In recent years, evaluating quality of life (QoL) has become increasingly i
mportant as an additional measured outcome in cancer clinical trials, in pa
rticular in the field of breast cancer. This paper, after a general introdu
ction to the present debate on the methodological issues involved in QoL ev
aluation, reviews results and open questions regarding the use of this meas
ure in surgical, adjuvant and metastatic studies.