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. 2009 Apr 15;2009(2):CD003372. doi: 10.1002/14651858.CD003372.pub3

Gundersen S 1986.

Study characteristics
Methods Accrual (June 1982‐ December 1983)
RCT ‐ Allocation by random number generation ‐ no stratification
Norway ‐ multi‐centre
Groups well balanced according to age, disease free interval and time from first metastases to randomisation
Participants 128 women with metastatic BC, histologically proven with evaluable lesions 
Those previously treated with Adriamycin were excluded ‐ all were hormone resistant‐
100% MBC
100% Firstline
Randomised no:
1) n = 62 (Mean age 59)
2) n = 66 (Mean age 56)
Interventions A vs V1+A+C
1) Doxorubicin 20 mg/week to max dose 750 mg/m2
2) Vincristine 2 mg
+ Adriamycin 50 mg/m2 to max dose 500 mg/m2
+ Cyclophosphamide 600 mg/m2
(VAC every 3 weeks)
Outcomes Overall survival curves calculated by actuarial life table method ‐ survival calculated from start of treatment
No TTP curves
Mean TTF
1) 33 mths
2) 29mths
OR (CR+PR)
1) 19/62
2) 24/66
Toxicity WHO 3
Vomiting
1) 4/62
2) 43/66
Alopecia
1) 5/62
2) 52/66
Toxic death ‐ NR
Notes F/U min 3mths (based on first assessment of response or review of treatment)‐ max 24mths (from survival curve
ITT ‐
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Allocation by random number generation
Allocation concealment (selection bias) Low 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