Quality of life in patients with metastatic breast cancer receiving eitherdocetaxel or sequential methotrexate and 5-fluorouracil. A multicentre randomised phase III trial by the Scandinavian Breast Group

The purpose of this study was to evaluate the effects of two alternative ch emotherapy regimes on the quality of life (QoL) of patients with advanced b reast cancer. In a multicentre trial, 283 patients were randomised to recei ve either docetaxel (T) or sequential methotrexate and 5-fluorouracil (MF). QoL was assessed at baseline and before each treatment using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Q uestionnaire (QLQ-C30). Initial compliance in the QoL study was 96% and the overall compliance 82%. QoL data were available for 245 patients (T 130 an d 115 MF). Both treatment groups showed some improvement in emotional funct ioning during treatment, with a significant difference favouring the MF gro up at treatment cycles 5 and 6. In the T group, the scores on the other fun ctional scales remained stable throughout the first six cycles. There were significant differences favouring the MF group on the social functioning sc ale at treatment cycle 6 and on the Global QoL scale at treatment cycles 5 and 6. On most symptom and single-item scales there were no statistically s ignificant differences between the groups. However, at baseline, the T pati ents reported more appetite loss, at treatment cycles 2-4, the MF patients reported more nausea/vomiting, and at treatment cycle 6, the T patients rep orted more symptoms of fatigue, dyspnoea and insomnia. There were no statis tically significant differences between the groups in the mean change score s of the functional and symptom scales. Interindividual variance was, howev er, larger in the T group. Differences in QoL between the two treatment gro ups were minor. Hence, given the expectancy of comparable QoL outcomes, the choice of treatment should be made on the basis of the expected clinical e ffect. (C) 2000 Elsevier Science Ltd. All rights reserved.