Cummings 1981a.
Study characteristics | ||
Methods | Accrual dates: not reported (before 1981) Sample size: 268 Number of centres: unknown (USA) Randomisation method: 'randomly allocated' but method not described Baseline comparability: no significant imbalance apparent or reported other than AVI group with higher percentage postmenopausal women and diagnosis more than 5 years before entry | |
Participants | Female Age range: under 70 82% dominant metastatic site visceral or bone 100% had prior chemotherapy but unclear if adjuvant or for MBC | |
Interventions | AV vs AVD vs AVI
Arm I: (AV) doxorubicin + vincristine
Arm II: (AVD) doxorubicin + vincristine + dibromodulcitol
Arm III: (AVI) doxorubicin + vincristine + ICRF‐159 Cummings 1981a = AV vs AVD |
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Outcomes | Overall survival Time to treatment failure (TTF) (date entry to date progression or death from breast cancer within 6 weeks of ceasing therapy) Response (defined as ≥ 50% reduction in tumour size) Toxicity | |
Notes | 230/268 evaluable: patient withdrew from study or died without objective progression within 8 weeks (26), reason for drop out not reported (12). Follow up details not reported. Based on median TTF: ‐ estimated minimum 3.5 months ‐ estimated maximum 24 months Time‐to‐event data extracted directly from time‐to‐event curve.Toxicity related deaths not reported. Doses of the same chemotherapy agent are reduced in the addition of a drug arm. | |
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 | Unclear risk | B ‐ Unclear |
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, all outcomes reported |
Other bias | High risk | C ‐ Higher proportion of premenopausal patients in AV group |