Abstract
The aim of this study was to compare the effects on health-related quality of life (HRQOL) of two treatment regimens in the TEX trial during 9 month from random assignment, with emphasis on the 2- and 9-months assessments. A total of 287 patients were randomized to treatment in 3-week cycles with either epirubicin plus paclitaxel (ET, 143 patients), or epirubicin, paclitaxel and capecitabine (TEX, 144 patients). HRQOL was assessed by the EORTC-QLQ C30 and EORTC QLQ-BR23 questionnaires at five points during 9 months. A total of 252 (88%) completed questionnaires before randomization. Response rate for the following assessments was >75%. There were no statistically significant differences between the TEX group and the ET group on any of the subscales 2 months after randomization. Small clinical differences (5–10 points) in favor of the ET group were found for global quality of life, role functioning, social functioning, and insomnia. At the 9-months assessment, the TEX group scored statistically significantly higher on global quality of life and physical functioning. Small clinically significant differences were found for global quality of life, physical functioning, role functioning, emotional functioning, dyspnoea, and insomnia, all in favour of the TEX group. At the 2-months assessment, when side-effects of chemotherapy were present, patients in the TEX group appeared to fare a bit worse than those receiving ET. However, after 9 months, when the patients had adapted to treatment, the TEX group seemed to have a slightly better quality of life.
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This research was funded by the King Gustav V Jubilee Clinic Cancer Research Foundation, the Swedish Cancer Society, and the Swedish Breast Cancer Association (BRO).
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This study is conducted for the TEX-study group.
Members of the TEX-study group are listed in Appendix.
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Appendix
Members of the TEX-study group are given below:
Thomas Hatschek (Coordinating Investigator), Yvonne Brandberg (QoL), John Carstensen (Statistics), Mårten Fernö (Translational research), Marianne Frostvik Stolt (Laboratory), Mats Hellström (CTO), Maarit Maliniemi (CTO), Helene Svensson (CTO), Gunnar Åström (Radiology), Jonas Bergh, Judith Bjöhle, Elisabet Lidbrink, Sam Rotstein, Birgitta Wallberg (Karolinska Univ. Hospital, Stockholm), Zakaria Einbeigi (Sahlgrenska Univ. Hospital, Gothenburg), Thomas Walz (Linköping Univ. Hospital), Martin Söderberg (Malmö Univ. Hospital), Niklas Loman, Per Malmström (Lund Univ. Hospital), Martin Malmberg (Helsingborg Gen. Hospital), Lena Carlsson (Sundsvall Gen. Hospital), Birgitta Lindh (Umeå Univ. Hospital), Marie Sundqvist (Kalmar Gen. Hospital), Lena Malmberg (Karlstad Gen. Hospital).
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Svensson, H., Einbeigi, Z., Johansson, H. et al. Quality of life in women with metastatic breast cancer during 9 months after randomization in the TEX trial (epirubicin and paclitaxel w/o capecitabine). Breast Cancer Res Treat 123, 785–793 (2010). https://doi.org/10.1007/s10549-010-1084-8
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DOI: https://doi.org/10.1007/s10549-010-1084-8