Durvalumab-combined chemotherapy for biliary tract cancer in a Japanese expert center: initial 50 cases in daily practice.

Combination regimen consisting of gemcitabine, cisplatin, and durvalumab (GCD) has been employed for unresectable biliary tract cancer (BTC) since the end of 2022 in Japan. Here, we summarize our experience with GCD to demonstrate the clinical outcomes in a practical setting. Patients who underwent GCD for unresectable/recurrent BTC between January and December 2023 were investigated retrospectively. Data for maximal response rate (RR), disease control rate (DCR), and adverse events (AEs) were collected. Progression-free survival (PFS) and overall survival (OS) curves were generated using the Kaplan-Meyer method. Fifty (initially unresectable, n = 32; recurrence after surgery, n = 18) consecutive patients were enrolled, 19 of whom started GCD as second-line therapy or later. Overall RR was 24.0% including complete response in 1 (2%) patient and partial response in 11 (22%) patients; DCR was 68.0%. The median PFS and OS were 7.1 months and not reached, respectively. During a median follow-up period of 8.5 months, 8 (16%) patients underwent surgical resection. A total of 36 (72%) patients suffered Grade 3-5 AE, and 3 immune-related AE were controlled with injection of corticosteroid or observation. The efficacy of GCD for unresectable/recurrent BTC was confirmed in the practical setting, with acceptable toxicity, prolonged survival, and potential probability of resection.