Thuss‐Patience 2005.
Methods | Multicentre RCT 2 arms Quality score: A | |
Participants | n = 90 Median age: 62.5 years Metastatic disease: 98% ECOG 2‐3: 3% | |
Interventions | DF: docetaxel 75 mg/m² d 1 + FU 200 mg/m²/day as a 24‐hour continuous infusion d 1‐21, repeated at d 22 versus ECF: epirubicin 50 mg/m² d 1 + cisplatin 60 mg/m² d 1 + FU 200 mg/m²/as a 24‐hour continuous infusion d 1‐21, repeated at d 22 | |
Outcomes | Tumour response Median survival Median time to progression Toxicity | |
Notes | Phase II study The trial was not intended and not statistically powered to perform a head‐to‐head comparison of response rate and toxicity of the 2 treatment arms. ECF serves as an internal control arm to avoid selection bias. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers |
Allocation concealment (selection bias) | Low risk | Central allocation |
Incomplete outcome data (attrition bias) efficacy | Low risk | Analysis of the full analysis set |
Incomplete outcome data (attrition bias) safety | Low risk | Analysis of the full analysis set |
Selective reporting (reporting bias) | Low risk | Report includes all expected outcomes |
Other bias | High risk | The trial was not intended and not statistically powered to perform a head‐to‐head comparison of response rate and toxicity of the 2 treatment arms, ECF serves as an internal control arm to avoid selection bias. |
Blinded review of CT/MRI‐scans? | Low risk | Tumour response was assessed together with an independent radiologist |