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 |
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Outcomes | Response rates Time to treatment failure Time to progression Overall survival Toxicity |
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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 |