Abstract
520 Background: FOLFOX as second-line therapy remains the standard of care in patients with biliary tract cancer (BTC), but its efficacy is suboptimal. Currently, cytotoxic chemotherapy, targeted therapy, and immunotherapy alone or in combination are being tested in patients with pretreated advanced BTC for in clinical trials. This study aimed to evaluate and compare the anticancer of distinct treatment regimen in patients with advanced BTCs who progress after first-line chemotherapy. Methods: Patients diagnosed BTC who received second-line therapy were retrospectively identified at 3 sites across the Zhejiang province between January 1, 2018, and June 31, 2022. Clinicopathological information and therapeutic outcome, including subtype of BTC, response per RECIST v1.1, treatment duration, adverse events (AE), progression-free survival (PFS), and overall survival (OS), were recorded and estimated. Results: A total of 98 patients with BTCs were reviewed and recruited eventually: the chemotherapy group (cohort A, n=30), the chemotherapy plus ICIs group (cohort B, n=25), the TKIs group (cohort C, n=17), and the TKIs plus ICIs group (cohort D, n=26). The median PFS and OS were 2.4 months (95%CI: 1.6–3.2) and 7.0 months (95% CI: 6.4–7.5) for cohort A, 3.9 months (95%CI: 2.8–5.0) and 10.7 months (95% CI: 6.9–14.5) for cohort B, 1.6 months (95%CI: 0.8–2.4) and 7.1 months (95% CI: 0.7–13.5) for cohort C, and 4.7 months (95%CI: 3.1–6.2) and 10.1 months (95% CI: 4.1–16.1) for cohort D, respectively. In the cohort A, B, C, and D, confirmed ORRs were 10%, 20%, 11.8% and 19.2%, separately, and DCRs were 46.7%, 68%, 43.8% and 76.9%, respectively. The efficacy of ICIs plus TKIs was optimal in terms of tumor response and associated with prolong PFS. Six patients (20%), nine patients (36%), five patients (29.4%), and elven patients (42.3%) were experienced ≥ grade 3 treatment-related AEs in cohort A, B, C, and D, respectively. Conclusions: Immunotherapy combination strategy beyond first-line systemic chemotherapy plays a positive role in advanced BTCs. Both TKIs plus ICIs and chemotherapy plus ICIs could be considered as candidates to second-line trails and turn into a competitive second-line treatment regimen for advanced BTCs in clinical practice.
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