An open-label, randomized, multicenter study of S-1 vs Gemcitabine in patient wi
PUBLISHED: 2015-11-27  398 total views, 1 today

Jianming Xu1, Yan Sun2, Liwei Wang3, Ruihua Xu4, Yi Ba5, Lin Shen6, Shukui Qin7, Nong Xu8, Li Bai9, Jin Li10, Chunmei Bai11, Jifeng Feng12Minhu Chen13, Dong Ma14, Ying Yuan15, Haijun Zhong16, Shiying Yu17Min 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


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