Greco 1995.
Methods | RCT | |
Participants | 56 women with advanced cancer either resistant or refractory to initial standard therapy or with an untreated primarily resistant tumour type. Median age in the trial was 57 years (Range: 30 to 73 years). 39 (69%) women had an Eastern Cooperative Oncology Group performance status of 1. Tumour types were as follows: Breast cancer: 17 (30.5%), Non‐small cell lung cancer (NSCLC): 16 (28.5%), Ovarian cancer: 9 (16%), Small cell lung cancer: 5 (9%), Colorectal cancer: 2 (3.5%), Other: 7 (12.5%). |
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Interventions | Paclitaxel 135 mg/m2 infused as a single dose over 1 hour or divided into 3 doses infused over 1 hour on 3 consecutive days. | |
Outcomes | Toxicity, objective response. | |
Notes | There were no serious acute hypersensitivity reactions with either paclitaxel schedule. 7/28 responders had received 1 day schedule 4/28 responders had received 3 day schedule |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Before randomization, patients were stratified according to performance status ... primary disease site, and previous chemotherapy. They were then randomized by a random card system". |
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 | Low risk | % analysed for response: 56/56 (100%) "All patients were evaluable for the toxicity assessment ... After two courses, 48 of the 56 patients were evaluable for response. The other eight patients were considered treatment failures". |
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 |