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中国全科医学

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胰腺癌术后GS与SOXIRI辅助化疗疗效与安全性分析

陈京京1,2，白新源1,2，沙慧子2，孙怡2,4，倪嘉遥1,2，同帆1,2，邹璐1,2，孟凡岩3，杜娟1,2*   

  1. 1.210008 江苏省南京市，南京中医药大学鼓楼临床医学院 南京鼓楼医院肿瘤科 2.210008 江苏省南京市，南京大学医学院附属鼓楼医院肿瘤中心 3.210008 江苏省南京市，南京大学医学院附属鼓楼医院研发转化平台中心实验室 4.210008 江苏省南京市，南京中医药大学附属江苏省中医院放射肿瘤科
  • 收稿日期:2025-10-13 接受日期:2025-12-09
  • 通讯作者: 杜娟，主任医师；E-mail：dujuanglyy@163.com
  • 基金资助:
    国家自然科学基金资助项目（82373280）；江苏省卫生健康委医学科研项目（K2024038）；南京市卫生健康委员会重点项目（ZKX24021）

Analysis of the Efficacy and Safety of GS and SOXIRI as Adjuvant Chemotherapy for Pancreatic Cancer

CHEN Jingjing1, 2, BAI Xinyuan1, 2, SHA Huizi2, SUN Yi2, 4, NI Jiayao1, 2, TONG Fan1, 2, ZOU Lu 1, 2, MENG Fanyan3, DU Juan1, 2*   

  1. 1.Department of Oncology, Nanjing Drum Tower Hospital, Clinical College of Drum Tower, Nanjing Univrsity of Chinese Medicine, Nanjing, China 2.The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China 3.Department of Laboratory Medicine, Nanjing Drum Tower Hospital, The Affiliated Hospital of Medical School, Nanjing University, Nanjing, China 4.Department of Radiation Oncology, Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China
  • Received:2025-10-13 Accepted:2025-12-09
  • Contact: DU Juan, Chief physician; E-mail: dujuanglyy@163.com

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摘要： 背景 mFOLFIRINOX（改良的氟尿嘧啶/亚叶酸钙/伊立替康/奥沙利铂）方案与GX（吉西他滨/卡培他滨）方案是胰腺导管腺癌（PDAC）切除术后的标准辅助化疗方案，但mFOLFIRINOX存在显著毒性。SOXIRI（替吉奥/伊立替康/奥沙利铂）和GS（吉西他滨/替吉奥）方案分别为上述方案的改良方案。目前尚无GS与SOXIRI方案的直接比较研究。目的 比较辅助化疗方案GS与SOXIRI治疗PDAC的疗效与安全性。方法 本研究为回顾性队列研究。纳入2018年3月—2023年6月南京鼓楼医院肿瘤科接受胰腺癌术后辅助化疗的41例患者为研究对象，其中接受GS方案治疗的患者21例（GS组），接受SOXIRI方案治疗的患者20例（SOXIRI组），通过查阅电子病历及电话等方式对入组患者进行随访，随访截至2024-08-31。主要终点为无病生存期（DFS），次要终点包括2年总生存期（OS）率及不良事件（AEs）。采用Kaplan-Meier法绘制两组患者的DFS和OS生存曲线，采用Log-rank检验对两条生存曲线的差异进行统计学比较。采用单因素和多因素Cox比例风险回归分析影响DFS和OS的相关因素。结果 GS组与SOXIRI组的中位无病生存期（mDFS）分别为18.65个月和13.03个月，2年OS率分别为84.7%和66.0%，两组mDFS和2年OS率比较，差异均无统计学意义（χ2 =0.646，P=0.421；χ2 =3.269，P=0.071）。多因素Cox风险比例回归分析显示，术后CA19-9水平（HR=3.66，95%CI=1.26~10.64）及切缘状态（HR=2.64，95%CI=1.05~6.61）是DFS的独立影响因素，而高龄（HR=3.42，95%CI=1.13~10.36）与TNM分期（HR=5.68，95%CI=1.40~22.97）是OS的独立影响因素。亚组分析显示，GS方案与SOXIRI方案治疗疗效比较，差异均无统计学意义（P均>0.05）。SOXIRI组的总体腹泻（χ2 =7.796，P=0.005）和周围神经毒性（χ2 =7.552，P=0.006）发生率高于GS组。结论 在PDAC术后辅助化疗中，GS方案在疗效上不劣于SOXIRI方案，且安全性更佳，腹泻与周围神经毒性发生率更低。

关键词: 胰腺癌, 辅助化疗, 替吉奥, 疗效, 队列研究, 回顾性研究

Abstract: Background mFOLFIRINOX (modified Fluorouracil/Leucovorin/Irinotecan/Oxaliplatin) regimen and GX (Gemcitabine/Xeloda) regimen are standard adjuvant chemotherapies for resected Pancreatic Ductal Adenocarcinoma(PDAC), but mFOLFIRINOX exhibits significant toxicities. SOXIRI (S-1/Irinotecan/Oxaliplatin) and GS (Gemcitabine/S-1) are used as modified on the basis of mFOLFIRINOX and GX regimen. The comparison of GS and SOXIRI has not been reported. Objective we aimed to compare the efficacy and safety of adjuvant GS with SOXIRI for PDAC retrospectively. Methods This retrospective cohort study analyzed 41 patients with PDAC who underwent radical resection between 2018 and 2023 (21 in the GS group and 20 in the SOXIRI group). The enrolled patients were followed up via review of electronic medical records and telephone calls. The follow-up period continued until August 31, 2024. The primary endpoint was disease-free survival (DFS). Secondary endpoints included the 2-year overall survival (OS) rate and adverse events (AEs). Survival curves were plotted using the Kaplan-Meier method and compared with the log-rank test. Univariate and multivariate Cox proportional hazards models were used to identify factors associated with DFS and OS. Results The median disease free survival (mDFS) was 18.65 months in the GS group and 13.03 months in the SOXIRI group, with the 2-year overall survival (OS) rates being 84.7% and 66.0%, respectively. No statistically significant differences were observed in mDFS and 2-year OS rate between the two groups (χ2 =0.646, P=0.421; χ2 =3.269, P=0.071). Multivariate Cox proportional hazards regression analysis revealed that postoperative CA19-9 level(HR=3.66, 95%CI=1.26-10.64) and surgical margin status (HR=2.64, 95%CI=1.05-6.61) were independent influnce factors for DFS, whereas advanced age (HR=3.42, 95%CI=1.13-10.36) and TNM stage (HR=5.68, 95%CI=1.40-22.97) were independent influnce factors for OS. Subgroup analysis showed no statistically significant difference in therapeutic efficacy between the GS and SOXIRI regimens (all P>0.05). The incidences of overall diarrhea (χ2 =7.796, P=0.005) and peripheral neurotoxicity (χ2=7.552, P=0.006) were significantly higher in the SOXIRI group than in the GS group. Conclusion For postoperative adjuvant therapy in pancreatic cancer, the GS demonstrated noninferiority to the SOXIRI regimen in efficacy and better safety with lower diarrhea/peripheral nerve toxicity incidence.

Key words: Pancreatic cancer, Adjuvant chemotherapy, S-1, Efficacy, Cohort Study, Retrospective Study

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