Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-Gu, Seoul, 05505, Republic of Korea.
Department of Pathology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
Langenbecks Arch Surg. 2022 May;407(3):1091-1097. doi: 10.1007/s00423-021-02414-3. Epub 2022 Jan 10.
Although surgery is the primary treatment for ampullary cancer (AC), the benefit of adjuvant chemotherapy (CTx) has not yet been confirmed.
AC patients who were administered 5-fluorouracil(FU)/leucovorin(LV)-based CTx after curative intent surgery between 2011 and 2019 were included. Prognosis was compared between the observation (OB) and CTx groups after propensity score matching (PSM) using perioperative variables to control differences in patient characteristics.
Before PSM, of 475 patients, those in the CTx group (n = 281) had worse 5-year overall survival (OS) (82.1% vs. 78.5%, p = 0.017) and worse 5-year recurrence-free survival (RFS) (54.9% vs. 75.7%, p < 0.001) than those in the OB group (n = 194). In addition, the CTx group had a higher rate of poor prognostic factors such as a high T stage (p < 0.001), node metastasis (p < 0.001), and poor differentiation (p < 0.001). After PSM, perioperative outcomes were comparable. In addition, there were no significant differences in OS (hazard ratio [HR], 1.085; 95% confidence interval [CI], 0.688-1.710; p = 0.726) or RFS (HR, 0.883; 95% CI, 0.613 1.272; p = 0.505) between the CTx (n = 123) and OB (n = 123) groups even after stratification by TNM stage. Intestinal subtype showed better 5-year OS (83.7% vs 33.2%, p = 0.015) and RFS (46.5% vs 24.9%, p = 0.035) rate compared with pancreatobiliary/mixed subtype.
Patients who received adjuvant chemotherapy based on 5-FU/LV showed comparable oncologic outcomes to patients in the OB group even after stratification by tumor stage. The patients with intestinal subtype showed oncologic benefit for adjuvant 5-FU/LV CTx compared with pancreatobiliary or mixed subtypes.
尽管手术是壶腹癌（AC）的主要治疗方法，但辅助化疗（CTx）的益处尚未得到证实。
纳入了 2011 年至 2019 年期间接受根治性手术并接受氟尿嘧啶（FU）/亚叶酸（LV）为基础的 CTx 的 AC 患者。通过倾向性评分匹配（PSM），根据围手术期变量来控制患者特征的差异，比较观察（OB）和 CTx 组之间的预后。
在 PSM 之前，在 475 名患者中，CTx 组（n=281）的 5 年总生存率（OS）（82.1% vs. 78.5%，p=0.017）和 5 年无复发生存率（RFS）（54.9% vs. 75.7%，p<0.001）均较 OB 组（n=194）差。此外，CTx 组具有更高比例的不良预后因素，如高 T 分期（p<0.001）、淋巴结转移（p<0.001）和低分化（p<0.001）。PSM 后，围手术期结果相当。此外，在 TNM 分期分层后，CTx 组（n=123）和 OB 组（n=123）之间的 OS（风险比[HR]，1.085；95%置信区间[CI]，0.688-1.710；p=0.726）或 RFS（HR，0.883；95%CI，0.613-1.272；p=0.505）均无显著差异。肠型与胰胆管/混合型相比，5 年 OS（83.7% vs. 33.2%，p=0.015）和 RFS（46.5% vs. 24.9%，p=0.035）率更高。
接受基于 5-FU/LV 的辅助化疗的患者，即使按肿瘤分期分层，其肿瘤学结果与 OB 组相当。与胰胆管或混合亚型相比，肠型患者接受辅助 5-FU/LV CTx 具有更好的肿瘤学获益。
