Wang 2013.
Methods | Single‐centre RCT 2 arms Quality score: B |
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Participants | n = 82 participants with metastatic or locally recurrent gastric cancer ECOG 2: 8.5% |
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Interventions | S‐1 +paclitaxel: S‐1 depending on body surface area (BSA < 1.25 m2: 80 mg/d; BSA 1.25 to < 1.5 m2: 100 mg/d; BSA > 1.5 m2, 120 mg/d twice daily) d 1‐14, paclitaxel 60mg/m2 d 1,8,15, repeated at d 29 versus S‐1: S‐1 depending on body surface area (BSA < 1.25 m2: 80 mg/d; BSA 1.25 to <1.5 m2: 100 mg/d; BSA > 1.5 m2, 120 mg/d twice daily) d 1‐14, repeated at d 29 |
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Outcomes | Overall survival Progression‐free survival Response rate Toxicity |
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Notes | Second‐line therapy with cisplatin or irinotecan in more than half of the patients | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated, random sequence |
Allocation concealment (selection bias) | Low risk | Consecutively numbered opaque sealed envelopes |
Incomplete outcome data (attrition bias) efficacy | Low risk | No patients lost to follow‐up and all outcomes could be confirmed |
Incomplete outcome data (attrition bias) safety | Low risk | No patients lost to follow up and all outcomes could be confirmed |
Selective reporting (reporting bias) | Low risk | OS, PFS, ORR, safety |
Other bias | Unclear risk | N/A |
Blinded review of CT/MRI‐scans? | High risk | Tumor assessment was undertaken with CT or MRI consistently every 2 months by principal investigators |