Koizumi 2014.
Methods | Multicentre RCT
2 arms Quality score: D The study was conducted in Japan and Korea. |
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Participants | n = 639, 635 eligible (ITT) Median age: 65 years Advanced disease: 83%, relapse: 17% ECOG 2‐3: 0% | |
Interventions | S‐1+docetaxel: docetaxel (40mg/m2 d1) + S‐1 (40‐60mg/m2 ‐according to BSA‐ twice daily d 1‐14), repeated at d 21 versus S‐1: S‐1 (40‐60mg/m2 ‐according to BSA‐ twice daily d 1‐28), repeated at d 42 |
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Outcomes | Overall survival, progression‐free survival, response rate, safety | |
Notes | The study was conducted in Japan and Korea. The dose of S‐1 which was used in this trial may not be valid for non‐Asian populations for this reason. This study was registered (NCT00287768). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) efficacy | Low risk | 4 (0.6%) patients were ineligible (no measurable or non‐measurable lesions) |
Incomplete outcome data (attrition bias) safety | Low risk | All treated patients were included (98%) |
Selective reporting (reporting bias) | Low risk | Report includes all expected outcomes |
Other bias | High risk | Second‐line treatment was given to 69.7% of patients in the S‐1+docetaxel group and 76% in the S‐1 group, planned interim analysis |
Blinded review of CT/MRI‐scans? | Unclear risk | Images were reviewed by a central review board. |