Jianming Xu¹, Yan Sun², Liwei Wang³, Ruihua Xu⁴, Yi Ba⁵, Lin Shen⁶, Shukui Qin⁷, Nong Xu⁸, Li Bai⁹, Jin Li¹⁰, Chunmei Bai¹¹, Jifeng Feng¹², Minhu Chen¹³, Dong Ma¹⁴, Ying Yuan¹⁵, Haijun Zhong¹⁶, Shiying Yu¹⁷, Min Tao¹⁸, Hongming Pan¹⁹, Jun Zhang²⁰, Rongcheng Luo²¹ 

¹Digestion and oncology, The Affiliated Hospital of Military Medical Sciences, ²Chinese Academy of Medical Sciences, Cancer Institute and Hospital, ³oncology department, Shanghai General Hospital, ⁴Internal Medicine, Sun Yat-sen University Cancer Center, ⁵Digestion and oncology, Tianjin Medical University Cancer Institute and Hospital, ⁶Digestion and oncology, beijing cancer hospital, ⁷Medical Oncology, The 81st Hospital of Chinese PLA, ⁸Zhejiang University School of Medicine, The First Affiliated Hospital, ⁹Medical Oncology, Chinese PLA General Hospital, ¹⁰Medical Oncology, Fudan University Shanghai Cancer Center, ¹¹Medical Oncology, Peking union   Medical College Hospital, ¹²Internal Medicine, Jiangsu Cancer Hospital, ¹³Sun Yat-Sen University, The First Affiliated Hospital, ¹⁴Medical Oncology, Guangdong General Hospital, ¹⁵Medical Oncology, The 2nd Affiliated Hospital of Zhejiang University School of Medicine, ¹⁶Chemotherapy center, Zhejiang Cancer Hospital, ¹⁷Tongji Medical College, Tongji Hospital, ¹⁸oncology department, Suzhou the First Affiliated Hospital of Soochow University, ¹⁹Zhejiang University School of Medicine, SIR RUN RUN SHAW hospital, ²⁰Shanghai Jiao Tong University School of Medicine, Ruijin Hospital, ²¹oncology department, Nanfang Hospital of Southern Medical University

Objective:Gemcitabine (GEM) is a standard treatment in patients with advanced pancreatic cancer (PC). S-1 has shown a good efficacy and well safety in Japanese patients from previous studies and has been approved in Japan. However, the effectiveness in Chinese patients is unknown. The study objective is to evaluate the efficacy and safety of S-1 in Chinese PC patients. Method: Patients with pancreatic cancer who had pathologically confirmed advanced PC, ECOG performance status of 0-1, aged 18-75 years with adequate organ functions. Patients were randomized in 1:1 ratio to receive either S-1 group (80-120 mg/day, bid, day 1 to 28, every 6 weeks) and GEM group (1000 mg/m², on day 1, 8 and 15, every 4 weeks). The primary endpoint was overall survival (OS) with Non-Inferiority margin of hazard ratio (HR) as 1.33. The study is registered with ClinicalTrials.jp, JAPIC CTI-111480.Result: From January 2011 to November 2013, 243 patients were randomized from 21 institutions and received S-1 group (n=122) or GEM group (n=121) with six months follow up from last patient randomized. In the S-1 and GEM group, median OS was 6.67 months and 6.54 months (Cox HR=1.11; 95% CI: 0.84-1.46) respectively, median PFS was 2.79 months in the S-1 group and 2.99 months in the GEM group (Cox HR=1.20; 95% CI: 0.90-1.61). The incidences of Grade 3 or higher of adverse events were 48.3% vs. 61.3%, especially of neutropenia were 5.9% vs. 35.3%, in the S-1 group and the GEM group respectively. Conclusion:S-1 has shown the similar efficacy profile for advanced pancreatic cancer against GEM with well safety profile. S-1 would be a treatment choice in Chinese patient with advanced PC.

Key Words: Advanced pancreatic cancer  S-1  GEM