Ayoub 1988.
| Methods | RCT (stratified) | |
| Participants | Subset of 43 patients with stage IV and recurrent endometrial cancer from total study population of 262 patients 20 were randomised to chemotherapy and 23 to chemo‐hormonal therapy Randomisation was stratified by the site of advanced disease (pelviabdominal versus distant metastases) The median age of the patients was 63 years (range: 40 to 74 years) Multiple centre trial from Canada |
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| Interventions |
Intervention CAF (cyclophosphamide, adriamycin, 5‐fluorouracil) and MPA (medroxyprogesterone acetate) 200 mg od for 3 weeks followed by tamoxifen (TMX) 20 mg for 3 weeks Control CAF only |
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| Outcomes | Overall survival Objective tumour response (complete/partial/stable/progression) Duration of remission |
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| Notes | The treatment groups were well balanced with respect to whether patients had received palliative radiation or not, prior to commencing chemo‐ or chemo‐hormonal therapy The exact log rank P value from the Kaplan Meier plot was not reported so it was not possible to estimate the hazard ratio (Parmar 1998) From the KM plot, the median duration of follow up was 24 months "Hormonal therapy‐related toxicity revealed a high incidence of phlebitis" |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | "Eligible patients were prospectively randomized to chemotherapy or chemo‐hormonal therapy after stratification on the basis of advanced pelviabdominal disease vs distant metastatic disease". |
| Allocation concealment? | Unclear risk | Not reported |
| Blinding? All outcomes | Unclear risk | Not reported |
| Incomplete outcome data addressed? All outcomes | Low risk | % analysed; 43/46 (93%) "Three patients refused to begin chemotherapy, so that 43 patients were evaluable". |
| Free of selective reporting? | Unclear risk | Insufficient information to permit judgement |
| Free of other bias? | Unclear risk | Insufficient information to assess whether an additional risk of bias exists |
| Accurate classifications of outcomes? | Low risk | "Response criteria were based on those suggested by the International Union against Cancer (UICC). Standard ECOG criteria were used to assess toxicity." |