Alberts 1987.
Methods | Randomised Phase II trial | |
Participants | 119 women with incurable squamous cell carcinoma unsuitable for surgery or radiotherapy. No previous chemotherapy exposure | |
Interventions | Arm 1: mitomycin C 10 mg/m2 iv d2, 44, vincristine 0.5 mg/m2 iv d2, 4, 44, 46, bleomycin 30 mg continuous iv infusion over 24 h for 4 days d1‐4, 43‐46, cisplatin 50 mg/m2 iv d1, 22, 43, 64 Arm 2: mitomycin C 12 mg/m2 iv d1, 43, cisplatin 50 mg/m2 iv d1, 22, 43, 64 Arm 3: cisplatin 50 mg/m2 iv d1, 22, 43, 64 |
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Outcomes | Response rate Response duration Median survival Toxicity (SWOG) |
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Notes | 5 ineligible patients (reasons not stated). Arm 3 stopped early owing to slow accrual. Not clear whether ITT analysis performed | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not documented |
Allocation concealment (selection bias) | Unclear risk | Not documented |
Blinding (performance bias and detection bias) All outcomes | High risk | Not documented |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 ineligible patients (reasons not stated). Arm 3 stopped early owing to slow accrual. Not clear whether ITT analysis performed |
Selective reporting (reporting bias) | Unclear risk | Insufficient information |
Other bias | High risk | Cisplatin arm stopped early despite appearing to have better results so only 9 patients evaluable |