Koizumi 2008.
Methods | Multicentre RCT
2 arms
Quality score: A The study was conducted in Japan. |
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Participants | n = 305 Median age: 62 years Metastatic disease: 100% ECOG 2‐3: 3% | |
Interventions | S‐1 + cisplatin: S‐1 twice daily d 1‐20 repeated at d 36, dose of S‐1 according to the patient’s body surface area (< 1.25 m²: 40 mg; 1.25–1.5 m²: 50 mg; > 1.5 m²: 60 mg) + cisplatin 60 mg/m² d 8, repeated at d 36 versus S‐1 : S‐1 twice daily d 1‐27 repeated at d 41, dose of S‐1 according to the patient’s body surface area (< 1.25 m²: 40 mg; 1.25–1.5 m²: 50 mg; > 1.5 m²: 60 mg) |
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Outcomes | Hazard ratio for overall survival Tumour response Toxicity | |
Notes | This study was conducted in Japan. Due to polymorphic differences in the CYP2A6 gene in Asians and whites, the tolerability of S‐1 is different in whites (Ajani 2006). The dose of S‐1, which was used in this trial may not be used in non‐Asian populations for this reason. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Minimisation by use of biased coin method |
Allocation concealment (selection bias) | Low risk | Central allocation |
Incomplete outcome data (attrition bias) efficacy | Low risk | 298/305 patients included in analysis. |
Incomplete outcome data (attrition bias) safety | Low risk | 298/305 patients included in analysis. |
Selective reporting (reporting bias) | Low risk | Report includes all expected outcomes |
Other bias | Low risk | If second‐line treatment was started without progressive disease (i.e. due to adverse events), patients were censored |
Blinded review of CT/MRI‐scans? | Low risk | Images were assessed by an extramural review committee |