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Randomized Controlled Trial
. 2015 Oct 27;6(33):35107-15.
doi: 10.18632/oncotarget.5959.

S-1 plus cisplatin versus fluorouracil plus cisplatin in advanced gastric or gastro-esophageal junction adenocarcinoma patients: a pilot study

Yu Hong Li  1 , Miao Zhen Qiu  1   2 , Jian Ming Xu  3 , Guo Ping Sun  4 , Hui Shan Lu  5 , Yun Peng Liu  6 , Mei Zuo Zhong  7 , He Long Zhang  8 , Shi Ying Yu  9 , Wei Li  10 , Xiao Hua Hu  11 , Jie Jun Wang  12 , Ying Cheng  13 , Jun Tian Zhou  14 , Zeng Qing Guo  15 , Zhon Gzhen Guan  1 , Rui Hua Xu  1
Affiliations
Randomized Controlled Trial

S-1 plus cisplatin versus fluorouracil plus cisplatin in advanced gastric or gastro-esophageal junction adenocarcinoma patients: a pilot study

Yu Hong Li et al. Oncotarget. .

Abstract

The safety and efficacy of S-1 plus cisplatin in Chinese advanced gastric cancer patients in first line setting is unknown. In this pilot study, patients with advanced gastric or gastro-esophageal junction adenocarcinoma were enrolled and randomly assigned in a 1:1 ratio to receive S-1 plus cisplatin (CS group) or 5-FU plus cisplatin (CF group). The primary endpoint was time to progression (TTP). Secondary end points included overall survival (OS) and safety. This study was registered on ClinicalTrials. Gov, number NCT01198392. A total of 236 patients were enrolled. Median TTP was 5.51 months in CS group compared with 4.62 months in CF group [hazard ratio (HR) 1.028, 95% confidential interval (CI) 0.758-1.394, p = 0.859]. Median OS was 10.00 months and 10.46 months in CS and CF groups (HR 1.046, 95%CI 0.709-1.543, p = 0.820), respectively. The most common adverse events in both groups were anemia, leukopenia, neutropenia, nausea, thrombocytopenia, vomiting, anorexia and diarrhea. We find that S-1 plus cisplatin is an effective and tolerable option for advanced gastric or gastro-esophageal junction adenocarcinoma patients in China.

Keywords: S-1; first-line chemotherapy; fluorouracil; gastric cancer.

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Conflict of interest statement

CONFLICTS OF INTEREST

All authors declared that there is no conflict of interest.

Figures

Figure 1
Figure 1. CONSORT diagram
Figure 2
Figure 2. Kaplan-Meier curves of time to progression in these two groups of patients
Group A: CS group. Group B: CF group.
Figure 3
Figure 3. Kaplan-Meier curves of overall survival in these two groups of patients
Group A: CS group. Group B: CF group.
See this image and copyright information in PMC

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