Background: Ampullary adenocarcinoma is a rare cancer for which there are no standard adjuvant treatment recommendations due to the lack of randomized clinical trials. The primary aim of this analysis is to investigate the efficacy of adjuvant FOLFIRINOX treatment in patients with resected ampullary adenocarcinoma. Materials and Methods: This multicenter retrospective cohort study was conducted at 15 institutions in Turkey between August 2007 and January 2024, involving 211 patients with resected, non-metastatic ampullary adenocarcinoma receiving adjuvant chemotherapy with various chemotherapy regimens with or without chemoradiation. Clinicopathological and treatment-related parameters were recorded. Disease-free survival (DFS) and overall survival (OS) were analyzed by using Kaplan–Meier estimates. Cox proportional hazards regression was used to identify covariates associated with OS. Results: The median follow-up time was 52 months, and 116 patients (55.2%) were alive at the time of the analysis. The median age was 61 years (32–82). mFOLFIRINOX was administered to 16.6% of the patients (n= 35). The 3-year DFS rate was 79.41% in the FOLFIRINOX-treated arm and 53.9% in the other treatment arm (p= 0.034 for mDFS). The median OS was non-reached in patients receiving mFOLFIRINOX treatment, while it was 51 months in patients receiving other treatments (p= 0.071). While no statistically significant results were reached, a trend toward statistically significant survival times was observed in the FOLFIRINOX arm. After adjustment for other prognostic parameters, mFOLFIRINOX remained an independent statistically significant parameter for better OS (HR; 95% CI: 3.24; 1.02–10.9;p= 0.046). Conclusions: FOLFIRINOX treatment has shown efficacy in the adjuvant treatment of ampullary cancer, independent of histological subtype. The findings should be validated in large prospective trials.
背景：壶腹腺癌是一种罕见癌症，由于缺乏随机临床试验，目前尚无标准的辅助治疗推荐方案。本分析的主要目的是探讨FOLFIRINOX辅助治疗方案对壶腹腺癌切除术后患者的疗效。 材料与方法：这项多中心回顾性队列研究于2007年8月至2024年1月在土耳其15家机构开展，共纳入211例接受手术切除的非转移性壶腹腺癌患者，所有患者术后均接受含不同化疗方案的辅助化疗（部分联合放化疗）。研究记录了临床病理特征及治疗相关参数，采用Kaplan-Meier法评估无病生存期（DFS）和总生存期（OS），并通过Cox比例风险回归模型分析与OS相关的协变量。 结果：中位随访时间为52个月，截至分析时116例（55.2%）患者存活。患者中位年龄为61岁（范围32-82岁）。16.6%的患者（n=35）接受了mFOLFIRINOX方案治疗。FOLFIRINOX治疗组的3年DFS率为79.41%，其他治疗方案组为53.9%（中位DFS差异p=0.034）。接受mFOLFIRINOX治疗的患者中位OS未达到，而接受其他治疗方案的患者中位OS为51个月（p=0.071）。虽然未达到统计学显著性，但FOLFIRINOX组显示出具有统计学显著性趋势的生存时间优势。在调整其他预后参数后，mFOLFIRINOX方案仍是改善OS的独立显著影响因素（风险比HR=3.24，95%置信区间1.02-10.9，p=0.046）。 结论：FOLFIRINOX方案在壶腹癌辅助治疗中显示出明确疗效，且疗效与组织学亚型无关。该发现仍需大型前瞻性试验进一步验证。
肿瘤(癌症)患者之家