Nishikawa 2012.
Methods | Multicentre RCT
4 arms Quality score: D The study was conducted in Japan. |
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Participants | n = 161 Median age: 67 years ECOG 2‐3: 0 % |
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Interventions | Group A (sequential 5‐FU + paclitaxel): 5‐FU 800 mg/m² c.i.v. d 1‐5, repeated at 4 weeks, followed by paclitaxel 80 mg/m² d.i.v. d 1, 8, 15, repeated at 4 weeks after progression Group B (sequential S‐1 + paclitaxel): S‐1 80 mg/m² p.o. d 1‐28 , repeated at 6 weeks + paclitaxel 80 mg/m² d.i.v. d 1, 8, 15, repeated at 4 weeks after progression Group C (concomitant 5‐FU +paclitaxel): 5‐FU 600 mg/m² c.i.v. d 1‐5 + paclitaxel 80 mg/m² d.i.v. d 8, 15, 22, repeated at 4 weeks Group D (concomitant S‐1 + paclitaxel): S‐1 80 mg/m² p.o. d1‐14 + paclitaxel 50 mg/m² d.i.v. d1,15, repeated at 3 weeks | |
Outcomes | Overall survival (10 months overall survival rate) Progression‐free survival Time to treatment failure Response rates Toxicity |
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Notes | This study was conducted in Japan. After publication of the results of the SPIRITS trial (Koizumi 2008) candidates for accrual were informed about the new treatment standard in Japan and they were offered the alternative to receive the combination therapy instead of participating in the trial. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Centralised dynamic randomisation |
Allocation concealment (selection bias) | Low risk | Centralised dynamic randomisation |
Incomplete outcome data (attrition bias) efficacy | Low risk | Only two patients in arm A and two in arm C declined therapies before the start of the assigned treatment |
Incomplete outcome data (attrition bias) safety | Low risk | Only two patients in arm A and two in arm C declined therapies before the start of the assigned treatment |
Selective reporting (reporting bias) | Low risk | Expected endpoints are reported |
Other bias | Unclear risk | An irinotecan‐containing regimen was recommended for use in case if further lines of treatment were given. No information about the percentage of patients receiving second line treatment is provided. |
Blinded review of CT/MRI‐scans? | Unclear risk | not stated |