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. 2017 Aug 29;2017(8):CD004064. doi: 10.1002/14651858.CD004064.pub4

Summary of findings 10. S‐1 versus 5‐FU‐containing regimens for advanced gastric cancer.

S‐1 versus 5‐FU‐containing regimens for advanced gastric cancer
Patient or population: people with advanced gastric cancer
 Settings: outpatient clinics participating in international multicentre studies, mostly performed in Asia
 Intervention: S‐1‐containing regimens
Control: 5‐FU‐containing regimens
Outcomes Illustrative comparative risks* (95% CI) Relative effect
 (95% CI) No of Participants
 (studies) Quality of the evidence
 (GRADE) Comments
Assumed risk Corresponding risk
5‐FU‐containing regimens S‐1 containing regimens
Overall Survival Study population HR 0.91 
 (0.83 to 1.00) 1793
 (4 studies) ⊕⊕⊕⊕
 high Weighted average of median survival durations from included studies
9.1 months 9.6 months
Tumour response Study population OR 1.73 
 (1.01 to 2.94) 1753
 (7 studies) ⊕⊝⊝⊝
 very low1,2  
256 per 1000 374 per 1000 
 (258 to 503)
Moderate
320 per 1000 449 per 1000 
 (322 to 580)
Progression‐free survival Study population HR 0.85 
 (0.70 to 1.04) 1942
 (4 studies) ⊕⊕⊝⊝
 low1 Weighted average of median survival durations from included studies
4.3 months 5.0 months
Time‐to treatment failure Study population HR 0.88 
 (0.76 to 1.01) 1818
 (5 studies) ⊕⊕⊝⊝
 low1 Weighted average of median survival durations from included studies
3.1 months 3.9 months
Treatment‐related deaths Study population OR 0.56 
 (0.30 to 1.06) 1962
 (4 studies) ⊕⊕⊕⊝
 moderate2  
27 per 1000 15 per 1000 
 (8 to 28)
Moderate
5 per 1000 3 per 1000 
 (2 to 5)
Treatment discontinuation due to toxicity Study population OR 0.85 
 (0.63 to 1.13) 1726
 (3 studies) ⊕⊕⊕⊕
 high  
128 per 1000 111 per 1000 
 (85 to 142)
Moderate
144 per 1000 125 per 1000 
 (96 to 160)
*For time‐to‐event outcomes, e.g. overall survival, the assumed and corresponding risks were obtained by calculating the weighted average of the median survival durations reported in included studies. For dichotomous outcomes, the assumed and corresponding risks (and their 95% confidence interval) are based on proportions of events in the control and intervention groups respectively.
 CI: Confidence interval; OR: Odds ratio; HR: Hazard ratio;
GRADE Working Group grades of evidence
 High quality: Further research is very unlikely to change our confidence in the estimate of effect.
 Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
 Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
 Very low quality: We are very uncertain about the estimate.

1 Downgraded by two levels for severe statistical heterogeneity.
 2 Downgraded by one level for imprecision.