ECOG Cummings 1985.

Study characteristics
Methods	Randomised controlled trial. Method of randomisation not reported. Pts stratified by performance status and site of metastases. Dates of accrual: May 1978 to November 1979. Baseline imbalance in disease free interval (DFI). 41% of pts had a DFI <1month in CAF arm vs 29% in CMFP arm. 10% of pts had a DFI of 5+ yrs in CAF arm, 20% in CMFP arm.
Participants	177 pts (155 evaluable for CAF vs CMFP comparison arms) Women with histologically documented recurrent or metastic breast cancer aged 65 yrs or younger. Age distribution: 84% aged 50+ yrs in CAF arm; 75% aged 50+ yrs in CMFP arm. No prior cytotoxic chemotherapy.
Interventions	CAF vs CMFP Arm A: CAF cyclophosphamide 100mg/m2/d orally on days 1, 14: adriamycin30mg/m2 and 5‐fluorouracil 500mg/m2 given iv on days 1, 8. 4 week cycles x 8 cycles Arm B: CMFP cyclophosphamide 100mg/m2 orally on days 1 ‐14; methotrexate 40mg/m2 iv on days 1 and 8; 5‐fluorouracil 600mg/m2 iv. on days 1, 8; prednisone 40mg/m2 orally on days 1‐ 14. 4 week cycles x 6 cycles.
Outcomes	Response Overall survival Time to treatment failure Toxicity
Notes	177 women randomised to CAF (82) CMFP (83) or CAF + Cp immunotherapy (12). CAF+Cp arm dropped at 6 months due to poor accrural and not included in this analysis. 10 pts not evaluated: ineligibility (6), transfered hospitals (1), pt refusal(1), reason not reported (2). 155 evaluable pts included in efficacy analysis. Min follow‐up = 30 months, Max f/up=48 months. There was no statistically significant difference between median response duration, times to treatment failure and survival times between the 2 arms. Treatment‐related deaths were not reported. 1 case of severe cardiotoxicity was reported in a pt in the CAF+Cp arm.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear