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 |
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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 |
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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) |
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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 |