Huang 2013.
Methods | Multicentre RCT 2 arms Quality score: D | |
Participants | n = 240
Median age: 55 years Metastatic disease: 93% |
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Interventions | Paclitaxel+S‐1: Paclitaxel 60 mg/m2 d 1,8,15, 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) twice daily d 1‐14, repeated at d 29 versus Paclitaxel+5‐FU: Paclitaxel 60 mg/m2 d 1,8,15, 5‐FU 500mg/m2 d 1‐5, leucovorin 20 mg/m2 d 1‐5 repeated at d 29 |
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Outcomes | Response rates Progression‐free survival Time to treatment failure Toxicity |
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Notes | 6% of patients had no adenocarconoma | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not mentioned |
Allocation concealment (selection bias) | Low risk | Central randomisation |
Incomplete outcome data (attrition bias) efficacy | Low risk | 229/240 included in full analysis set: One patient was not eligible for the current analysis due to a lack of measurable lesions, 11 patients withdrew informed consent |
Incomplete outcome data (attrition bias) safety | Low risk | 229/240 included in full analysis set: One patient was not eligible for the current analysis due to a lack of measurable lesions, 11 patients withdrew informed consent |
Selective reporting (reporting bias) | Low risk | All expected outcomes except OS analysed |
Other bias | Unclear risk | OS not analysed |
Blinded review of CT/MRI‐scans? | Unclear risk | Not stated |