OBJECTIVE To evaluate treatment outcomes, overall survival (OS), and prognostic factors for OS in patients diagnosed with T1 ampullary cancer. BACKGROUND Ampullary cancer is a rare gastrointestinal malignancy with limited data from large cohorts, especially regarding T1 disease. METHODS Patients diagnosed with clinical (c) T1 ampullary cancer and patients with pathological (p) T1 in the case of cTx were included from the Netherlands Cancer Registry (2014-2021). Primary endpoint was OS, analyzed using the Kaplan-Meier estimator. Multivariable Cox proportional hazards regression was used to identify OS predictors. RESULTS Overall, 244 patients with cT1 ampullary cancer were included, of whom 75% (n=184) underwent resection. Among these, 68% (n=125) were upstaged to a higher pathologically T classification (pT2:40%, pT3:22%, pT4:5%). Similarly, cN0 was upstaged to pN1 in 47% of patients (n=87). Next, 100 patients with pT1 and cTx ampullary cancer were included, making a total of 159 patients with pT1 tumor. 92% (146/159) underwent pancreatoduodenectomy while 8% (13/159) underwent endoscopic or local surgical resection. The 1- and 5-year OS for cT1N0 ampullary cancer were 72% and 36%, while for pT1N0 they were 94% and 75%. Independent poor prognostic factors for OS were pN1 classification (HR 2.12; 95%CI 1.15-3.94, P=0.017), pNx classification (i.e. locally resected patients) (HR 2.82; 95%CI 1.22-6.55, P=0.016), and poorly differentiated tumors (HR 4.05; 95%CI 1.33-12.40, P=0.014). CONCLUSION In patients with cT1 ampullary cancer, more than two-thirds had a pathologically higher T classification, and almost half had a pathologically higher N classification. These findings suggest that pancreatoduodenectomy is recommended for cT1 ampullary cancer.

中文翻译：

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临床诊断为 T1 壶腹癌患者治疗和总生存期的人群队列研究。


目的 评估诊断为 T1 壶腹癌患者的治疗结局、总生存期 （OS） 和 OS 的预后因素。背景 壶腹癌是一种罕见的胃肠道恶性肿瘤，来自大型队列的数据有限，尤其是关于 T1 疾病的数据。方法 诊断为临床 （c） T1 壶腹癌的患者和 cTx 病例中的病理性 （p） T1 患者来自荷兰癌症登记处 （2014-2021）。主要终点是 OS，使用 Kaplan-Meier 估计器进行分析。多变量 Cox 比例风险回归用于识别 OS 预测因子。结果 共纳入 244 例 cT1 壶腹癌患者，其中 75% （n=184） 接受了切除术。其中，68% （n=125） 被提升到更高的病理 T 分类 （pT2：40% 、 pT3：22% 、 pT4：5%）。同样，47% 的患者 （n=87） 的 cN0 上调为 pN1。接下来，纳入 100 例 pT1 和 cTx 壶腹癌患者，共计 159 例 pT1 肿瘤患者。92% （146/159） 接受胰十二指肠切除术，而 8% （13/159） 接受内窥镜或局部手术切除。cT1N0 壶腹癌的 1 年和 5 年 OS 分别为 72% 和 36%，而 pT1N0 的 OS 分别为 94% 和 75%。OS 的独立不良预后因素是 pN1 分类 （HR 2.12;95% CI 1.15-3.94，P=0.017）、pNx 分类 （即局部切除患者） （HR 2.82;95%CI 1.22-6.55，P = 0.016） 和低分化肿瘤 （HR 4.05;95% CI 1.33-12.40，P = 0.014）。结论 在 cT1 壶腹癌患者中，超过 2/3 的患者具有病理学较高的 T 分类，近一半的 N 分类较高。这些发现表明胰十二指肠切除术推荐用于 cT1 壶腹癌。