BrachytherapyDose–effect relationship and risk factors for vaginal stenosis after definitive radio(chemo)therapy with image-guided brachytherapy for locally advanced cervical cancer in the EMBRACE study
Section snippets
Patients
The EMBRACE study opened in July 2008 and comprises 24 centers worldwide (www.embracestudy.dk). Eligible patients have previously untreated, biopsy proven squamous-, adeno- or adenosquamous carcinoma of the uterine cervix, FIGO stage IB-IVA (and stage IVB with para-aortic metastatic nodes below L1-L2 only), treated with curative intent with definitive radio(chemo)therapy. The study was approved in all participating centers by the relevant local Research Ethics Committee. For the present
Results
For this analysis, the EMBRACE database was extracted in February 2015. Of the 1238 registered patients, 921 patients had complete data available of which 630 patients were treated in centers that registered more than 50 patients in the study and therefore were included in the analysis.
Median follow-up time was 24 months (IQR 12–36 months). Patients completed in median 6 prospective follow-up assessments (IQR 4–8); 5% of the cohort had only one follow-up assessment. Patient, disease and treatment
Discussion
In this prospective analysis, tumor extension in the vagina, EBRT dose and total recto-vaginal reference point dose (EBRT plus brachytherapy) are risk factors for vaginal stenosis G ⩾ 2. With increasing dose to the recto-vaginal reference point, the probability of developing such vaginal morbidity increased significantly.
Few retrospective studies using the historic standard loading patterns prescribed to point A, have tried to establish a maximum tolerance dose of the vaginal mucosa, but these
Conflict of interest
There are no conflicts of interests to declare.
Acknowledgments
This study was sponsored by the Medical University of Vienna. Uncommitted research funding was provided by Nucletron, an Elekta company and Varian Medical Systems.
Financial support by the Austrian Federal Ministry of Economy, Family, and Youth and the Austrian Foundation for Research, Technology, and Development and Danish Cancer Society and CIRRO – The Lundbeck Foundation Center for Investigational Research in Radiation Oncology is gratefully acknowledged.
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