title: Quality of life in women with metastatic breast cancer during 9 months after randomization in the TEX trial (epirubicin and paclitaxel w/o capecitabine).
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.
authors.affiliation: Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden. helene.svensson@gu.se
authors.forename: Helene
authors.initials: H
authors.lastname: Svensson
authors.forename: Zakaria
authors.initials: Z
authors.lastname: Einbeigi
authors.forename: Hemming
authors.initials: H
authors.lastname: Johansson
authors.forename: Thomas
authors.initials: T
authors.lastname: Hatschek
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Brandberg
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000523:psychology / Q000556:secondary; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004417:Dyspnea / Q000209:etiology; D004644:Emotions / Q000187:drug effects; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D011788:Quality of Life; D012044:Regression Analysis; D007319:Sleep Initiation and Maintenance Disorders / Q000209:etiology; D012919:Social Behavior; D011795:Surveys and Questionnaires; D013548:Sweden; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003841:Deoxycytidine; D015251:Epirubicin; D000069287:Capecitabine; D017239:Paclitaxel; D005472:Fluorouracil