Camrelizumab in combination with chemotherapy and targeted therapy improves the prognosis in patients with advanced biliary tract cancer: a single-center retrospective clinical study

Abstract

Background: Biliary tract cancer (BTC) is an aggressive neoplasm with poor overall survival. Chemotherapy has improved the prognosis of BTC, but the outcomes still remain very unsatisfactory. Immune checkpoint inhibitor (ICI) therapy has shown promising efficacy in multiple solid tumors, including BTC. However, despite significant progress, the use of immunotherapy for the treatment of BTC is still in its early stages, and the evidence for its use is mixed, possibly due to inaccurate grouping based on the expression of programmed death ligand 1, a reliable candidate biomarker if carefully handled. Here, we reviewed the outcomes of camrelizumab, an Food and Drug Administration-approved anti-PD-1 ICI, combined with chemotherapy or targeted therapy in patients with advanced BTC.

Methods: Patients with advanced BTC treated with camrelizumab in combination with chemotherapy or targeted therapy as the first-line therapy from September 2020 to September 2023 were included in this retrospective, non-randomized and single-center design study. Treatment efficacy and treatment-related adverse events were subjected to statistical analysis.

Results: Fifteen patients were enrolled in this study. The mean age of the patients was 62 years (ranging from 25 to 75 years old), comprising 9 males and 6 females. The pathological diagnoses included 11 cases of intrahepatic cholangiocarcinoma, 1 case of extrahepatic cholangiocarcinoma, and 3 cases of gallbladder carcinoma. Among them, 5 cases diagnosed at stage IIa were deemed inoperable for surgery due to anticipated insufficient residual liver volume. Additionally, there were 5 cases classified as stage IIIb and 5 cases as stage IV. Seven patients achieved a partial response, and the study had an overall response rate of 46.7%. Seven patients had stable disease, with a disease control rate of 93.3%. At the cut-off date of September 30, 2023, the median follow-up time was 15.7 months (range, 1.7-33 months). The patients had a median progression-free survival time of 18 months (95% confidence interval: 12.4-not reached). Of the patients, nine (60.0%) were deemed eligible for surgery. Six patients (40%) developed grade III neutropenia, one (6.7%) developed grade IV neutropenia, and one (6.7%) developed grade III thrombocytopenia.

Conclusions: The application of camrelizumab as neoadjuvant therapy in the treatment of patients with advanced BTC showed encouraging efficacy and safety.

Keywords: Advanced biliary tract cancer (advanced BTC); biomarker; chemotherapy; immunotherapy.

Figure 1

Overall survival and progression-free survival. OS, overall survival; PFS, progression-free survival.

Figure 2

Multivariate Cox regression model of OS (upper panels) and PFS (lower panels) events in patients taking camrelizumab. Adjusted variables include W/L, N/L, P/L, and LDH level. AIC, Akaike Information Criterion; CI, confidence interval; HR, hazard ratio; LDH, lactate dehydrogenase; L, lymphocytes; N, neutrophils; OS, overall survival; P, platelets; PFS, progression-free survival; W, white blood cells.