Peng Yuhuai, Xia Guoyi, Li Yufeng, Zhou Jia, Liu Sulai, Peng Chuang, Tao Yuewei, Li Ou, Song Yinghui
Central Laboratory, Hunan Provincial People's Hospital/The First Affiliated Hospital of Hunan Normal University, Changsha, P. R. China.
Department of Hepatobiliary Surgery, Hunan Provincial People's Hospital/The First Affiliated Hospital of Hunan Normal University, Changsha, P. R. China.
Oncologist. 2025 Jun 4;30(6). doi: 10.1093/oncolo/oyaf163.
The prognosis of biliary tract cancers (BTC) after radical resection is still unsatisfactory. However, the clinical value of adjuvant therapy remains controversial. This retrospective study aimed to evaluate the clinical value of adjuvant chemotherapy and adjuvant chemoimmunotherapy in patients with BTC after radical resection.
Data from BTC patients who underwent radical resection were retrospectively obtained from Hunan Provincial People's Hospital between January 2020 and July 2024. Patients were divided into observation group, adjuvant chemotherapy group, and adjuvant chemoimmunotherapy group according to the treatment received by the patient after surgery. Survival curves were determined by the Kaplan-Meier method. The COX proportional hazards regression model was used to determine independent prognostic risk factors. The adjuvant chemotherapy group and adjuvant chemoimmunotherapy group were analyzed by PSM at a 1:1 ratio.
A total of 219 patients with BTC were reenrolled in this study, with 108 cases of iCCA, 39 cases of pCCA, 15 cases of DCCA, and 57 cases of GBC. Eighty-seven patients (39.73%) received surgery alone, 69 patients (31.51%) received postoperative adjuvant chemotherapy, and 63 patients (28.77%) received postoperative adjuvant chemoimmunotherapy. There was no different significance for median recurrence-free survival (RFS) in the 3 groups (13.20 vs 20.40 vs 19.68 months; P = .195). The median overall survival (OS) was the longest in the chemoimmunotherapy group (29.20 vs 31.5 vs 43.27 months; P = .003). After propensity score matching (PSM), there was no difference in median RFS in the 2 adjuvant groups (22.03 vs 19.87 months; P = .350). The median OS was longer in the chemoimmunotherapy group (45.27 vs 29.40 months; P = .015). In Cox analysis, lymph node metastasis, differentiation, and adjuvant treatment were the independent predictors of OS in patients with BTC. The most common adverse events were of any grade of hematologic toxicity. No drug-related deaths occurred in either group.
The safety of chemoimmunotherapy was acceptable and could significantly prolong the overall survival of BTC. These data provided a basis for an additional prospective clinical trial to evaluate the efficacy of chemoimmunotherapy in adjuvant therapy for BTC.
根治性切除术后胆道癌（BTC）的预后仍不尽人意。然而，辅助治疗的临床价值仍存在争议。本回顾性研究旨在评估辅助化疗和辅助化疗免疫疗法在根治性切除术后BTC患者中的临床价值。
回顾性收集2020年1月至2024年7月在湖南省人民医院接受根治性切除的BTC患者的数据。根据患者术后接受的治疗将患者分为观察组、辅助化疗组和辅助化疗免疫治疗组。采用Kaplan-Meier法确定生存曲线。使用COX比例风险回归模型确定独立的预后危险因素。辅助化疗组和辅助化疗免疫治疗组按1:1的比例进行倾向评分匹配（PSM）分析。
本研究共纳入219例BTC患者，其中肝内胆管癌（iCCA）108例，肝门部胆管癌（pCCA）39例，远端胆管癌（DCCA）15例，胆囊癌（GBC）57例。87例患者（39.73%）仅接受手术治疗，69例患者（31.51%）接受术后辅助化疗，63例患者（28.77%）接受术后辅助化疗免疫治疗。三组的中位无复发生存期（RFS）无差异（13.20个月vs 20.40个月vs 19.68个月；P = 0.195）。化疗免疫治疗组的中位总生存期（OS）最长（29.20个月vs 31.5个月vs 43.27个月；P = 0.003）。倾向评分匹配（PSM）后，两个辅助治疗组的中位RFS无差异（22.03个月vs 19.87个月；P = 0.350）。化疗免疫治疗组的中位OS更长（45.27个月vs 29.个月；P = 0.015）。在Cox分析中，淋巴结转移、分化程度和辅助治疗是BTC患者OS的独立预测因素。最常见的不良事件是任何级别的血液学毒性。两组均未发生与药物相关的死亡。
化疗免疫治疗的安全性可接受，且能显著延长BTC患者的总生存期。这些数据为进一步开展前瞻性临床试验以评估化疗免疫疗法在BTC辅助治疗中的疗效提供了依据。
