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