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. Author manuscript; available in PMC: 2014 Sep 16.
Published in final edited form as: Cochrane Database Syst Rev. 2012 Mar 14;3:CD004706. doi: 10.1002/14651858.CD004706.pub4
Methods Randomised controlled trial
Participants 85 FIGO (1976) IA-IB Grade 2 and 3
Interventions Cisplatin 50 mg/m2 × 6 cycles Q 28/7 versus observation
Outcomes DFS 83% versus 64%
OS 88% versus 82%
Adverse events in adjuvant chemotherapy arm: nausea and vomiting in more than 2/3 of patients; but in severe form in less than 10% of courses; leukopenia and thrombocytopenia in 14% of patients but >= Grade 3 in only 1% of patients; no episodes of febrile infection
Adverse events in no adjuvant chemotherapy arm: not reported
Median follow-up: 69 months
Notes Patients with residual disease in both arms
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Low risk Based on tables of random numbers
Allocation concealment (selection bias) Low risk Central randomisation by telephone call to co-ordinating centre
Incomplete outcome data (attrition bias)
All outcomes
Low risk Deemed ineligible after randomisation:
T: 0/41 (0%)
C: 2/44 (5%)
Did not report whether any further loss to follow-up occurred
Blinding of outcome assessors (detection bias) Unclear risk Not reported
Selective reporting (reporting bias) Unclear risk Intention-to-treat analysis; adverse events in the ‘no adjuvant chemotherapy’ arm were not reported