Berruti D 2002.

Study characteristics
Methods	Accrual (October 1995 ‐ March 2001) RCT ‐ Multicentre Randomisation not described (stratification by investigator site done prior to randomisation) Major clinical characteristics well balanced across the 2 arms
Participants	185 women with measurable or assessable (WHO criteria) and histologically proven MBC 100% MBC 100% Firstline Randomised no: 1) n = 93 (median age = 59; 28‐75) 2) n = 92 (median age 57; 33‐75)
Interventions	E vs E+CDDP 1) EPI only = 60 mg/m2 slow IV push on days 1 and 2 2) EPI+CDDP = EPI 60 mg/m2 slow IV push on days 1 and 2 + CDDP 30mg/m2 x 1hr IV infusion on days 1 and 2 CDDP and EPI infusions were repeated every 21 days A median of 6 cycles (1‐8) was given
Outcomes	Survival ‐ Not reported for arm of interest. PFS curve poor quality. Excluded. OR (CR + PR) 1) 47/93 2) 53/92 Toxicity: WHO 3‐4 Nausea and vomiting 1) 17/91 2) 24/90 Leukopenia 1) 2/91 2) 4/90 Toxic death 1) 3 2) 3
Notes	F/U TTP ‐ min 4.5mths ‐ max 64mths (estimated from no of cycles and curve) Patients randomised into 4 arms **** Only EPI and CDDP arms of this study included ITT ‐ stated in text
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	Low risk	No missing outcome data
Selective reporting (reporting bias)	Low risk	All expected outcomes reported