Komatsu 2011.

Methods	Multicentre RCT 2 arms Quality score: D
Participants	n = 95 Median age: 66 years ECOG 2‐3: 0%
Interventions	irinotecan/S‐1: irinotecan 75 mg/m2 as iv infusion d 1, 15 repeated at d 29 + S‐1 initial 40–60 mg/m2 orally twice daily d 1‐14, repeated at 4 weeks versus S‐1: S‐1 initial 40–60 mg/m2 orally twice daily d 1‐28, repeated at 6 weeks In subsequent cycles doses were varied according to the most severe adverse events during the preceding cycle
Outcomes	Response rates Time to treatment failure Time to progression Overall survival Toxicity
Notes	This study was conducted in Japan.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Minimization
Allocation concealment (selection bias)	Unclear risk	Not stated
Incomplete outcome data (attrition bias) efficacy	Unclear risk	16.7 versus 9.4% were not evaluable for tumour response (RECIST)
Incomplete outcome data (attrition bias) safety	Low risk	Two untreated patients who were excluded from safety evaluation
Selective reporting (reporting bias)	Low risk	Response rates Time to treatment failure Time to progression Overall survival Toxicity
Other bias	High risk	Patients aged over 70 years were more frequent in the group treated with irinotecan and S‐1: 45.8% (irinotecan/S‐1) vs. 14.9% (S‐1). Median age was 70 years for patients treated with irinotecan/S‐1 and 63 years for patients treated with S‐1 alone.
Blinded review of CT/MRI‐scans?	High risk	High risk