Ahmann 1991.
Study characteristics | ||
Methods | Single centre randomised controlled trial. Pts were stratified by menopausal age, ECOG performance score, hormonal treatment and dominant disease status. Patients randomised according to a dynamic allocation scheme. Method of allocation concealment not reported. Dates of accrual not reported. Baseline comparability achieved. | |
Participants | 94pts (93 eligible) Women with histologically confirmed BC, and progressive metastatic disease not amenable to standard surgical or radiotherapeutic techniques. No patients had prior treatment with the chemotherapy agents used in this study. Age range: 36‐75 yrs in CAP arm; 33‐78 yrs in CFP arm. Median age 58 yrs in CAP arm, 56 years in CFP arm | |
Interventions | CAP vs CFP Arm A: CAP cyclophosphamide 400mg/m2 iv over 30min; doxorubicin 40mg/m2 by iv push every 4 weeks in stable or responding patients; prednisone 30mg po on days 2‐14, 20mg orally on days 15‐21 and 10mg orally therafter Arm B: CFP cyclophosphamide 150mg/m2 iv by push over 30min on each of 5 sucessive days every 5 weeks if stable or responding, 5‐flurouracil 300mg/m2 by iv push every 30mins on each 5 successive days every 5 weeks, prednisone 30mg po on days 2‐14, 20mg orally on days 15‐21 and 10mg po thereafter. Regimens continued until objective evidence of progressive disease ‐ or a maximum culminative dose of doxorubicin was 450mg/m2 was reached‐ then pts just received CP |
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Outcomes | Response Overall Survival Time to progression Toxicity | |
Notes | One pt was ineligible due to heart disease, 93 eligible pts were included in the analyses. Follow‐up details not reported. Estimated min = 5.5 months (median time to progression, averaged over both arms ), est. max 0S =66 months (from curve), est max PFS= 34.5 months (from curve). Toxic deaths not reported. Cardiac toxicity was observed in 4 pts on the CAP arm but it was not clinically severe. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |