Yamamura 1998.
Methods | Multicentre RCT 2 arms Quality score: C | |
Participants | n = 71 | |
Interventions | MTX/5‐FU/THP: methotrexate 50 mg/m², 5‐FU 650 mg/m², pirarubicin 20 mg/m² d 1, repeated at d 15 versus 5‐FU: 5‐FU 650 mg/m² d 1, repeated at d 15 | |
Outcomes | Median survival Toxicity | |
Notes | Study translated from Japanese | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Low risk | Centralised. Phone call |
Incomplete outcome data (attrition bias) efficacy | Low risk | 71/74 evaluable |
Incomplete outcome data (attrition bias) safety | Low risk | 71/74 evaluable |
Selective reporting (reporting bias) | High risk | No response rates available JCOG criteria for toxicity |
Other bias | Unclear risk | Study translated from Japanese |
Blinded review of CT/MRI‐scans? | Unclear risk | N/A |
Abbreviations: BSA: body surface area BSC: best supportive care CI: continuous infusion CT: computed tomography d: day dFUR: 5‐Deoxyfluouridine ECOG: Eastern Cooperative Oncology Group 5‐FU: 5‐Fluorouracil FA: folinic acid h: hour IQR: interquartile range ITT: intention‐to‐treat i.v.: intravenous KI: Karnofsky‐Index KPS: Karnofsky performance status Lv: leucovorin NCI‐CTC: National Cancer Institute Common Toxicity Criteria OS: overall survival p.o.: per os (orally) PFS: progression‐free survival QoL: quality of life RCT: randomised controlled trial RR: response rate TTP: time to progression UFT: uracil/ftorafur w: week WHO: World Health Organization
If not stated differently, all drugs were given as intravenous bolus or short infusion (duration max. 2 hours)