McGuire 1989.
Methods | Randomised Phase III trial 1984 to 1987 |
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Participants | 394 patients with histologically confirmed squamous carcinoma of the cervix, recurrent disease following primary therapy or metastases. No previous chemotherapy allowed | |
Interventions | Arm 1: carboplatin 400 mg/m2 d1 q28 Arm 2: iproplatin 270 mg/m2 d1 q28 |
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Outcomes | Response rates Response duration Toxicity (GOG) OS |
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Notes | 23 ineligible (7 non‐squamous histology, 4 other primaries, 8 previous other malignancy, 3 no pathological documentation of primary tumour, 1 previous chemotherapy). 10 additional patients not evaluable for toxicity or response. 7 did not receive treatment. 3 lost to follow‐up. ITT analysis not performed | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block design with balanced assignments |
Allocation concealment (selection bias) | Unclear risk | Not documented |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not documented but OS unlikely to be affected by blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 23 ineligible and 10 additional patients not evaluable for toxicity or response balanced across groups. ITT analysis not performed |
Selective reporting (reporting bias) | Low risk | Published report included all pre‐specified outcomes |
Other bias | Low risk | No hint at any other possible biases |