Skip to main content
. 2017 Aug 29;2017(8):CD004064. doi: 10.1002/14651858.CD004064.pub4

Huang 2013.

Methods Multicentre RCT
 2 arms
 Quality score: D
Participants n = 240
 Median age: 55 years
Metastatic disease: 93%
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
Outcomes Response rates
Progression‐free survival
Time to treatment failure
Toxicity
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