Quality of life in women with metastatic breast cancer during 9 months after randomization in the TEX trial (epirubicin and paclitaxel w/o capecitabine).

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.

Health-related quality of life as prognostic factor for response, progression-free survival, and survival in women with metastatic breast cancer.

The purpose of this study was to, on an exploratory basis, investigate the role of health-related quality of life (HRQoL) at randomization as an independent prognostic factor for response to treatment, progression-free survival (PFS), and survival. In the TEX trial, 287 patients with locally advanced or distant metastatic breast cancer were randomized to either epirubicin and paclitaxel (ET) or epirubicin, paclitaxel, and capecitabine (TEX). Treatment was repeated every 3 weeks. The EORTC QLQ-C30 questionnaire was used to assess HRQoL before randomization. A total of 252 (88%) patients completed EORTC QLQ-C30 before randomization. Clinical conditions included in the multivariate model were age, number of metastases, ECOG performance status, time between diagnosis and randomization, and treatment arm. Univariate analysis revealed an association between prolonged survival and the HRQoL variables global health, physical functioning, role functioning, fatigue, and pain (P < 0.01). After controlling for clinical conditions, only fatigue remained statistically significant. No statistically significant relationships were found between HRQoL and PFS. In the analysis of the association between HRQoL and response to treatment, role functioning, social functioning, fatigue, nausea/vomiting, and appetite loss remained statistically significant. HRQoL variables could act as important predictors of response to treatment, progression-free survival, and overall survival in women with metastatic breast cancer.

Psychological reactions to progression of metastatic breast cancer--an interview study.

Knowledge about how patients experience their situation at the point of disease progression after first-line chemotherapy is limited. It is important to investigate this area to better understand and support women with advanced-stage disease. The study explored psychological reactions and coping on disease progression after first-line chemotherapy among women with metastatic breast cancer. Interviews were held with 20 patients with breast cancer who were included in a randomized study of first-line chemotherapy for metastatic breast cancer. Three themes emerged. "Before the information": most of the women reported symptoms related to the disease progression before information about treatment failure. Thus, they were not surprised by the information. "Immediate after information": a range of psychological reactions were described. Most patients experienced sadness, disappointment, and setback in view of disease progress. Anxiety and worry about the future were reported. "Life after being informed of disease progression": Various strategies to cope with their situation were used, for example, work, social support, and church attendance. All women had disease progression. Worry was the most common emotional response. A number of strategies were used to cope with the situation. Most of the women responded with acceptance.