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 |
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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 |