QUALITY-OF-LIFE OF EARLY-STAGE BREAST-CANCER PATIENTS TREATED WITH RADICAL-MASTECTOMY OR BREAST-CONSERVING PROCEDURES - RESULTS OF EORTC TRIAL-10801

In 1980 the EORTC-BCCG initiated a multicentre randomised clinical tri al comparing modified radical mastectomy (MRM) with breast-conserving therapy (BCT) in stage I and II breast cancer. The main endpoint of th e trial was survival. A brief quality of Life (QoL) questionnaire cons isting of two multi-item scales (body image and fear of recurrence) an d two single items (satisfaction with treatment and cosmetic result) w as included in the trial. A cosmetic evaluation of the breast after co nservative surgery was also performed. This report concentrates on the results of the QoL study and the cosmetic evaluation. Multitrait scal ing analysis was employed to verify the hypothesised scale structure o f the questionnaire. Treatment comparison of the QoL scores at 2 years post-treatment was performed using a stratified Wilcoxon rank sum tes t. Both patients' and doctors' ratings of the cosmetic result were doc umented on the clinical follow-up form. A multivariate analysis was pe rformed to identify which factors influenced the cosmetic outcome. In total, 127 patients in the MRM arm and 151 in the BCT arm completed a QoL questionnaire at approximately 2 years after randomisation (months 25-36). The Cronbach's alpha coefficients were 0.79 and 0.73 for the body image and fear of recurrence scales, respectively. Significant be nefit in body image and satisfaction with treatment was observed in th e BCT patients. No significant difference was observed in fear of recu rrence between the two groups. Ratings of cosmetic results decreased w ith time, in line with clinical observations of longterm side-effects of radiotherapy. Wide excision appeared to be the most important predi ctive factor for poor cosmetic result. In this multicentre randomised study, BCT helped to maintain the patients' body image, resulted in hi gher satisfaction with treatment and yielded no significant difference from MRM with respect to fear of recurrence. (C) 1998 Elsevier Scienc e Ltd. All rights reserved.