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. 2010 Nov 10;2010(11):CD003368. doi: 10.1002/14651858.CD003368.pub3

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