Xue Jiahao, Lu Xinjun, Shi Xiangde, Huang Kenglong, Ye Yanfang, Tang Qibin, Yu Xianhuan, Liu Chao
Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation and Department of Biliary-Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, China.
Clinical Research Design Division, Sun Yat-sen Memorial Hospital, Guangzhou 510120, China.
Oncologist. 2025 Jun 4;30(6). doi: 10.1093/oncolo/oyaf104.
The efficacy and safety of chemotherapy combined with programmed cell death protein-1 (PD-1) inhibitors in postoperative adjuvant therapy of pancreatobiliary subtype ampullary adenocarcinoma (AAC) are uncertain. This study aims to evaluate the effect of such treatment on the survival of this patient population.
We retrospectively collected patients with pancreatobiliary subtype AAC who underwent surgical treatment at the Sun Yat-sen Memorial Hospital from January 2018 to December 2022. Patients with high-risk recurrence factors after surgery were divided into surgery alone group, adjuvant chemotherapy group, and adjuvant chemoimmunotherapy group. The Kaplan-Meier method was used to plot survival curves, and the Log-Rank method was used to compare the differences in overall survival (OS) and recurrence-free survival (RFS) between groups.
A total of 71 people were enrolled, including 24 patients received surgery alone, 31 patients received adjuvant chemotherapy, and 16 patients received adjuvant chemoimmunotherapy. The median time of clinical follow-up was 17.8 [IQR 8.3-28.4] months. The 1-year OS rates of the surgery alone group, adjuvant chemotherapy group, and adjuvant chemoimmunotherapy were 41.7%, 71.0%, and 93.3%, respectively. The 2-year OS rates were 28.6%, 47.7%, and 84.0%, respectively. The median OS was 6.8 months and 22.1 months, but the adjuvant chemoimmunotherapy group did not reach (P = .0002). The median RFS was 4.7 months, 15.7 months, and 14.8 months, respectively, but the differences were not statistically significant (P = .0613). Univariate and multivariate Cox analysis results showed that tumor size >2.3 cm (HR = 2.06, 95% CI, 1.06-4.04; P = .034) and the treatment regimen were independent factors affecting prognosis, compared to surgery alone and adjuvant chemotherapy (HR = 0.521, 95% CI, 0.26-1.04; P = .065), adjuvant chemoimmunotherapy (HR = 0.106, 95% CI, 0.02-0.47; P = .003) significantly improves patient survival. There was no statistically significant difference in any complications between the 3 groups (P > .05). Compared with the adjuvant chemotherapy group, patients in the adjuvant chemoimmunotherapy group are more likely to experience hypothyroidism (P = .044) and pruritus (P = .022). There is no statistically significant difference in other AEs between the 2 groups (P > .05).
Compared with surgery alone or adjuvant chemotherapy, patients with pancreatobiliary subtype AAC who received adjuvant chemoimmunotherapy showed better OS, and the drug-related toxicity was acceptable.
化疗联合程序性细胞死亡蛋白-1（PD-1）抑制剂在胰胆亚型壶腹腺癌（AAC）术后辅助治疗中的疗效和安全性尚不确定。本研究旨在评估这种治疗对该患者群体生存的影响。
我们回顾性收集了2018年1月至2022年12月在中山大学孙逸仙纪念医院接受手术治疗的胰胆亚型AAC患者。术后有高危复发因素的患者分为单纯手术组、辅助化疗组和辅助化疗免疫治疗组。采用Kaplan-Meier法绘制生存曲线，Log-Rank法比较各组总生存（OS）和无复发生存（RFS）的差异。
共纳入71例患者，其中24例接受单纯手术，31例接受辅助化疗，16例接受辅助化疗免疫治疗。临床随访中位时间为17.8 [IQR 8.3 - 28.4]个月。单纯手术组、辅助化疗组和辅助化疗免疫治疗组的1年OS率分别为41.7%、71.0%和93.3%。2年OS率分别为28.6%、47.7%和84.0%。中位OS分别为6.8个月和22.1个月，但辅助化疗免疫治疗组未达到（P = 0.0002）。中位RFS分别为4.7个月、15.7个月和14.8个月，但差异无统计学意义（P = 0.0613）。单因素和多因素Cox分析结果显示，肿瘤大小>2.3 cm（HR = 2.06，95%CI，1.06 - 4.04；P = 0.034）和治疗方案是影响预后的独立因素，与单纯手术和辅助化疗相比（HR = 0.521，95%CI，0.26 - 1.04；P =
