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Real-world data from patients treated with chemotherapy for biliary tract cancer: Insights from a prognostic model
Julien Edeline1, Richard Jackson2, Andrea Casadei-Gardini3
1Centre Eugène Marquis, Rennes, France.
Background & Aims:
Cisplatin-gemcitabine (CisGem) chemotherapy with immunotherapy is the standard-of-care first-line treatment for advanced biliary tract cancer (BTC). However, some relevant clinical questions cannot be answered through randomised clinical trials because of feasibility issues: the role of maintenance chemotherapy, the equivalence of the gemcitabine-oxaliplatin (GEMOX) regimen, and the preferred treatment for patients with a performance status (PS) of 2. We thus built a large multicentre database and created a prognostic model to provide corrected comparisons of outcomes of patients treated in the real-world setting.
Methods:
This is a retrospective analysis of patients treated at 15 European institutions with first-line chemotherapy for advanced BTC. We built a prognostic model for patients treated with CisGem, performed internal validation, and used this model to provide corrected comparisons between treatments.
Results:
A total of 1,947 patients were included, of whom 1,022 were treated with CisGem. Parameters included in the prognostic model were tumour differentiation, PS, extent of the disease (locally advanced vs. metastatic), albumin, and carbohydrate antigen 19.9 (CA19.9). Maintenance chemotherapy did not impact progression-free survival (PFS) or overall status (OS) (n = 79, median 17.0 with vs. 23.7 months without; hazard ratio [HR] 1.63, 95% CI 0.95-1.74); p = 0.078). GEMOX was inferior to CisGem (n = 1,471, median 9.9 vs. 11.4 months; HR for OS 1.18, 95% CI 1.00-1.41; p = 0.049). CisGem was superior to gemcitabine in patients with PS 2 (n = 233, median OS 6.8 vs. 3.6 months; HR 1.70, 95% CI 1.30-2.22; p <0.001).
Conclusions:
This large multicentre database allowed for the development of a prognostic model that provides useful data to address clinically relevant unanswered questions. The cessation of chemotherapy after eight cycles is recommended. CisGem is endorsed as the main backbone chemotherapy over GEMOX. CisGem should be preferred over single-agent gemcitabine for patients with PS 2.
Impact And Implications:
This study aims to address unresolved questions in biliary tract cancer treatment. We confirmed that cisplatin-gemcitabine is a better chemotherapy backbone than GEMOX. We recommend that maintenance chemotherapy does not improve overall survival and that cisplatin-gemcitabine should be preferred over single-agent gemcitabine for patients with a performance status of 2.
