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. 2012 Oct 17;2012(10):CD006469. doi: 10.1002/14651858.CD006469.pub2

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
Outcomes Response rate
Response duration
Median survival
Toxicity (SWOG)
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