Nemoto 1982a.
| Study characteristics | ||
| Methods | Accrual dates: July 1974 to October 1975 Sample size: 126 Multicentre: 2 sites in USA Randomisation method: 'closed envelopes' kept at one of the centres (unclear how randomisation was achieved) Baseline comparability: no imbalance apparent or reported | |
| Participants | Female Age range not reported (> 50 to < 70 years) 100% MBC 100% first‐line | |
| Interventions | AC vs CFP vs CAF vs CFP‐CA
Arm I: (AC) cyclophosphamide + doxorubicin
Arm II: (CFP) cyclophosphamide + 5‐fluorouracil + prednisone
Arm III: (CAF) cyclophosphamide + doxorubicin + 5‐fluorouracil
Arm IV: (CFP‐CA) CFP as above, then cyclophosphamide + doxorubicin Nemoto 1982a = CFP vs CFP‐CA |
|
| Outcomes | Overall survival Time to progression (TTP) Response (defined as ≥ 50% reduction in tumour size) Toxicity | |
| Notes | 117/126 evaluable: reason for exclusion, 9 withdrawn due to early death or withdrawal from study (no reason given). There is conflicting information in the paper, it is clearly stated that all 126 patients have been included in analysis, however, the graph displays N = 120 with the groups as follows CFP 18; CFP‐CA 20; CAF 40; CA 42. The group numbers as detailed which total to 120 (CFP 18; CFP‐CA 20; CAF 40; CA 42) have been used in this review. Follow‐up details not reported. Based on median TTP: ‐ estimated minimum 12 months ‐ estimated maximum 54 months Time‐to‐event data extracted directly from time‐to‐event curve. Reported that no toxic deaths occurred. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | B ‐ Unclear |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate, closed envelope |
| 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 | Low risk | A ‐ Adequate |
| Incomplete outcome data (attrition bias) Time to progression | Unclear risk | B ‐ Unclear |
| Incomplete outcome data (attrition bias) Overall survival | High risk | C ‐ Inadequate |
| Selective reporting (reporting bias) | Unclear risk | B ‐ Unclear |
| Other bias | Low risk | A ‐ Adequate |