Peretz 1995.
Methods | RCT. | |
Participants | 521 patients with relapsed breast cancer | |
Interventions | Single agent paclitaxel at standard dose (175mg/ m2). 3 versus 24 hour infusion. | |
Outcomes | Toxicity, response, time to progression | |
Notes | Abstract only, only total randomised given, no breakdown by arm. We have assumed 1:1 randomisation in this trial, but this may be misleading and should be interpreted with caution since the outcomes are reported as crude numbers rather than percentages. Objective responses were reported in 29% of women receiving an infusion of three hours duration compared with 32% of women having a 24 hour infusion. Median time to progression was 3.8 months for the three hour infusion compared to 4.6 months for a 24 hour infusion (P =0.02). Median overall survival was 9.8 months for the three hour infusion compared with 13.4 months for the 24 hour infusion (P = 0.02). After adjustment for prognostic factors these differences were not significant (time to progression P =0.08, survival P =0.10). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The trial is described as randomised, but no further details are reported. |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists |