关键词: 胆道肿瘤, 复发转移, 化疗, 靶向, 免疫, 临床应用

Abstract:

Objective To evaluate the clinical efficacy and safety of gemcitabine and oxaliplatin (GEMOX) combined with target-immunity therapy (lenvatinib and programmed cell death 1 [PD-1] monoclonal antibody) in patients with advanced biliary tract cancer (BTC). Methods Twenty-four patients with advanced BTC received GEMOX combined with target-immunity therapy visited Integrative Oncology Department or Hepatobiliary Surgery Department of our hospital from January 2015 to January 2024 were recruited. The primary end points were set as overall survival (OS) and progression-free survival (PFS), and the secondary end points were objective response rate (ORR), disease control rate (DCR) and safety. The safety and overall clinical efficacy of GEMOX combined with target-immunity therapy regimen on advanced BTC were comprehensively evaluated via tumor marker indexes (carcinoembryonic antigen [CEA], carbohydrate antigen 125 [CA125], CA199), adverse reactions rates, quality of life scores, imaging indicators, and other data. Results None of the 24 patients had complete remission (CR). ORR was 33.3% (8/24, 8 patients had PR), DCR was 66.7% (16/24; 8 patients had SD and 8 patients had PD, respectively), median OS was 13 months and median PFS was 8 months. After treatment, the levels of CA199 were significantly lower than those before treatment (P<0.05). The incidence of adverse events in 24 patients were rash (14/24, 58.3%), leucopenia (22/24, 91.6%), anemia (20/24, 83.3%). One patient had serious adverse events and withdrew from treatment, one patient died of biliary obstruction with infection during treatment. Conclusion GEMOX combined with target-immunity therapy regimen is safe and effective in the treatment of advanced BTC, it may be used clinically.

Key words: biliary tract neoplasms, recurrence and metastasis, chemotherapy, targeting, immunization, clinical application