Chlebowski 1983.

Study characteristics
Methods	Accrual dates: not reported (accepted for publication May 1982) Sample size: 35 Number of centres: unknown (USA) Randomisation method: not reported Baseline comparability: no significant imbalance apparent or reported
Participants	Female 100% MBC Unclear if this is a first line trial for MBC: 'patients admitted to study if they had failed an initial combination chemotherapy program' 'all patients received prior chemotherapy with at least cyclophosphamide and 5‐FU'. However, patients typically received prior chemotherapy of CMF or CMFP which are typically adjuvant regimens. Age range 24‐74 years Median 50 (both groups)
Interventions	A‐CCNU vs A‐CCNU‐V Arm I: (A‐CCNU) Doxorubicin + CCNU (lomustine) Arm II: (A‐CCNU‐V) Doxorubicin + CCNU (lomustine) + vincristine
Outcomes	Overall survival (not defined) Response (objective response, defined as ≥ 50% reduction in tumour size) Toxicity
Notes	35/35 evaluable for toxicity and response. Follow‐up details not reported. ‐ estimated minimum 30 months ‐ estimated maximum 30 months Presents survival as life tables not Kaplan‐Meier curves. Time‐to‐event data extracted directly from time‐to‐event curve. Toxicity related deaths not reported.
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 ‐ difference between groups in proportion of pre/post menopausal patients