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

Eagan RT 1976.

Study characteristics
Methods RCT
Randomisation not described ‐ stratified by site
Groups fairly comparable ‐ Single group was younger and closer to menopause
Participants 39 women previously treated and failed CT 
Anthracycline and Taxane naive 
100% MBC
Unclear as to whether pre‐treatment was as adjuvant treatment or treatment for MBC
Assessable no: 
1) n = 19
2) n = 20
Interventions ETO (VP‐16) vs V1+A
1) VP‐ 16 ‐ slow infusion over 30‐45 minutes on days 1,3,5, repeated every 4‐5 weeks
2) Vincristine + Adriamycin ‐ 1.5mg V1 IV on days 1 and 2 and A 45mg/m2 IV on day 3
Treatment repeated every 4‐5 weeks
All drug dosages adjusted to produce adequate but clinically tolerable effects
Outcomes No survival curves or TTP curves
Response (PR only)
1) 2/19 
2) 4/20
Toxicity:
Leukopenia
1) 16/19 
2) 18/20 
Alopecia
1) 17/19
2) 19/20
Toxic death 
1) 0
2) 1 (CNS Haemorrhage)
Notes Not ITT ‐ 42 patients entered the trial ‐ 3 patients disqualified post randomisation due to protocol violations. Randomised numbers not provided by group
Crossover on treatment failure
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported states 'partially randomised'
Allocation concealment (selection bias) Unclear risk Not reported
Incomplete outcome data (attrition bias)
All outcomes High risk Some missing outcome data but not enough information to fully assess
Selective reporting (reporting bias) High risk The study fails to report survival or TTP