Quality of life as an outcome in breast cancer. Clinical application.

In clinical trials of anticancer agents, the assessment of objective effects has historically been the primary end-point. However, because of the limited impact of these agents on survival, the study of quality of life (QOL) has become increasingly important. QOL evaluation is difficult and the approaches of physicians and reimbursors of healthcare are quite different. In addition, QOL is not a simple concept and several different methods have been used to evaluate it. These methods can be divided into the following 2 groups: experimental methods [the best known is the quality-adjusted life-year (QALY), which utilise some kind of experimentation; and observational methods, which use questionnaires and are often multifactorial. Some of these questionnaires are used for patients with all types of pathologies, while others are cancer-specific; all questionnaires must be validated. We conducted 3 QOL studies in patients with breast cancer using the Functional Living Index-Cancer (FLIC) questionnaire. In the first, a French translation of the FLIC questionnaire was validated. The FLIC and Functional Living Index-Emesis (FLIE) questionnaires were used to assess QOL in a second study comparing 2 different antiemetics for the control of nausea and vomiting. Finally, QOL was evaluated in patients with breast cancer during adjuvant chemotherapy. Several other studies employing different questionnaires in patients with breast cancer have been published. Clinical applications for QOL evaluation in oncology may be the prognostic implications of QOL, evaluation of toxicity and duration of treatment, and evaluation of utility and QOL. However, although assessment of QOL is important for both physicians and funders, there is no gold standard method available, and the results of QOL studies have to be interpreted cautiously.