Kalem Ali, Kus Tulay, Sahin Taha Koray, Dizdar Omer, Efil Safa Can, Sendur Mehmet Ali Nahit, Aykut Talat, Araz Murat, Bolek Hatice, Urun Yuksel, Sever Nadiye, Bayoglu Ibrahim Vedat, Cavdar Eyyup, Sagıroglu Muhammed Fatih, Gunes Tugce Kubra, Ozcelik Melike, Demirel Nadide, Yıldız Bulent, Karabuga Berkan, Yalcıntas Arslan Ulku, Gokcek Savas, Unek Ilkay Tugba, Saray Seray, Aslan Ferit, Acar Omer, Erdogan Atike Pınar, Seyyar Mustafa, Aktas Gokmen, Yalcın Suayib
Department of Medical Oncology, School of Medicine, Gaziantep University, Gaziantep 27310, Turkey.
Department of Medical Oncology, School of Medicine, Hacettepe University, Ankara 06100, Turkey.
Cancers (Basel). 2025 Aug 22;17(17):2730. doi: 10.3390/cancers17172730.
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.
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.
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 ( = 35). The 3-year DFS rate was 79.41% in the FOLFIRINOX-treated arm and 53.9% in the other treatment arm ( = 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 ( = 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; = 0.046).
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.
壶腹腺癌是一种罕见的癌症，由于缺乏随机临床试验，尚无标准的辅助治疗推荐。本分析的主要目的是研究辅助性FOLFIRINOX治疗对已切除壶腹腺癌患者的疗效。
本多中心回顾性队列研究于2007年8月至2024年1月在土耳其的15家机构进行，纳入了211例已切除、非转移性壶腹腺癌患者，这些患者接受了含或不含放化疗的各种化疗方案的辅助化疗。记录临床病理和治疗相关参数。采用Kaplan-Meier估计法分析无病生存期（DFS）和总生存期（OS）。使用Cox比例风险回归来确定与OS相关的协变量。
中位随访时间为52个月，分析时116例患者（55.2%）存活。中位年龄为61岁（32 - 82岁）。16.6%的患者（n = 35）接受了mFOLFIRINOX治疗。FOLFIRINOX治疗组的3年DFS率为79.41%，其他治疗组为53.9%（mDFS的P = 0.034）。接受mFOLFIRINOX治疗的患者中位OS未达到，而接受其他治疗的患者为51个月（P = 0.071）。虽然未得出具有统计学意义的结果，但在FOLFIRINOX组观察到生存时间有统计学意义的趋势。在调整其他预后参数后，mFOLFIRINOX仍然是OS更好的独立统计学显著参数（HR；95%CI：3.24；1.02 - 10.9；P = 0.046）。
FOLFIRINOX治疗在壶腹癌的辅助治疗中显示出疗效，与组织学亚型无关。这些发现应在大型前瞻性试验中得到验证。
