Analysis of the Efficacy and Safety of Gemcitabine plus S-1 Regimen versus S-1 Combined with Oxaliplatin and Irinotecan Regimen as Adjuvant Chemotherapy for Pancreatic Ductal Adenocarcinoma

doi:10.12114/j.issn.1007-9572.2025.0407

Chinese General Practice ›› 2026, Vol. 29 ›› Issue (26): 3767-3773.DOI: 10.12114/j.issn.1007-9572.2025.0407

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Analysis of the Efficacy and Safety of Gemcitabine plus S-1 Regimen versus S-1 Combined with Oxaliplatin and Irinotecan Regimen as Adjuvant Chemotherapy for Pancreatic Ductal Adenocarcinoma

1. Department of Oncology, Nanjing Drum Tower Hospital/Clinical College of Drum Tower, Nanjing University of Chinese Medicine, Nanjing 210008, China
2. The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing 210008, China
3. Department of Laboratory Medicine, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing 210008, China
4. Department of Radiation Oncology, Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210008, China

Received:2025-10-13 Revised:2025-12-09 Published:2026-09-15 Online:2026-08-11
Contact: DU Juan

胰腺导管腺癌术后吉西他滨联合替吉奥方案与替吉奥联合奥沙利铂和伊立替康方案辅助化疗疗效与安全性分析

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

通讯作者: 杜娟
作者简介:
作者贡献：
陈京京收集分析数据，起草并修改论文；白新源收集分析数据；沙慧子和孙怡对论文进行审阅与修订；倪嘉遥、同帆与邹璐负责数据收集；孟凡岩设计研究方案和框架；杜娟明确研究方向，审核论文，对文章整体负责。
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)

Abstract

Abstract:

Background

The mFOLFIRINOX regimen(oxaliplatin, irinotecan, leucovorin and 5-fluorouracil) and GX regimen (gemcitabine combined with capecitabine) are standard adjuvant chemotherapies for resected pancreatic ductal adenocarcinoma(PDAC), but mFOLFIRINOX exhibits significant toxicities. SOXIRI regimen(S-1 combined with oxaliplatin and irinotecan) and GS regimen(gemcitabine plus 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

To compare the efficacy and safety of adjuvant GS with SOXIRI for PDAC retrospectively.

Methods

This study analyzed 41 patients with PDAC who underwent postoperative adjuvant chemotherapy at the Oncology Center of Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, from March 2018 to June 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 rates 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 influence factors for DFS (P<0.05), 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 (P<0.05). Subgroup analysis showed no statistically significant difference in therapeutic efficacy between the GS and SOXIRI regimens (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 PDAC, 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

摘要：

背景

改良的奥沙利铂+伊立替康+亚叶酸钙+氟尿嘧啶（mFOLFIRINOX）方案与吉西他滨+卡培他滨（GX）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方案存在显著毒性。替吉奥+奥沙利铂+伊利替康（SOXIRI）方案和吉西他滨+替吉奥（GS）方案分别为上述方案的改良方案。目前GS与SOXIRI方案的直接比较研究尚少。

目的

比较GS与SOXIRI辅助化疗方案治疗PDAC的疗效与安全性。

方法

纳入2018年3月—2023年6月于南京大学医学院附属鼓楼医院肿瘤中心接受胰腺导管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。主要观察终点为无病生存期（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比例风险回归分析显示，术后糖类抗原19-9（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（P<0.05），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（P<0.05）。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>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

CLC Number:

R 736.7

CHEN Jingjing,BAI Xinyuan,SHA Huizi, et al. Analysis of the Efficacy and Safety of Gemcitabine plus S-1 Regimen versus S-1 Combined with Oxaliplatin and Irinotecan Regimen as Adjuvant Chemotherapy for Pancreatic Ductal Adenocarcinoma[J]. Chinese General Practice, 2026, 29(26): 3767-3773. DOI: 10.12114/j.issn.1007-9572.2025.0407.
陈京京,白新源,沙慧子等. 胰腺导管腺癌术后吉西他滨联合替吉奥方案与替吉奥联合奥沙利铂和伊立替康方案辅助化疗疗效与安全性分析[J]. 中国全科医学, 2026, 29(26): 3767-3773. DOI: 10.12114/j.issn.1007-9572.2025.0407.

Figures/Tables 9

References 29

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组别	例数	术后CA19-9		肿瘤分化		脉管侵犯		切缘状态		TNM分期
组别	例数	≥27 U/mL	<27 U/mL	低/中低分化	中/中高分化	有	无	R0	R1	Ⅰ期	Ⅱ/Ⅲ期
GS组	21	3（14.3）	18（85.7）	13（61.9）	8（38.1）	9（42.9）	12（57.1）	15（71.4）	6（28.6）	12（57.1）	9（42.9）
SOXIRI组	20	4（20.0）	16（80.0）	6（30.0）	14（70.0）	5（25.0）	15（75.0）	15（75.0）	5（25.0）	11（55.0）	9（45.0）
χ²值		—		4.193		1.453		0.067		0.019
P值		0.697		0.041		0.273		0.796		0.890
组别	年龄		性别		ECOG评分		肿瘤位置
组别	≥65岁	<65岁	男	女	0分	1分	胰腺头颈部	胰腺体尾部
GS组	10（47.6）	11（52.4）	8（38.1）	13（61.9）	12（57.1）	9（42.9）	10（47.6）	11（52.4）
SOXIRI组	6（30.0）	14（70.0）	17（85.0）	3（15.0）	7（35.0）	13（65.0）	9（45.0）	11（55.0）
χ²值	1.366		9.471		2.020		0.867
P值	0.248		0.001		0.199		0.726

组别	例数	术后CA19-9		肿瘤分化		脉管侵犯		切缘状态		TNM分期
组别	例数	≥27 U/mL	<27 U/mL	低/中低分化	中/中高分化	有	无	R0	R1	Ⅰ期	Ⅱ/Ⅲ期
GS组	21	3（14.3）	18（85.7）	13（61.9）	8（38.1）	9（42.9）	12（57.1）	15（71.4）	6（28.6）	12（57.1）	9（42.9）
SOXIRI组	20	4（20.0）	16（80.0）	6（30.0）	14（70.0）	5（25.0）	15（75.0）	15（75.0）	5（25.0）	11（55.0）	9（45.0）
χ²值		—		4.193		1.453		0.067		0.019
P值		0.697		0.041		0.273		0.796		0.890
组别	年龄		性别		ECOG评分		肿瘤位置
组别	≥65岁	<65岁	男	女	0分	1分	胰腺头颈部	胰腺体尾部
GS组	10（47.6）	11（52.4）	8（38.1）	13（61.9）	12（57.1）	9（42.9）	10（47.6）	11（52.4）
SOXIRI组	6（30.0）	14（70.0）	17（85.0）	3（15.0）	7（35.0）	13（65.0）	9（45.0）	11（55.0）
χ²值	1.366		9.471		2.020		0.867
P值	0.248		0.001		0.199		0.726

变量	赋值
年龄	<65岁=0，≥65岁=1
性别	男=0，女=1
ECOG评分	0分=0，1分=1
肿瘤位置	胰腺头颈部=0，胰腺体尾部=1
术后CA19-9	<27 U/mL=0，≥27 U/mL=1
肿瘤分化	中/中高分化=0，低/中低分化=1
脉管侵犯	无=0，有=1
切缘状态	R0=0，R1=1
TNM分期	Ⅰ期=0，Ⅱ/Ⅲ期=1
化疗方案	SOXIRI=0，GS=1

变量	赋值
年龄	<65岁=0，≥65岁=1
性别	男=0，女=1
ECOG评分	0分=0，1分=1
肿瘤位置	胰腺头颈部=0，胰腺体尾部=1
术后CA19-9	<27 U/mL=0，≥27 U/mL=1
肿瘤分化	中/中高分化=0，低/中低分化=1
脉管侵犯	无=0，有=1
切缘状态	R0=0，R1=1
TNM分期	Ⅰ期=0，Ⅱ/Ⅲ期=1
化疗方案	SOXIRI=0，GS=1

项目	DFS		OS
项目	HR（95%CI）	P值	HR（95%CI）	P值
年龄	1.34（0.59~3.04）	0.478	3.08（1.08~8.80）	0.036
性别	0.93（0.40~2.12）	0.853	1.30（0.47~3.59）	0.618
ECOG评分	2.12（0.90~4.97）	0.086	2.65（0.84~8.37）	0.095
肿瘤位置	0.76（0.40~1.69）	0.498	0.67（0.24~1.86）	0.440
术后CA19-9	4.89（1.85~12.94）	0.001	3.48（1.13~10.67）	0.030
肿瘤分化	1.66（0.74~3.71）	0.218	1.37（0.50~3.81）	0.543
脉管侵犯	1.47（0.65~3.30）	0.358	1.36（0.49~3.76）	0.557
切缘状态	2.21（0.96~4.12）	0.061	2.26（0.80~6.41）	0.126
TNM分期	3.68（1.58~8.55）	0.002	6.93（1.91~25.13）	0.003
化疗方案	1.15（0.50~2.63）	0.748	1.13（0.38~3.33）	0.825

Analysis of the Efficacy and Safety of Gemcitabine plus S-1 Regimen versus S-1 Combined with Oxaliplatin and Irinotecan Regimen as Adjuvant Chemotherapy for Pancreatic Ductal Adenocarcinoma

胰腺导管腺癌术后吉西他滨联合替吉奥方案与替吉奥联合奥沙利铂和伊立替康方案辅助化疗疗效与安全性分析

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不良事件类型	GS组（n=21）		SOXIRI组（n=20）
不良事件类型	1~2级	3~4级	1~2级	3~4级
血液学毒性
白细胞减少	13（61.9）	3（14.3）	7（35.0）	3（15.0）
中性粒细胞减少	12（57.1）	4（19.0）	9（45.0）	4（20.0）
血红蛋白降低	16（76.2）	1（4.8）	13（65.0）	0
血小板减少	7（33.3）	2（9.5）	6（30.0）	2（10.0）
非血液学毒性
恶心与呕吐	8（38.1）	0	12（60.0）	2（10.0）
腹泻	2（9.5）	0	8（40.0）	3（15.0）
丙氨酸氨基转移酶升高	4（19.0）	0	4（20.0）	0
天冬氨酸氨基转移酶升高	5（23.8）	0	1（5.0）	0
周围神经毒性	3（14.3）	0	11（55.0）	0
发热	6（28.6）	0	4（20.0）	0

[1]	SI Xinying, MA Wenyuan, GUO Zhixun, QI Shuo, CHEN Xiaoheng, LI Zhe, LI Lu, DING Zhiguo. Preliminary Development of a Syndrome Efficacy Evaluation Scale for Hypothyroidism Secondary to Hashimoto's Thyroiditis: Based on Expert Consultation and Clinical Investigation [J]. Chinese General Practice, 2026, 29(24): 3528-3537.
[2]	LI Xueni, LIU Gejing, LIU Yongming. Efficacy and Safety of Semaglutide in Patients with Heart Failure: a Meta-Analysis [J]. Chinese General Practice, 2026, 29(24): 3509-3519.
[3]	YANG Haifei, SUN Wu, WU Cheng, REN Wei, LI Rutian. Analysis of Predictors for Immune-related Adverse Events and the Correlation with Efficacy in Progressive Esophageal Squamous Cell Carcinoma [J]. Chinese General Practice, 2026, 29(06): 710-717.
[4]	ZHANG Ling, HUANG Shuangying, XU Hui, MEI Huiting, HONG Yongping. Effects of Different Exercise Types on Fall Efficacy in the Elderly: a Network Meta-analysis [J]. Chinese General Practice, 2026, 29(06): 741-751.
[5]	CHEN Xiaoying, ZHU Xuebo, CHEN Yue. Research on the Mechanism Influencing Professional Identity of Rural Targeted-admission Medical Students Based on Social Cognitive Career Theory [J]. Chinese General Practice, 2026, 29(04): 530-537.
[6]	ZENG Minghui, KUAI Wentao, CHEN Lin, HAN Jiaxin, XU Lianxin, GE Liying, DAI Rongrong, MI Yuqiang, XU Liang. Effect of Type 2 Diabetes Mellitus on the Efficacy of Nucleoside (Acid) Analogues in the Treatment of Chronic Hepatitis B [J]. Chinese General Practice, 2025, 28(35): 4414-4420.
[7]	WANG Lizhu, LI Sihan, WANG Xinyi, MAO Sunxi, QIU Yang, WANG Zhonghua. Pathway Analysis of the Impact of Diabetes Knowledge and Self-efficacy on Self-management and Quality of Survival among Rural Patients with Type 2 Diabetes Mellitus Based on ITHBC Modeling [J]. Chinese General Practice, 2025, 28(34): 4351-4358.
[8]	Expert Panel of the National Key R&D Program "Research on the Effects and Mechanisms of Multiple Types of Physical Stimulation on Body Function", Brain Function Detection and Regulation Rehabilitation Professional Committee of Chinese Association of Rehabilitation Medicine, Cerebral Small Vessel Disease Professional Committee of Beijing Neurology Association. Expert Consensus on the Effects and Efficacy Evaluation of Non-invasive Neuromodulation in Elders with Disability and Dementia [J]. Chinese General Practice, 2025, 28(34): 4258-4281.
[9]	YANG Yingtian, LYU Qianyu, WU Qian, HOU Xinzheng, SONG Jianjun, YE Xuejiao, YANG Chenyan, WANG Shihan. Efficacy of Five-body Balance Exercise on Obesity-related Hypertension Based on the Rehabilitation Model of "Hospital-Gym-Community" : a Randomized Controlled Trial [J]. Chinese General Practice, 2025, 28(32): 4038-4046.
[10]	ZHI Congcong, CHENG Yicheng, HUANG Zichen, WANG Xiaolong, LI Xue, ZHENG Lihua. Collection and Determination of Clinical Questions and Outcome Indicators Based on the Guidelines for Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Hemorrhoids (2025 Edition) [J]. Chinese General Practice, 2025, 28(32): 4089-4094.
[11]	HUANG Lili, JIANG Yan, TANG Min, ZHANG Jialei, HE Jiabei, ZHUANG Jianlin. A Study on the Influence of Health Education Based on the Know-Belief-Act Model and Self-efficacy Theory on the Consumption of Sugary Drinks among Grade 4 Elementary School Students [J]. Chinese General Practice, 2025, 28(28): 3558-3565.
[12]	MA Wenyuan, QI Shuo, SHANG Jianwei, CHEN Xiaoheng, LI Zhe, LI Huilong, HU Rui, LI Lu, SI Xinying, DING Zhiguo. Preliminary Development of a TCM Syndrome Evaluation Scale for Hashimoto's Thyroiditis with Normal Thyroid Function: Based on Expert Consultation and Clinical Survey [J]. Chinese General Practice, 2025, 28(28): 3590-3600.
[13]	LI Hao, LI Jiangtao, LIU Dan, WANG Jianjun. Efficacy and Safety of Belimumab, Anifrolumab, and Telitacicept on the Treatment of Systemic Lupus Erythematosus: a Network Meta-analysis [J]. Chinese General Practice, 2025, 28(23): 2924-2933.
[14]	RUAN Wanbai, LI Junfeng, YIN Yanmei, PENG Lei, ZHU Kexiang. Research Progress of Targeted Therapy and Immunotherapy for Pancreatic Cancer [J]. Chinese General Practice, 2025, 28(23): 2950-2960.
[15]	MA Panpan, WANG Sijing, YOU Na, DING Dafa, LU Yibing. Efficacy and Safety of Danuglipron and Orforglipron in the Treatment of Type 2 Diabetes Mellitus: a Meta-analysis [J]. Chinese General Practice, 2025, 28(21): 2679-2685.

项目	DFS		OS
项目	HR（95%CI）	P值	HR（95%CI）	P值
术后CA19-9	3.66（1.26~10.64）	0.017	1.83（0.55~6.04）	0.324
切缘状态	2.64（1.05~6.61）	0.038	3.86（0.65~7.28）	0.341
年龄	1.34（0.91~1.97）	0.491	3.42（1.13~10.36）	0.030
TNM分期	2.20（0.87~5.54）	0.096	5.68（1.40~22.97）	0.015

项目	DFS		OS
项目	HR（95%CI）	P值	HR（95%CI）	P值
术后CA19-9	3.66（1.26~10.64）	0.017	1.83（0.55~6.04）	0.324
切缘状态	2.64（1.05~6.61）	0.038	3.86（0.65~7.28）	0.341
年龄	1.34（0.91~1.97）	0.491	3.42（1.13~10.36）	0.030
TNM分期	2.20（0.87~5.54）	0.096	5.68（1.40~22.97）	0.015