Steiner R 1983.

Study characteristics
Methods	Accrual (May 1977 ‐ Jan 1980) RCT ‐ methodology not described Groups at baseline similar in age and diagnosis, post operative disease free interval and time interval between diagnosis and commencement of treatment. Performance status more favourable in combination group
Participants	119 women with MBC with no prior chemotherapy for ABC, no signs of cardiac failure and the presence of progressive disease in evaluable lesions 116 patients had previous endocrine therapy 100% MBC 100% firstline Randomised numbers not provided Assessable no: 1) n = 53 2) n = 54
Interventions	A vs A + V1 1) Doxorubicin 70 mg/m2 IV on day 1 of a 3/52 cycle 2) Doxorubicin 70 mg/m2 IV on day 1 of a 3/52 cycle + Vincristine 1.4 mg/m2 (max 2mg) on days 1 and 8 **Maximum of 8 courses
Outcomes	No survival curves. Survival curves for responders only No TTP curves Median survival 1) 10mths 2) 14mths OR (CR+PR) 1) 30/53 2) 28/54 Toxicity: Nausea and vomiting 1) 42/53 2) 47/54 Alopecia 1) 44/53 2) 47/54 WCC 1) 3/53 2) 10/54 Toxic death 1) 1/53 (septicaemia) 2) 1/54 (pantocytopenia)
Notes	Not ITT ‐ 119 women were entered into the study but 10 were excluded from the analysis. A further 2 women who died soon after randomisation were included in the survival analysis but not in the response analysis.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Randomisation numbers not provided and insufficient information provided to permit judgement
Selective reporting (reporting bias)	High risk	Provides survival information for responders only