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. 2010 Nov 10;2010(11):CD003368. doi: 10.1002/14651858.CD003368.pub3

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
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