Ajani 2010.
Methods | Multicentre RCT 2 arms Quality score: A |
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Participants | n = 1053 Median age: 59 years ECOG 2‐3: 0% Metastatic disease: 96% |
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Interventions | S‐1+Cisplatin: S‐1 (50 mg/m2) in two daily doses d1‐21orally + cisplatin (75 mg/m2) repeated at d 28 versus FU+Cisplatin: fluorouracil (1000 mg/m2/24 hrs as 120‐hour infusion) + cisplatin (100 mg/m2), repeated at d 28 Cisplatin was discontinued after 6 cycles; provision to continue S‐1 or FU until progression of disease or unacceptable toxicities |
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Outcomes | Overall survival Progression‐free survival Time to treatment failure Tumour response Toxicity |
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Notes | Second‐line therapy in 31.4% of patients, most frequently with fluoropyrimidine | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated dynamic randomisation |
Allocation concealment (selection bias) | Low risk | Centralised randomisation |
Incomplete outcome data (attrition bias) efficacy | Low risk | Full analysis set of all treated patients (98.8% in S‐1+cisplatin arm and 94.6% in FU+cisplatin arm) |
Incomplete outcome data (attrition bias) safety | Low risk | Full analysis set of all treated patients |
Selective reporting (reporting bias) | Low risk | PEP: OS SEP: ORR, PFS, TTF, safety |
Other bias | Low risk | None |
Blinded review of CT/MRI‐scans? | Low risk | Radiographic evidence of response to treatment was also independently reviewed. An independent data monitoring committee oversaw the safety and efficacy data along with other aspects of the conduct of the study. |