5PSQ-093 Effectiveness and safety of durvalumab in unresectable or metastatic cholangiocarcinoma

<h3>Background and Importance</h3> Unresectable or metastatic cholangiocarcinoma (CCUoM) is a type of biliary tract cancer with poor prognosis. Results from the pivotal trial ‘TOPAZ-1’ suggest that adding durvalumab (anti-PD-L1) to standard therapy (platinum-gemcitabine (PtGem)) may improve survival outcomes. <h3>Aim and Objectives</h3> Evaluate the effectiveness and safety of durvalumab with PtGem (PtGemDur) as first-line therapy for CCUoM, with a comparison to a historical cohort, PtGem, and with results from TOPAZ-1. <h3>Material and Methods</h3> A retrospective descriptive study of patients with CCUoM. Two cohorts were included: patients treated with PtGem from 06/2018–06/2021 and those treated with PtGemDur (current cohort) from 06/2021–06/2024. Data collected from Oncofarm software and medical records were: sex, age, ECOG and tumour location. Effectiveness was evaluated in terms of overall survival (OS) and progression-free survival (PFS) according to the Kaplan-Meier method, using SPSS statistical software. Safety was determined from the type of adverse events (AEs) and discontinuations. <h3>Results</h3> A total of 34 patients were included, 25 received PtGem and 9 PtGemDur. Data collected in the historical cohort were: median age 66 (41–81) years, 64% men, ECOG1: 76%, rest ECOG0 and 76% intrahepatic. In the current cohort: median age 70 (49–80) years, 92% men, ECOG0: 55.6%, rest ECOG1 and 55.6% intrahepatic. In TOPAZ-1, median age 64 (20–84) years, 49.6% men, ECOG0: 50.7% and 55.7% intrahepatic. Median OS was 13 (9.9–18.4) months with PtGem and with PtGemDur was not reached. Median PFS was 9 (7.6–23.2) months with PtGem and 9 (8.8–10.2) months for PtGemDur. In TOPAZ-1 OS was 12.8 (11.1–14) months and PFS 7.2 (6.7–7.4) months. Regarding toxicity, 92% had AEs of any grade with PtGem, 100% with PtGemDur and 99.4% in TOPAZ-1. The most frequent AEs were haematologic, 31% in historical cohort vs 15.4% in current cohort and digestive, 13.8% vs 23.1%. Discontinuations were 68% vs 44%. There were no immune-mediated effects. In TOPAZ-1 48.2% were haematologic, 40.2% digestive and 12.7% immune-mediated. Discontinuations occurred in 13%. <h3>Conclusion and Relevance</h3> In our study, the current cohort sample is small, so results obtained need to mature to confirm the benefits in OS. The PFS results are similar to and slightly superior to those of TOPAZ-1. In terms of safety, AEs were similar in both cohorts and with respect to the TOPAZ-1. No immune-mediated effects were observed in our populations. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest