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Fiteni F.,Besancon University Hospital Center | Pam A.,Besancon University Hospital Center | Anota A.,Besancon University Hospital Center | Anota A.,University of Franche Comte | And 6 more authors.
Expert Review of Anticancer Therapy

Overall survival (OS) has been considered as the most relevant primary endpoint but trials using OS often require large numbers of patients and long-term follow-up. Therefore composite endpoints, which are assessed earlier, are frequently used as primary endpoint but suffer from important limitations specially a lack of validation as surrogate of OS. Therefore, Health-related quality of life (HRQoL) could be considered as an outcome to judge efficacy of a treatment. An alternative approach would be to combine HRQoL with composite endpoints as co-primary endpoint to ensure a clinical benefit for patients of a new therapy. The decision rules of such design, the procedure to control the Type I error and the determination of sample size remain questions to debate. Here, we discusses HRQoL as co-primary endpoints in randomized clinical trials in oncology and provide some solutions to promote such design. © Informa UK, Ltd. Source

Bjelic-Radisic V.,Medical University of Graz | Bjelic-Radisic V.,EORTC QoL Group | Jensen P.T.,Copenhagen University | Jensen P.T.,East Kent Gynaecological Oncology Center | And 18 more authors.
European Journal of Cancer

Aim: Annually about 500,000 women worldwide are diagnosed with cervical cancer. For many patients, young age at the time of diagnosis and a good prognosis regarding the disease imply a long life with the side-effects and sequels of various treatment options. The present study investigated the extent to which different quality of life (QoL) domains in patients during and after treatment for cervical cancer are affected according to menopausal status, treatment status and treatment modality. Methods: QoL data from 346 cervical cancer patients from 14 countries who were included in a cervical cancer module validation study of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of life Group were analysed according to menopausal status, treatment status and treatment modality. QOL was assessed using the EORTC Quality of life Questionnaire (QLQ)-C30 and the QLQ-CX24 module. Statistical analyses were performed using descriptive statistics and analysis of covariance. Results: Active treatment had the strongest negative impact on 13 different QoL domains: physical, role, emotional, cognitive, social functioning, global health/QoL, fatigue, nausea and emesis, pain, appetite loss, constipation, symptom experience and sexual enjoyment. Irradiation alone ± other therapy was associated with most symptoms of diarrhoea. Age had the most negative impact on sexual activity and the strongest positive effect on sexual worry. Conclusion: Our results revealed that patients with cervical carcinoma had different side-effects with different impacts on QOL depending on the menopausal status and therapy modalities. Patients should be informed about the possibility that therapy may have a negative impact on QoL. © 2012 Elsevier Ltd. All rights reserved. Source

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