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 |
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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) |
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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) |
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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 |
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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 |