Pannuti 1984.
Study characteristics | ||
Methods | Accrual dates: not reported Sample size: 46 Randomisation method not reported Baseline comparability: no significant imbalance apparent or reported | |
Participants | Female 100% MBC (87% with metastases of bone or viscera) Unclear if prior chemotherapy received by 17% was for MBC Age range: 36‐74 years Median age: 55 (both arms) | |
Interventions | CMF vs R14 Arm I: (CMF) cyclophosphamide + methotrexate + 5‐fluorouracil Arm II: (R14) arm I + vincristine + vinblastine + doxorubicin |
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Outcomes | Overall survival Response (defined as ≥ 50% reduction in tumour size) Toxicity | |
Notes | 46/46 included in analysis Follow‐up details not reported: ‐estimated minimum follow‐up 5.5 months ‐estimated maximum follow‐up 45 months (from survival curve) Time‐to‐event data extracted directly from time‐to‐event curve. Treatment related deaths not reported. Doses of the same chemotherapy agent are markedly different between treatment arms. | |
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 | Low risk | A ‐ Adequate |
Incomplete outcome data (attrition bias) Overall survival | Unclear risk | B ‐ Unclear |
Selective reporting (reporting bias) | Low risk | A ‐ Adequate, outcomes reported |
Other bias | High risk | C ‐ Inadequate, higher proportion of R14 group premenopausal, small study groups |