Narahara 2011.
Methods | Multicentre RCT
2 arms Quality score: D The study was conducted in Japan. |
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Participants | n = 326 Median age: 63 years Metastatic disease: 20% ECOG 2‐3: 3% |
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Interventions | S‐1: oral S‐1 80 mg/m²/day d 1‐28, repeated at 6 weeks S‐1 + irinotecan: oral S‐1 80 mg/m²/d d 1‐21 + irinotecan iv 80 mg/m² d 1 + 15, repeated at 6 weeks |
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Outcomes | Overall survival Time to treatment failure Response rates Toxicity |
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Notes | This study was conducted in Japan. Pre‐planned follow‐up of ≥ 1.5 years after registration of all patients was continued to 2.5 years because of a unexpectedly high survival rate of 22% at the cut‐off date after a follow‐up of 1.5 years. Second‐line chemotherapy was administered to 76% of patients. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Centralised dynamic allocation |
Allocation concealment (selection bias) | Low risk | Centralised dynamic allocation |
Incomplete outcome data (attrition bias) efficacy | Low risk | Full analysis set |
Incomplete outcome data (attrition bias) safety | Unclear risk | 4 patients found to be ineligible after starting treatment were excluded from safety analysis ‐ ?per‐protocol analysis |
Selective reporting (reporting bias) | Low risk | Expected endpoints reported |
Other bias | High risk | Second‐line chemotherapy was administered to a total of 76% of patients. This is likely to dilute the effect of both treatments on overall survival, but not on progression‐free‐survival. |
Blinded review of CT/MRI‐scans? | Unclear risk | Extramural review is described (does not neccessarily mean blinded) |