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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 92 FIGO stage I
Interventions Melphalan chemotherapy versus treatment on progression
Outcomes DFS and OS
Adverse events in adjuvant chemotherapy arm: 79% had some degree of myelosuppression; 7 patients (16%) had severe myelosuppression; 5 patients (12%) had platelet count nadirs under 50,000 per cubic mm; 4 patients (9%) had platelet count nadirs under 2000 per cubic mm; no infectious complications related to leukopenia; no bleeding episodes related to thrombocytopenia induced by chemotherapy. 11 patients (26%) reported mild-to-moderate gastric gastrointestinal side effects. No other adverse effects were reported. One patient died 6 years after completing treatment, with a diagnosis of aplastic anaemia; no other myeloprolific disorders or second cancers were seen after > 250 person-years follow-up
Adverse events in no adjuvant chemotherapy arm: not reported
Median follow-up of surviving women: 6 years
Notes Melphalan produced severe myelosuppression
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Low risk Based on computer-generated 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: 5/48 (10%)
C: 6/44 (14%)
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 ITT analysis; adverse events in ‘no adjuvant chemotherapy’ arm not reported

C = control; DFS = disease-free survival; ITT = intention-to-treat; OS = overall survival; T = treatment