Ochenduszko 2015.
| Methods | Randomised, single‐centre phase 3 study | |
| Participants | "Most patients had metastatic disease and more than 50 % of patients in each arm have undergone gastrectomy (primary tumor resection) as part of curative or palliative treatment. Significantly more patients in the mDCF arm presented with metastases in the liver (48.1 vs. 17.2 %; p = 0.029)" | |
| Interventions | "The EOX regimen was given every 3 weeks, initially for a maximum of eight cycles (24 weeks of treatment). It consisted of epirubicin 50 mg/m2 (intravenous bolus), followed by oxaliplatin 130 mg/m2 (2‐h intravenous infusion); capecitabine was administered orally, twice daily at the dose of 625 mg/m2 for 21 days. The mDCF regimen was administered every 2 weeks, initially for a maximum of 12 cycles (24 weeks of treatment), docetaxel 40 mg/m2 (intravenous infusion over 60 min) on day 1, followed by leucovorin 400 mg/m2 (intravenous infusion over 120 min) on day 1, followed by 5‐fluorouracil 400 mg/m2 (intravenous bolus) on day 1, and then 5‐fluorouracil 1000 mg/m2/day continuous intravenous infusion on day 1 and day 2, followed by cisplatin 40 mg/m2 (intravenous infusion over 60 min) on day 3." | |
| Outcomes | OS PFS ‐ the definition of PFS was not clearly stated Safety |
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| Notes | ||
| 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 | No loss to follow‐up |
| Incomplete outcome data (attrition bias) safety | Low risk | Only one patient from mDCF arm excluded due to rapid disease progression |
| Selective reporting (reporting bias) | Unclear risk | RR not provided |
| Other bias | High risk | "Significantly more patients in the mDCF arm presented with metastases in the liver (48.1 vs. 17.2 %; p = 0.029)" ‐ no statistical adjustment was made for baseline imbalance CT scans every 8–12 weeks; and disease progression could also be evaluated based on clinical symptoms and urgent CT was requested whenever needed |
| Blinded review of CT/MRI‐scans? | Unclear risk | Not stated |