Methods | The collaborative Nordic and European study randomly studied the effect of adding a platinum based chemotherapy regimen to hysterectomy and radiotherapy for women with surgically excised endometrial cancer | |
Participants | The latest report provides data on 63 women from 12 EORTC centres. The eligibility criteria included histologically proven endometrial cancer of any type and infiltration to more than half the myometrial thickness. Women with positive peritoneal cytology and/or positive pelvic lymph nodes were also eligible and participants must have been fit to receive combination chemotherapy, have a WHO performance status of 0 to 2, adequate bone marrow, renal, hepatic and pulmonary function and give informed consent | |
Interventions | Early participants in the chemotherapy arm received four courses of cisplatin = 50mg/m2 + doxorubicin 50mg/m2 or epirubicin 75mg/m2. Later in the trial, several regimens were allowed, of which cisplatin + doxorubicin, paclitaxel 175mg/m2 + epirubicin 60mg/m2 + carboplatin AUC 5, and paclitaxel 175mg/m2 + carboplatin AUC 5/6 were most popular The control group were treated by pelvic radiotherapy ± vaginal brachytherapy to a dose of 44 Gray |
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Outcomes | The primary outcome was relapse free survival. The secondary endpoints were:
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Results (OS & PFS) | see the combined EORTC and NSGO table | |
Results (site of recurrence) | see the combined EORTC and NSGO table | |
Toxicity | see the combined EORTC and NSGO table | |
Notes | The data are still immature and the survival curves will evolve as later recruiters reach 5 years survival. The EORTC have not yet published the full report but early data are available from ASCO presentations and a report including the MaNGO trial is in the 2010 European Journal of Cancer | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence generation was organised by the EORTC headquarters using a minimisation procedure with the stratification factors for each centre |
Allocation concealment (selection bias) | High risk | It is not possible to conceal treatment allocation from the participants but the treatment allocation will have been concealed from the data analysts |
Blinding (performance bias and detection bias) All outcomes |
Low risk | The data collection was by the EORTC data centre, an organisation of the highest scientific standard |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | The trial has not yet been reported but the data will be analysed by the EORTC data centre, an organisation of the highest scientific standard |
Selective reporting (reporting bias) | Low risk | The trial has not yet been reported but the data will be analysed by the EORTC data centre, an organisation of the highest scientific standard |
Other bias | Unclear risk | The main issue are that details of the study population have not yet been formally published |
Main problems with the trial as perceived by this analysis | Unclear risk | The trial has not yet been reported |