biliary tract cancer (BTC) treated with cisplatin, gemcitabine and durvalumab (CGD) in first-line setting.

Methods

The study population consisted of 319 patients with BTC from 11 Eastern and Western Countries. Using multivariate analysis, we previously developed a prognostic model called the CGD index by combining the 5 baseline positive variables and assigning a weight from 1 to 5 as follows: 1 for metastatic disease, 2 for CEA increased levels, 3 for albumin decreased levels, 4 for GGT increased levels, 5 for NLR ≥3. Patients were stratified into three risk-groups as follows: low risk-group (RG) (score from 0 to 5), intermediate RG (score from 6 to 10), and high RG (score from 11 to 15).

Results

Median progression-free survival was 10.5 months (95% CI: 8.4-11.9 months) in low RG (27.3%), 8.7 months (95% CI: 7.1-9.9 months) in intermediate RG (38.9%), and 5.5 months (95% CI: 4.4-7.4 months) in high RG (33.8%; low risk HR: 0.44, intermediate risk HR: 0.63, high risk HR: 1, p<0.01]. Median overall survival was 17.9 months (95% CI: 13.5-17.9 months) in low RG,15.6 months (95% CI: 10.2-18.4 months) in intermediate RG, and 8.0 months (95% CI: 7.4-12.5 months) in high RG (low risk HR: 0.32, intermediate risk HR: 0.52, high risk HR: 1, p<0.01). There was no difference in objective response rate (low risk: 28.7%, intermediate risk: 36.3%, and high risk: 29.6%; p=0.26), while disease control rate was significantly different in the three RGs (low risk: 78.2%, intermediate risk: 72.6%, and high risk: 61.1%; p<0.01) as well as the rate of patients receiving a second-line therapy (low risk: 21.8%, intermediate risk: 23.4%, and high risk: 17.6%; p=0.02). The safety profile was similar in the three RGs, except for nausea (low risk: 36.8%, intermediate risk: 42.7%, high risk: 26.8%; p=0.04), leukopenia (low risk: 28.7%, intermediate risk: 33.1%, high risk: 16.7%; p=0.01), and neutropenia (low risk: 55.2%, intermediate risk: 55.6%, high risk: 23.1%; p<0.01).

Conclusions

The CGD index is an easy-to-use tool able to stratify patients with BTC undergoing first-line therapy with CGD. Further studies are needed to prospectively test and validate this index.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.