Skip to main content
. 2010 Nov 10;2010(11):CD003368. doi: 10.1002/14651858.CD003368.pub3

Creech 1979.

Study characteristics
Methods Accrual dates: not reported (Accepted for publication March 1978)
Sample size: 78
Number of centres: Unknown (USA)
Randomisation method not reported
Patients were stratified according to poor or good risk
Baseline comparability: no significant imbalance apparent or reported
Participants 100% women with visceral MBC
Age range: 34‐79 years CAMF arm; 32‐87 years CMF arm
Median age: 56 both arms
Interventions CMF vs CAMF
Arm I: (CMF) cyclophosphamide + methotrexate + 5‐fluorouracil
Arm II: (CAMF) as arm I plus doxorubicin
Outcomes Response (defined as ≥ 50% reduction in tumour size)
Survival (reported by response status)
Progression‐free survival (reported by response status)
Toxicity
Notes 78/78 evaluable. ITT analysis. CMF patients crossed over to doxorubicin on progression.
‐ estimated minimum follow‐up = 5 months
‐ estimated maximum follow‐up = 39 months
Overall survival and time to progression were reported for subsets of patients by response status and not extracted for this review. No statistically significant difference between CAMF and CMF were reported for time‐to‐event data. Median survival for PR/CR patients was 20 months in CAMF arm vs 19 months in CMF arm. Treatment related deaths were 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
Blinding (performance bias and detection bias)
All outcomes Unclear risk B ‐ Unclear
Incomplete outcome data (attrition bias)
Response Low risk A ‐ Adequate
Incomplete outcome data (attrition bias)
Toxicity Unclear risk B ‐ Unclear
Incomplete outcome data (attrition bias)
Time to progression 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, other sources of bias not identified in methods