Segaloff 1985.
Study characteristics | ||
Methods | Accrual dates: July 1971 to October 1976 Sample size: 427 Number of centres: 11(USA) Randomisation method: 'randomised from a central statistical office' Baseline comparability: no significant imbalance apparent or reported | |
Participants | Female Age range: > 40 to 65+ years 91% MBC, 9% locally advanced Unclear if a first line trial for MBC 'patients eligible if they had a trial with 1 or 2 single agents' | |
Interventions | CMFP vs CMFVP Arm I: (CMFP) Cyclophosphamide + methotrexate + 5‐fluorouracil + prednisone Arm II: (CMFVP) arm I + vincristine |
|
Outcomes | Overall survival Response Toxicity | |
Notes | All randomised patients included in analyses. Mean follow‐up times reported, 17 months CMFP arm and 19 months CMFVP arm. Survival curve calculated using life table methodology. Time‐to‐event data estimated from statistics presented in trial publication. Toxic related deaths not reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | B ‐ Unclear |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear, patients less than 1 year postmenopausal were centrally randomised |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | B ‐ Unclear |
Incomplete outcome data (attrition bias) Response | Unclear risk | B ‐ Unclear |
Incomplete outcome data (attrition bias) Toxicity | Unclear risk | B ‐ Unclear |
Incomplete outcome data (attrition bias) Overall survival | Unclear risk | B ‐ Unclear |
Selective reporting (reporting bias) | Low risk | A ‐ Adequate, outcomes reported |
Other bias | Low risk | A ‐ Adequate |